Quick viewing(Text Mode)

The Modern Woman Tips for Creating, Marketing Trendy Products Geared Toward Women

The Modern Woman Tips for Creating, Marketing Trendy Products Geared Toward Women

® NATURAL PRODUCTS

A SPECIAL ALL-DIGITAL ISSUE VOLUME 5 ISSUE 21 $20.75 US September 2015 The Modern Woman Tips for creating, marketing trendy products geared toward women

R KSM-66 a s h w a g a n d h a WORLD’S BEST ASHWAGANDHA

october 05-09 MANDALAY BAY expo hall october 07 & 08 LAS VEGAS supplysideshow.com ® NATURAL A SPECIAL ALL-DIGITAL ISSUE PRODUCTS Vol. 5, No. 21 September 2015 naturalproductsinsider.com CONTENTS

5 3 Viewpoint: What Women Want Powering Superwoman 5 Women’s bodies are designed to do incredible things, e.g., create life. Rachel Adams takes a look at the top researched ingredients used to help power today’s superwomen through all of life’s stages.

Current Trends in Women’s Health 16 Kate Lloyd provides the latest information on what’s selling in women’s health, including particular areas of interest for the modern woman.

Structure/Function Claims • • 23 for Women’s Health With the increasing amount of information available on female health choices, there is no need to risk making disease claims by comparing dietary supplements to prescription or over-the-counter (OTC) drugs. Attorney Anthony Young discusses how to make legal claims in the women’s health sector.

Formulating for Breast Health: Research, 25 Ingredients and Therapeutic Targets Isaac Eliaz, M.D., offers insight on a variety of ingredients that may help prevent the growth and spread of breast cancer.

Thinking Outside the Pink Box: 29 Brand Strategies in Women’s Health In the natural health industry, women represent more than 90 percent of the spending. This indicates the women’s health market is rich with opportunity. Brandhive’s Heidi Rosenberg reveals helpful tips for successfully marketing to the female demographic. •• 32 Takeaways for Your Business

Copyright © 2015 Informa Exhibitions LLC. All rights reserved. The publisher reserves the right to accept or reject any advertising or editorial material. Advertisers, and/or their agents, assume the responsibility for all content of published advertisements and assume responsibility for any claims against the publisher based on the advertisement. Editorial contributors assume responsibility for their published works and assume responsibility for any claims against the publisher based on the published work. Editorial content may not necessarily reflect the views of the publisher. Materials contained on this site may not be reproduced, modified, distributed, republished or hosted (either directly or by linking) without our prior written permission. You may not alter or remove any trademark, copyright or other notice from copies of content. You may, however, download material from the site (one machine readable copy and one print copy per page) for your personal, noncommercial use only. We reserve all rights in and title to all material downloaded. All items submitted to NATURAL PRODUCTS INSIDER become the sole property of Informa Exhibitions LLC.

2 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com VIEWPOINT

What Women Want

et’s try to answer that age-old question: What do women want? Well, in the world of natural products, L it’s simple. We want well-researched, efficacious products that will keep us happy and healthy, address our top health concerns—stress, fatigue, depression, hormone imbalance, etc.—and help us maintain active lifestyles well into old age. Is that too much to ask? Joking aside, the category of women’s health is extremely important in the industry, as women make the majority of purchasing decisions within the average household. This rings especially true in the realm of health. Women today are researching their health products more than ever, and they’re buying from reputable brands selling items that reflect companies’ honesty and transparency. Plus, women tend to stay up-to-date on the latest health and nutrition trends, so they’re more likely to look for clean-label, organic, allergen-friendly and sustainably sourced products when shopping. I can attest to this; as a Millennial, nothing makes it into my shopping cart without a careful label inspection (sometimes even an in-store Google search for product reviews). Manufacturers and marketers of women’s health products should also consider the various needs women have during different life stages. For example, the nutritional needs of a teenager going through puberty differ greatly from a woman of child-bearing age expecting her first baby. Then there’s perimenopause, menopause and post-menopause, each of which brings its own challenges for women who hit these life stages. Hormones play a huge role in all phases, so it’s no surprise that hormone balancing has become a hot topic in recent years. And women looking to even out , progesterone and levels are turning to natural ingredients for help. In this digital issue, we’ll look at research on today’s top women’s heath ingredients for hormone balancing, including maca, Ayurvedic herbs, and cinnamon; healthy pregnancies, such as magnesium, iron and choline; and bone loss, including vitamin D, calcium and collagen. We’ll also dip into market trends, regulatory matters, formulation techniques and tips for successful marketing. There’s a lot to learn about what women want, but luckily, this digital issue can bring you closer to finding the answer—in the health realm, at least.

