New Opportunities in Digestive Enzymes

SPORTS NUTRITION FERTILITY MINERALS The Female Customer, p. 28 Can Supplements Help? p. 34 Mighty Magnesium, p. 40

September 2018 Vol. 21, No. 7 GUT CHECK New opportunities in digestive enzymes

SupplySideVisit us West at

Booth 3353

Give them the results they’re looking for with Setria® Performance Blend**

Kyowa’s Setria® Performance Blend is a unique combination of Pre-EX Post-EX 30 post-EX Setria® Glutathione and L-Citrulline backed by research suggesting † Placebo it may help support and sustain nitric oxide (NO) production L-Citrulline post-workout.* Sustained NO levels may lead to reduced fatigue Setria and may support recovery.* Sports Nutrition is one of the hottest Setria +

Plasma NOx (uM) L-Citrulline categories in the industry. Give your next product the competitive edge you’re looking for with Setria Performance Blend. Mean±SEM. N=15, † P<0.05 vs Placebo One week of daily oral supplementation with 200 mg of Setria † and 2 grams of L-Citrulline enhanced NO levels at 30 min. post exercise. McKinley-Barnard et al. Journal of the International Society of Sports Nutrition (2015) 12:27.

Setria® Glutathione + L-Citrulline may 1. Support NO levels* Nitrite Concentration (uM) * Control L-Citrulline Setria Setria + 2. Sustain NO levels for a long-lasting effect L-Citrulline † P<0.05 vs Control 3. Aid in vasodilation to fuel muscles* A combination L-Citrulline (CIT) and Setria supplementation significantly increased NO levels in HUVECs.

McKinley-Barnard et al. Journal of the International Society of Sports Nutrition (2015) 12:27.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

** Patent pending

Nutritional Outlook Editorial Advisory Board

UBM Life Sciences 310/445-4200 • Fax: 310/445-4299 Mark Blumenthal Founder and Executive Director Vice President/Group Publisher ...... Michael Tessalone American Botanical Council 732/346-3016 • [email protected] Publisher/Brand Director ...... Tim Baudler George A. Burdock, PhD 310/445-3757 • [email protected] Editor-in-Chief ...... Jennifer Grebow Founder 310/445-3763 • [email protected] Burdock Group Associate Editor ...... Sebastien Krawiec 732/346-3036 • [email protected] Lauren Clardy, BSc Managing Editor, Special Projects...... Kaylynn Chiarello-Ebner Founder and CEO 732/346-3033 • [email protected] NutriMarketing Art Director ...... Quinn Williams Production Manager ...... Anbarasan Mannar John R. Endres, ND Audience Development Manager ...... Krystal Hoheisel Chief Science Offi cer Marketing Team Lead ...... Brianne Pangaro AIBMR Life Sciences Inc. Digital Product Development Manager...... Justin Belinski

Dan Fabricant, PhD EXECUTIVE OFFICERS CEO Chief Executive Ofﬁ cer, UBM Americas...... Scott Schulman Natural Products Association Chief Operating Ofﬁ cer, UBM Americas ...... Brian Field Executive Vice President/Senior Managing Director UBM Life Sciences...... Tom Ehardt James Gormley Vice President/Managing Director, Pharma Publishing UBM Americas ...... Dave Esola VP and Senior Policy Advisor Citizens for Health Circulation Management: Krystal Hoheisel, [email protected] C.A.S.T. Data and List Information: Kim Kawa, BSc Melissa Stillwell, [email protected] Reprints: Wright’s Media, 877/652-5295 Natural Products Specialist

SPINS Nutritional Outlook (ISSN 1098-1179) is published monthly, except combines Jan/Feb and Jul/ Aug, by UBM LLC 131 W. 1st St Duluth MN 55802-2065. Periodicals postage paid at Duluth MN 55806 and at additional mailing offi ces. SUBSCRIPTIONS—Free to qualifi ed subscribers as defi ned on the subscription card. Basic subscription price $150 (one year). Delivery outside the Douglas “Duffy” MacKay, ND United States by air service. For telephone inquiries regarding subscriptions, call 888/527-7008. Senior VP, Scientifi c and Regulatory Aff airs POSTMASTER—Please send address changes to Nutritional Outlook PO Box 6000 Duluth MN 55806-6000, USA. Publications Mail Agreement No 40612608. Return Undeliverable Canadian Council for Responsible Nutrition Addresses to: IMEX Global Solutions, PO Box 25542 London ON N6C 6B2. Canadian G.S.T number: R-124213133RT001. Printed in U.S.A.

EDITORIAL CONTRIBUTIONS—Unsolicited materials will receive every reasonable care; Irfan Qureshi, ND however, the publishers assume no responsibility for safety of artwork, photographs, or Executive Director, Research and Regulatory Aff airs manuscripts. Healthy Directions NOTICE—Every precaution is taken to ensure accuracy of content, but the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Harry B. Rice, PhD Printed in USA. Copyright ©2018 by UBM. All rights reserved. VP, Regulatory and Scientifi c Aff airs Reproduction in whole or in part without written permission is prohibited. Global Organization for EPA and DHA Omega-3s

Brian Tanzer, MS, CNS Manager, Scientifi c Aff airs the Vitamin Shoppe Inc.

John E. Villafranco Partner Kelley Drye & Warren LLP

Lu Ann Williams Director of Innovation Innova Market Insights

4 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK PROMOTES JOINT COMFORT

Perluxan® softgels are a unique, premium quality supplement primarily used to support joint health and soothe aches from overexertion of everyday activities.

www.soft-gel.com

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

SEPTEMBER 2018 VOLUME 21, ISSUE 7

22 FEATURES

22 Digestive Health Emerging trends in the digestive enzymes market 28 Sports Nutrition Formulating for women’s sports nutrition needs 34 Fertility Nutritional supplements for couples trying to conceive On the Cover: Photo © Shutterstock.com/Rhenzy 40 Minerals Magnesium for muscle function and performance 48 Joint Health Redeﬁ ning the joint-health category 53 Quality Control Recall readiness, high-quality testing, and more

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 7 SEPTEMBER 2018

UP FRONT NutritionalOutlook.com

10 From the Editor Nutra-Q, the online supplier directory that does more 12 News Do we need a mandatory product registry for dietary Nutra supplements? Looking for a nutraceuticals supplier directory you can count on? Nutra-Q is a qualiﬁ ed directory, vetted thoroughly and often, by Nutritional Outlook.

Are you a supplier to the nutraceuticals industry? COLUMNS Register your company on Nutra-Q now! www.nutra-q.nutritionaloutlook.com 18 Marketing Probiotics TOP ONLINE STORIES 74 Research Update

78 Last Bite Colors

Blue Diamond extends Practitioner into functional supplement brand RESOURCES ingredients with new wins lawsuit against almond protein unauthorized reseller ubm.social/u16Shc ubm.social/5bmeDZ 76 Advertiser Index

77 Classiﬁ ed @Nutritionalo @JenniferGrebow

MANAGE YOUR SUBSCRIPTION For fast and easy subscription service, visit NutritionalOutlook.com • Renew your subscription Digital delivery now available! • Change your address For all other customer-service • Sign up for a new subscription inquiries, e-mail fulﬁ ll@superﬁ ll.com • Cancel your subscription

8 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Concerned about Botanical ∃ Identification? Learn more about Jiaherb recognizes that there is much uncertainty among manufacturers and consumers, about the integral Jiaherb’s ID Program, quality of the botanical products they purchase. As a testament to our never-ending commitment to scan QR code below. customer satisfaction, and to ease customer concerns about the integrity of our products, Jiaherb proudly introduces HerbaLink.™ HerbaLink, a unique chain-of-custody program, offers ultimate transparency in product identification and traceability. The program not only assures best practices in identifying sustainable and socially conscious sources, but also the implementation of stringent testing methods that include DNA, HPTLC, HPLC and GC throughout the processing and preparation of the finished product — documenting every link of the product’s journey from harvest to packaging.

1.888.JIAHERB www.jiaherbinc.com FROM THE EDITOR

Misgivings over FDA Registry?

Would the dietary supplements market, in- Th ere is, for instance, the question of what kind of cluding industry companies and FDA regu- system a federal registry would be. Would it simply be lators, beneﬁ t if FDA were to create a man- a notifi cation-based system with no FDA judgment on datory ﬁ nished-products registry for dietary whether a product is acceptable in the marketplace? Or, supplements, much in the way that other in- if a product were accepted in the registry, would that dustries, such as medical devices, must regis- somehow imply that FDA tacitly or directly endorsed the ter their products with the agency? product—or vice versa? On page 12, industry experts discuss the pros and cons Mister used the analogy of a birth certifi cate to high- of such a registry. For instance, one benefi t of mandatory light the diff erences between those two scenarios. “I sort registry is that companies would be bound by law to par- of look at it like the diff erence between a birth certifi cate ticipate, and FDA could go after companies that didn’t. and a driver’s license,” he said. “Everyone who is born On the other hand, even as a federal registry boosted gets a birth certifi cate. Th e government cannot deny you transparency, it would also give companies a whole new of your birth certifi cate. It’s a legal document; if you’re set of requirements to fulfi ll. born, you get one. But with a driver’s license, they can What kind of information should such a registry con- control and they can limit who gets a driver’s license and tain? Many of those I interviewed said it should be pret- who doesn’t.” ty basic: label information such as dosages, ingredients, He continued, “And that’s the distinction for us. As manufacturer name and contact information, etc. (Th e long as it’s a registry, I think that the industry is fi ne with same kind of information is captured in the voluntary, that and it does what we talked about. It gives FDA that industry-led Supplement OWL registry that the Council window to see what the dietary supplement marketplace for Responsible Nutrition, CRN, created last year.) looks like. But if it starts to look more like a driver’s license But some in the industry have misgivings of how FDA and they get to tell you whether or not you can be on the would use even basic data. Th ey fear the agency could market or not, that sounds like premarket approval and one day leverage that information to impose new reg- that is something that the industry has always been very ulations on industry. Some of their questions include: concerned about, FDA’s potential ability to keep you off How much data would FDA demand? What kind of data the market if they don’t agree with your science or if they would it require? don’t like your ingredient.” Some of those questions stem from a historic fear of Michelle Zerbib, director of standards at New Hope many in the supplements industry that FDA will over- Network (Boulder, CO), producer of the Natural Products step its authority and over-regulate the industry. Attor- Expo East and West trade shows, said another fear could ney Scott Bass, a partner at law fi rm Sidley Austin LLP, be whether FDA would eventually start charging compa- whom I interviewed in July, said there is mistrust among nies a lot of money to register their products, much like those who believe that FDA has tried to suppress the sup- the agency does for medical devices in part to cover ad- plements industry in the past. “What led to [the passage ministrative costs. She noted that registration fees could of the Dietary Supplement Health and Education Act of be “pretty expensive,” and that for medical devices, “it’s a 1994] was the underlying premise that FDA abused its couple thousand dollars” per device. authority, which it did, and that they couldn’t be trusted It’s debatable whether, in this current political climate, because they were constantly out to kill the industry. But something as major and controversial as the creation that’s history,” he added, expressing his belief that those of a federal product registry would see the light of day. currently overseeing the Offi ce of Dietary Supplements Some of the momentum would have to come from the “are not against the dietary supplement industry.” industry itself, Mister said. If a federal registry were ever created, “I think [all of in- “I think how quickly it moves really is going to depend dustry’s concerns] would have to be worked out up front on whether the industry looks at this and says this is with assurances that FDA understood what the purpose something we want to do or not,” he said. of that registry was and would commit that it would live by those expectations,” said Steve Mister, president and Jennifer Grebow CEO of CRN. “Th ere’s this long history of tension between Editor-in-Chief the industry and the agency that if the agency is allowed to regulate, will they go too far?”

10 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Visit us at Natural Products Expo East Booth #3137

THE FREEDOM FOR ACTIVE ADULTS TO REMAIN ACTIVE

UC-II® UNDENATURED TYPE II COLLAGEN FOR JOINT-HEALTH SUPPORT

UC-II® undenatured type II collagen delivers clinically studied joint-health benefi ts. Lonza’s UC-II® provides consumers healthy mobility and joint comfort by working with the ONCE-DAILY SMALL DOSE body’s natural repair mechanism. UC-II® undenatured type THREE CLINICAL STUDIES II collagen is proposed to work in the immune system to support joint health in one, 40 mg dose. Feel empowered STUDIED IN HEALTHY, ACTIVE ADULTS in your own body, regardless of age or ability. BENEFITS COMPARED TO GLUCOSAMINE + CHONDROITIN Visit UC-II.com to learn more about the fastest-growing joint-health ingredient.*

*U.S. Food, Drug, Mass Channel (Source: Nielsen xAOC52 weeks ended 3/24/2018 These statements have not been evaluated by the U.S. Food and Drug Administration or any other regulatory authority. Lonza’s products are not intended to use to diagnose, treat, cure or prevent any disease. All product information corresponds to Lonza’s knowledge on the subject at the date of publication, but Lonza makes no warranty as to its accuracy or completeness and Lonza assumes no obligation to update it. Proper use of this information is the sole responsibility of the recipient. Information provided by Lonza is not intended and should not be construed as a license to operate under or a recommendation to infringe any patent or other intellectual property right. All trademarks belong to Lonza or its affiliates or to their respective third parties and are used here only for informational purposes. ©2018 Lonza. NEWS Stay informed! See the latest news at NutritionalOutlook.com

Do We Need Mandatory Product Registry?

If FDA had a comprehensive, mandatory, unless government knows what is on the creation of the Supplement OWL with access industry-wide database of every single di- market.” available to FDA regulators. “If FDA doesn’t etary supplement product on the market, Bass is adamant that a mandatory regis- know what the industry looks like, it’s much would such information help regulators as try, not a voluntary registry, is needed: “A vol- harder for them to regulate,” he said. well as industry better police the dietary untary listing program is the right idea but However, Mister said that a self-regulatory supplement market? Also, how could FDA by defi nition will only include the good play- registry like the Supplement OWL, which CRN create such a registry? Th ese questions are ers who want a clean market. Th e whole pur- created with industry input, is preferable at being debated more often as the dietary pose of the listing is to identify those who are this point in time “rather than having [a reg- supplement industry faces more public on the market and those who shouldn’t be on istry model] foisted upon us.” Mister said that scrutiny and ongoing discussion about the market, and a voluntary listing doesn’t do someday, perhaps, industry’s registry could whether the existing regulatory framework that,” he said. serve as a solid framework for a federal regis- for supplements is eff ective. Many of the sources Nutritional Outlook try if FDA should ever be tasked with creating It also should be noted that a voluntary, interviewed in August, a month after pub- one. “One of the advantages of the Supplement industry-sponsored dietary supplement lishing the July interview with Scott Bass, OWL, and the fact that it’s being created by product registry was created just last year said they support the overall suggestion for the industry through our association, is that it by industry association the Council for Re- a registry, but not everyone agrees that it gives us the opportunity to create a registry the sponsible Nutrition (CRN; Washington, DC). should be mandatory (federally mandated way we want to so that if it did ever become In April 2017, CRN created a product registry and maintained by FDA); some feel it should mandatory, there is a very clear template for called the Supplement OWL (Online Well- be voluntary. what it would look like,” Mister said. “FDA ness Library). Participation is open to all in- Attorney Jason Sapsin, JD, MPH, of coun- would not have to start from scratch and po- dustry members and is heavily encouraged. sel at Faegre Baker Daniels LLP (Boulder, tentially put things in there or put in require- CRN says its goal is to build the Supplement CO), supports the general idea of a registry. ments that we don’t like.” Mister said that CRN OWL into the industry’s comprehensive He told Nutritional Outlook, “Consumers and has not, however, discussed with FDA the no- product registry that could also serve as retailers value transparency. A registry for tion of using the Supplement OWL as a tem- a regulatory resource for FDA to draw on dietary supplement products would demon- plate for a possible federal registry. should the agency choose to do so. To date, strate industry’s commitment while also of- Th e biggest drawback to a voluntary reg- the registry includes 10,000 product labels, fering researchers, regulators, and healthcare istry is, of course, that participation is not le- with CRN aiming to double that number by providers valuable information about prod- gally enforceable, meaning there are no teeth next year, according to Steve Mister, CRN’s ucts available in the marketplace.” to force a company to register. president and CEO. A comprehensive registry could even help Mister acknowledged that a voluntary reg- Th e Supplement OWL is a voluntary reg- industry enhance quality right down to its istry might not capture all companies, but he istry. It is not federally mandated; companies trade shows. Michelle Zerbib, director of said that CRN is trying to create some pretty can opt in or out as they choose. One person standards at New Hope Network (Boulder, strong “market-based incentives” to encour- Nutritional Outlook interviewed recently said CO), producer of the Natural Products Expo age companies to participate in the Supple- he thinks that a mandatory product regis- East and West trade shows, told Nutritional ment OWL—namely, by asking retailers to try, maintained by FDA at the federal level, Outlook that she and her colleagues would make participation in the Supplement OWL would be more eff ective than a voluntary fi nd a mandatory product registry benefi cial a requirement for the brands whose products registry in fulfi lling the goal of making sure as they work to maintain exhibitor standards they sell. “Hopefully, some retailers will very all products are included in the registry. and diff erentiate between good and bad soon be announcing that you must be in the In July, Nutritional Outlook interviewed players in the industry. “It would be so great, Supplement OWL if you want to be in their attorney Scott Bass. Bass helped draft the so helpful, to have a [registry] for what we do stores.” Many of the industry’s large dietary Dietary Supplement Health and Education in the standards program at Natural Prod- supplement companies are already partici- Act statute of 1994 (DSHEA). Bass said ucts Expo East and West,” Zerbib said. (Dis- pating in the Supplement OWL. Still, he said, that not having a mandatory registry crit- closure: Nutritional Outlook and New Hope “there will still be companies that won’t.” ically limits FDA’s ability to police the U.S. Network are both owned by Informa plc.) Not everyone believes a registry is needed. supplements market. His words: “[Th ere CRN’s Mister said he believes a compre- “People have been talking about this kind is] no hope for eff ective fraud prevention hensive registry is important—hence, CRN’s of thing”—a federal registry—“for years, but

12 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Color from Natural Sources

Our unique color crystals are the perfect solution for a multitude of food and beverage applications.

• Carrier-Free • OU Kosher • Non-GMO • Solution • Halal • Organic Compliant for Global • SO Free • Fast Solubility Distribution 2 • Zero Calories • Crystal & Liquid Color

Check Out Our New BROWN & RED CRYSTAL COLORS!!

formerly known as:

CONTACT US TODAY for more information or a sample 800.557.0220 • [email protected] California Natural Color is a 5631 E. Olive Ave., Fresno, CA 93727 • californianaturalcolor.com division of the E. & J. Gallo Winery NEWS

it’s a nothingburger. It’s a big nothingburger,” gets labels. Th ey get labels through certifi - Fabricant was director of FDA’s Division of said Daniel Fabricant, PhD, president and cate-of-free-sale applications (when you want Dietary Supplement Programs in 2011-2014. CEO of the Natural Products Association to ship things to foreign countries) and they “We certainly gathered labels when I was at (NPA; Washington, DC). get them through cGMP [current Good Manu- the agency,” he said. “We used them for pre- FDA already has the power to gather the facturing Practices] inspections. So the notion liminary [work] looking at things to see what same information that would be included that somehow if FDA had all the labels that it’s was out there.” in a registry, Fabricant said, and already gets a tighter-regulated market—FDA already has that information in other ways. “FDA already that information at their fi ngertips, or should.” The Power to Create a Registry Th anks to the Supplement OWL, we’ve already seen how the industry can create its own product registry. But what would it take for FDA to create a mandatory registry? Does the agency currently have existing statutory power to mandate registration, or would doing so require new legislation? In- dustry opinions are mixed. In July, Bass said he believes FDA “has the power under its current statutory mandate.” As Nutritional Outlook reported: “When asked which parts of the Federal Food Drug and Cosmetic Act today would allow FDA to mandate listing, Bass points to two. First, he points to 21 CFR 402(f)(1)(A), which makes it illegal to market an adulterated dietary supplement. Th is provision, he says, could be interpreted as requiring FDA to know the full scope of products on the market… Th e second existing statute Bass points to is the FD&C Act’s new dietary ingredient (NDI) regulation (Section 413(a)(2)). Th is regulation could be interpreted to mean that in order to establish and maintain an NDI process, FDA would need to know which companies need to fi le an NDI notifi cation. ‘And to be able to know who has to fi le, you need to have a listing,’ Bass said.” New Hope’s Zerbib said another existing route could be the FD&C Act’s structure/ function claims notifi cation law that requires dietary supplement companies to notify FDA within 30 days of marketing a product if that product is making a structure/ function claim. “Th is current regulation is a great place for FDA to step in and get dietary supplement information,” she said. “All a company would need to do is submit the label, and the label already has all the information” you would enter into a registry, including the list of ingredients, the statement of identity, and who the manufacturer is, she said. “So, the information would be there. Companies could simply submit to FDA [their label] with the claims they’re going to make, and FDA could

14 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

NEWS

drop [that information] into a registry, no product on the market. But it could be a would likely be challenged by someone in the new regulation required.” place to start. industry, which would tie it up in litigation Zerbib did, however, acknowledge that Mister, on the other hand, said he does for years,” he added. “So if it were going to be in this scenario, companies not making not believe FDA has existing authority to done, for expediency it would probably need structure/function claims would not be mandate registry. “Th e FDA probably does to be done through legislation.” required to submit a 30-day notifi cation not have the authority under the current NPA’s Fabricant said that although FDA and thus would not submit labels, mean- law to create a registry, and if they did try to “can grab labels on inspections” at present, ing this system might not capture every do it by regulation or something like that, it if the agency wants to “mandate that people send them their labels, they would defi nitely need statutory authority for that.” He added that if the dietary supplement industry were held to a new mandatory regis- Booth #3963 try requirement, it could “put another target [on the industry’s] back.” He explained that in the same way that California’s Proposition 65 regulation has made companies more vulnerable to predatory lawsuits as well as to class action suits and lawsuits from states “that will sue off of consumer protections,” a registry requirement could make dietary supplement companies more legally vulnerable. “You could set up an environment where someone goes, ‘Whoops, FDA didn’t get your labels on time,’ so then states start suing you. Th at’s crazy, and that will be exactly what t9ZMPPMJHPTBDDIBSJEF1SFCJPUJD will happen,” he said. A federal law would need to “preempt the states,” he said. “Unless [a registry require- t&YUFOTJWF$MJOJDBM3FTFBSDI ment were] done legislatively with some kind of preemption for the states, why would the industry even contemplate [the creation of a t-PX%PTBHF federal registry]? It’s just adding to our bur- den, which is already pretty substantial.”

t4IFMG4UBCMF Anytime Soon? How likely is mandatory registration to happen? In July, Bass said, “I don’t think it’s t&BTZUP'PSNVMBUF a dream far away. Let’s just say there’s a lot in motion now. Th is is not just some idea for fi ve years from now.” t/PO(.0 Mister and Fabricant said they haven’t heard of any developments regarding mandatory registry. t'%"(3"4 “As far as I know, there is nobody who has drafted legislation or shopped anything like that on Capitol Hill,” Mister said. “As you t&'4"/PWFM'PPE"QQSPWFE know, even things that are not controversial in Washington take a long time to get through Congress.” Fabricant said he doesn’t foresee anything happening “at least not this Congress, and www.aidp.com | 866.262.6699 likely not next Congress either. Nothing’s [email protected] | @aidpinc happening legislatively to make this move along.”