Read on and enjoy,

Kate Lloyd Managing Editor (480) 675 8181 [email protected] @katek_lloyd

3 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com Making A ! SplashIn Joint, Bone & Skin Health

Only AIDP’s clinically proven collagens cover you from head to toe.

KoACT® Naticol® KollaGenII-xs™ Instagen™

BONE BEAUTY JOINT BEVERAGE STRENGTH FROM WITHIN HEALTH GRADE Improves bone Fish collagen, Relieves joint pain Instantly dissolving strength over calcium improves skin appearance in 30 days collagen

*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. www.aidp.com T: 866.262.6699 [email protected] | | GMP Registered WOMEN’S HEALTH INGREDIENTS

Powering Superwoman Recapping the latest research on natural ingredients for women’s health by Rachel Adams

omen’s bodies are designed INSIDER’s Take to do incredible things. After ¾ The hormones estrogen, progesterone and all, a woman’s body can create testosterone are critical to women’s health W throughout all stages of life. life through pregnancy. However, before a ¾ A variety of research-backed ingredients can woman reaches her reproductive years, ease symptoms of menopause, PMS or other there’s puberty, and once a women hormone-related conditions. ¾ Women are prone to decreased bone health surpasses those reproductive years, in later stages of life, and can benefit from menopause sets in. Each stage of life brings ingredients such as calcium, soy and its own set of challenges: premenstrual vitamins K and D. |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| syndrome (PMS) during adolescent and adult years; and hot flashes, mood swings, fatigue, depression, irritability and changes in libido, among other symptoms, during menopausal years. Pregnancy is an entirely different ballgame. Instead of only one person’s needs to consider, now the needs of both the mother and developing fetus must be met. An expectant mother could be faced with nausea, fatigue, mood swings or constipation, while a growing baby needs specific nutrients to ensure adequate development. Hormonal stages aside, women are faced with several additional challenges that require proactive care, such as issues related to bone health, mineral deficiencies and cardiovascular health. Supplementation with natural ingredients can help women of all ages avoid both health concerns and the general discomforts that can accompany the various life stages.

Hormones—The Name of the Game Hormones are “chemical communicators” that carry messages to and from organs in the body. Various organs throughout the body secrete hormones (the pancreas, for example, is associated with insulin and glucagons). Not surprisingly, the most important hormones for women—estrogen, progesterone and testosterone—are produced primarily in the ovaries. These hormones set the stage for a woman’s menstrual cycle (including symptoms

of PMS), and are also responsible for channeling women into, IN THIS ISSUE and through, menopause. Viewpoint p. 3 Considered one of the most dramatic hormonal changes for Market Trends p. 16 most women, menopause is defined as the one-year mark after a woman’s last menstrual cycle; this signifies the end of Table of Contents p. 2

5 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com

WOMEN’S HEALTH INGREDIENTS

menstruation. Before a woman reaches menopause, she’ll encounter perimenopause. During perimenopause, estrogen fluctuates and becomes irregular, and eventually drops to a very low level. Progesterone production stops after a woman has her final menstrual cycle. “The menopause transition and the perimenopause are the transitional periods from reproductive to non-reproductive life actually taking place,” explained Carolina Burki-Sozzi, director of product development at Horphag Research, supplier of Pycnogenol®. “During this time, many women experience hot flashes, night sweats, mood swings, irregular periods, loss of libido and vaginal dryness.” According to James Frame, CEO of Natural Health International, lesser known health issues associated with peri- and post-menopause include increased cholesterol and triglycerides, brain fog or memory issues, increased body weight and reduced bone density. “All of these symptoms are either directly or indirectly related to the loss of or imbalance of hormones,” he said. Frame cited research showing the benefits of maca, a root that grows in the Peruvian mountains, to help balance hormones. “Clinical studies show that maca impacts the endocrine system in many ways, including 1 2 supporting increased libido and sexual well-being in Maca, a root that both men and young women,” he said. “Maca has also been shown to affect the adrenal glands and ovaries in grows in Peruvian young women.” mountains, has Frame noted that there are 13 different phenotypes of maca that are “different colors, have different active shown benefits in ingredient profiles and elicit different physiological balancing hormones. effects.” He noted that Maca-GO (as found in Femmenessence by Natural Health International) ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| is a proprietary blend of specific types of maca to balance hormones. Also important for balancing hormones are magnesium and zinc. According to Max R. Motyka, M.S., R.Ph., consultant to Albion Minerals, “Magnesium and zinc are the key cofactors in the conversion of fatty acids to GLA and the further production of the prostaglandins.” He further explained that prostaglandins, like PGE1, regulate hormonal balance and support menopausal health. A plant lignin found in whole grains and the Norway spruce Piciea abies (7-Hydroxymaitairesinol [7-HMR] as HMRlignan by Linnea USA) decreased hot flashes in 22 postmenopausal females not receiving hormone-replacement therapy.3 During the single-blind, parallel, pharmacokinetic and dose-