16 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK SYNSIGHT ™ Robust ﬂavor data. Guiding your next move.

Nutritional Platform Expansion + Flavor Trendspotting Grasp the unknown | (847) 487-1011 | synergytaste.com Follow Synergy Flavors now! GLOBALMARKETING

Probiotics in 2018 Interest in fermented products is invigorating the probiotics market.

BY INNOVA MARKET INSIGHTS

espite ongoing interest in functional In the U.S., Danone’s Dfoods, probiotics—the ingredients that Activia pioneered the pioneered the functional food boom in the mainstream market for pro- 1980s—now appear to have a much lower biotic yogurt in the mid-2000s profi le. According to Innova Market Insights and despite concerns over claims data, less than 1% of global food and drinks continues to focus on probiotic launched in the 12 months ending in April benefi ts. Th eir range has expanded 2018 were marketed as containing probiot- to encompass fruit, fruit-on-the- ics. (In the U.S., this fi gure was slightly higher, bottom, light, Greek, fi ber, and lac- at nearly 2%.) tose-free varieties, as well as a num- Dairy is the key application area globally. ber of dairy drinks, all with a focus Just over 40% of launches featuring probiot- on digestive health. A recent launch ics are in the dairy category, ahead of baby in 2018 was Activia Probiotic Dailies, and toddler products at 24%, pet foods at a dose-delivery format in line with sis- 11%, and soft drinks at just over 10%. In ter brand DanActive’s DanActive Dailies, the U.S., the picture is slightly diff erent and marketed on an immune support platform. Lifeway’s Keﬁ r Cup “has the thick, creamy more diverse, with dairy accounting for just texture of your favorite Greek yogurt with under 36% of new probiotic launch activity, The Rise of Keﬁ r up to twice as many probiotics.” followed by pet foods at 22% and soft drinks A revamp and repositioning of other relat- at 18%. ed spoonable and drinkable cultured dairy lactose-free varieties are also increasingly Regulatory issues in some countries, such options followed, including crème fraiche, common. as uncertainty as to whether probiotic claims smetana, skyr, ayran, lassi, and kefi r. Kefi r While health remains a key focus, kefi r are allowed, have resulted in repositioning of has been one of the key growth areas in fer- launches have also taken on a wider range many probiotic products away from probiot- mented beverages in recent years. It originat- of other on-trend themes, including more ex- ic claims, particularly in the dairy category. ed in the Caucasus Mountains and was con- otic fl avors, regional recipes, and even non- However, the recent rise in interest in fer- sumed most commonly in Eastern Europe, dairy options. mentation in food and drink processing has Southwest Asia, and Russia. Lifeway Foods was a key kefi r pioneer in brought a new lease of life to some areas of Th e U.S. pioneered the kefi r market in the the U.S., and it now has a wide range of kefi r the market. west and brought value-added options in products, including organic and non-organic Yogurt is possibly the best-known fer- resealable plastic bottles to the mainstream options, protein varieties, Greek-style for- mented food and had already moved into market, allowing more direct competition mulations, and probiotic shots. Recent addi- public awareness with the rise of probiotic with other dairy and non-dairy beverag- tions include a Kefi r Cup spoonable product yogurt in the mid-1980s. Greater focus was es. Kefi r is strongly promoted on its health in Strawberry Rosehip and Granola varieties, paid to yogurt’s health benefi ts, particularly benefi ts, and all U.S. launches recorded by as well as a Plantiful Plant-Based Probiotic with regards to digestive and immune health. Innova Market Insights in the 12 months Drink range in Vanilla, Mango, Reishi Choco- In the 12 months ending April 2018, 22.5% ending April 2018 used some kind of health late, and Maca Coconut varieties. of U.S. yogurt launches used a probiotic positioning. Th e kefi r market’s initial em- platform, and over 60% of the much small- phasis was its probiotic claims, but there Kombucha Gains Ground er drinking yogurt/fermented beverages is now also rising activity in low-fat and Key probiotic categories outside of the dairy sub-category did the same. reduced-sugar claims, while organic and category include sauces and seasonings, PHOTO FROM LIFEWAY FOODS INC. PHOTO FROM LIFEWAY

18 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK 1DWXUH·V3UHPLHU&ROODJHQDQG+\DOXURQLF$FLG0DWUL[ THE PROOF IS IN THE RESULTS THE INGREDIENT LEADING BRANDS TRUST!

BioCell Collagen® is clinically shown to: • Promote joint comfort & mobility* • Enhance post-exercise recovery* • Support skin & joint collagens (type I, II & III)*

Patented Synergistic Ingredient

Hydrolyzed Collagen II

Hyaluronic Chondroitin Acid Sulfate www.biocelltechnology.com

BioCell Collagen is a registered trademark of BioCell Technology LLC. Irvine, California, USA (Protected by Patents) * These statements have not been evaluated by the Food and Drug Administration. © 2018 BioCell Technology LLC. All rights reserved. This product is not intended to diagnose, treat, cure, or prevent any disease. MARKETING

bakery and beverages, pickled products (such as natural sauerkraut and kimchi), sourdough bread, and kombucha drinks. Kombucha, the ancient, fermented, lightly eff ervescent black or green tea drinks from China, traditionally contained multiple species of yeast and bacteria, along with organic acids, active enzymes, amino acids, and polyphenols produced by these microbes. Th ese drinks have been available in other countries outside of Asia for some years; however, with rising interest in functional beverages and fermented products, they have moved out of the specialty sector into the mainstream. A review of recent product activity in the U.S. indicates the increas- Dannon’s Activia Dailies ing range of fl avors and ingredients Probiotic Drink are a used as the kombucha market has “quick, easy, and tasty developed. Th e 2018 introductions way to enjoy your daily include Better Booch Morning Glory probiotics.” and Golden Pear premium kombucha teas in cans, and Bambucha Chef Crafted Kombuchas in a range of exotic fl avors, including Orange Blossom, Th ai Ginger, Blueberry Tart, Hibiscus Rose, and Mango Masala. Nearly 95% of global launches are positioned on a health platform, with clean labeling and digestive health key areas of interest. Over 85% of launches carry a clean-label positioning of some kind (natural, organic, no additives/preservatives, GMO-free), while digestive health and/or probiotic claims featured on 65% of introductions.

Probiotic Opportunities Th ere is clearly still interest in the use of probiotic cultures for health, primarily for yogurts and fermented beverages, as well as in supplements. With a wider focus on fermentation, which is seen as a natural and authentic process, new product development and heightened consumer awareness are combining to bring a raft of more traditional products back to the fore. Th e market for probiotic foods and drinks has struggled in some parts of the world, particularly Europe and North America, with health claim regulation issues. Th e fermented foods route could present a new way forward for this type of product, particularly when the natural and authentic image of fermentation as a traditional food processing method can also be used to a brand’s advantage. Innova Market Insights is your source for new-product data. The Innova Database (www.innovadatabase.com) is the product of choice for the whole product-development team, offering excellent product pictures, search possibilities, and analysis. See what food manufacturers are doing around the world: track trends, competitors, ingredients, and flavors. In today’s fast-moving environment, this is a resource you cannot afford to be without. PHOTO FROM DANNON

20 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK who maximizes the goodness of cranberries? — cran-max™ whole-fruit cranberry extract

Cran-Max™ is a concentrated whole fruit cranberry extract, made from 100 percent of the cranberry. Cran-Max™ provides a good source of PACs and anthocyanins, compounds known to support urinary tract and overall health.† Pharmachem, a division of Ashland, uses 34 pounds of cranberries to make one pound of Cran-Max™ and there are no carriers, solvents, added sweeteners, ﬂavorings or added colors. It can be used in a variety of foods and beverages, including bars, powdered drink mixes, chewables, tablets and more. ashland.com/whole9

® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries ©2018, Ashland FNB18-111 NO9 † These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Digestive Health GUT CHECK Emerging trends in the digestive enzymes market

BY MIKE STRAUS

igestive health is a growing market with Enzymes Gain Popularity in ample opportunities for manufacturer and High-Protein Formulations Dbrand expansion. Take digestive enzyme Protein supplements and high-protein products were supplements. Data provided to Nutritional Outlook by once the domain of bodybuilders and professional Innova Market Insights (Arnhem, Netherlands) show athletes, but now, mainstream consumers are adopt- an 8.6% compound annual growth rate (CAGR) in the ing protein as a daily supplement to their diet. With number of digestive enzyme products launched from an expected CAGR of 6.3% from now until 2025, ac- 2013 to 2017. While sports nutrition products remain cording to Grand View Research, the global protein the top market category for digestive enzymes, ac- supplement market is gaining new consumers such counting for 82% of all product launches, Innova’s as women who do strength training and older con- data show that digestive enzymes are branching off sumers who want to maintain an active lifestyle.2 into more categories. For instance, soft drink product Tod Burgess, vice president of sales at Deerland launches containing digestive enzymes grew by 78% Enzymes (Kennesaw, GA), says digestive enzymes to account for 4.5% of new food and beverage prod- are ideal for use in high-protein products due to uct launches, according to Innova. Dairy products their ability to break down large proteins into usable featuring enzymes, while still a minor trend, also saw amino acids. signifi cant growth, increasing by 57% to account for Says Burgess: “As an increasing number of people 2.7% of product launches, Innova says. are taking whey protein to obtain more desirable lean New product launches like these aren’t the only muscle mass, enzymes like our branded and patented market growth indicators for supplementary en- ProHydrolase become more critical. To be eff ective, zymes. Analysts and researchers are also predicting protein must be broken down into a smaller particle an increase in overall market valuation. According size within about 90 minutes of consumption. Whey to Credence Research, the global digestive enzymes proteins are often too large to be eff ectively assimilat- market, which had an estimated valuation of $845.8 ed, leaving large peptides that can cause discomfort million in 2016, is expected to see a 6.9% CAGR for in some consumers.” the next seven years, growing to $1.58 billion by 2025.1 Mike Smith, vice president of Specialty Enzymes As the digestive enzyme market continues to grow (Chino, CA), agrees, noting that enzymes are par- and more SKUs enter the category, experts say several ticularly useful in formulating high-protein meal key trends are starting to emerge. Here are just a few replacement shakes. “Typically, adults can only of the ways the digestive enzymes space is evolving. digest about 2 oz of protein at a time. But athletes SHUTTERSTOCK.COM/ RHENZY

22 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK DIGESTIVE ENZYMES AND...BRAIN HEALTH?

Scientists have long theorized that phenomena in the brain also has an impact on the digestive system. According to Jay Pasricha, MD, director of the Johns Hopkins Center for Neurogastro- enterology (Baltimore, MD), however, the gut- brain connection may also work in the opposite direction. Pasricha says research now indicates that poor gastrointestinal health may contribute to mood changes by acting on the central nervous system. It is for this reason, he says, that gas- troenterologists sometimes prescribe antide- pressants to patients with irritable bowel syndrome. Furthermore, Pasricha hypothesizes that phenomena in the digestive system may affect cognition and memory—an area that he says is fertile ground for further study.4 While further research is needed, the nature of the gut-brain connection means digestive enzymes may ﬁ nd an easy foothold in the brain health market.

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 23 Digestive Health

and bodybuilders need to consume more in order to reduce catabolism of muscle tissue. Protease enzymes increase digestion of pro- PRODUCT BLENDS: PROBIOTICS AND MORE tein and improve absorption of the resulting amino acids, which improves the nutrition- In the early days, single-ingredient products were traditionally been more popular than blends al value of meal replacement shakes,” he in the enzyme market, with the earliest digestive enzyme supplement consisting of a single explains. enzyme: amylase.5 Now, however, manufacturer innovation and market demand for more Th e broader adoption of protein-rich sup- versatile solutions are giving rise to a class of combination enzyme products that incorpo- plements and increasing consumer aware- rate additional ingredients. Brands have already introduced combination enzyme-herb and ness around protein will allow proteolytics enzyme-vitamin blends that incorporate ingredients like marshmallow root (Althaea ofﬁ cinalis), brands to gain market share as a mainstream elm bark (Ulmus fulva), and vitamin B12 in their formulations. consumer product. As the protein supple- Specialty Enzymes’ Mike Smith says that one of the most popular emerging combina- ment market continues to grow, expect tion products is the enzyme-probiotic complex, a class of multi-enzyme supplements that protein products to incorporate additional includes multiple probiotic strains. As innovation in product blends continues, combination proteolytic enzymes like pepsin and trypsin products will likely diversify. in new formulations.

Plant-Based Enzymes See don’t require enteric or protective coating to in life stress, and it can create more instances Substantial Growth survive exposure to gastric acid in the stom- of acid refl ux, cramping, constipation, diar- Smith says that while enzymes sourced from ach. Th is survivability allows plant-sourced rhea, and fl atulence. Th at’s why we’re seeing animals previously dominated the market, enzymes to maintain activity further along in so many digestive health products advertised the trend has reversed, and today, plant- the digestive tract relative to animal-sourced on television compared to a generation ago.” based and microbial enzymes are the norm. enzymes. Majeed says that while lifestyle and die- Animal-sourced enzymes fell out of favor “Animal-based enzymes work better at a tary habits are generally the culprits behind among large consumer groups due to reli- lower body temperature and a neutral-to-al- all manner of digestive distress, consumer gious and lifestyle choices, he says, which is kaline pH range,” Majeed notes. “But plant- awareness around digestive health is grow- why manufacturers and brands have turned based enzymes and their microbe-based ing. Th is new awareness, in turn, is generat- to plant-based enzymes instead. counterparts are very active at higher tem- ing demand in the digestive enzyme market. “We’re seeing a lot of growth in plant- peratures and in acidic environments.” “Lifestyle and dietary changes can cause sourced enzymes, like bromelain extracted any number of discomforts, but the digestive from the pineapple stem, as well as micro- Lifestyle Habits Give Enzymes system is most aff ected,” Majeed says. “Th e bial-sourced enzymes produced through an Upward Boost National Digestive Diseases Information fermentation,” he says. “Th ese enzymes are Digestive health is a rapidly growing mar- Clearinghouse says that 60 to 70 million peo- suitable for vegetarians and they’re both ko- ket, one that is driven by the busy lifestyles ple are aff ected by digestive health–related sher and halal-certifi ed, which means almost of those who consume digestive enzyme conditions. As consumers have recently be- anyone can take them.” products. Data gathered by Grand View Re- come more aware of the impact of a healthy Lifestyle factors and growth of the vegan search shows that consumer demand for di- digestive system on their overall health, they market in general are two signifi cant drivers gestive enzyme supplements is the result of are exploring options to support digestive behind the growth in plant enzymes. Burgess a signifi cant increase in the consumption of health.” points to another, more formulation-based packaged food, which, in turn, is the result of consideration that is fueling the plant-based a growing population of workers who regu- Enzymes for Pet Health: enzyme submarket. Says Burgess: “Plant cell larly clock overtime hours and whose sched- Demand Drives Formulation walls contain cellulose, which is very diffi - ules do not allow for proper meals.3 Burgess Improvements cult for humans to digest because we don’t agrees, noting that an unprecedented rise Th e pet health market is a rapidly growing produce the enzyme cellulase. Vegans in par- in the number of supplements and pharma- market opportunity for supplement brands, ticular need to supplement with dietary en- ceuticals targeting digestive distress refl ects with enzymes off ering easy inroads for zymes in order to ensure they obtain all the a generational shift in lifestyle and eating brands that have traditionally focused on hu- nutritional benefi ts of fresh produce.” habits. man consumers. Burgess says that digestive Furthermore, plant-sourced enzymes “Lifestyles are hectic, and people don’t take enzyme supplements are useful for pets with present some signifi cant advantages over the time to eat as slowly or as nutritiously as sensitive stomachs or digestive problems, as animal-sourced enzymes when formulating past generations did,” Burgess explains. “Eat- well as pets that are transitioning to a new an enzyme-based product. Shaheen Majeed, ing quickly—and not drinking enough water type of food. He also notes the importance president of Sabinsa Worldwide (East Wind- during meals—puts pressure on the digestive of enzymes for keeping older pets healthy sor, NJ), says that plant-sourced enzymes system. Make this a continued habit and add as they age, as aging pets tend to lose their

24 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

Digestive Health

Enzyme products are featuring in formulations for all manner of wellness concerns. NATURAL, NON-GMO ARE KEY MARKETING CLAIMS

Deerland Enzymes’ Tod Burgess says consumers are developing a preference for non-GMO and naturally sourced products, a preference to which enzyme man- ability to produce endogenous enzymes over say enzyme products are entering new do- ufacturers should cater. “Consumers un- time. Burgess says that the same changes mains and featuring in formulations for all derstand ‘non-GMO’ to mean ‘pure’, ‘as currently underway in the human protein manner of wellness concerns. Majeed points nature intended’, and ‘not augmented supplement market are also taking place in to joint health, immune health, mental by synthetic means,’” he says. “Consum- the pet protein market, noting that “we’re see- health, sports nutrition, and weight manage- ers also link purity with safety, and they ing an emphasis on increased quantities and ment as fi ve key areas where enzymes are believe consuming non-GMO products higher-quality protein in pet foods and pet gaining ground. means their bodies don’t have to process supplements. Deerland’s protease enzyme “Undigested food material is likely to ac- unnatural elements.” blend, which is formulated to maximize pro- cumulate in the intestine, where it creates Burgess stresses that consumers’ de- tein digestion, has been of particular interest the right conditions for pathogenic microbial sire to consume naturally sourced non- to companies developing pet supplements.” growth,” he says. “Th is leads to a weakened GMO products isn’t a trend; rather, he Smith notes that canine supplements will immune system. Clearly, digestive enzymes says it is a “tectonic shift” in lifestyle drive the majority of digestive enzyme mar- have a major role in immune health.” management. ket growth in the pet health arena. Dogs are Smith notes that an emerging trend in- well known for their tendency to eat any- volves featuring enzymes in condition-spe- thing and everything, he says, which makes cifi c products. Dipeptidyl peptidase IV supplement delivery practical and straight- blends, for instance, are often marketed as Mike Straus is a freelance writer living in forward. In contrast, other animal markets supplements for consumers with gluten sen- Kelowna, Canada. He has written for pub- are showing resistance to digestive enzymes. sitivities. “Th ese products can help individu- lications including Canadian Chiropractor “Th e pet health digestive market is very als with gluten sensitivity while also protect- Magazine, Massage Th erapy Canada, and strong for dogs, but not so much for cats or ing against hidden gluten in some processed Iconic Concierge Vancouver. horses. Cats aren’t terribly cooperative, and foods,” Smith says. horses have a much more complex digestive Mental health is another new arena where system that presents challenges,” he says. digestive enzymes are expected to become References Majeed says growth in the pet health popular. Burgess says that as awareness of 1. Credence Research. “Global digestive en- market is driven by the heavily processed the gut-brain connection grows, there will zymes supplement market is expected to pet foods that maintain market supremacy. emerge new opportunities for digestive en- reach US $1579.5 Mn by 2025.” Published on- Th ese pet foods originate from low-quality zyme products to expand into the mental line September 9, 2017. sources and contain a high concentration of health market: “Unfortunately, people of all 2. Grand View Research. “Protein supplements preservatives, he says, which creates stress ages are experiencing heightened stress, market analysis by raw material (whey, ca- on pets’ digestive systems. which often triggers nervous tension symp- sein, pea), by source, by product (protein “Just like human beings, pets are living toms like anxiety and gut discomfort. It’s very powder, protein bar, RTD), by distribution longer,” Majeed says, “and they’re facing true that ‘we are what we eat.’” channel, by application, and segment fore- age-related health issues just like human casts, 2018-2025.” beings. Consumers consider their pets to Bright Future 3. Grand View Research. “Digestive enzyme be extended family members and are con- With consumers gaining awareness about supplements market analysis by origin cerned for their pets’ well being. Th at’s why the importance of digestive health, the (animal, plant, microbial), by application researchers estimate that annual spending digestive enzyme arena is expected to di- (additional supplements, medical & infant on pet supplements is over USD$1.8 billion.” versify, with the high-protein, vegan, pet nutrition, sports nutrition), by region (North health, and convenience markets present- America, Europe, Asia Pacifi c, CSA, MEA), Beyond Digestion: Enzymes for ing new opportunities for savvy brands. Th e and segment forecasts, 2018-2025.” Immune Support, Joint Health, enzyme brands that succeed in this evolv- 4. Johns Hopkins Medicine. “Th e brain-gut con- and More ing market will be those that can pivot and nection.” Published online September 22, 2014. Enzymes have long featured prominently in off er more specialized products for each of 5. Deerland Enzymes. “Th e history of enzyme the digestive health arena, but now, experts these verticals. supplements.” Published online June 30, 2005.

26 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Visit us at Natural Products Expo East Booth #3137

A clear choice for clean label solutions.

Discerning customers expect more out of their supplements. Sometimes fewer ingredients with a better delivery is just right. Vcaps® Plus capsules are the premier vegetarian clean label solution for the health and nutrition markets. These capsules deliver superior performance with only two simple ingredients. With a glossy, high-end fi nish, these capsules are Non-GMO Project Verifi ed, vegetarian, vegan, kosher and halal certifi ed and offer a clear path forward to broad market

acceptance. To learn more about Vcaps® Plus capsules solutions for liquid and powder concepts, visit capsugel.com. 18CAPS13046-E

Vcaps® Plus vegetarian capsules with Licaps® Fusion Technology Sports Nutrition

Girl’s Got GAME Formulating for women’s sports nutrition needs

BY KIMBERLY J. DECKER

hen President Richard Nixon But while women’s sports have come Good Sports signed Title IX into law in 1972, a long way, women’s sports nutrition still High-profi le female athletes are only the tip Wjust one in 27 girls participated seems stuck in a pre-Title IX era wherein not of a spear launching women of all ages, siz- in high school sports; 40 years after the land- nearly as much eff ort goes into understand- es, and interests into active lifestyles that mark statute put an end to discrimination on ing, let alone formulating for, the unique place as much emphasis on wellbeing as on the basis of sex in federally funded education needs of athletic or even just active women winning competitions or losing weight. Th is programs, that proportion had risen to about as goes into doing so for men. movement isn’t so much about staying skin- two in fi ve, according to the Women’s Sports All of which suggests that it’s time for ny or being fi rst across the fi nish line; rather, Foundation.1 In those same four decades, some affirmative action in the dietary the goal is to feel better, in body and mind. women’s participation in college athletics supplement and functional foods space. Notes Nina Hughes-Likins, global market- vaulted more than 600%. As Bruce Brown, president, Natreon ing director, Prinova USA (Hanover Park, IL), Add to that the strides that female athletes Inc. (New Brunswick, NJ), says, “As more “Women are realizing that working out isn’t have made in Olympic competition, World women find opportunities to embrace a just a component of a fl eeting fad diet, but Cup soccer, and traditionally male-dominat- healthy lifestyle in everything from fitness actually benefi ts them mentally and phys- ed pursuits like body building and basketball routines to the foods they eat, sports nu- ically. Strength is empowering: it produces and the conclusion is clear: Th e days when trition brands will respond by investing visible results and fosters a more consistent “You play like a girl!” were an insult are over. in innovative ingredients with targeted fi tness regimen.” After all, who wouldn’t want to play like Sere- benefits, rather than solely focusing on Elyse N. Lovett, MBA, MS, marketing man- na Williams, or swim like Katie Ledecky? male-centered formulations.” ager, Kyowa Hakko USA (New York City), SHUTTERSTOCK.COM/JACOB LUND

28 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Sports and exercise nutrition research has historically focused on healthy males aged 18 to 35.

agrees. “We’ve entered the age where ‘strong Vive la Difference and sports nutrition supplementation adds is the new skinny’—where women all over And female consumers are identifying, in yet another.” the world are looking at Olympians and droves. But whether they realize it or not, strong, fi t infl uencer moms as role models their identity as females plays a fundamental How Little We Know when it comes to body image.” Th e upshot: role not only in determining which sports Of course, not all active women are pregnant Statista research2 found that, on average, nutrition products best suit their needs, but or lactating, but even among healthy adult 17.8% of the domestic female population en- how their bodies respond to sport in the fi rst females who aren’t, “the demands of exercise gaged in sports or exercise every day in 2017, place. impact energy, micronutrient and mineral compared to 15.6% two years prior. “Women’s bodies are biologically and needs depending on the exercise volume physiologically diff erent from males’,” and intensity, and on dietary intake,” Pankow Fitness Fuel Hughes-Likins says, noting that the former Fritz reiterates. Th e catch: “Th ere are cur- It should come as no surprise that all those carry 6%-11% more body fat than the latter, rently no offi cial nutrient dietary recommen- bodies in motion generate growing demand “likely due to estrogen, as it suppresses fat dations based on exercise volume and activi- for sports nutrition products designed to fuel oxidation, making it more diffi cult for wom- ty level that are specifi c to gender.” their next fi tness session—or reward the one en to lose fat.” Women also metabolize some “Some of the broader conclusions about just completed. And the fact that this market nutrients diff erently than do men, resulting the nutritional needs of active females are is entirely female signals a turning point for in higher requirements for iron, calcium, vi- inferences or culminations of understanding the entire category. tamin D, and folate, to name a few. about the physiological diff erences between Carolina Ordonez, senior consumer Adds Sandy Chien, PhD, vice president of males and females, and how the context health analyst, Euromonitor International innovative products, Horn (La Mirada, CA), of exercise might aff ect nutritional needs,” (Chicago), sees it as a broadening. “Histori- “Women also have lower sweating rates Pankow Fritz explains. And though these cally, female bodybuilders and athletes were than men, mostly due to a lower metabolic conclusions give us an idea of why men’s and the ones more interested in sports nutri- rate and smaller body mass. And women women’s needs diff er, “they don’t provide us tion. But with sports nutrition’s consumer have to deal with the rise and fall of estro- with evidence of how these diff erences might base expanding, more women are following gen and progesterone, which aff ects ener- aff ect sports performance, or how they can fi tness trends and looking for sports nutri- gy and water retention, as well as physical be addressed with supplementation.” Th is tion products that can support their fi tness performance.” underscores the need for more research. goals.” Indeed, it’s this ebb and fl ow of repro- Alas, a 2017 study3 published in the Eu- To Emily Pankow Fritz, PhD, technical ser- ductive hormones—including luteinizing ropean Journal of Sport Science found that vices manager, active wellness platform, hu- hormone and follicle stimulating hormone— among the more than 6 million participants man nutrition & health division, Kemin (Des that accounts for what Pankow Fritz calls tracked in the 1,382 sports and exercise med- Moines, IA), it’s all of a piece with the chang- “the most obvious diff erences” between icine research papers that the researchers es reshaping the category. “Ten to 15 years men’s and women’s metabolic profi les and analyzed, only 39% were female. ago, sports nutrition products were exclu- optimal energy intakes. Sports and exercise nutrition research has sively used by bodybuilders and professional Consider pregnancy and lactation, which historically focused on healthy males aged athletes. Now, the category is sold in mass pose “unique nutritional needs outside the 18 to 35, perhaps because “some researchers merchandisers, welcomes a wider range of context of activity level,” Pankow Fritz con- believe that conducting clinical research on consumers, uses more creative formats, and tinues. “Increases in recommended energy females requires extra steps, and that the has broader claims aimed at overall health and micronutrient requirements during results could be swayed by the complexi- and wellness. Overall, the defi nition has ex- pregnancy and lactation are focused on op- ty of the menstrual cycle,” Hughes-Likins panded to be more inclusive and active, and timizing fetal development and preventing says. And the need to administer pregnancy provides a broader defi nition for consumers nutrient defi ciencies; the demands of phys- tests to potential subjects adds to already to identify with,” she says. ical activity add another layer of complexity, weighty research costs. Nevertheless, says

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 29 Sports Nutrition

Hughes-Likins, “Claims based on clinical re- important. So, I think products that can synthesis (MPS)—“key to enhanced muscle search performed on men may not be appli- enhance their active nutrition performance growth and quicker muscle recovery,” he cable to women.” while making them feel great will be key driv- says. “Th is is relevant for active and athlet- Th at said, the situation may be headed ers for the category.” ic women who want to amplify the eff ect of for a turnaround. Although precious little And do us a favor: make women’s sports protein or BCAAs on muscle growth. And research has investigated sports nutrition nutrition products easy to use, and to be- because less protein is needed to boost MPS, supplements or dietary interventions spe- hold. As Chien says, “Women prefer delivery it’s also relevant to those who want more im- cifi c to females, Pankow Fritz says, “this is systems with easy use, such as sachets and pact from their protein with fewer calories.” where ongoing eff orts to close the gap are drinks instead of powders. Th ey also pre- Another “focal point” for female active focused: researchers are making attempts fer vibrant, bright colors with simple, clean nutrition involves increasing energy, enhanc- to include both women and men in clinical packaging and messaging compared to the ing mental focus, and heightening cognitive trials so that we can substantiate effi cacy in color black marketed to men.” function, Komorowski continues. “Nootrop- both genders.” ic supplements have been on the rise and Make Your Ingredients Count are geared toward improving focus, mental What Women Want So, looks do count. But ingredients count acuity, and energy. Consumers looking for (from Sports Nutrition) more. And even in the absence of conclusive products with a nootropic eff ect are grow- Until they do, sports nutrition marketers science on women’s sports nutrition needs, ing more interested in ‘naturally’ boosting don’t have much concrete information to go “Companies that off er innovative ingredients energy and focus without caff eine, jitters, or on when formulating for women’s sports nu- backed by clinical research are fi lling the gap” in a crash.” Nutrition 21’s Nitrosigine ingredi- trition needs. In the absence of targeted nu- products directed toward women, Brown says. ent combines the amino acid arginine with tritional strategies, they may fi nd themselves Of course, protein ingredients are as pop- silicon, stabilizing the blend with inositol, a leaning more toward targeted concepts. And ular with active females as with everyone carbocyclic sugar sometimes referred to as that requires asking active women not what else, and James Komorowski, chief science vitamin B8. Clinical results indicate that it they need, but what they want. offi cer, Nutrition 21 (Purchase, NY), says that improves processing speed and executive “Many women are looking for products athletic women “increasingly look for quicker function and increases energy levels without that enhance their workouts holistically by ways to incorporate more protein into their changing heart rate or blood pressure. reducing stress, increasing restful sleep, or diets for sustained energy and satiety and Not quite a vitamin and not quite an ami- providing lean muscle building rather than to help them achieve their health goals. Th is no acid, L-carnitine is perennially popular bulk,” says Brown. “Furthermore, natural has shifted the protein market over the last with the gym crowd who prize it for its pur- and non-GMO ingredients continue to gain decade away from a concentrated focus on ported fat-burning and performance-boost- momentum.” sports nutrition consumers toward a wider ing properties. But because Lonza’s Carni- Ordonez points to a rough consensus focus on consumers interested in improving pure brand of the ingredient “is fl exible and among experts that as go Millennial women, consumption to help improve general health.” adaptable for the sports nutrition market,” so goes the gender in general. “After discuss- Collagen protein in particular is attracting Bellamine says, “it lends itself to the growing ing this topic with sports nutrition players,” attention, and as Aouatef Bellamine, PhD, requirements of active and athletic women. she says, “we all agree that Millennial moms senior scientifi c manager, consumer health Studies show it provides signifi cant recovery are becoming a very important target in & nutrition, Lonza Nutrition & Health (Ba- benefi ts by reducing tissue damage, muscle sports nutrition.” Female Millennials spend sel, Switzerland), points out, it has special soreness, and injury after exercise. It’s also two times more on self-care than Boomers, relevance for female athletes. “As young been proven to help improve cardiovascular she notes, adding, “Th is female consumer is women tend to be more prone to ankle in- health by enhancing endothelial function very educated and looks for sports nutrition juries,” Bellamine explains, “they may need through increase blood fl ow.” products that represent her values: transpar- appropriate joint-support supplementation.” Also a boon to fi tness recovery is curcum- ency, organic, non-GMO, plant based, few Her company’s UC-II undenatured type II in (Curcuma longa), “which has a myriad of natural ingredients, local sources, vegan or collagen from chicken sternum cartilage of- health benefi ts including anti-infl ammation vegetarian, and so on.” Credibility matters, fers formulators a “natural, eff ective option and delayed-onset muscle soreness preven- too, and brands that have it include Truvani for women’s sports nutrition products” with tion,” says Mariko Hill, product developer and Clean Machine, Ordonez says. plenty of science supporting its role in joint at Gencor Nutrients Inc. (Anaheim, CA). But a product needs more than progres- health, she says. Gencor and its partner Pharmako Biotech- sive bona fi des to succeed with active wom- Komorowski adds that active women nologies (New South Wales, Australia) off er en. It also needs to produce a palpable eff ect. might appreciate his company’s Velositol formulators Hydrocurc, a cold-water-dis- “Females love products that make them feel blend of amylopectin and chromium, which persible curcumin ingredient with 90% load- good—they love to ‘feel’ something,” Lovett studies show helps the body mobilize the ing that functions in eff ervescent, capsule, says. “While improving their outer image branched-chain amino acids (BCAAs) in di- and powder formats. “Its application in eff er- is important, their inner ‘feeling’ is just as etary protein to accelerate muscle protein vescent tablets with its natural orange color

30 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

Sports Nutrition

DO WOMEN “BULK UP” WITH WHEY PROTEIN SUPPLEMENTS?

Protein supplementation is touted for increasing muscle mass and What does this all mean? According to researchers, whey protein strength in men, but one common question when it comes to wom- caused only modest increases in lean mass, and without infl uenc- en is whether protein supplementation will lead to excessive female ing fat mass or total body mass, regardless of whether subjects hypertrophy (“bulkiness.”) Purdue University researchers conducted restricted calories or resistance trained. When whey protein supple- a meta-analysis addressing this question, now published in Nutrition mentation was combined with calorie restriction (such as during a Reviews.1 According to the researchers, this is the fi rst systematic weight-loss program), the increases in lean body mass were more review and meta-analysis to examine the impact of whey protein pronounced. supplementation on female body composition when factoring in the Again, any increase in lean mass was moderate only, leading the effects of calorie restriction and resistance training. researchers to conclude that “[t]his moderate increase in lean mass Researchers included data from randomized controlled trials con- over time (0.37 kg) represents <1% of the total lean mass of study ducted in women who supplemented with whey protein compared participants and therefore does not support the public perception to control subjects not supplementing with whey protein. Within that [whey protein] causes excessive hypertrophy or ‘bulkiness’ in each overall group (supplementation and control), researchers clas- adult women.” sifi ed subjects into the following subgroups: 1) subjects restricting The researchers wrote: “In summary, fi ndings from this systematic calories via dietary changes, 2) subjects engaged in resistance train- review and meta-analysis indicate that [whey protein] supplemen- ing, 3) subjects combining calorie restriction and resistance train- tation improves body composition in adult women by modestly in- ing, and 4) subjects who neither restricted calories nor resistance creasing lean mass without infl uencing changes in fat mass.” trained. In addition, they added, “Whey protein may be more benefi cial for The meta-analysis included 488 female participants aged 20- improving body composition when included as part of a weight-loss 64, and spanned whey protein supplement dosages ranging from program. Although more research is needed to specifi cally assess the 6 g/day to 48 g/day. Whey supplements included those containing effects in varying states of energy suffi ciency and exercise training, whey protein concentrates, isolates, and hydrolysates, but no oth- the overall fi ndings support consumption of [whey protein] in wom- er protein types (such as casein). en seeking to modestly improve body composition.” The researchers analyzed changes in whole-body composition, in- This study was funded by the U.S. Whey Protein Research Consor- cluding body mass, lean mass, and fat mass, with or without calorie tium, an industry-funded research and education group whose part- restriction or resistance training. Overall, researchers found that com- ners include dairy cooperatives, dairy associations, dairy processors, pared to those not supplementing with whey protein, whey protein and multinational companies. subjects overall saw positive, but modest, changes in lean mass and no The researchers noted that “females are underrepresented in this signifi cant changes in fat mass. line of research,” with most studies examining whey protein’s effects Their subgroup analysis found that among whey protein subjects: performed in male-only populations. In general, they pointed out, 1) the “most robust positive change” in lean mass happened in sub- “there is a paucity of protein supplementation research in women.” jects restricting calories only (but not resistance training), 2) there was no difference in body composition in subjects resistance training only Reference (but not cutting calories), and 3) there was decreased fat mass but no 1. Bergia RE et al. “Effect of whey protein supplementation on effects on lean or body mass in subjects neither resistance training nor body composition changes in women: a systematic review and cutting calories. In addition, researchers said there was not enough meta-analysis.” Nutrition Reviews. Online April 23, 2018. data to come to a conclusion on the effects in groups both restricting calories and resistance training. and fl avor is perfect for the category, as its nutrition space. As consumer awareness of References: ability to form stable dispersions in water re- health and wellness increases, female con- 1. Women’s Sports Foundation. “Get your game fl ects the ease of use in a sports or on-the-go sumers will soon gravitate toward this trend on, girls! Celebrating the 40th anniversary of Title IX.” www.womenssportsfoundation.org/ setting,” Hill says. to incorporate a healthier lifestyle.” media-center/press-releases/press-release- Th e more that formulators turn to ingre- june-23-2011/ dients like this and others, the better able Kimberly J. Decker writes for the food 2. Statista. “Percentage of US population engaged in they’ll be to create sports nutrition products and nutrition industries from her base in sports and exercise per day from 2010-2017.” 2018. that “serve female consumers more eff ective- 3. Costello JT et al. “Where are all the female partic- the San Francisco area, where she enjoys ipants in sports and exercise medicine research?” ly than they have in the past,” Hill says. “Th e eating food as much as she does writing European Journal of Sport Science, vol. 14, no. 8 focus on women’s sports and active nutrition about it. (April 25, 2014): 847-851 will have a signifi cant impact on the sports

32 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

Fertility

BEARING FRUIT Nutritional supplements for couples trying to conceive

BY MAUREEN KINGSLEY

he United States Department of of a number of factors contributing to fertility 2. Antioxidant supplementation may Health and Human Services’ Offi ce problems, making the argument for supple- be benefi cial for promoting fertility T on Women reports CDC fi ndings mentation that much stronger. in the male partner of a woman un- that about 10% of American women of dergoing infertility treatment. childbearing age have diffi culty becoming Nutrition and Fertility: 3. Long-chain omega-3 fatty acids ap- or staying pregnant. CDC defi nes infer- Recent Findings pear to improve female fertility. tility as the condition of not being able to In April of this year, a review of the current 4. Adherence to a healthy diet “favoring achieve pregnancy within one year of try- body of scientifi c literature studying the seafood, poultry, whole grains, fruits, ing, or within six months of trying for wom- relationship between diet and human fer- and vegetables is related to better en older than 35. Nationwide, infertility af- tility was published in American Journal of fertility in women and better semen fects about 6.1 million women between the Obstetrics and Gynecology by two Harvard quality in men.” ages of 15 and 44. professors, Audrey Gaskins, ScD, and Jorge CDC also notes that about one-third of Chavarro.1 Th e authors identifi ed some clear Additionally this year, in July, British Jour- infertility cases are caused by medical prob- patterns: nal of Nutrition published a study by Keewan lems in women, and another one-third are Kim et al. whose fi ndings suggest that low caused by medical problems in men. Th e 1. Intake of supplemental folic acid, manganese, selenium, and sodium levels in- fi nal third are a combination of female and particularly at doses higher than creased the risk of sporadic anovulation (no male reproductive issues and unknown those recommended for preventing egg release, and therefore, no conception) in causes. neural-tube defects in babies, has women.2 Additionally, low levels of magne- Th e market for dietary supplements that been “consistently related to lower sium were found to be associated with lower support reproductive health in women—and frequency of infertility, lower risk of testosterone levels, while very low levels of also in men—is established and substantial. pregnancy loss, and greater success potassium were associated with higher tes-

Additionally, CDC lists poor nutrition as one in infertility treatment.” tosterone levels. (For the study, 259 women SHUTTERSTOCK.COM/GOLUBOVYSTOCK