7 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com WOMEN’S HEALTH INGREDIENTS

comparison study, subjects were administered either a regimen of 36 mg/d 7-HMR (low-dose) or 72 mg/d dose (high-dose) for eight weeks. From baseline to week eight, plasma 7-HMR levels increased by 191 percent in the low-dose group and by 1,238 percent in the high-dose group. Additionally, the mean number of weekly hot flashes decreased by 50 percent, from 28.0/week to 14.3/week in the high-dose group. Hops extract is another ingredient researchers are exploring to aid with menopausal symptoms. In fact, researchers recently conducted a preliminary safety study on certain compounds found in hops, including 8-prenylnaringenin (8-PN), a potent , the related flavanones 6-prenylnaringenin and (IX), and the prenylated chalcone xanthohumol (XN).4 Results indicate no acute toxicity, as well as long half-lives of the estrogenic and proestrogenic prenylated phenols in hops. According to Richard van Breemen, Ph.D., director of the UIC/NIH Center for Botanical Dietary Supplements at University of Illinois, and one of the study’s authors, “Instead of extracting the bitter acids that are sought after for beer flavors, we were extracting and using a group of flavonoids and polyphenols called prenylated phenols. These compounds have some pre- estrogenic-type activities,” he said, explaining that the compounds can be metabolized into more potent estrogens in the human body. The organization plans to conduct three more short-term safety studies on the ingredient in the next five years, van Breemen said. Importantly, hormone imbalance doesn’t only affect women in mid- to latter stages of life. Hormone imbalance can be caused by factors such as stress, dieting, anxiety, or conditions such as polycystic ovary syndrome (PCOS). Judi Quilici Timmcke, M.S., Ph.D., vice president of product development, In-Ingredients, cited a recent study showing cinnamon extract (as Cinulin PF from In-Ingredients) helped women with PCOS to improve menstrual imbalance.5 PCOS is characterized by hormone imbalance that can cause irregular or absent menstrual cycles, difficulty getting pregnant and, if left untreated, can lead to health problems such as diabetes and heart disease. “The study demonstrated that Cinnulin PF aids women with their menstrual cycles and may support hormonal imbalances,” Timmcke said. “It showed that women taking Cinnulin PF had significantly improved menstrual cyclicity over the placebo group in women with polycystic ovary syndrome.” In a recent cross-sectional study evaluating 42 women with PCOS and 34 without, vitamin D was associated with insulin resistance (IR) in women with PCOS, where vitamin D levels were lower in overweight women with PCOS compared with overweight controls.6 However, researchers noted large intervention studies are needed to determine if vitamin D supplementation can reduce IR in PCOS.

8 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com WOMEN’S HEALTH INGREDIENTS

To aid women experiencing decreased libido, fenugreek seed extract showed positive effects on sexual arousal and desire in women.7 For the double blind, randomized, placebo-controlled study, 80 women aged 20 to 49 years were administered either standardized fenugreek seed extract (as Libifem by Gencor Lifestage Solutions) at a dose of 600 mg/d or placebo over two menstrual cycles. There was a significant increase in free testosterone and in the active group, as well as sexual desire and arousal, compared with placebo. For those struggling with PMS, a study published in 2015 shows curcumin may provide beneficial effects.8 The randomized, double blind, clinical trial divided women suffering from PMS into two groups: one placebo group and one that received curcumin. Each participant received two capsules daily for seven days before menstruation and for three days after menstruation for three successive cycles. Participants recorded the severity of their symptoms via a daily questionnaire. The study authors concluded, “Our results for the first time showed a potential advantageous effect of curcumin in attenuating severity of PMS symptoms, which were probably mediated by modulation of neurotransmitters and anti-inflammatory effects of curcumin.”