34 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK aged 18 to 44 were recruited; the women kept food diaries and had blood drawn and tested by the researchers throughout their HERBAL INGREDIENTS FOR A COMPLEMENTARY menstrual cycles.) Taken all together, the APPROACH TO INFERTILITY fi ndings of this particular study appear to recommend that women seeking to con- Brien Quirk, director of R&D at Draco Natural Products (San Jose, CA), points to a handful ceive adhere to the recommended daily al- of herbs and botanicals used in traditional Chinese medicine to combat infertility. “We have lowances of these elements to support reg- some great recommendations for both female and male infertility,” he says. “For women, ular ovulation. in traditional Chinese medicine, dodder seed (Cuscuta chinensis) is the most commonly Successful, competitive supplement recommended single herb by clinical practitioners, while the multiherbal formula most rec- brands are staying alert to these recent sci- ommended is dang-gui-sha-yao-san. That formula consists mainly of blood-moving herbs, entifi c discoveries, formulating products such as dong quai, lovage root, white peony root, poria, Atractylodis macrocephala root, that provide ample amounts of folic acid/ and Alisma rhizome. These address blood stasis, a major cause of female infertility.” folate in combination with other ingredients, Another formula Quirk cites is Rehmannia 8, which he says “can address polycystic ovar- such as minerals, antioxidants, omega-3 fatty ian disease [PCOS], a major cause of female infertility due to excess body weight and met- acids, and herbs. abolic syndrome.” In men, celery and red ginseng are backed by some studies showing they improve sperm A Pre-Prenatal Vitamin quantity and quality, Quirk says. Herbs that increase sperm production or enhance their One particularly well-known and success- health and motility, he adds, include Cuscuta chinensis seed, goji berries, fupenzi or Chinese ful fertility supplement line is Fairhaven raspberry fruit, schisandra berry, plantaginis seed, Chinese yam, Chinese foxglove root or Health’s FertilAid, which includes a FertilAid prepared radix rehmanniae, Rosa laevigata fruit, and glossy privet berry. for Women product and a FertilAid for Men. Quirk cites a number of scientiﬁ c papers in support of traditional Chinese herbs and bo- Th e women’s version is essentially a prenatal tanicals marketed for fertility, including one from the journal Complementary Therapies in supplement containing 600 mcg of folic acid Medicine in which the authors write, “Our review suggests that management of female in- (150% RDA), plus the B vitamins, vitamin D3, fertility with Chinese Herbal Medicine can improve pregnancy rates 2-fold within a 4-month vitamin C, vitamin A, vitamin E, minerals, period compared with Western Medical fertility drug therapy or IVF.”5 and a blend of herbs intended to both support fertility and maintain a healthy preg- to company literature. “In women, EPA magnesium, zinc, selenium, and iron, as well nancy. Th e herbal blend features selections and DHA are believed to help regulate hor- as the amino acid L-arginine plus green tea to “stimulate and balance hormones that mones, reduce infl ammation, promote cer- extract and chaste berry extract. Th e formu- control ovulation,” according to the compa- vical mucus production, and reduce blood la “signifi cantly improves ovulation health ny, including chaste tree berry extract and clotting, all of which is benefi cial for fertil- and hormonal balance,” says Daily Wellness red clover extract. (For more on herbs and ity,” the literature reads. “EPA and DHA are Co. president Denny Kwock. He cites a dou- botanicals for fertility, see the sidebar above.) also believed to be important for helping ble-blind, placebo-controlled study pub- Th e men’s product contains large concen- to prevent miscarriages and preterm labor lished in 2006 in Clinical and Experimental trations of antioxidants and minerals, and and for brain and eye development in the Obstetrics & Gynecology that he says showed its formulation is supported by clinical trial fetus. In men, low intake of omega-3 fats the FertilityBlend women’s supplement im- data presented at the American Society of has been associated with poor sperm pro- proved the success rate of couples trying to Andrology’s Annual Proceedings in 2009.3 duction and quality.” conceive by three times over placebo.4 Th e randomized, double-blind study was Fairhaven also off ers a product aimed Th e men’s FertilityBlend formula contains undertaken through 2006 over three months, singularly at improving cervical-mucus vitamins C, E, B6, and B12, plus folate, zinc, to determine the eff ects of FertilAid on men quality (another indicator of fertility) and and selenium. Th e supplement also includes with “abnormal sperm parameters” as de- a newer FertileDetox product containing the amino acid L-carnitine, plus green tea fi ned by the World Health Organization. Th e herbs, amino acids, botanicals, and probi- extract and dong quai extract, for improved researchers noted statistically signifi cant im- otics for the purpose of “promoting the ef- sperm quality. provements in sperm motility (an indicator fi cient elimination of environmental toxins of male fertility) for subjects using the dietary from the body” by “supporting the body’s Improving on the Already Proven supplement, and also suggested that the use own detoxifi cation and cleansing systems”: Folic Acid of FertilAid for Men may improve sperm the liver and the intestines. Folic acid is an established star in the try- count. Another brand adhering closely to the lat- ing-to-conceive and prenatal supplement In line with fi ndings that omega-3 fatty est science is Daily Wellness Co., seller of the industry. As reported by Nutritional Out- acid intake is associated with better fertil- supplements FertilityBlend for Women and look this summer, a recent small study of ity, Fairhaven’s FH Pro Omega-3 contains FertilityBlend for Men. Th e women’s formula 30 couples with histories of infertility or “clinical-grade EPA and DHA,” according contains a blend of folic acid, letter vitamins, miscarriage found that a full 26 of those 30

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 35 Ingredients, solutions, innovation This is how you win

Prinova creates value for global food, beverage and supplement manufacturers. As one of the world’s largest distributors of functional ingredients and a trusted provider of integrated solutions such as nutrient premixes and other services, we will help you develop successful products, improve speed to market and grow your business.

Get Your Custom Sample Learn how Prinova can help you win! Visit prinovausa.com/trends/ffsamples or call 630-868-0300.

Nutrients / Flavors / Essential Oils & Aroma Chemicals / Premixes / Particle Management Fertility

Savvy supplement brands aren’t just following the science of nutrition and fertility; they’re creating whole trying-to-conceive programs that combine technology with supplemental nutrition.

were able to conceive after consuming a supplemental nutrition. One of these is Fruit- hormone, thyroid-stimulating hormone, novel folate ingredient called Quatrefolic (a ful Way, a company that off ers an app to help triiodothyronine, free T4, cortisol), levels of 5-MTHF glucosamine salt manufactured by users “optimize [their] chances of getting the sex-hormone-binding globulin protein, Gnosis S.p.A.; Desio, Italy) for four months. pregnant” via a fertility assessment, an ovula- levels of thyroid peroxidase antibodies, and Th e ingredient is a biologically active form of tion cycle tracker, a menstrual period calen- levels of DHEA. Th e personalized plan pro- folate (the naturally occurring form of folic dar, personalized health and lifestyle recom- vided by Th orne is based on test results and acid) “that does not need to be converted by mendations, and a nutritional-supplement includes supplement recommendations; the body via the folate enzymatic pathway dosage reminder and tracker. Th e company’s Th orne’s fertility-related supplements in- that includes the enzyme methylenetetrahy- related supplements include Fruitful Couple clude its Basic Prenatal, recommended for drofolate reductase (MTHFR), which shows (for women and men), featuring omega-3 women trying to conceive in addition to common polymorphisms of around 40% in fatty acids; Fruitful for Her, with folic acid, those who are already pregnant or lactating. the world population,” according to a num- the B vitamins, and vitamins E, A, and D; and It features L-5-MTHF (glucosamine salt), vi- ber of studies cited by Gnosis. In other words, Fruitful for Him, made with the antioxidants tamin B12, antioxidants, and minerals. Th e those persons in whom MTHFR is mutated L-carnitine, vitamin E, and selenium. company also sells a Super EPA omega-3 may not metabolize supplemental folic acid Udi Alroy, Fruitful Way’s CEO and fatty acid supplement. effi ciently, in which case, the Quatrefolic in- co-founder, tells Nutritional Outlook that his gredient may be a better alternative. company’s app is “focused on a personal- Maureen Kingsley is a freelance writer, ed- Gnosis also points to studies indicating ized solution based on the proprietary fer- itor, and proofreader based in Los Angeles. that folate levels measured in semen have tility algorithm developed by Fruitful Way She covers a variety of industries, including been associated with sperm count and to accommodate [users’] lifestyles and re- medical technology, food-ingredient manu- health. “Folate supplementation had a ben- lationship management, reduce stress, and facturing, and cinematography. efi cial eff ect on spermatogenesis, possibly by formulate the best nutrition solution on the increasing cellular cohesion within the sem- new-family level.” iniferous epithelium, thus preventing abnor- He adds, “Our technology enables us to References mal release of immature germ cells into the connect the couples on a daily basis, assist- 1. Gaskins AJ et al. “Diet and fertility: a review.” lumen,” Gnosis literature and spokesperson ing in the trying-to-conceive process, syn- American Journal of Obstetrics & Gynecology, Lorena Carboni assert. “Over the years, a large chronizing the fertility window for both, and vol. 218, no. 4 (April 2018): 379-389 number of genetic studies focusing on the as- optimizing his and her physical condition. 2. Keewan K et al. “Dietary minerals, reproduc- sociation between genetic MTHFR polymor- Th e Fruitful Way personalized supplements tive hormone levels and sporadic anovula- phism and male infertility have been carried are science-based with the intention to im- tion: associations in healthy women with out with diff erent meta-analyses published. prove… conditions toward conceiving.” regular menstrual cycles.” British Journal of High levels of homocysteine in subjects with Another brand combining fertility sup- Nutrition, vol. 120, no. 1 (July 2018): 81-89 MTHFR polymorphism have been associated plements with tech is Th orne Research, 3. Clifton GD et al. “Prospective study of with low sperm quality,” Gnosis reports. “No- which sells a direct-to-consumer fertility FertilAid vitamin in men with low sperm table, diff erent meta-analyses correlated the test for just under $400 and provides re- quality.” Poster 25. Presented at American polymorphism with risk of male infertility,” sults and recommendations to the user’s Society of Andrology Annual Proceedings, according to the company, suggesting that desktop computer or mobile device. Th e April 2009. men wishing to conceive may also benefi t test kit includes materials for at-home 4. Westphal LM et al. “A clinically proven nat- from supplementation with the Quatrefolic blood and saliva collection, and samples ural fertility remedy.” Clinical and Experi- ingredient. are subsequently mailed back by the user. mental Obstetrics & Gynecology, vol. 33, no. 4 Th ose samples are tested, and Th orne re- (2006): 205-208 Fertility? There’s an App for That search sends a digital summary of results 5. Ried K et al. “Effi cacy of Traditional Chi- Savvy supplement brands aren’t just fol- and recommendations within three to fi ve nese Herbal Medicine in the management lowing the science of nutrition and fertility; days. Biomarkers tested include hormone of female infertility: a systematic review.” they’re creating whole trying-to-conceive levels (estradiol, progesterone, testosterone, Complementary Th erapies in Medicine, vol. programs that combine technology with follicle-stimulating hormone, luteinizing 19, no. 6 (December 2011): 319-331

38 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK nutritional Beverages made better with Maltrin® maltodextrins

MALTRIN® maltodextrins and corn syrup solids from GPC not only improve mouthfeel and body, they balance sweetness and provide creaminess in both dry mix and ready-to-drink meal replacement beverages. Product developers can adjust viscosity and build solids without affecting flavor. Contact GPC today. grainprocessing.com/MALTRIN

Non-GM available | Improves body and mouthfeel | Readily digestible | Rapid dispersion | Gluten free

Magnesium Strong Magnesium is an essential mineral for muscle function and performance.

BY IRFAN QURESHI, ND

agnesium is a mineral that is a high levels of physical activity increase the Estimated Average Requirements (EAR) for crucial cofactor for over 300 en- body’s demand for magnesium. Further stud- this nutrient. Strikingly, for adults aged 71 Mzymes, playing a core role in the ies in individuals on a strength training pro- and over, this percentage rises to two-thirds structure and function of the human body. gram have found that suboptimal magnesium of the population.3 Th e Recommended Die- Magnesium’s broad-reaching importance ex- status leads to decreased endurance, while tary Allowance (RDA) for magnesium ranges tends to areas including energy production, higher magnesium intake in aerobic exercise from 400 to 420 mg per day for males aged the synthesis of DNA and proteins, struc- is associated with a requirement for less ox- 14 to over 70. For women, the RDA for those tural roles in bone and cells, facilitating cel- ygen and improved cardiorespiratory fi tness.2 aged 14 to over 70 ranges between 310 and lular signaling, and nerve function.1 With its Although maintaining optimal levels of 320 mg per day. breadth of reach and infl uence over human magnesium is essential for all, athletes and In addition to nearly 60% of adults fall- physiology, it’s not surprising that magne- others who are physically active may have in- ing short of these guidelines, reviews sug- sium is a critical mineral for muscle function. creased requirements for magnesium. Simi- gest that magnesium consumption in most Magnesium infl uences muscle perfor- larly, those with sarcopenia as well as those athletes falls well below amounts that are mance by participating in energy metabo- experiencing other muscular issues related considered adequate.4 As magnesium is an lism and maintenance of muscle contraction to the aging process may also need higher electrolyte, strenuous exercise causes a sig- and relaxation. Research further shows that intakes of magnesium. However, according nifi cant amount to be lost through urine and magnesium defi ciency can lead to a disrup- to USDA data, almost half of all individuals sweat. Th is can increase magnesium require- tion of neuromuscular function—and that have magnesium intake levels below the ments by 10%-20%.5 SHUTTERSTOCK.COM/STOCKFOUR

40 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Magnesium infl uences muscle performance by participating in energy metabolism and maintenance of muscle contraction and relaxation.

Magnesium and Muscle Function utilization and metabolism is critical for skeletal muscle mass (fat-free mass as a per- A recent review coauthored by Mario Bar- shuttling glucose to where it’s needed in the centage of body weight), leg explosive power bagallo and Ligia Dominguez from the Uni- body during exertion. (a measure of the force and velocity of mus- versity of Palermo (Palermo, Italy) outlines cle contraction of the quadriceps), and cir- several important ways in which magnesium Beneﬁ ts of Optimal Intake across culating levels of the infl ammation marker impacts muscle function and performance.6 Demographics CRP. Quite remarkably, the diff erence in leg As physical exertion depletes magnesium Alisa Welch and colleagues from the Univer- explosive power was shown to be more than and leads to increased oxidative stress, sity of East Anglia (Norwich, UK) recently 24% greater in those women with the highest higher levels of reactive oxygen species, or conducted two relevant studies evaluating versus lowest magnesium intake. In terms of free radicals, are generated. Th ese free rad- the signifi cance of magnesium intake for infl ammation, the diff erences in CRP con- icals may contribute to the development of muscle health across broad spectrums of the centrations is signifi cant as magnesium may muscle fatigue. Magnesium has antioxidant population. play a greater role in skeletal muscle con- eff ects that can confer protection to muscle In one study, the researchers analyzed servation in older women via attenuating tissue. data from a cohort of 156,575 men and wom- the production and eff ect of infl ammatory Additionally, magnesium plays a funda- en aged 39-72 to assess the impact of die- cytokines. mental role in mitochondrial energy pro- tary levels of magnesium on skeletal muscle Moreover, an analysis from the Maastricht duction. Over one-third of total cellular mag- and bone health parameters.8 Th ey found Sarcopenia Study in the Netherlands com- nesium is found in the mitochondria and is that higher dietary intakes of magnesium pared nutrient intakes in 227 older adults present complexed together with adenosine were positively associated with greater grip (aged 65 or older) and found that individuals triphosphate (ATP) and as a component of strength, skeletal muscle mass, and bone with sarcopenia had signifi cant nutrition- membranes. Magnesium is, therefore, criti- mineral density in both men and women. al diff erences in fi ve nutrients compared cal for basic mitochondrial functions, includ- In men over the age of 60, the relevance of to those without sarcopenia.10 Sarcopenic ing the production of ATP, and confers a pro- higher magnesium intake as it relates to grip individuals had a 10%-18% lower intake of tective role to skeletal muscle mitochondria. strength was even more exaggerated com- omega-3 fatty acids, vitamin B6, folic acid, Furthermore, infl ammation is a criti- pared with younger men, emphasizing the vitamin E, and magnesium, with the diff er- cal factor in reduced muscle performance. importance of ensuring optimal magnesium ence in magnesium intake approaching 12% Poor magnesium status is known to exac- consumption in this group. Furthermore, between the groups. erbate the infl ammatory state and leads to when the researchers analyzed the bene- Th ese data taken together substantiate increased circulating levels of pro-infl am- fi ts of greater magnesium intake across this the critical importance of ensuring optimal matory markers. Magnesium intake, on the population versus the annual losses of bone magnesium intake for skeletal muscle health other hand, has repeatedly been found to re- mineral density and skeletal muscle with through the lifespan. duce systemic infl ammation, including sig- age, they concluded that the fi ndings were of nifi cant reductions in the cytokine IL-6 and clinical signifi cance in terms of higher mag- Magnesium Supplementation and C-reactive protein (CRP) levels, two markers nesium intake stemming these decreases Physical Performance of infl ammation. over time. Dietary levels of magnesium may, Clinical trials involving magnesium supple- Magnesium may also infl uence muscle therefore, have relevance for prevention of mentation for improving athletic perfor- function and exercise performance in an- sarcopenia, frailty, falls, and fractures. mance and muscle function have yielded other important way. Hsuan-Ying Chen and In a second study, Welch and colleagues mixed results; however, some recent studies colleagues from Providence University in analyzed cross-sectional data from 2,570 point to positive benefi ts in professional and Taichung, Taiwan, found that administering women aged 18 to 79 years to determine the recreational athletes, as well as the elderly. magnesium to animals prior to a treadmill eff ect that dietary magnesium intake has In one recent study conducted by Cór- exercise led to increased glucose availability on age-related skeletal muscle loss, power, dova Martínez Alfredo and colleagues in muscle and brain tissue while increas- and chronic low-grade infl ammation.9 Th ey from the University of Valladolid (Soria, ing the clearance of lactate from muscle.7 found that higher dietary magnesium intake Spain), researchers investigated the eff ects Th is central role of magnesium in glucose was signifi cantly positively associated with Continued on page 44

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 41 Minerals

IS MAGNESIUM AWARENESS GROWING IN ACTIVE NUTRITION?

Evidence continues to build showing magnesium is crucial for muscle play important roles in fi ghting against oxidative stress and reduc- function, but are supplement shoppers getting the message? Nutri- ing infl ammation, thereby reducing muscle damage. Magnesium is tional Outlook interviewed one industry expert, Stephen Ashmead, involved in a multitude of processes that impact muscle function, in- MS, MBA, senior fellow for Balham Corp., Albion Minerals (Layton, cluding oxygen uptake, electrolyte balance, and energy production. UT), about how well consumers understand the link between mag- Proper magnesium intake can enhance exercise performance. nesium and active nutrition and sports nutrition. What kind of inroad has magnesium made in the sports nutri- Nutritional Outlook: How aware are today’s sports nutrition tion market? Can you comment on the volume of sports nutri- customers about the role of magnesium in muscle function tion products you see now incorporating magnesium? and performance? According to the Nutrition Business Journal, magnesium supple- Ashmead: While scientifi c evidence continually emphasizes the ments had almost 9% in sales growth in 2017. In fact, it is predicted importance of proper magnesium intake, and despite the fact that that by next year, magnesium sales will overtake calcium as the single consumers have access to more information about magnesium than largest mineral sold in the market. Some of this growth can certainly ever before, research consistently shows that people aren’t getting be attributed to growing interest from the sports nutrition market, the recommended amounts in their diet. According to the National which is also growing steadily. Euromonitor reports that sports nutri- Health and Nutrition Examination Survey (NHANES) 1999-2000, re- tion sales grew from US $7.3 billion in 2011 to $13.6 billion in 2017, searchers found 68% of Americans consumed less than the recom- and is expected to continue growing at nearly 8% CAGR by 2021. mended minimum daily intake (400 mg) of magnesium. However, there is greater and growing awareness within the sports What kind of synergistic benefi ts does magnesium have with nutrition market of the many roles of magnesium. The lines between other commonly used sports nutrition ingredients? Are you athletes and “lifestyle users” have blurred, and active nutrition is an seeing those combinations featured in the end-product mar- important segment of the sports nutrition market. With growing in- ket today? terest in leading active lifestyles and increased participation in sports When formulating sports nutrition products, it is also important and fi tness activities, the demands within this market are evolving. to consider the cognitive aspects, along with the physical benefi ts of Both athletes and active-lifestyle consumers want supplements that the ingredients. Nootropics are gaining substantial interest in sports help support specifi c goals for energy, endurance, performance, nutrition. Minerals such as iron, zinc, and magnesium play important weight loss, muscle comfort, and overall wellness. roles in achieving optimal physical and cognitive sports performance, We are seeing tremendous growth for magnesium in this sector. and are considered to have nootropic characteristics. Magnesium sales will continue to grow as more consumers recog- For example, magnesium is crucial in ATP synthesis. ATP is the pri- nize the benefi t of adequate magnesium in their diets and lifestyles. mary energy source for mitochondria in every cell, including those in They will use it to prevent defi ciencies due to diets or other issues, the brain. ATP must be bound to magnesium in order to be activated. and to support physiological function and their active lifestyles. Magnesium combined with B vitamins can help maximize the energy potential. Magnesium joined to creatine has shown to increase work Can you highlight the importance of magnesium to athletic output over individual components and is present in many powder performance? formulations in the market today.* As cognition and active lifestyles Magnesium is the catalyst or cofactor in many of the oxidative gain more awareness, magnesium and benefi cial combinations with phosphorylation reactions, converting sugars into glycogen and other nutrients will become more important. ultimately ATP (adenosine triphosphate) needed for refueling in preparation for future exercise or athletic performance. Sports per- How well does magnesium formulate into the many types of formance and exercise require a high supply of the energy produced sports nutrition products on the market? by magnesium-sparked reactions. Magnesium has traditionally been supplemented as tablets and As we exercise, the body burns through our glycogen stores. The capsules, and can still be used in that way. However, magnesium longer and the more intense the exercise, the more glycogen we burn. lends itself well in the many sports nutrition applications, including Fast glycogen recovery or refueling is most important in athletes who sports drinks, powders, bars, “shots,” and gummies. Selecting the train multiple times per day or participate in back-to-back events. In right form of magnesium for the application is important based upon these individuals, a proper refueling strategy is essential, otherwise delivery mechanism, other ingredients, and organoleptic properties. they put themselves at risk for poor performance and even injury. Minerals play important roles in counteracting the impact that * Editor’s note: Balchem/Albion supplies a magnesium creatine exercise performance can have on the body. Magnesium and zinc chelate ingredient called Creatine MagnaPower.

42 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Chromax® from Nutrition 21— Not all chromium is the same.® • Prop 65 compliance^ independently verified1 • Significant improvement in body composition2 • Significant reduction in carbohydrate cravings and appetite3 • Significant reduction in caloric intake4 More than 2x reduction in carbohydrate cravings Average caloric intake reduced by 374 calories per day4** and 1.8x reduction in appetite vs. placebo3† Superior Reduction in Daily Calorie Intake Improvement in Reduction of Symptom Scores Weeks Carbohydrate 0 1 2 3 4 5 6 7 8 Appetite Eating Craving 0 0 -50 -.2 -100 -.4 Q Chromax® Q Placebo -150 -.6 -200 -.8 Kcal/day -250

-1 -300

HAM-D Item Scores * -1.2 * -350 *p<0.05 * *p<0.05 -400 * -1.4 Baseline Kcal/day, Chromax® =~1,500, Placebo=~1,800; ® Chromax dosed at 600 mcg chromium per day Chromax® dosed at 1000 mcg chromium per day Learn more at Nutrition21.com or email [email protected]. Additional claims available supporting: Energy • Mood • Metabolism • Cognition • Lean Body Mass Not All Chromium is the Same ^Proposition 65 compliance independently veriﬁed for arsenic, cadmium, hexavalent chromium, lead, and mercury levels. † In subjects with atypical depression and high carbohydrate cravings. ** In healthy, overweight, adult women with carbohydrate cravings. ©2017 Nutrition 21, LLC. Chromax® is a registered trademark of Nutrition 21, LLC. 1. Data on ﬁle 2017, Nutrition 21, LLC. 2. Kaats et al., Current Therapeutic Research 1998. 3. Docherty et al., Journal of Psychiatric Practice 2005; 11(5):302-14. 4. Anton et al., Diabetes Technology & Therapeutics 2008; 10(5):405-12. DRA1176102317 * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Minerals

Continued from page 41 regularly for at least 30 minutes four days In the 12-week randomized controlled of magnesium supplementation on mus- per week for the prior three months were study, 139 women (average age of 71) were al- cle damage in male professional basketball randomly divided into a placebo groulp or located to either a magnesium group (300 mg/ players.11 Twelve elite basketball players a supplementation group. Th e subjects were day as magnesium oxide) or a control group who were members of a team were asked to asked to supplement with 350 mg of magne- (no intervention). Th e primary outcome as- supplement with 400 mg magnesium daily sium sulfate or placebo nightly before dinner sessed during the study at baseline and week in the form of magnesium lactate during the for fourteen days. Th ey underwent the Win- 12 was a change in the Short Physical Perfor- entire basketball season (approximately 32 gate test at the beginning of the trial period mance Battery (SPPB), which consists of three weeks). Blood samples assessing parame- and again at the end. Th e Wingate test is a objective physical function tests: 4-meter gait ters of muscle damage were taken through- stationary bicycle test of exhausting physi- speed, repeated chair stands, and standing out the season at eight-week intervals. As cal anaerobic activity. It involves 30 seconds balance in increasingly challenging positions. a comparison, twelve college age students of maximal exertion (pedaling as fast as Secondary outcomes included changes in who played recreational basketball and possible) following a fi ve-minute warmup peak torque isometric and isokinetic strength competed in minor university leagues were session. of the lower limbs and handgrip strength. used as a control group to assess baseline Baseline SPPB scores were similar between parameters. Th is group was not supple- the supplement group and control group; mented with magnesium. however, at 12 weeks, magnesium supplemen- Serum magnesium levels did not diff er As the majority of the tation led to signifi cant improvements in total signifi cantly at baseline between the profes- SPPB scores, chair stand times and 4-meter sional players and the recreational players adult population walking speeds. No signifi cant changes were serving as controls. Over the course of the in the U.S. fails to seen in the secondary measures of muscle study, serum magnesium levels registered a strength. Overall, the authors concluded that decrease at the third timepoint with respect meet basic RDA levels, 12 weeks of supplementation with magnesium to the fi rst and second timepoints; however, improved physical performance in healthy el- these levels recovered and were signifi cant- improving magnesium derly women and noted that those with mag- ly higher at the fourth timepoint versus the nesium intake lower than the recommended third. Additionally, there was no signifi cant intake is essential. daily allowance saw the greatest benefi ts. increase in the parameters of muscle damage versus baseline levels in the profession- Blood was drawn both prior to and af- Beneﬁ ts for All al athletes, indicating a protective eff ect on ter the test. Th e muscular activity of the Magnesium’s importance in muscle health muscle tissue associated with magnesium right leg (three main muscle groups) was and physical performance in individuals of all supplementation. assessed by an electromyography (EMG) ages can’t be overemphasized. Its necessity In general, with exertion levels seen in device. While in the placebo group a de- for skeletal muscle function is indispensable. these athletes, a rise in these markers of cline was noted in mean power frequency As the majority of the adult population in muscle damage is expected. Th e parameters (an indicator of muscular motor unit fa- the U.S. fails to meet basic RDA levels, improv- assessed included myoglobin, lactate dehy- tigue) between pre-test and post-test num- ing magnesium intake is essential. In athletes, drogenase, aldolase, serum urea, and total bers, magnesium supplementation led to the infl uence of magnesium in improving ath- proteins, along with the liver enzymes ALT signifi cant increases in these values post- letic performance combined with the poten- and AST. Overall, this small study supported test, suggesting an increase in the ability tial increased needs in those who are physical- the use of magnesium supplementation in of muscle fi bers of the leg to continue to ly active necessitates a second look to ensure elite athletes for preventing the normal drop fi re. Magnesium supplementation led to adequate intake in this group of individuals. seen in serum magnesium with intense phys- reduced muscular fatigue and enhanced After taking a closer look at improving dietary ical activity as well as mitigating an increase performance on the Wingate test, while intake, a simple cost-eff ective approach would in biochemical markers of muscle damage no signifi cant changes were noted with be to supplement with this mineral in at-risk during the basketball season. placebo. Th e results of the study suggest populations. Th is could lead to better perfor- Another study aimed to assess the eff ect of that magnesium supplementation benefi ts mance in athletes, better physical fi tness with magnesium on muscle fatigue. Conducted by muscle function during anaerobic exercise age, and better overall musculoskeletal health researchers at the University of Mazandaran performance. throughout life. (Babolsar, Iran), the randomized controlled Earlier, Nicola Veronese from the Uni- trial looked at the benefi ts of magnesium versity of Padova (Padova, Italy) led a study supplementation on muscular fatigue fol- looking at the ability of magnesium to im- Irfan Qureshi, ND, is executive director, lowing intense anaerobic exercise.12 pact physical performance in healthy elder- research and regulatory aff airs for Healthy In this pilot study, 16 physically active ly individuals involved in a weekly exercise Directions. male college-aged volunteers who exercised program.13

44 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Nourishing the skin from within is vital to strengthen and protect skin while inhibiting factors that accelerate aging*.

OptiMSM® (MSM, methylsulfonylmethane) supports and preserves connective tissue, where the building blocks of healthy skin are formed.

IN A RECENT STUDY, PARTICIPANTS USING OPTIMSM EXPERIENCED IMPROVEMENTS IN: Fine lines and wrinkles* Elasticity* Skin Firmness*

A 38% REDUCTION IN TOTAL WRINKLE COUNT IN AS LITTLE AS 8 WEEKS!

FOR ADDITONAL INFORMATON ON OPTIMSM® [email protected] www.optimsm.com 888-733-5676

References 3. NHANES 2005-2006. “What We Eat in America.” 5. Nielsen FH et al. “Update on the relationship 1. Linus Pauling Institute. “Magnesium.” 2014. www.ars.usda.gov/ARSUserFiles/80400530/ between magnesium and exercise.” Magnesi- https://lpi.oregonstate.edu/mic/minerals/ pdf/0506/usual_nutrient_intake_vitD_ca_ um Research, vol. 19, no. 3 (September 2006): magnesium Retrieved August 5, 2018. phos_mg_2005-06.pdf. Retrieved 5 August 5, 180-189 2. Zhang Y et al. “Can magnesium enhance 2018. 6. Barbagallo M et al. “Magnesium, oxidative exercise performance?” Nutrients. Published 4. Volpe SL. “Magnesium and the athlete.” Current stress, and aging muscle.” Aging. (December online August 28, 2017. Sports Medicine Report, vol. 14, no. 4 (July-August 2014): 157-166 2015): 279-283 7. Chen HY et al. “Magnesium enhances exercise performance via increasing glucose availability in the blood, muscle, and brain during exercise.” PLoS One. Published online January 20, 2014. 8. Welch AA et al. “Dietary magnesium may be protective for aging of bone and skeletal muscle in middle and younger older age men and women: Cross-sectional fi ndings from the UK Biobank Cohort.” Nutrients. Published online October 30, 2017. 9. Welch AA et al. “Dietary magnesium is positively associated with skeletal muscle power ™ and indices of muscle mass and may attenu- Veri-te Resveratrol CWD 90 ate the association between circulating C-re- for Excellent Dispersion active protein and muscle mass in women.” Journal of Bone and Mineral Research, vol. 31, no. 2 (February 2016): 317-325 Introducing Veri-te™ Resveratrol CWD 90 10. Ter Borg S et al. “Diff erences in nutrient intake and biochemical nutrient status be- Evolva has partnered with Pharmako Biotechnologies to create tween sarcopenic and nonsarcopenic older ™ ® Veri-te Resveratrol CWD 90, using LipiSperse Dispersion Technology. adults-results from the Maastricht Sarcope- With a 90% trans-resveratrol content, this unique ingredient system nia Study.” Journal of the American Medical is designed to deliver a large amount of resveratrol into aqueous Directors Association, vol. 17, no. 5 (May 1, environments in a simple, effective way. With a neutral taste, the 2016): 393-401 11. Córdova Martínez A et al. “Eff ect of magne- system is easy to ﬂavor in a variety of formulations. sium supplementation on muscular damage markers in basketball players during a full season.” Magnesium Research, vol. 30, no. 2 L D WA (May 1, 2017): 61-70 O T E 12. Talebi V et al. “Th e eff ects of magnesium sup- C R Verite™ Resveratrol CWD 90 offers you a wide range of delivery opportunities plementation on electromyography indexes of muscle fatigue after intense anaerobic • Functional beverages • Effervescent tablets exercise.” International Journal of Applied Sci- • Liquid shots • Fast melt powder sticks ence in Physical Education, vol. 2, no. 2 (April DISPERSIBLE • Oral dispersible tablets • Instant powder drinks 14, 2018): 58-66 13. Veronese N et al. “Eff ect of oral magnesium supplementation on physical performance in healthy elderly women involved in a weekly exercise program: a randomized controlled trial.” American Journal of Clinical Contact us today Nutrition, vol. 100, no. 3 (September 2014): 974-981 to learn more about this exciting veriteresveratrol.com new technology and how it 1.800.250.1032 might work with your formulas [email protected]

LipiSperse® is a registered trademark of Pharmako Biotechnologies. Veri-te™ is a trademark of Evolva. SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

Joint Health

SYNERGY SELLS

Innovative formulations and a widening consumer base are redeﬁ ning the joint health category.

BY MELISSA KVIDAHL

hough SPINS reports that sales of plements, says Deanne Dolnick, science Taking a small daily dose also helped pre- supplements targeted for joint health director at TR Nutritionals (Alpharetta, serve the integrity of the cancellous bone at Twere down about 10% overall during GA). Younger consumers are doing so not tibial metaphysis, and limited further dam- the 52 weeks ending June 17, 2018, the news only because they’re generally a group age to the articular cartilage. “As such, the isn’t all bad. In fact, in the natural channel, that’s open to taking supplements, but study demonstrates that a clinically relevant sales are up, to the tune of 6.6%. And if you also because they’ve gravitated towards daily dose of the UC-II brand, when applied ask Jaume Reguant, director of Spain-based group workouts like CrossFit and Spartan immediately after injury, can improve the Bioiberica Health Care Business Unit, in- challenges, the intensity of which can put mechanical function of the injured knee— creased growth is on the horizon as the pop- stress on the joints. preventing excessive deterioration of the ulation continues to age and, simultaneous- One ingredient on many supplement con- articular cartilage,” says senior marketing ly, up the amount of physical activity in their sumers’ minds is collagen. New research manager Juliana Erickson. daily lives. coming out of Lonza Health & Nutrition (Ba- But collagen isn’t the only game in town. “Th e joint health market is thriving as sel, Switzerland) and recently published in “Virtually everybody suff ers from some sort an increasingly aging as well as active pop- Osteoarthritis and Cartilage supports the use of joint discomfort and it’s not the type of ulation looks towards natural solutions to of Lonza’s UC-II undenatured type II collagen ailment where the consumer runs to the support their range of motion, fl uidity, and in supporting joint health across diff erent doctor,” Dolnick explains. “And because joint fl exibility,” agrees Samantha Ford, business age groups.1 problems are either ongoing or intermittent, development director at AIDP (City of Indus- Th e aim of the study was to determine most people do not want to take NSAIDs for try, CA). “People are simply living longer and the ability of the ingredient to prevent ex- an unspecifi ed period of time or even for a recognize the importance of taking care of cessive articular cartilage deterioration in week or two, so they turn to supplements.” their bones and joints for the sake of quality a rat model with osteoarthritis. Th e results of life into their later years.” found that immediate treatment with UC-II Trends to Watch Also driving sales is the fact that young- preserved the weight-bearing capacity of the A number of trends are driving sales across er consumers are taking joint health sup- limb with deteriorated articular cartilage. the joint health market. SHUTTERSTOCK.COM/KAMOMEEN

48 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK ENZYME AND PROBIOTIC INGREDIENTS FOR SPORTS NUTRITION

Supports Muscle Building and Recovery

GO Supports Digestion and Immunity WITH YOUR for Improved Performance PROHYDROLASE® Protein-digesting enzyme blend increases the availability of amino acids required for muscle-building and recovery. DE111® GUT Highly stable probiotic strain improves body composition and performance in conjunction with whey protein while supporting digestion and immunity.

CLINICALLY PROVEN NON-GMO PROJECT VERIFIED HEALTH CANADA APPROVED

800.697.8179 DeerlandEnzymes.com Joint Health

“People are simply living longer and recognize the importance of taking care of their bones and joints for the sake of quality of life into their later years,” says Samantha Ford of AIDP.

First is an increased interest in alternative Pending publication is new research that health, including the ability to reduce infl am- delivery formats. “Consumers don’t want to supports the eff ects of Mythocondro at 600 matory mediators COX-2 and 5-LOX which take yet another pill or capsule, but rather mg per day, Pisoni says. Th e randomized, helps alleviate discomfort,” says Sebastien a convenient supplement—in a food, drink, double-blind, placebo-controlled study was Bornet, vice president of global sales and or powder format—that can easily be part of carried out in 60 individuals over the course marketing, Horphag Research. their daily routine,” says Ford. of 12 weeks. Researchers evaluated pain in- Because many ingredients in the bone and If you ask Erickson, younger consumers tensity at motion and rest using the Visual joint health market are animal-derived, fi nd- with busier schedules look for alternative Analog Scale; knee function as assessed by the ing ethical and equally eff ective alternatives formats like shots, bars, ready-to-drink bev- WOMAC Index; and knee pain, health-related to appeal to clean label and vegan consumers erages, and gummies, which help “pave the quality of life, and infl ammation markers in has been an ongoing challenge and category way for increased supplement usage in the plasma at baseline, four weeks, and 12 weeks. driver. AIDP recently launched Phytodroitin, joint health category.” “All endpoint results show a statistically sig- a 100% plant-origin alternative to chondroit- Th e challenge, according to TR Nutrition- nifi cant modifi cation of the parameters with in. According to Ford, the ingredient mimics als’ Dolnick, is that many manufacturers impressive results related to the decrease in the structure and function of animal-based need extracts that are water soluble, which the WOMAC Index and the Tegner Lysholm chondroitin and is Vegan Society registered. aren’t always easy to fi nd. And, even if they Knee Scoring,” says Lorena Carboni, product Finally, combination supplements are res- do fi nd it, it’s usually “not too tasty,” she says, support specialist, Gnosis. Mythocondro can onating with consumers in the joint health especially in the case of turmeric, a hot joint be used at a daily dosage of 600 mg, and off ers space. “Any of the popular combinations health ingredient for which Dolnick says her a once-a-day alternative to larger chondroitin of nutrients designed for the bone or joint company receives quote requests daily. sulfate pills that need to be taken twice a day, categories usually have a synergistic eff ect Another trend is consumer demand for the company says. on each other,” says Steve Holtby, president transparency, which is driving sales and in- Pycnogenol, a French maritime pine bark and CEO of Soft Gel Technologies Inc. (Los terest in vegan and vegetarian joint health extract from Switzerland-based Horphag Re- Angeles), “or often target the functionality of ingredients and supplements. “In the infor- search, was the subject of a recent study pub- that category through diff erent pathways to mation age, with so much false information lished 2017 in the journal Nutrients2, which support the overall health of that system.” and hype, consumers are increasingly be- showed that the polyphenols from Pycnog- Some suppliers and formulators are meet- coming more skeptical about the ingredi- enol are distributed directly into the synovial ing this trend by targeting systemic infl am- ents in the products they consume and are fl uid of patients with osteoarthritis. mation with ingredients like turmeric. Oth- demanding more transparency from manu- Th e double-blind study examined 33 indi- ers are creating proprietary blends, as in the facturers,” explains Suhail Ishaq, president viduals diagnosed with severe osteoarthritis, case of Valensa (Eustis, FL). “Formulations of BioCell Technology LLC (Irvine, CA), sup- and who were scheduled for knee replace- that attack joint issues from multiple path- plier of branded ingredient BioCell Collagen. ments. Participants were supplemented with ways provide a better product overall and “Everything from the source, quality, purity, 200 mg of Pycnogenol daily over the course better diff erentiation for our brand partners,” non-GMO, and clinical substantiation are all of three weeks leading up to their surgeries. says Valensa senior vice president of global factors that consumers consider in their pur- Synovial fl uid samples were collected during sales and marketing Doug Lynch. “In short, chasing behavior.” surgery to detect and measure the presence one physiological mechanism equals a better And, according to Silvia Pisoni, market- of polyphenols. claim; multiple mechanisms equal a better ing manager at Gnosis S.p.A. (Desio, Italy), Results from the synovial fl uid samples consumer response.” this desire for transparency and quality is show that the polyphenols found in Pyc- Valensa’s fl agship joint formulation, Flex- translating into demands for ethical and nogenol, including taxifolin, ferulic acid, Pro MD, received its 18th patent in 2018. Its non-animal-based ingredients. Th e compa- and catechin, were distributed throughout FlexPro ES formulations capitalize on the ny’s vegetarian chondroitin sulfate, Mythoc- the synovial fl uid in the Pycnogenol-tested synergy trend by off ering egg membrane ondro, gained U.S. GRAS status in the U.S. group. Taxifolin and ferulic acid were not de- alongside astaxanthin. “Our FlexPro line and Novel Food Approval in the beginning tected in control group serum samples. “Th is works on synergies of multiple mechanisms of 2018. “Non-animal origin claims are rec- research further supports previous studies to support your joints,” Lynch adds. “Ulti- ognized as added value,” Pisoni says. examining Pycnogenol’s benefi ts for joint mately, FlexPro brings anti-infl ammatory

50 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK unlimited ways to reach your potential customers across the world! the across unlimited to ways reach your potential customers and andservices you innovative with content, reliable products Outlook industry. inthe international powerhouse biggest the become has provider leading information the shows, and trade digital products, websites, of inclusive magazines, offamily brands UBM the market. Nowwith nutraceuticals American North in the years, 20 For 38% SHARE OF MARKET 184 ADVERTISERS is the most comprehensive and effective platform providing platform comprehensive andeffective most isthe Nutritional Outlook FOR MARKETING OPPORTUNITIES, CONTACT: 81% has remained the leading publication leading publication remained the has MAGGIE EDITORIAL EDITORIAL MAGGIE NutritionalOutlook.com GROWTH IN THE PAST 10 YEARS PAST Tim Baudler–Brand Director AWARD WINS [email protected] Phone: 310-445-3757 4 Nutritional

Onchira Wongsiri/Shutterstock.com Joint Health

“Convenient dosage and intake, eff ective and safe ingredients from natural origin, a reliable producer— that’s what consumers are asking for,” says Jaume Reguant of Bioiberica. benefi ts to the joints themselves, and our use of phospholipids in the formulation—coming from krill oil or vegetarian sources—unlocks the antioxidant benefi ts of astaxanthin.” In support of synergistic formulas, Bergstrom Nutrition (Vancouver, WA) recently published a study demonstrating that adding 500 mg of MSM to glucosamine and chondroitin doubles the benefi ts of the latter ingredients3. And while Bergstrom’s OptiMSM ingredient is benefi cial as a standalone ingredient, this study makes the case that OptiMSM also delivers synergistic eff ects when formulated with other ingredients, says vice president of sales and marketing Tim Hammond. Bioiberica plans to launch a new combination ingredient for joint and mobility in 2019, called Mobilee, the company says. It will blend hyaluronic acid with polysaccharides and collagen for joint function and muscle strength. According to Bioiberica’s Reguant, this ingredient responds to the market trend that has evolved the joint health market to encompass bone and muscle health for overall mobility support. At Lonza Consumer Health & Nutrition, DuoCap capsule-in-capsule technology can help “overcome complex formulation challenges by allowing manufacturers to incorporate traditionally incompatible ingredients together in one single dosage form,” says Erickson, which addresses “diverse health needs from bone and joint health to cardiovascular and weight management.” Going forward, supplements that target athletic consumers will fi nd favor, too, says Valensa’s Lynch, as will those that step outside the box on delivery and off er vegetarian or vegan labels. Reguant agrees: “Con- venient dosage and intake, eff ective and safe ingredients from natural origin, a reliable producer—that’s what consumers are asking for.”