Nutrition for Pregnancy During pregnancy, women undergo several physiological changes, including cardiovascular, hematologic, metabolic and respiratory changes, to ensure the fetus can grow properly. These changes are compounded by the effects of the hormonal changes a woman experiences, along with the nutritional needs of the mother and fetus.

During pregnancy, women undergo several physiological changes to ensure the fetus can grow properly.

According to Motyka, women’s needs for magnesium increase during pregnancy. “Its deficiency can result in poor fetal growth, pre-eclampsia, leg cramps and premature uterine contractions,” he said, adding that fetal exposure to pre-eclampsia has been linked to autism. Importantly, he noted that the need for all nutrients is higher during pregnancy and lactation, “and particularly so for iron, calcium and magnesium.”

9 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com One in every four women suffers loss of sexual desire

Libifem supports female sexual arousal*

Libifem is clinically shown to promote healthy sexual function*

Could this award-winning ingredient be your next successful product?

A woman’s decreased desire, low Introducing Libifem®, a clinically DISF-SR standard*. For a full report arousal, or inability to enjoy climax tested supplement that helps revive on the study, or to introduce a female can be attributed to many factors, her drive.* Winner of Engredea’s sexual health ingredient to your including normal hormonal changes. “most novel ingredient” award, product line, call 949-502-5760. Women now have a natural way to Libifem raised sexual desire and You can read about Libifem at arouse sexual desire. arousal in a placebo-controlled study gencorpacific.com on 80 healthy females using the

®

Revive Her Drive™

* 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.

© 2015 Gencor WOMEN’S HEALTH INGREDIENTS

Supplementation with magnesium reduced frequency of leg cramps in healthy pregnant women.9 Subjects were 14 to 34 weeks of gestation who had leg cramps at least twice per week. During the double blind, randomized, placebo-controlled trial, subjects were administered either 300 mg/d magnesium bisglycinate chelate or a placebo. Details of leg cramps were recorded before beginning the treatment and at the fourth week of study. Fifty-percent reduction of cramp frequency was significantly higher in the magnesium group than the placebo group (86.0 percent versus 60.5 percent). The 50-percent reduction of cramp intensity was also significantly higher in the treatment group than in the placebo group (69.8 percent versus 48.8 percent). The importance of iron intake during pregnancy and lactation was underlined by an American Journal of Epidemiology paper linking insufficient maternal iron intake with Autism Spectrum Disorder (ASD) as a part of the CHARGE (Childhood Autism Risks from Genetics and Environment) study.10 For the study, researchers evaluated daily iron intake during the three months preceding pregnancy, through gestation and during breastfeeding. “The highest quintile of iron intake during the index period was associated with reduced ASD risk compared with the lowest, especially during breastfeeding,” the study authors wrote. “Low iron intake significantly interacted with advanced maternal age and metabolic conditions; combined exposures were associated with a five-fold increased ASD risk.” However, iron supplementation can come with unwanted gastrointestinal (GI) discomfort. An iron A mother’s choline multi-amino acid chelate ingredient (Ferractiv® by consumption during Biotron Laboratories) showed a significant reduction in side effects compared to ferrous sulfate, a pregnancy can affect commonly used and well-absorbed iron salt, in a the child’s IQ and study of 60 healthy, premenopausal women.11 According to Steven Zeisel, M.D., Ph.D., Kenan memory tests.

Distinguished Professor in the Department of ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Nutrition and Director of the Nutrition Research Institute at University of North Carolina, a mother’s choline consumption during pregnancy can affect the child’s IQ and memory tests. “The mother’s choline intake during pregnancy can be related to children’s performance when they’re school age,” Zeisel said. He noted that children born to women with lower intakes of choline during the first and second trimesters of pregnancy did not perform as well in intelligence and visual memory tests at 7 years of age as did children born to women who had consumed higher levels of choline during pregnancy. In addition to its impact on the brain throughout life, choline also acts like a folate in preventing neural tube defects (NTD) in fetal development.12

11 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com WOMEN’S HEALTH INGREDIENTS