References 1. C Bagi et al. “Oral administration of undenatured native chicken type II collagen (UC-II) diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA).” Osteoarthritis and Cartilage, vol. 25, no. 12 (December 2017): 2080-2090 2. Mulek M et al. “Distribution of constituents and metabolites of maritime pine bark extract (Pycnogenol®) into serum, blood cells, and synovial fl u- id of patients with severe osteoarthritis: A randomized controlled trial.” Nutrients, vol. 9, no. 5 (April 28, 2017) 3. Lubis AMT et al. ”Comparison of glucosamine-chondroitin sulfate with and without methylsulfonylmethane in grade I-II knee osteoarthritis: A double-blind randomized controlled trial.” Acta Medica Indonesiana, vol. 49, no. 2 (April 2017): 105-111

Melissa Kvidahl is a freelance journalist and copywriter specializing in the health and wellness industry.

SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK QUALITY CONTROL: Playing the Long Game Regulatory

Which dietary supplement ingredients have captured FDA attention?

BY KIMBERLY J. DECKER

Kratom (Mitragyna speciosa)

lose observers of the dietary sup- to be dangerous,” Prochnow concedes. “But I Angeles), and Phusion Projects LLC (Chi- plement industry have their pick don’t really believe it’s gotten any more heat- cago), maker of Four Loko—for marketing Cof metaphors for describing the ed than before.” caff einated alcoholic beverages, “but only sector’s regulatory state-of-play: a jungle, a after college kids started going to the hos- minefi eld, a game of whack-a-mole (or got- Reactionary Agency pital and congressional representatives cha, if you happen to be one of the moles Why not? Chalk it up to the downstream ef- started raising issues,” Prochnow says. getting whacked). But given the current ad- fects of starving the bureaucratic beast. Years “Th en about four or fi ve years ago,” he ministration’s inclination toward relaxed reg- of funding and personnel cuts have turned continues, “there was a focus on caff eine in ulating, is FDA as ready, able, and willing as FDA into what Prochnow calls “a pretty reac- energy drinks and supplements—again when ever to take action against supplement ingre- tionary agency” that focuses on ingredients Congress raised issues. And about a year or dients that arouse its suspicion? mainly after they capture public—and con- two ago, FDA sent out warning letters about As far as attorney Justin J. Prochnow, gressional—attention. picamilon”—a nootropic synthesized from ni- shareholder, Greenberg Traurig LLP (Den- Case in point: In 2010, FDA took action acin and gamma-aminobutyric acid—“after ver), can tell, FDA’s eagerness doesn’t always against “the Four Lokos of the world”— Missouri Senator Claire McCaskill raised translate into escalated enforcement. “FDA namely, Charge Beverages Corp. (Portland, issues.” continues to take action against companies OR), New Century Brewing Co., LLC (Bos- So with FDA’s enforcement seemingly con-

selling products with ingredients it believes ton), United Brands Company Inc. (Los tingent upon the volume of congressional SUNTORNKIJ SHUTTERSTOCK.COM/YANAWUT

54 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Concerned about Botanical ∃ Identification? Learn more about Jiaherb recognizes that there is much uncertainty among manufacturers and consumers, about the integral Jiaherb’s ID Program, quality of the botanical products they purchase. As a testament to our never-ending commitment to scan QR code below. customer satisfaction, and to ease customer concerns about the integrity of our products, Jiaherb proudly introduces HerbaLink.™ HerbaLink, a unique chain-of-custody program, offers ultimate transparency in product identification and traceability. The program not only assures best practices in identifying sustainable and socially conscious sources, but also the implementation of stringent testing methods that include DNA, HPTLC, HPLC and GC throughout the processing and preparation of the finished product — documenting every link of the product’s journey from harvest to packaging.

1.888.JIAHERB www.jiaherbinc.com Regulatory

outcry, it’s no wonder some brands “continue orange extract that a manufacturer stan- So with uncertainty the only certainty, we to push the envelope,” says Prochnow, “selling dardizes to 30% p-synephrine qualifi es as asked the experts which ingredients have products with the next alternative to ingredi- an NDI because the amount of p-synephrine caught not just retailers’ and regulators’ eyes, ents that FDA’s already questioned.” that occurs naturally in bitter orange is only but their own. about 6%, Prochnow says. “So the view of Functional Foods the New Frontier whether an ingredient requires an NDI noti- Cannabidiol (CBD) Th e trend has been especially evident in the fi cation or not may depend on whose view it functional food and beverage space, where a is: FDA’s or the private brand owner’s.” (FDA blurring of the boundary with supplements released a revised NDI draft guidance in may encourage some brands to pursue in- 2016, and though it falls short of settling all gredients that are common in the latter— outstanding questions, it at least keeps the activated charcoal, algae, and “medicinal” conversation going.) mushrooms like chaga, reishi, and cordyceps, Prochnow notes—but that aren’t generally Clear Boundaries recognized as safe (GRAS) for use in foods “I would say the number-one thing FDA and beverages. could do to make the line clearer is actually Yet despite this, “It’s a very rare occasion to take action and enforce issues like GRAS, when FDA actually asks for GRAS confi rma- or whether an ingredient is a dietary ingre- tion from a brand owner,” Prochnow says. dient or not,” Prochnow concludes. “As men- “Th is cues many companies to push the enve- tioned, FDA’s regulation is somewhat spo- FDA doesn’t yet permit the food, beverage, lope and include ingredients for which there’s radic and more reactionary than proactive. or (some argue) dietary supplement use of no previous evidence of GRAS. Th e result is But tighter enforcement of GRAS and dietary cannabidiol (CBD), a non-intoxicating can- more products on the market with question- ingredient requirements would result in a nabinoid constituent of cannabis with prov- able ingredients, leading more companies to clearer demarcation between permissible en therapeutic value. So far, their decision is think it’s okay to use those ingredients.” and impermissible ingredients.” based on what’s going on in the pharmaceu- Adds Sylvia Laman, managing toxicologist tical world. Grey Areas for dietary supplements, NSF International Yes, marijuana remains on the DEA’s list of To be fair, it isn’t always clear which ingredients (Ann Arbor, MI), “Supplement brands should Schedule 1 drugs; and yes, CBD’s association companies can conclusively consider “okay.” feel encouraged to reach out directly to FDA with that much-maligned plant continues to In the case of dietary supplements, a per- when they’re unsure about the regulatory cloud its reputation. But FDA’s beef with CBD missible ingredient must meet the defi nition status of a dietary ingredient. In addition, stems less from the agency’s reefer madness of a “dietary ingredient” as spelled out in the brands should collaborate with companies than from an investigational new drug (IND) Federal Food, Drug and Cosmetic Act—that or individuals dedicated to substantiating application that GW Pharmaceuticals (Cam- is, it must be “a vitamin; mineral; herb or oth- the legal status and, more importantly, miti- bridge, UK) fi led for a CBD isolate in 2006. er botanical; amino acid; dietary substance gating the risk associated with all ingredients And as Greenberg Traurig’s Prochnow ex- for use by man to supplement the diet by used in product formulations.” plains, “If an ingredient was investigated as increasing the total dietary intake; or a con- a new drug prior to being used in a supple- centrate, metabolite, constituent, extract, or The Mouse Is Winning ment, food, or beverage, it’s then precluded combination of the preceding substances.” For now, FDA’s hamstrung posture gives from being used in those products.” (In June, But some synthetic herbal and botani- the mouse an advantage in this perennial FDA went full steam and approved GW cal extracts that would otherwise appear cat-and-mouse chase. “Th e agency has lim- Pharma’s Epidiolex CBD drug, the fi rst drug to meet these standards have caught FDA’s ited resources and must therefore prioritize the agency has approved for those with a rare attention “because they were never actually acting on consumer safety,” Prochnow says. form of epilepsy called Dravet syndrome.) constituents of the original plant,” Prochnow “Th us, ingredients that might not technically Prochnow emphasizes that this IND- explains. And he’s noticed “some diff erence be GRAS are unlikely to be challenged unless based prohibition diff ers from “an express of opinion” among experts as to whether safety concerns are raised.” law” prohibiting CBD’s use—as would be processing can turn a previously established Paradoxically, brands are as likely to face the case with, say, a targeted regulation pro- dietary ingredient into a new dietary ingredi- a challenge these days from commercial re- hibiting the use of ephedrine alkaloids in ent (NDI) for which FDA would require safe- tailers like Whole Foods or Target—“both supplements. “With CBD, it’s FDA’s opinion ty notifi cation from the manufacturer before of whom are more vigilant than FDA about and interpretation of the law that precludes it could appear in a product. ensuring that ingredients are legally permis- use,” Prochnow says. “But many in industry For example, while bitter orange extract sible,” Prochnow says—as they are from FDA disagree with FDA and are prepared to chal-

is an established dietary ingredient, a bitter proper. lenge it.” SHUTTERSTOCK.COM/ELROI

56 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK And how. Following the Epidiolex approval issued warning letters in May to three kra- lower blood pressure, and reduce neural dam- as a new drug, and while the agency main- tom marketers responsible for a total of 68 age from stroke. tains its position that CBD is not a permissible products—Front Range Kratom (Aurora, CO), And as with CBD, FDA’s chief complaint is ingredient, agency personnel have confi rmed Kratom Spot (Irvine, CA), and Revibe Inc. with the drug claims—“not kratom’s capacity that FDA “must prioritize enforcement activ- (Kansas City, MO)—alleging their illegal sales as a dietary ingredient,” Villafranco says. “Kra- ities with a likely focus on products making of unapproved kratom-containing drug prod- tom marketers are making very strong claims express disease-treatment claims—as for, say, ucts with unproven claims to treat cancer and related to cancer, diabetes, blood pressure, cancer or epilepsy,” Prochnow says. opioid addiction and withdrawal, relieve pain, chronic pain, improved immune response, Th e upshot: FDA has issued roughly 20 warning letters to companies selling products that contain CBD, but in each letter it’s the companies’ explicit disease claims that STEPPING FDA takes exception to. “Th ey’re less likely to take action against companies making either structure-function claims or no claims at all,” Prochnow notes. Creativity In any case, opponents are running out of reasons to justify CBD’s continued prohi- Pomegranate Hibiscus Tea bition. “As more information comes out, it seems it’ll be harder for FDA to keep CBD off Refresh and Recharge with shelves,” Prochnow predicts. “Obviously, the age-old view of marijuana and cannabis as Hilmar Whey Protein ‘dangerous drugs’ is continuing to evolve as more states legalize it.” Still, he counsels companies to “proceed with some caution.” With FDA telegraphing its focus on disease claims, he suggests that companies pressing the issue pay careful at- A drink that quenches thirst and provides energy? tention to labeling and advertising eff orts. It’s the sweet spot for consumer demand. And it’s “Th is is probably the most changing area of deliciously, nutritiously possible when the drink is regulation and enforcement in the FDA spec- fortified with Hilmar Whey Protein. trum,” Prochnow says. “Weekly, if not daily, we see new announcements about congressio- Let’s get creative. We can show you how to use nal bills being passed. FDA regulation—the whey protein in beverages. Create drinks with status quo now—will likely not be the status on-trend specialty flavors like pomegranate quo at year’s end.” hibiscus tea and fortify with whey protein for valuable nutrition and functional benefits. Kratom If you haven’t heard of kratom, you haven’t Whey protein delivers: been paying attention. After all, says John Hunger satisfaction E. Villafranco, partner, Kelley Drye & War- %XLOGLQJEORFNVIRUOHDQPXVFOH ren LLP (Washington, DC), “It’s all over the Functional benefits including clarity, solubility news.” and clean flavor Known botanically as Mitragyna speciosa Korth., kratom is a tropical plant in the coff ee family native to Southeast Asia with a long history of medicinal use for its purported stimulant eff ects at low doses and sedative ones at high. Advocates praise it as a pain killer, diarrhea medicine, recreational drug, Whey Protein Lactose Milk Powder and even treatment for opioid addiction. Yet, says Villafranco, “Kratom has a very © 2018 HILMAR INGREDIENTS loyal and vocal following, as well as powerful Learn more at hilmaringredients.com or give us a call: 209.667.6076 adversaries.” As evidence of the latter, FDA

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 57 Regulatory

stroke treatment, neurological disease treat- While the compound occurs naturally ment, and mood enhancement,” he says. Such in everything from coff ee and chocolate to claims lie outside the structure-function realm kola nut extract, when added to a cola-type that law permits for dietary supplements. beverage as an ingredient, caff eine falls un- Complicating things further is kratom’s der the strictures of the Federal Food, Drug presence in the opioid treatment space, and Cosmetic Act. And per that act, caff eine which Villafranco calls “a lightning rod, con- in amounts not exceeding 0.02% (200 ppm) sidering the extent of this country’s opioid is considered generally recognized as safe epidemic.” Because FDA considers kratom (GRAS). an opioid analogue, the agency believes it “Th is doesn’t mean you can’t use it in oth- may actually contribute to opioid addiction er products,” Prochnow notes, “but it must rather than help curb it, Villafranco adds. be established as GRAS through the GRAS unimaginable that they’d be the subject of Six states have already banned kratom, self-affi rmation process to go into use le- regulatory skepticism. and it wouldn’t surprise Villafranco “to see gally.” And that’s precisely what a number of But on the other, it might be precisely their that list grow in future months.” But don’t companies have done. success that has watchdogs looking more discount the substance’s “fi ercely loyal fol- But within the past few years, concerns closely at these “good gut bugs,” and at how lowing,” he argues. “Industry groups estimate have surfaced in Congress questioning caf- marketers are formulating with them and there being 3 to 5 million kratom users na- feine’s presence in applications ranging well disclosing information about them. tionwide, and they’re organized. Just last beyond the usual territory of coff ee, tea and, Notes NSF’s Laman, “From a certifi er’s week, the Kratom Community Grassroots, a as Prochnow calls it, “soda pop.” And though perspective, labeling and safety substantia- nonprofi t advocacy organization, led a week detractors initially set their sights on all caf- tion for products formulated with probiotics of advocacy on Capitol Hill. Th ey appear to feinated products, their eff orts eventually may be inconsistent from brand to brand.” have a head of steam and aren’t shying away shifted to those marketed toward children, But absent direction on how best to eval- from a fi ght. So we shall see.” with calls to limit levels, implement warn- uate the acceptability of probiotic dietary Is FDA’s concern justifi ed? “Hard to say ings, and impose other restraints in tow. ingredients, she says, “supplement brands until we’ve seen the science,” Villafranco But congressional and media attention may consider it a pass to create their own concludes. “Certainly, a lot of consumers notwithstanding, “FDA has essentially come standard. Th is could lead to probiotics be- swear by kratom products. But their en- out and stated that caff eine in amounts ing used in supplement formulations with dorsement isn’t enough. Government agen- around 400 mg or less per day is not unsafe potentially inadequate substantiation that cies need to evaluate the substantiation. So for healthy adults,” Prochnow says. Prioritiz- they’re legal dietary ingredients, or that the do marketers considering taking a kratom ing safety over scare tactics, the agency tar- strains are reasonably expected to be safe at product to market. Th ey’ll need to rely on geted caff eine in alcoholic beverages as non- the recommended daily dose.” competent and reliable scientifi c evidence GRAS (see above re: Four Loko), and more So trade associations and regulators to make health claims. And they’ll need to recently took action against makers of highly worldwide are reaching the consensus that comply with the law if they insist on making concentrated forms of caff eine powder, cit- probiotic ingredients “should be labeled,” drug claims.” ing safety concerns. Laman says, “and that risk associated with Ultimately, though, FDA’s greater interest exposure should be mitigated at the strain Caffeine was in stemming the potential proliferation level.” Meanwhile, industry and certifi ers of caff einated products across categories, continue to work with regulators “toward including snacks, syrups—“even foods like clear guidance on probiotics in an eff ort waffl es,” Prochnow says—with the theory to relieve the confusion that supplement being that consumers would have a harder brands are experiencing.” time keeping track of their daily intake if the compound were coming at them from SARMs all directions. Because the desire to grow fi tter and strong- As for whether the concerns have merit, er with a minimal input of eff ort is likely Prochnow believes that those related to al- universal—and maybe even inevitable— cohol, children, and high concentrations do. there will always be a market for products “Otherwise,” though, “at some point, we have that contain ingredients like SARMs (selec- to let people regulate themselves.” tive androgen receptor modulators). Demonstrating a fl air for understatement, But while these steroid-like compounds Prochnow describes caff eine’s regulatory Probiotics are no stranger to performance-enhanc- history as “very interesting.” He can say that Probiotics have been such a supplement ing products, they’re also associated with

again. success story that, on one hand, it’s almost such safety concerns as liver damage and SHUTTERSTOCK.COM/ DMITRIJ SKOROBOGATOV ISTOCKPHOTO.COM/ROYALTYSTOCKPHOTO

58 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK FDA REGISTERED / cGMP / USP • EP • JP • FCC • ACS

We are the leading supplier of high purity Calcium, Magnesium and Zinc Citrate

At Jost Chemical Co. we manufacture our family of Calcium, Magnesium and Zinc Citrate products with exceptionally low levels of heavy metals. Our high purity specialty chemicals are manufactured using innovative, controlled processes that yield products that go beyond the established high purity standards.

With 30 years of experience, Jost manufactures high purity USP/EP/FCC mineral salts in cGMP compliant, FDA-registered facilities. Our products are fully reacted, consistent from lot-to-lot and meet all customer requirements.

jostchemical.com 314-428-4300 Regulatory

increased risk for heart attack and stroke. Now Senators Orrin Hatch (R-UT) and And as far as FDA is concerned, they’re un- Sheldon Whitehouse (D-RI) have intro- approved drugs, which is why the agency duced legislation that would not only issued warning letters late last year to Infan- place SARMs under the Drug Enforcement try Labs LLC (O’Fallon, MO), IronMagLabs Administration’s purview per the 2014 De- (Henderson, NV), and Panther Sports Nutri- signer Anabolic Steroids Control Act to tion (Garfi eld, NJ) for distributing products cover SARMs, but would add SARMs to the containing SARMs. list of Schedule III drugs and prohibit their

illegal import, export, manufacture, and distribution. TABLETS | CAPSULES While an analysis on Govtrack.us gives the POWDERS | GRANULATION bipartisan SARMs Control Act of 2018 a 3% chance of being enacted, the legislation has no dearth of support from within the supplement industry. In the wake of the act’s introduction BOTTLING | BLISTER PACKS in April, leaders of organizations including POUCHES the American Herbal Products Association (Silver Spring MD), the Consumer Healthcare Products Association (Washington, DC), the Council for Responsible Nutrition (Washing- CUSTOM FORMULATIONS ton, DC), the United Natural Products Alliance (Washington, DC), and the U.S. Anti-Doping Agency (Colorado Springs, CO) released a joint statement directed at the bill’s sponsors pledg- PRODUCT RESEARCH ing “to work with you and all of Congress to & DEVELOPMENT deliver a strong bill to the President.”

Kimberly J. Decker writes for the food and nutrition industries from her base in the San GMP Registered vestanutra.com Francisco area, where she enjoys eating food Tel: 317.895.9000 | Fax: 317.895.9340 | [email protected] as much as she does writing about it. SHUTTERSTOCK.COM/PETEJERKK

60 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK who knows their way around a particle? — we do.

Blending. Agglomerating. Spray drying. Chilsonating. Instantizing. Granulating, and more. Pharmachem, a division of Ashland, has a breadth of processing and formulation capabilities to solve your toughest product development challenges. With more than 35 years of expertise, we also offer: o custom formulation o premix and fortiﬁcation o DTH (drum-to-hopper) o custom processing of USP and value-added vitamins and minerals o packaging of custom food and beverage powders o raw material sourcing

ashland.com/blend9

RECALL READINESS

How ERP systems help companies mitigate risk and vet their recall preparedness.

BY DANIEL ERICKSON, PROCESSPRO

ecall is a word that no one in the Control and Prevention estimate that one product or raw materials used to create the manufacturing industry wants to in six Americans get sick each year from end product. Recalls are most common due R 2 hear. In addition, the negative atten- foodborne illnesses. to a defect or safety concern, including due tion that social media can circulate adds an- Mitigating the eff ects of a recall or prevent- to undeclared ingredients or allergens, in- other dimension of fear over a recall incident. ing recalls from happening in the fi rst place adequate plant safety, mislabeled products, Disparaging tweets, unfavorable Facebook is essential. Being prepared is critical, and it’s cross-contamination, or lack of temperature posts, or poor online reviews can project un- imperative your manufacturing company has control. Th e procedures involved in execut- desirable information about your products an eff ective recall management plan and solu- ing a recall are tedious, thorough, and in- and company out of your control, production in place to identify and reduce unneces- volve oversight by the FDA. ing long-lasting eff ects brought on by loss of sary risks in your organization. Your company needs to be proactive trust and/or tarnishing the company’s brand rather than reactive in addressing safety well into the future. Recalls Deﬁ ned concerns. It’s important to ensure unsafe Unfortunately, recalls are not uncom- Product recalls involve retrieving a batch products are removed from store shelves and mon. FDA issued over 9,000 product recalls or entire production run of an end product, reported per regulatory standards in a timely in 2017.1 In fact, the Centers for Disease usually involving a lot or many lots of the manner. SHUTTERSTOCK.COM/MICHAIL PETROV

62 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK ARE YOU READY FOR YOUR NEXT GMP AUDIT?

NSF’s expert trainers give you the tools to build a highly qualified team. View GMP training courses near you: www.nsf.org Prepare

Recall Costs 1. Utilize Effective Tools resolve any communication issues through Recalls happen to even the most con- Ensure that you have a documented, FSMA practice is key. Once in place, a plan can scientious of companies; yet, it is how a compliant Food Safety Plan. A recall proce- help to drive the recall process and deliver company responds to a recall that makes dure should include integral components consistent and timely company messages a diff erence in mitigating negative blow- such as an appointed and properly certifi ed to the appropriate individuals. Th ese ele- back. Failure to handle a recall eff ectively coordinator, traceability procedures, contact ments should be included in the communi- has serious consequences both fi nancially information for regulatory agencies and le- cation plan: and legally. Being unprepared leaves your gal counsel, sample notifi cation letters for company open to risks and potential liti- media and retailers, and access to a current • Identifi cation of stakeholders aff ected gation, including the inability to recall a list of customer purchase history. A chain of by a recall, both internal and external product, untimely recall handling, or lack command should also be designated to es- • Clearly defi ned communication meth- of compliance with governmental regula- tablish protocols and accountability for im- ods and updated contact information tions, all causing potentially devastating plementation of the plan. • Detailed responsibilities for each consequences. An industry-specifi c ERP (enterprise re- communication team member Even with the most comprehensive resource planning) software solution is a vital • Key messages that address disposal call management plan, both direct and tool in recall preparedness and eff ective man- procedures, risks, and concerns indirect costs can occur. Direct expens- agement. ERP can assist with helping to pre- • Press release templates and other es include laboratory testing, production vent and execute a product recall. A real-time, communication channel templates stoppage, overtime pay, legal penalties, integrated software with full forward and • Document procedures for notifying class action lawsuits, managing the return backward lot traceability and allergens track- regulatory bodies and disposal of aff ected products, and ing saves time and eliminates errors caused post-recall marketing eff orts to lessen the by manual methods and disparate systems, Having a communication plan in place pri- negative eff ect on your company’s repu- providing timely identifi cation and location of or to a product recall allows for the effi cient tation. Indirect monetary eff ects include possible contaminants. and eff ective sharing of critical information erosion of customer confi dence, stock An ERP system can help you achieve end- to necessary individuals. An ERP solution price instability, and loss of brand loyalty to-end traceability, maintaining a compre- retains contact information of stakeholders and future sales—all costing your compa- hensive record that tracks ingredients and and regulatory bodies and detailed data re- ny in unquantifi able ways that will require products throughout the supply chain using cords, including purchase orders, bills of lad- damage control. barcode scanning, linking product and lot ing, CofAs, and shipping information to eas- information to batch tickets, shipping doc- ily identify aff ected outlets and consumers. Consumer Attentiveness uments, and labels. Certifi cates of analysis Consumer are increasingly growing aware— (CofAs) and quality-control tests can be gen- 3. Perform Mock Recalls and concerned—about safety in the food erated to bolster preventative measures in Th e importance of mock recalls cannot be supply chain. Health demands from the production, ensuring product consistency. stressed enough. Th e adage “practice makes public further highlight the need for recall ERP functionality supports current Good perfect” is truly applicable in this setting. preparedness to meet supplier, retailer, and Manufacturing Practices (cGMPs) and FDA Even though regulatory requirements do not regulatory expectations. requirements and industry regulations with require a company to conduct mock recalls, Pressure to meet these rising expec- the ability to manage and retain detailed in- they’re a crucial component of your compa- tations has become a focus of compa- ventory information, allowing raw materials ny’s preparedness plan and should be con- nies as they strive to foster transparency and fi nished projects to be located quickly sidered a best practice for process manufac- throughout their manufacturing opera- within the fi rst maximum 24-hour time pe- turers. With an integrated ERP system at the tions. Consumers are oftentimes the driv- riod of a product recall. helm to guide the mock recall process, you’re ing force behind increased governmental able to test and refi ne plans regarding recall regulations as their knowledge prompts 2. Develop a Communication Plan procedures. legislative change regarding the quality, Th e value of communication is often over- Simulated exercises test recall procedures, safety, and health benefits of products looked, but its impact on recall preparedness the goal being the ability to locate 100% of consumed. Today’s increasing connectivi- is immense. Failure to address proper com- designated products within the assigned ty of consumers makes them a voice to be munication channels can have devastating timeframe and notify interested parties. Em- heard by all manufacturers. consequences, worsening the impact of a ployees also have the opportunity to familiar- product recall on your brand and reputation. ize themselves with procedures and respon- Recall Prep: As Easy as 1, 2, 3 Establishing a sound and comprehensive sibilities within the plan. To institute a successful recall, three steps communication plan that details recall ef- While a successful simulation involves be- must be taken to mitigate risk and plan for forts to all stakeholders and that involves ing able to locate all contaminated products the possibility. ways to test the plan’s eff ectiveness and and notify clients, vendors, and government

64 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK agencies quickly, ideally the goal is to identify References 2. Centers for Disease Control and Preven- trouble spots to improve the plan. Conduct- 1. FDA. “FDA Enforcement Statistics tion. “Estimates of Foodborne Illness ing a mock recall identifi es issues, mistakes, Summary Fiscal Year 2017.” www.fda. in the United States.” www.cdc.gov/ and defi ciencies of the plan and allows your gov/downloads/ICECI/Enforcemen- foodborneburden/2011-foodborne-esti- company to refi ne the key personnel, pro- tActions/UCM592790.pdf. Accessed mates.html. Accessed August 2018. cesses, and the communication plan. Mul- August 2018. tiple mock recall simulations may be necessary to solidify procedures. Your organization should develop a schedule for regular performance of mock recalls to evaluate the recall plan’s eff ectiveness.

Recall Ready An industry-specifi c ERP solution supports the following for recall preparedness:

• Full forward and backward lot traceability • Allergen tracking • In-process quality-control testing • Historical data recordkeeping, including batch tickets, bills of lading, CofAs, and shipping documents • Easy identifi cation of possible contaminated products and batch tickets • Real-time location of raw materials and fi nished goods • Mock recall practices

With the time, money, and eff ort you’ve expended to bring your company’s products to market, it’s important to make sure a recall doesn’t destroy your eff orts. Implementing proactive measures and crafting a well man- aged response plan prevents recalls and saves lives while allowing your brand to continue to thrive. With eff ective tools, a detailed communication plan, and utilization of mock recalls, you’ll have a well-thought-out, well-executed plan to succeed and remain competitive in the marketplace in the event of a product recall.

Daniel Erickson has been with ProcessPro since 1999. As ProcessPro product strategy manager, Erickson focuses on driving overall market success by ensuring products meet both current and future market demands. His diverse experience with the customer base within the food, beverage, nutraceutical, personal care, pharmaceutical, cannabis, and chemical industries within ProcessPro provides a strong foundation for his position.

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 65 Testing

PUTTING Ingredients to the Test

The need for quality assurance in the dietary supplements industry is more important than ever before. Here is a primer on the basics of high-quality testing.

BY JUSTIN BATH, PRESIDENT, BIOVATION LABS

Test. Th e word itself can raise blood pres- Partnering with contract manufacturers responsible for establishing limits for the sure and bring back unbidden memories of brings several benefi ts, not least of which types of contamination that may adulterate unprepared students awaiting the scores of is that these companies are, or should be, or lead to adulteration of the fi nished batch their high school chemistry exams. Out in the familiar with the proper processes and proof the dietary supplement. “real” world, particularly in the natural prod- cedures required to comply with the regula- Th ese cGMPs are designed to prevent the ucts industry, the word test means some- tions governing these products. Such com- inclusion of the wrong ingredient, the addi- thing completely diff erent. It means trust; it pliance should be second nature to them. tion of too much or too little of an ingredient, means quality; and above all, it means safety. the possibility of contamination, and the im- Nutraceutical and dietary supplement Good Manufacturing Practices proper packaging and labeling of a product. makers are responsible for manufacturing As part of its dietary supplement current Th e manufacturer must then ensure that the the highest-quality products possible. As good manufacturing practices (cGMPs; 21 tests and examinations they use to deter- more companies recognize the need for CFR 111), the U.S. Food and Drug Adminis- mine whether these specifi cations are met heightened quality assurance, there has been tration (FDA) says that to ensure the quality are based on appropriate, scientifi cally valid a widespread shift wherein more fi rms are of the fi nished product, manufacturers are methods. (21 CFR 111.75) choosing to partner with contract manufac- responsible for establishing specifi cations turers who can help handle and manage the for identity, purity, strength, and compo- Deﬁ ning Test manufacturing and testing of high-quality sition related to components of dietary What is interesting is that these cGMPs do not products. supplements (21 CFR 111.70). Th ey are also dictate which specifi c tests and examinations SHUTTERSTOCK.COM/KPG_PAYLESS

66 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Muscles, Meet myHMB®

Train harder. Recover faster. Get the edge.

This allows athletes Muscles, to retain more lean ® muscle mass between each Meet myHMB workout, spend less time repairing damaged muscles, and attack their MyHMB® is unrivalled in its ability to accelerate next workout sooner and stronger. recovery time after intense training sessions. Supplementing with myHMB® has been shown to help build and maintain lean muscle mass, HMB (scientiﬁcally known as beta-hydroxy- increase strength, improve both recovery time beta-methylbutyrate) improves recovery by and body composition. simultaneously boosting muscle protein synthesis and decreasing muscle protein breakdown. Learn more at www.myHMB.com

TSI Group Ltd. and Metabolic Technologies, Inc. believe in the power of synergy which is why we have combined expertise to create the highest quality, clinically substantiated, nutritional products that maximize and maintain active, healthy lifestyles for consumers. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Testing

a company should use to substantiate that es- • SNIF-NMR (site-specifi c natural iso- For heavy-metal testing, one method used tablished specifi cations are met, only requir- tope fractionation–nuclear magnetic is inductively coupled plasma mass spec- ing that test methods be appropriate (fi t for resonance) trometry, or ICP-MS. Th is is an analytical purpose) and scientifi cally valid. Perhaps un- • IRMS (isotope ratio mass spectrometry) technique used for elemental determina- surprisingly, because margins can be thin and • Wet-chemistry methods tions. It is performed by ionizing a sample competition fi erce, some manufacturers, even with inductively coupled plasma and then contract manufacturers, take half-measures Purity using a mass spectrometer to separate and or skip critical tests in an eff ort to save money. If a contaminated product makes its way into quantify those ions. consumers’ hands, a number of problems can What to Test for arise, some potentially harmless and some Strength For those responsible companies seeking potentially deadly. When the contamination Testing for strength is testing to determine high-quality, fi t-for-purpose test methods, could cause a product to result in harm if con- how much of the active ingredient is present the following are examples of what is in- sumed, the product is deemed adulterated. in a particular dosage. Testing for strength is volved when testing for identity, purity, According to the Dietary Supplement Health performed by HPLC. HPLC measures how strength, and composition. Education Act (DSHEA) of 1994, adulteration much of an active ingredient is present. of a dietary supplement occurs when: Identity Composition Identity testing means testing to make sure • A product presents a signifi cant or Each component of a dietary supplement the raw material in hand is what it’s claimed to unreasonable risk of illness or injury needs to be verified to ensure what is be. Th e way to test for identity is to compare a under conditions of use recommend- listed on the label matches what’s in the sample of the raw material against a reference ed or suggested in labeling, or even bottle. There are two categories of supple- standard of that raw material. Th is is often ac- if no conditions of use are suggested ment component: 1) dietary ingredients, complished by using Fourier-transform infra- or recommended in the labeling but and 2) non-dietary ingredients. red spectroscopy (FTIR). when the consumer uses the product DSHEA defi nes the fi ve categories of sub- FTIR is used to make a qualitative match. under ordinary conditions of use stances that qualify as dietary ingredients: A beam comprising many frequencies of light • Contains a new dietary ingredient a vitamin; mineral; herb or other botanical; at once is shined at the sample. FTIR meas- (NDI) for which there is inadequate amino acid; or a dietary substance used to ures how much of that beam is absorbed by information to provide reasonable supplement the diet to increase the total the sample. Next, the beam is modifi ed to assurance that such ingredient does dietary intake of a nutrient; as well as a con- contain a diff erent combination of frequen- not present a signifi cant or unrea- centrate, metabolite, constituent, extract, cies, yielding a second data point. Th is pro- sonable risk of illness or injury or combination of any of the above ingredi- cess is repeated several times to infer what • Regulators declare that a product ents. Non-dietary ingredients, on the other the absorption is at each wavelength. poses an imminent hazard to public hand, include ingredients like fi llers, artifi - Th is process compares the sample’s test health or safety cial colors, sweeteners, fl avors, or binders. results with the test results from a refer- • Th e product is or contains a dietary Testing requirements for dietary and ence standard. Th e reference standard can ingredient that renders it adulterated non-dietary ingredients are diff erent. either be an internally provided standard or Non-dietary ingredient suppliers must be be obtained from an outside, independent Purity tests look for contamination to en- validated and approved by a manufacturer. standard provider, such as the United States sure there are no microcontaminations or Dietary ingredients are generally tested in Pharmacopeia (USP). Th e USP standardizes metals. Th ese include tests for yeast, mold, a qualifi ed laboratory to ensure they meet many types of raw material samples, which chloroform, salmonella, E. coli, and heavy standards and specifi cations. manufacturers can use to verify the identity metals. of the sample raw materials they have. Full-panel tests for microorganisms like Testing Processes Other tests that can satisfy the Dietary E. coli, yeasts, molds, etc., are well advised. It is important to note that cGMPs require Supplement cGMP identity-verifi cation re- Tests can be carried out to determine a total testing at the beginning and at the end quirements include: number of organisms on a surface, device, of manufacturing, as well as in-process. or instrument, or in a product. A surface is Also, while contract manufacturers should • HPLC (high-performance liquid swabbed to collect bacteria. Th e collected be following the testing protocols listed chromatography) material is measured (counted) against a above, nutritional supplement brand own- • TLC (thin-layer chromatography) standard. A count lower than the standard ers are ultimately responsible for confi rm- • NIR (near-infrared spectroscopy) indicates no danger; a count higher than the ing that products produced under its label • Organoleptic testing standard indicates the opposite. Tests in- conform to FDA’s requirements. Th e brand • ELISA (enzyme-linked immunosorbent clude, but are not limited to, sterility, general owner can be held responsible for selling assay) microbiology, and bioburden testing. non-conforming and/or adulterated prod-

68 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK uct, so it is important that companies • Finished-goods validation and test- common adulterants, toxic adulterants, al- choose a contract manufacturer carefully. ing (purity, potency, strength, and lergens, and fi llers. Understanding the requirements as composition) Moving forward, tests such as DNA se- outlined in 21 CFR Part 111 is essential for quencing with real-time (qualitative) poly- anyone producing a nutritional supple- Finally, it is important for a brand to en- merase chain reaction testing (PCR) will help ment. Choosing the right manufacturer sure that its chosen manufacturer follow all to continue to propel individual products as is an important part of the process, and cGMP processes before releasing fi nished well as the entire industry towards greater all brands should ensure they are prop- goods. Understanding and auditing how levels of safety and quality. erly educated on the FDA requirements. products are released at multiple stages in Below is a list of some of the most basic the manufacturing process will help any Justin Bath is president of Biovation Labs, testing requirements a brand should un- brand provide the highest-quality product a contract manufacturing, formulation, pri- derstand when producing nutritional sup- possible. vate label, and supplier company serving plements. (Note: this list is not intended the natural products industry. Th e company to be all-inclusive.) The Future of Testing works within the life science space, manu- Just like in high school, more tests are on facturing products for supplement and nu- • Raw material validation and test- the way. For instance, NSF International traceutical companies worldwide. Its new ing (purity, potency, strength, and recently launched an independent testing 104,000-sq-ft corporate headquarters hous- composition) protocol and verifi cation program for raw es a state-of-the-art, high-capacity manu- • Production testing to ensure all equip- botanical ingredients used in the dietary facturing facility serving the needs of both ment is clean and properly calibrated supplement industry. Th is protocol not large and early-stage companies. Biovation • In-line checks at regular intervals to only utilizes advanced DNA authentication Labs follows cGMP standards. For more in- confi rm lots and batches are being of the target species, the testing program formation, visit www.biovationlabs.com. produced to specifi cation also screens for contamination, including

Content Licensing for Every Marketing Strategy Logo Licensing | Reprints | Eprints | Plaques

Marketing solutions fit for: t Outdoor t Tradeshow/POP Displays t Direct Mail t Social Media t Print Advertising t Radio & Television

Leverage branded content from Nutritional Outlook to create a more powerful and sophisticated statement about your product, service, or company in your next marketing cam- paign. Contact Wright’s Media to find out more about how we can customize your acknowledgements and recognitions to enhance your marketing strategies.

For more information, call Wright’s Media at 877.652.5295 or visit our website at www.wrightsmedia.com

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 69 Quality

PLANNING for Quality How a Quality by Design model can beneﬁ t the dietary supplements industry at large

BY JENNIFER GREBOW, EDITOR-IN-CHIEF

uality by Design (QbD) is a qual- the ingredients fi lling a capsule. In this • Identity: Is the ingredient actually ity-assurance model centered scenario, how does a QbD model fi t in? what the supplier says it is? Qon preemptively building in QA Davis: An integrated supply chain is • Strict purity criteria controls from beginning to end. QbD has the foundation of quality. Each unit con- • Impurity limits to include contami- captured the interest and following of tributing to the product—internally and nants, elements, and solvents global industries, including automotive externally—must be unifi ed and aligned • Viral safety guarantees for animal-de- and pharmaceutical, as well as the atten- on product and testing expectations. Th ey rived ingredients (in our case, bovine tion of regulators worldwide. partner together to improve performance. for capsules) Christen Davis, director of quality, Lonza Th e cornerstone of a QbD model is to • Biological safeguards as it relates to Consumer Health & Nutrition (Greenwood, clearly defi ne expectations with partners— GMOs SC), recently talked to Nutritional Outlook and then require that they are met. For ingre- • Controlled use or absence of allergens about how Lonza Consumer Health & Nutri- dients, Lonza CH&N searches out raw mate- tion has implemented QbD, what it entails, rial suppliers who understand the regulatory Th e clearly defi ned standards can be ap- and how this model can benefi t all dietary guidelines for safety and effi cacy. Manufac- plied to each and every supplier. Th e supplier supplement manufacturers. turers should do the same. We want to know should not be used unless it can meet these we are receiving what we ordered, and so specifi cations with very little variation. Th is Nutritional Outlook: As a capsules suppli- should any supplement manufacturer. One can weed out any bad apples and ensure con- er, Lonza Consumer Health & Nutrition way to ensure this is to outline contractually sistency of product for a manufacturer. sources the ingredients required to pro- enforceable purchase specifi cation stand- duce its capsules and also, through cap- ards based on worldwide regulations and What kind of quality assurance challenges

sule fi lling, often has an extended view of guidelines. Some of the key standards are: has your company observed in the market? SHUTTERSTOCK.COM/SISACORN

70 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK

Quality

Davis: In a QbD operation, all divisions Davis: Lonza CH&N follows several key and qualifi cation process to make sure they are integrated and all are functioning at the steps in the verifi cation of a supplier from meet the most stringent regulatory and in- top of their games. But challenges will and any region of the globe to assure the supplier dustry standards that exist anywhere in the do arise. Here are some examples of what we meets our stringent cGMP screening that the world. Here are the fi ve components: have seen and heard—and our thoughts on material supplied is safe, pure, and eff ective. solutions. It includes: • Preliminary investigation: reviews the supplier’s quality system, state Capsule filling: When customers run • Creating a purchasing specifi cation of manufacturing technology, and their own capsule-filling operation, high- based on a validated method and as- scope of products and services of- er levels of defects can surface, ranging suring the supplier can meet it fered and determines the supplier’s from ingredient leakage to cracked cap- performance metrics in details sules. This can slow down filling speed and reduce yield, leading to waste and “Th e cornerstone of • Manufacturing-suitability eval- downtime. These issues can be solved uation: assess the crucial issue with a QbD approach to matching the a Quality by Design of whether the supplier’s raw ma- capsule-filling machine with the right cap- terials is compatible with Lonza sule for the specific density and dosage model is to clearly defi ne CH&N’s manufacturing processes amount for the ingredient. expectations and protocols Audit readiness: Unplanned audits can with partners—and then • Production trial: use of suppli- be tense. But an unexpected visit from a er’s raw material in large-scale, regulatory agency can be anticipated and require that high-volume production trials at “planned” for if a company sets up an In- various Lonza CH&N sites to con- ternal Audit Program (IAP). Th e IAP is a they are met,” says fi rm both fi nished capsule quality self-policing system that ensures cGMP re- and manufacturing effi ciency per- quirements are met at every step. Th e IAP Christen Davis, formance levels is a list of items checked and reviewed on a regular schedule. Th e checklist helps iden- Lonza Consumer Health • Onsite audit: full traceability exercise tify what is working and what is not work- and quality system check to ensure ing and needs to be corrected immediate- & Nutrition. compliance with applicable and Lon- ly. It also signals what could potentially za CH&N standards go wrong, spurring preventive action to minimize corrective action. Red fl ags can • Th orough review of all documenta- • Acceptance contract: formalizes the be raised by the trends that emerge in reg- tion and descriptions of manufactur- technical and commercial require- ular periodic reports from internal tracking processes ments and expectations, including ing of the records kept by various divisions. • Obtaining certifi cations from third both initial scale-up support and on- When all departments and supporting op- parties like NSF cGMP, ISO 9001- going quality erations are on constant lookout for issues 2015, etc. as they arise, quality can be reinforced • Obtaining three consecutive lots of Once suppliers are selected and qualifi ed, daily and a culture of “readiness” for audits materials to test against the purchas- we consistently monitor them to ensure can be cultivated. ing specifi cation ongoing quality. Th e evaluation process • Performing onsite audits assures supply chain traceability and fi n- Laboratory and manufacturing opera- ished capsules that comply with the highest tions: Cleanliness and organization is im- All our vendors must go through the same standards. Th e management involves con- perative to ensuring a succinct quality pro- level of scrutiny and meet the same stand- stant testing and regular in-depth onsite gram. When labs or operations are not using ards as part of FDA guidelines. audits. organized techniques, it only leads to more As already stated, Lonza CH&N insists on questions. security of capsule raw material. Our Sup- How do these insights and quality-control plier Selection and Qualifi cation Program best practices benefi t the customers that How can your company’s Certifi ed Vendor guarantees that our hard capsules meet the work with the company? Program serve as a model for enhancing highest standards for quality, traceability, Davis: Lonza has created white pa- quality and legal compliance? Can you de- and integrity. Th is core fi ve-phase program pers about its CVP and other quality in- scribe some of the most important steps requires critical key raw materials suppliers itiatives. These have been shared directly in such a program? to undergo an intensive, year-long selection with customers at trade shows and face-