No Bones About It Bone health is serious business for women, especially for older, post- menopausal women. According to the National Osteoporosis Foundation, roughly 80 percent of the 10 million Americans with osteoporosis—a disease characterized by weak and frail bones—are women. What’s more, approximately one in two women over the age of 50 years will break a bone because of osteoporosis. Unfortunately for women, the odds are naturally against them when it comes to osteoporosis; in a list of uncontrollable risk factors for osteoporosis compiled by the U.S. Department of Health and Human Services, Office on Women’s Health, the first three factors include: “being female,” “getting older” and “menopause.” According to Kathy Lund, vice president of business development & marketing, AIDP, bone loss begins after the body reaches its peak bone mass, which occurs between the ages of 18 and 25 years. Bone loss then speeds up during mid-life for both men and women, and accelerates for women after menopause.  FOR MORE “For most women, bone loss increases quickly after INFORMATION about menopause, when estrogen levels drop sharply,” Lund the role of nutrition in said. “In fact, in the five to seven years after menopause, women’s health, read women can lose up to 20 percent or more of their bone.” “Optimizing Fortunately, there are proactive measures women can Women’s Health take, including increasing physical activity and Through Nutrition,” consuming foods high in calcium and vitamin D, such as by CRC Press. dairy products. Supplementing with research-backed natural products is another option. The effects of vitamin D on bone mineral density (BMD) and total fractional calcium absorption were evaluated in a randomized, double blind, placebo- controlled study in postmenopausal women.13 For the study, 230 postmenopausal women aged 75 years or younger were administered either daily white and twice monthly yellow placebo, daily 800 IU vitamin D3 and twice monthly yellow placebo, and daily white placebo and twice monthly 50,000 IU vitamin D3. Results showed high-dose therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass or falls. However, according to a study published in 2015 in Osteoporosis International, vitamin D supplementation increased muscle strength and protected against sarcopenia, or muscle loss, in postmenopausal women.14 In this double-blind, placebo-controlled clinical trial, 160 Brazilian postmenopausal women were randomized into two groups and received

12 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com ®

The innovACTIVE folate!

Mood Prenatal Cellular & Lactation Health www.quatrefolic.com

• Structurally analogous to the reduced and active form of Folate • High water solubility • Long lasting stability • Improved bioavailability • Established safety

Quatrefolic® is a registered trademark of Gnosis Spa. advanced biotech

Gnosis USA Inc. 4259 West Swamp Road, 3rd Floor Suite 305, Doylestown, Pennsylvania 18902 - USA. Tel 215.340.7960 www.gnosis-bio.comi bi WOMEN’S HEALTH INGREDIENTS

either vitamin D3 1,000 IU/d orally or placebo group. In the group receiving vitamin D supplementation, researchers noted a significant increase in muscle strength (25.3 percent) of the lower limbs by chair rising tests, whereas there was considerable loss (6.8 percent) of lean mass among women in the placebo group. Daily consumption of a milk product with soy increased BMD in Spanish postmenopausal women compared to control in a double-blind, controlled, randomized trial.15 Researchers also noted that both milk beverages (control and beverage enriched with soy isoflavones) increased levels of 25-OH-vitamin D and decreased bone metabolism markers. A proprietary blend of collagen and calcium (as the calcium-collagen chelate KoACT® by AIDP) showed superior effects to calcium and vitamin D in slowing down the leaching of calcium from bones and rebuilding new bone strength in a recent randomized, controlled trial of postmenopausal women.16 For the study, 39 women were randomly assigned to one of two groups: 5 g of CC containing 500 mg of elemental calcium and 200 IU vitamin D (1,25-dihydroxyvitamin D3) or control (500 mg of calcium and 200 IU vitamin D) daily for twelve months. Total body, lumbar and hip BMD were evaluated at baseline, six and 12 months using dual-energy x-ray absorptiometry. Results showed the loss of whole body BMD in women taking CC was substantially lower than that of the control group at 12 months (-1.23 percent versus -3.75 percent, respectively). Vitamin K2, especially Menaquinone-7 (MK-7), has also shown benefits to bone health. A study published in 2011 determined daily consumption of extra- virgin olive oil enriched with MK-7 (as VitaMK7 from Gnosis) increased MK-7 plasma levels in a dose-dependent manner, where a high dose also significantly increased carboxylated osteocalcin (cOC) and decreased undercarboxylated osteocalcin (ucOC) plasma levels.17 Authors concluded that “regular consumption of MK-7-enriched olive oil may constitute a valid approach in order to preserve some key biochemical mechanisms controlling bone mineralization.” Another benefit of vitamin K2 is its ability to act as a “calcium sweeper” to keep arteries from becoming stiff and inflexible—a diseases called arthrosclerosis—which can lead to improved heart health and healthy blood pressure levels.18 According to new research published in Thrombosis and Haemostasis, supplementation with 180 mcg/d of vitamin K2 MK7 (in the form of NattoPharma’s MenaQ7) for three years reduced the age-induced increase in carotid-femoral pulse wave velocity (PWV; a measure of arterial stiffness) in 244 healthy, post-menopausal women. Whether promoting bone health or healthy hormone levels, natural products can provide an array of highly sought benefits for women of all ages and in any stage of life. ¾