72 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Th e investment in a quality system can save a business money as well as yield dividends for reputation and business growth in the long run. to-face meetings. In addition, they are Why is it important for everyone in the available for review on our website and supply chain, from the ingredient suppli- through online trade publication expo- ers to the dosage provider to the contract sures. We also offer to directly pass on manufacturer and the marketers them- our knowledge to our manufacturing cus- selves, to have a solid quality-control pro- tomers by showing them how to integrate cess and to consider implementing a QbD processes from a QbD model to their op- model? erations where appropriate. We partner Davis: First and foremost, because this with them to establish processes that will is how to best serve the consumer. If all help them to become more self-sufficient suppliers are in sync with quality-control and successful. Our Quality Engineer- processes, specs, and criteria, products ing Services (QES) can collaborate with can not only meet consumer expectations them through the entire manufacturing but work to exceed them. A brand can cul- process, from receiving raw materials to tivate a reputation for going far beyond supplement applications and production Acceptable Quality Levels and race far to improving capsule-filling productivity ahead of their competition. Consumers to bolster profits. will catch on and keep spending for top- As a more specific example, we can notch products that are known to be safe conduct an audit of a manufacturer to and effective. assist them in setting up a regulatory Integrated quality controls throughout foundation for their operation. We also the entire supply chain allow a manufac- embrace customer audits and visits to turer to be “audit prepared” at all times. our facilities to educate and openly show This is very good for business. Knowing them our quality processes to better un- their products would comply to regula- derstand them so they can more easily tions with flying colors, a manufacturer adapt them to their own businesses. On- and brand can remain consistently com- site visits help us both keep ahead of the petitive because their products can be re- latest regulations and be “audit prepared” leased to markets confidently and quickly, at all times. without worries of shutdowns or recalls Finally, through spearheading and host- due to consumer complaints or unplanned ing an annual Quality Summit, Lonza has visits from regulatory bodies. stepped onto the national podium as a A solid quality-control process is more quality torchbearer and industry educa- economical. Sure, there are upfront time tor. At the events, we share our practices and monetary expenditures to set up pro- in presentations and Q&A panel discus- cesses and certify vendors plus ongoing sions. We also bring together quality in- outlays for upkeep and monitoring. But dustry leaders to voice their opinions and consider how expensive it can be without fresh thinking about how to assure qual- such controls. Th ere can be costs for de- ity, adapt to regulatory challenges, man- fects of products already released, product age risk, and develop best practices. The waste, unproductive labor, and excessive August 2017 summit hosted 80 quality testing, as examples. professionals from North America at our From this vantage point, the investment Greenwood, SC, manufacturing headquar- in a quality system can save a business ters for the Americas. In October 2018, money as well as yield dividends for rep- Lonza will host another Quality Summit utation and business growth in the long in Greenwood. run.

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 73 RESEARCH UPDATE

Saffron Extract Improves symptoms, separation anxiety, social phobia, in epidermal water loss. A subjective visual Depression and Anxiety in and depression, compared with the placebo and touch assessment of non-irradiated skin Teenagers group. Parental reports of improvement in yielded higher scores following astaxanthin. Results from a new study indicate that saf- the subjects’ mental health were inconsis- While the skin parameter improvements fron (Crocus sativus L.) may help reduce de- tent. Th e researchers thus concluded that are believed to result from astaxanthin in- pression and anxiety symptoms in teenage “administration of a standardized saff ron ex- take, the company claims that its patented children. Th e fi rst-of-its-kind study found tract (Aff ron) for eight weeks improved anx- dispersant technology may have also been that supplementation with Aff ron, a brand- iety and depressive symptoms in youth with an important factor. Th e company says its ed saff ron extract from biotechnology fi rm mild-to-moderate symptoms, at least from technology has been shown to improve as- Pharmactive Biotech Products (Madrid), im- the perspective of the adolescent.” Aff ron was taxanthin absorption in the body. proved feelings of separation anxiety, social also found to be safe and well-tolerated. Th is latest study banks on previous animal phobia, and depression in young people. Th e study authors write that while the and cell studies, as well as a cosmetic trial on Th e randomized, double-blind, place- results are encouraging, the self-reporting women,2 that have found astaxanthin may bo-controlled study1 included 68 young nature of this study represents a limitation. have sun-protecting eff ects. A weakness of people between the ages of 12 and 16 with Pharmactive Biotech Products funded the this latest study, however, is that outside mild-to-moderate anxiety or depressive study. dietary astaxanthin intake was not moni- symptoms. According to data from the tored. Th e study took place in Japan, where World Health Organization, the study au- 1. Lopresti AL et al., “Aff ron, a standardized astaxanthin-rich crab, shrimp, salmon, and thors write, psychiatric disorders including extract from saff ron (Crocus sativus L.) for salmon roe are common foods. Had these re- anxiety and depression are among the lead- treatment of youth anxiety and depressive searchers measured blood and/or skin levels ing causes of disability in young people, with symptoms: a randomized, double-blind, pla- of astaxanthin in each study participant, they as much as 15%-20% of the youth popula- cebo-controlled study,” Journal of Aff ective believe their study design would have been tion experiencing an anxiety or depressive Disorders. Published online February 26, 2018. even stronger. disorder before the age of 18. Saff ron, they Astaxanthin is believed to protect the skin add, has been shown to be eff ective in re- Can Astaxanthin Give Sun from UV damage by acting as an antioxidant ducing feelings of depression and anxiety in Protection to Human Skin? that can reach the epidermis. Th e nutrient adults with mild-to-moderate depression. Could the red carotenoid astaxanthin, which seems to protect itself from UV damage, However, saff ron for depression and anxiety makes crabs and other animals red, one day too, since it’s best grown commercially in had not yet been studied in a youth popula- be found in sun-protection products? Algat- extremely sunny environments. Still, the pre- tion prior to publication of the current study, ech Ltd. (Kibbutz Ketura, Israel) is a manu- cise mechanisms by which astaxanthin may they said. facturer of natural astaxanthin from microal- function against UV light in humans and Th e researchers divided participants into gae. Recently, FujiFilm (Kanagawa, Japan) plants are yet to be fully understood. two groups. One group received 14 mg Af- conducted a research study on Algatech’s Algatech Ltd. supplied its AstaPure astax- fron, while another group received the same astaxanthin ingredient, which is featured in anthin to Fujifi lm for this study. Its astaxan- dosage of a placebo. Both groups were in- FujiFilm’s branded supplement, Astots. Th e thin is sourced from the microalgae Haema- structed to take one tablet of either Aff ron FujiFilm researchers sought to examine what tococcus pluvialis, which Algatech grows in or the placebo twice daily for a total of eight happens to humans when their skin is ex- the Arava desert of Israel where sun is always weeks. In order to determine what eff ects posed to UV light after oral consumption of plentiful. supplementation with Aff ron had on param- astaxanthin. Results of their study1 are now eters of anxiety and depression, participants published in the journal Nutrients. 1. Kaoki I et al. “Th e protective role of astax- completed a 47-item questionnaire called Twenty-three subjects were assigned to a anthin for UV-induced skin deterioration the Revised Child Anxiety and Depression 4-mg supplement of astaxanthin or placebo in healthy people—a randomized, dou- Scale (RCADS). RCADS includes subscales daily for nine weeks. Th eir skin was irradi- ble-blind, placebo-controlled trial.” Nutri- on separation anxiety, social phobia, general ated at the beginning of the study and after ents. Published online ahead of print June anxiety, panic, obsessions and compulsions, nine weeks of daily astaxanthin intake to see 25, 2018. and depression. Subjects’ parents also com- if any skin changes would be detected. 2. Akira S et al. “Eff ects of the intake of astax- pleted the parent-report version of RCADS; According to the researchers, astaxanthin anthin on the reduction of skin darkling those results served as the secondary out- intake was associated with a higher minimal induced by UV irradiation in adult women.” come measure. erythema dose (MED), meaning the amount Pharmacometrics, vol. 80, no. 1–2 (March 7, Th e group supplemented with Aff ron re- of UV exposure required to visibly redden the 2011): 7–11 ported improvements in overall internalizing skin. Th is eff ect was linked to a reduction

74 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK got AUDIT? In this ever-changing media landscape, it’s crucial to know that the amount you invest in advertising plans WILL reach your next potential customer.

Nutritional Outlook guarantees that you are reaching 13,000 AAM-qualified subscribers per issue. In addition, Nutritional Outlook has an AAM- audited website and e-newsletters. WHAT DOES THIS MEAN TO YOU? Our AAM-audit provides you solid assurance and insight that you are reaching the right key decision-makers with your marketing message.

TO LEARN MORE. MIND AND I/shutterstock.com Tim Baudler, Brand Director Phone: 310-445-3757 [email protected]

www.nutritionaloutlook.com Source: AAM Digital Audit, June 2017 ADVERTISER INDEX

Page(s) Company Name Website or E-mail Phone Number

16 ...... AIDP Inc...... www.aidp.com ...... 866/262-6699

25 ...... Albion Laboratories Inc...... www.albionminerals.com ...... 801/773-4631

IBC ...... Alpha Packaging...... www.alphap.com...... 800/421-4772

21, 61 ...... Ashland ...... www.ashland.com ...... 800/274-5263

BC ...... Berg Nutrition...... www.bioiberica.com ...... 734/253-2231

45 ...... Bergstrom Nutrition ...... www.bergstromnutrition.com ...... 888/733-5676

14 ...... Best Formulations ...... www.bestformulations.com ...... 626/912-9998

15 ...... BioCaps Enterprises Inc...... www.biocaps.net ...... 626/575-2862

19 ...... BioCell Technology LLC...... www.biocelltechnology.com...... 714/632-1231

12 ...... California Natural Color ...... www.californianaturalcolor.com ...... 800/557-0220

27 ...... Capsugel ...... www.capsugel.com ...... 888/783-6361

47 ...... Certiﬁ ed Nutraceuticals Inc...... www.certiﬁ ednutra.com ...... 949/455-9708

49 ...... Deerland Enzymes ...... www.deerlandenzymes.com...... 800/697-8179

46 ...... Evolva ...... www.veriteresveratrol.com...... 800/250-1032

33 ...... Gold Coast Ingredients Inc...... www.goldcoastinc.com ...... 323/724-8935

39 ...... Grain Processing Corp...... www.grainprocessing.com ...... 563/264-4265

57 ...... Hilmar Ingredients ...... www.hilmaringredients.com ...... 209/667-6076

9, 55 ...... Jiaherb Inc...... www.jiaherb.com ...... 973/439-6869

59 ...... Jost Chemical Co...... www.jostchemical.com ...... 314/428-4300

3 ...... KEB Nutraceutical ...... www.kebnutra.com...... 714/990-8830

IFC...... Kyowa Hakko USA Inc...... www.kyowa-usa.com ...... 212/319-5353

11 ...... Lonza Group ...... www.lonza.com ...... 888/403-8772

65 ...... Mount Franklin Nutritionals LLC . . . . . www.mountfranklinnutritionals.com ...... 915/877-1173

63 ...... NSF International ...... www.nsf.org ...... 734/ 769 8010

73 ...... NuLiv Science USA Inc...... www.nuliv.com ...... 909/594-3188

76 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK ADVERTISER INDEX

Page(s) Company Name Website or E-mail Phone Number

52 ...... Nutraceuticals International Group. . . www.nutraintlgroup.com ...... 800/651-2587

43 ...... Nutrition 21...... www.nutrition21.com ...... 914/701-4500

36-37 ...... Prinova...... www.prinovausa.com ...... 630/868-0300

Cover, 20, 31, 71. .Sabinsa Corp...... www.sabinsa.com ...... 732/777-1111

5 ...... Soft Gel Technologies Inc...... www.soft-gel.com ...... 800/360-7484

17 ...... Synergy Flavors Inc...... www.synergytaste.com ...... 847/487-1011

67 ...... TSI Health Sciences ...... www.tsiinc.com ...... 877/549-9123

60 ...... Vesta Ingredients Inc...... www.vestaingredients.com...... 888/558-3782

6 ...... Vidya Herbs Pvt. Ltd...... www.vidyaherbs.com ...... 732/784-1587

CLASSIFIED

PROCESSING EQUIPMENT

Content Licensing for FREE Every Marketing Strategy Logo Licensing | Reprints | Eprints | Plaques IN-PLANT TRIAL MIXERS & Marketing solutions fit for: t Outdoor t Direct Mail BLENDERS t Print Advertising t5SBEFTIPX101%JTQMBZT New & refurbished t4PDJBM.FEJB t3BEJP5FMFWJTJPO with genuine OEM warranty.

Try our mobile app: Leverage branded content from Nutritional Outlook to create a more QPXFSGVMBOETPQIJTUJDBUFETUBUFNFOUBCPVUZPVSQSPEVDU TFSWJDF mixers.com/web-app PSDPNQBOZJOZPVSOFYUNBSLFUJOHDBNQBJHO$POUBDU8SJHIUT .FEJBUPöOEPVUNPSFBCPVUIPXXFDBODVTUPNJ[FZPVSBDLOPXM- FEHFNFOUTBOESFDPHOJUJPOTUPFOIBODFZPVSNBSLFUJOHTUSBUFHJFT

For more information, call Wright’s Media at 877.652.5295 1-800-243-ROSS or visit our website at www.wrightsmedia.com www.Rental-Mixers.com

NUTRITIONAL OUTLOOK ■ SEPTEMBER 2018 77 LAST BITE GOT BLUE? Why blue is the Holy Grail of natural colors in beverages

BY JENNIFER GREBOW, EDITOR-IN-CHIEF

ocial media has spurred changes good director of global food marketing for Sensient Sand bad—among them, an obsession Colors LLC (St. Louis), at this summer’s Insti- with photographing food. Today, it’s not tute of Food Technologists’ Annual Meeting enough for food to taste good; it has to look & Food Expo (IFT) in Chicago. really good. But sometimes, making food look Th ese obstacles don’t just limit natural good is hard. Take ready-to-drink (RTD) bev- blue. “Any shades that use blue have been erages. Drink makers are always searching for challenging for the industry for a while—so, vibrant, arresting colors to catch consumer purples, greens, browns, which do use blue as At the IFT show, Sensient’s Rigg said his attention, whether via Instagram or on a mar- a primary color, are a bit of a challenge,” said company has a “novel,” proprietary natural ket shelf. Th ese same manufacturers, howev- Mukul Juneja, vice president, marketing, for blue source that isn’t huito and that is stable, er, have also been tasked with using natural Archer Daniels Midland’s Wild Flavors and especially in less-acidic drinks. Rigg called colors in place of artifi cial colors—and nat- Specialty Ingredients division (São Paulo), at the source “a unique anthocyanin.” ural colors sometimes just don’t stand up to the IFT show. Its color is actually a purple that appears the look and performance of artifi cial colors, Given spirulina’s sensitivities in beverages, blueish depending on the pH range, he said. especially in a drink matrix. color suppliers have explored other sources. “It’s our source that we’ve discovered that “To be successful in beverage applications, One of them is a tropical plant called huito provides a wonderful purple—really deep natural colors need to be able to withstand (Genipa americana). Huito is said to be more grape—in the low-pH range, and it’s blue pasteurization temperatures as well as be stable in acidic pH and less sensitive to heat at the higher [less acidic] pH ranges. It’s heat and light stable at the desired pH,” ex- and light compared to spirulina. Wild Fla- a beautiful blue, more like a Blue No. 2. It’s plains Cori Satkowski, lead product devel- vors and Specialty Ingredients off ers huito more of a denim blue at higher pH ranges, opment technologist for supplier California sourced from the Amazon region of Peru as a but in the low-pH range, it will be a deep, Natural Color (Fresno, CA). blue colorant. Juneja called it “the only natu- beautiful purple.” Natural blue is often considered the Holy ral blue that’s acid and heat stable.” As for blue for more acidic beverages, Grail of the beverage industry. One of the few Huito yields a diff erent shade of blue “Today, there’s still a gap for that,” Rigg add- natural blue sources today, spirulina extract than spirulina, which Juneja said his com- ed. “It’s something we continue to look for.” (Arthrospira platensis), was FDA-approved pany also supplies. “It’s not the same blue Color suppliers continue to search for as a color additive in 2013, but spirulina shade,” Juneja said. “Spirulina is going to be sources that make business sense. “I would still struggles in acidic beverages and under a traditional, brighter blue, and huito tends say shade, stability, and cost are the areas high-heat processing. While blue is one of to be more grayish, kind of a navy shade or a we’re exploring,” Juneja said, noting that the most requested natural colors for bev- shale blue.” By using both spirulina and huito, some natural color sources may not be prac- erages, “the industry is looking for a natural he added, Wild Flavors can achieve “a great tical if they are too expensive. “You’ll see replacement to [FD&C] Blue No. 1 and No. 2 range of diff erent blue shades, and those blue more innovation in those three areas, and that can overcome the acidic pH in beverage shades then allow us to do all sorts of diff er- sometimes it’s also about modifying what applications,” Satkowski says. ent purples and greens and browns.” you already have,” he added. In acidic beverages, the color of spiruli- As a color, huito is used more as a fruit juice Are we likely to fi nd other natural sources na extract “may fade rapidly or precipitate,” than an extract and thus does not require an for the color blue in the future? When asked says Winston Boyd, PhD, technical director FDA color additive petition, companies say—a if there are a lot of untapped potential nat- at Gold Coast Ingredients (Commerce, CA). process that can take “anywhere from fi ve to 10 ural color sources in general, Juneja said, Spirulina extract “functions best at a pH be- years,” Juneja said. When asked whether one “Oh, yeah, there are tons of them. I mean, if tween 4 and 8, and it still must be protected can get the same color intensity from a fruit you think about colors in nature, most fruits from heat and light,” he explains. juice as opposed to an extract, Juneja said, “It and vegetables have unique shades. So there “In low-water-activity, fat-based systems, just depends on the strength of the color you’re are a lot of sources we have not tapped yet.” spirulina is great. As soon as you add water looking for. Sometimes the juice is not strong Maybe that’s something to chase away for- SHUTTERSTOCK.COM/BYCHYKHIN OLEXANDR or heat, not so good,” seconded David Rigg, enough, so then you may need an extract.” mulators’ blues.

78 SEPTEMBER 2018 ■ NUTRITIONAL OUTLOOK Athletes perform best when they are prepared, and more than ever before, that preparation begins and ends with pre- and post-workout supplements. As your business grows to meet this demand, you need a packaging partner who can keep pace with you while protecting the quality and reputation of your product.

Our wide range of sports nutrition packaging includes HDPE and PET jars and canisters ranging in size from 8 ounces to 2 gallons. With seven North American manufacturing locations and one in Europe, we can minimize the shipping costs to get these bottles to your ﬁ llers, and help you keep shelves stocked. Whether you deliver supplements in powder, tablet, liquid or gummy formats, Alpha Packaging has the stock product solutions to help your brand perform. We can also engineer custom packaging solutions or set your brand apart with custom colors that help it compete on retail shelves.

Be a winner in sports nutrition with plastic packaging from Alpha. For more information, visit www.alphap.com/markets/sports-nutrition.php.

Alpha Packaging 800-421-4772 www.alphap.com www.technigraph.net Stock Packaging | Custom Molding | 8 Manufacturing Locations | Custom Colors The Native Type II Collagen from Bioiberica

PROVEN EFFICACY IN JOINT HEALTH

EFFECTS OF b-2Cool®

Joint pain relief Inflammation reduction Joint function improvement

Low daily dose: only 40mg a day Proven safe and well tolerated Manufactured by Bioiberica, the joint health expert www.bioiberica.com

Berg Nutrition is the exclusive distributor of Bioiberica in the United States. For more Information, please call: Berg Nutrition (734) 253-2231 221 Dino Drive, Suite A Ann Arbor MI 48103 or mail Emily Vercammen ([email protected]) or Cai Berg ([email protected]).