14 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com WOMEN’S HEALTH INGREDIENTS

References

1. Gonzales GF et al. “Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men.” Andrologia. 2002 Dec;34(6):367-72. 2. Zenico T et al. “Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial.” Andrologia. 2009 Apr;41(2):95-9. doi: 10.1111/j.1439-0272.2008.00892.x. 3. Udani JK et al. “Pharmacokinetics and bioavailability of plant 7- and effects on serum enterolactone and clinical symptoms in postmenopausal women: a single-blinded, parallel, dose-comparison study.” J Am Coll Nutr. 2013;32(6):428-35. DOI: 10.1080/07315724.2013.849578. 4. Van Breemen R et al. “Pharmacokinetics of prenylated hop phenols in women following oral administration of a standardized extract of hops.” Mol. Nutr. Food Res. 2014;58:1962-69. 5. Kort DH, Lobo RA. “Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial.” Am J Obstet Gynecol. 2014;211:487.e1-6. 6. Joham A et al. “Vitamin D in polycystic ovary syndrome: Relationship to obesity and insulin resistance.” Mol Nutr Food Res. 2015 Aug 10. DOI: 10.1002/mnfr.201500259. 7. Rao A et al. “Influence of a specialized Trigonella foenumgraecum seed extract (Libifem), on testosterone, estradiol and sexual function in healthy menstruating women, a randomised placebo controlled study.” Phototherapy Research. 2015. DOI: 10.1002/ptr.5355. 8. Khayar S et al. “Curcumin attenuates severity of premenstrual syndrome symptoms: A randomized, double-blind, placebo- controlled trial.” Complement Ther Med. 2015 Jun;23(3):318-24. doi: 10.1016/j.ctim.2015.04.001. 9. Supakatisant C, Phupong V. “Oral magnesium for relief in pregnancy-induced leg cramps: a randomised controlled trial.” Matern Child Nutr. 2015 Apr;11(2):139-45. doi: 10.1111/j.1740-8709.2012.00440.x. 10. Schmidt R et al. “Maternal Intake of Supplemental Iron and Risk of Autism Spectrum Disorder.” Am J Epidemiol. 2014 Nov 1;180(9):890-900. doi: 10.1093/aje/kwu208. 11. Fouad GT et al. “A Randomized, Double-Blind, Clinical Study on the Safety and Tolerability of an Iron Multi-Amino Acid Chelate Preparation in Premenopausal Women.” Journal of Dietary Supplements. 2013 Feb;10(1):17-28. 12. Kempson SA, Montrose MH. “Osmotic regulation of renal betaine transport: transcription and beyond.” Pflugers Arch. 2004;449:227–34. 13. Hansen KE et al. “Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial.” JAMA Intern Med. 2015 Aug 3. DOI: 10.1001/jamainternmed.2015.3874. 14. Cangussu LM et al. “Effect of vitamin D supplementation alone on muscle function in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial.” Osteoporos Int. 2015 May 9. [Epub ahead of print] 15. Garcia-Martin A et al. “[Effect of milk product with soy isoflavones on quality of life and bone metabolism in postmenopausal Spanish women: randomized trial].” Med Clin (Barc). 2012 Feb 4;138(2):47-51. DOI: 10.1016/j.medcli.2011.04.033. 16. Elam ML et al. “A Calcium-Collagen chelate Dietary Supplement Attenuates Bine Loss in Postmenopausal Women with Osteopenia: A Randomized Controlled Trial.” Journal of Medicinal Foods. 2015 Mar;18(3):324-31. 17. Bruge` et al. “Olive oil supplemented with menaquinone-7 significant;y affects osteocalcin carboxylation.” British Journal of Nutrition. 2011. DOI:10.1017/S0007114511001425. 18. Knapen MHJ et al. “Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women: double-blind randomized clinical trials.” Thromb Haemost. 2015 Feb 19;113(5). [Epub ahead of print]

15 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKET TRENDS

Current Trends in Women’s Health by Kate Lloyd

ver the past century, women’s INSIDER’s Take health concerns have dramatically ¾ Women’s No. 1 health concern is stress, shifted. In the early 1900s, according to a 2014 consumer health survey O conducted by Datamonitor. complications during childbirth made up the ¾ Other future concerns include sight leading cause of death among adult women, degeneration, cold/flu concerns, mainly due to lack of hygiene and medical osteoporosis and arthritis. ¾ Nearly 75 percent of U.S. women believe it is training, according to the CUNY School of important to live a healthy lifestyle, and almost Public Health. Now, data from the Centers for 70 percent say they “will take whatever Disease Control and Prevention (CDC) means necessary” to control their own health. |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| indicates chronic diseases such as heart disease and stroke are more significant issues. As women today adopt a more holistic view of health while keeping disease prevention front-of-mind, they are more commonly bypassing Western medicine and turning to natural ingredients to keep their bodies healthy. Because stress often plays a role in both stroke and heart disease, two leading causes of death among women today, it should come as no surprise that women’s No. 1 health concern is stress, according to a 2014 consumer health survey conducted by Datamonitor. With 54.1 percent of women concerned about stress, followed by tiredness/fatigue (51.6 percent), depression (34.5 percent) and insomnia (34 percent), it seems safe to assume women today feel over-worked and under-rested, causing significant energy depletion. This opens a huge door for companies marketing ingredients geared toward enhanced energy (such as green tea and ribose), improved sleep (melatonin), and of course, ingredients with calming effects for relaxation (Ashwaganda and lavender). “In more developed countries, women are under constant pressure both at the domestic as well as professional front,” explained Shaheen Majeed, marketing director, Sabinsa Corp. “Under such circumstances, stress leads to numerous health concerns. General physiological changes such as estrogen depletion, thyroid deficiencies and so on are [also] common health issues among women across the globe.” Datamonitor’s consumer health survey also asked consumers about their top health concerns for future years, IN THIS ISSUE and 33.6 percent of women indicated memory loss tops Women’s Health Ingredients p. 5 their list. Other future concerns included sight degeneration Regulatory p. 23 (25.8 percent), cold/flu concerns (25.6 percent), osteoporosis Table of Contents p. 2

16 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com SupplySide Storefronts are always open. Come on in. find and connect with suppliers All Year Long SupplySide Storefronts is a new online environment that enables a year-long business connection during the days the industry events SupplySide West, Ingredient Marketplace and Vitafoods aren’t taking place. It allows for the tens of thousands of buyers who are looking for ingredients, suppliers and solutions to find and connect with suppliers by requesting quotes, visiting their websites, downloading whitepapers, and viewing ingredients and solutions. Buyers can • Easy-to-use search for suppliers workflow tool for buyers looking for ingredients, suppliers and solutions by Ingredient, Solution, Location or Supplier • Access supplier Whitepapers, Videos, Website, Request a Quote, View Ingredients and more

EXPLORE

SupplySide Storefronts are always open. Come on in. MARKET TRENDS

(25 percent) and arthritis (23.2 percent). This means ingredients for cognitive function, eye health, immune health and bone/joint function could likely see an uptick in sales as more women educate themselves on natural ingredients to stay healthy for the long-term. “Over the past four decades, we have seen changes in the supplement market as women increasingly become more proactive in researching the products they need, purchasing the products that reflect research, and [investing in] education and advocating for the products from which they see results,” said Sébastien Bornet, vice president global sales and marketing, Horphag Research (supplier of Pycnogenol®). He added: “While women tend to become more cognizant of preventive aging and other health concerns, we’ve seen a spike in customers doing their own research and seeking out natural products that are clinically shown to be safe and effective.”

Marketing Multis: Where’s the Iodine? Iodine is one nutrient many women today are lacking and, according to the American Thyroid Association, deficiencies can lead to enlargement of the thyroid (called a goiter), hypothyroidism and mental retardation in infants when women are iodine deficient while pregnant. The association reported iodine deficiency is a major issue in the United States, and also in parts of Europe, Africa and Asia. This emerging health threat, specifically surrounding pregnant women who need iodine for proper fetal development, puts a new weight of responsibility on marketers of women’s multivitamins. Duffy MacKay, N.D., senior vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (CRN), stressed that marketers selling multivitamins intended for pregnancy or lactation should ensure their formulations include the recommended dosage of 150 mcg/d of iodine. In addition, as consumer education increases surrounding this issue, more women will likely seek out sources of iodine, making it important for marketers to update branding to reflect the product’s iodine content. “CRN is providing the leadership among its members, and we’re all volunteering to [check multivitamin formulas] with the hope that the rest of the industry sees this as the right thing to do,” MacKay said. “This is one of the unique times our industry can play a giant role in a public health issue.”

18 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKET TRENDS

Top Five Supplements Used by Women (by Category)

Vitamins/Minerals Sports Nutrition/Weight Management

Protein as powders, drinks, bars

Energy drinks/gels % 8% 71 % Garcinia cambogia Multivitamins 5 % Magnesium Green coffee % 4 12 % 3 Raspberry ketones 23% 35% 3% Calcium Vitamin D 23%

Vitamin C

Herbals/Botanicals Specialty Supplements

Coenzyme Q10 9% Green tea Glucosamine % and/or chondroitin % 7 % 7 Cranberry 13% 10 6% Garlic Fiber 19% % Omega-3s/ % 4 Echinacea 13 fatty acids Probiotics 4% Turmeric

Source: 2014 Council for Responsible Nutrition (CRN) Consumer Survey on Dietary Supplements

According to data from SPINS, both women’s multivitamins and products marketed for prenatal support (including vitamins, supplements herbs and homeopathic remedies) within the combined natural, specialty gourmet and conventional multi-outlet channels have experienced steady sales during the past year. Multivitamin sales declined modestly by 0.1 percent (to about US$273 million), while prenatal sales were down by 1.7 percent (at US$98 million) from June 2014 to June 2015. However, products marketed for menopause saw sales fall 16.3 percent (to US$60 million) since June 2014. Despite this slump in the menopause category, Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, for the Council for Responsible Nutrition (CRN), predicted sales of products geared toward hormone regulation will grow in the future—but not just from women buyers. Through his experience at recent medical conferences, MacKay said he has noticed more men concerned about their hormone levels and taking action to preserve “youthful hormone production” and to “delay the mental fog often associated with

19 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com PROTECT YOUR COMPANY:

Register now for those MASTER courses that address your key compliance concerns. GMPs • 21 CFR 111 Dietary Supplement GMP Overview Compliance tops a citation every time. That’s why • Batch Production Records –– SupplySide West offers GMP training courses every year Do’s and Don’ts from the best in the business –– NSF International. • Bring Your Product to Market — These training modules provide specific guidelines to Regulatory Requirements to Launch ensure you stay on the good side of the FDA. Plus, GMP registration boosts your credibility in the marketplace. • Botanical Testing It tells consumers you’re serious about their safety and • FDA Inspection Readiness Training verifies that the claims you make on your labels are true. • NDIs and GRAS Notification - A How To Presented by • SOPs and Record Keeping for Compliance to 21 CFR 111 • Top 10 Ways to Get a Warning Letter

october 05-09 2015 expo hall october 07 & 08

PRESENTED BY MANDALAY BAY R KSM-66 REGISTER TODAY. a s h w a g a n d h a WORLD’S BEST ASHWAGANDHA Limited Seating supplysideshow.com MARKET TRENDS

‘man-opause’” (a term used to describe declines in hormone production as men age). MacKay said he’s even noticed men are using products originally formulated for women to prevent osteoporosis. “Data is showing things like [hormone decline] and osteoporosis are not just affecting women,” MacKay added. “Men are becoming more concerned as well. We could likely see the [bone health] category, where people have been marketing for a long time toward women for preventing osteoporosis, start to shift to apply to both men and women.”

Understanding the hows and whys of women’s interest in health can help companies achieve their marketing goals.

Marketers of natural products should also note the shift within the sports nutrition market, traditionally dominated by males, to realize women’s increased interest in performance nutrition means more of these products could be marketed for the female audience. Chase Hagerman, brand director, Chemi Nutra, said more female sports products have hit the market recently, and many are geared toward building muscle as women realize taking these products will not cause them to “bulk up” or look more masculine. Some ingredients to watch in the women’s sports nutrition sector include protein for muscle-building, calcium and vitamin D for strong bones during high-impact training, and iron (such as Chemi Nutra’s IronAid®) for carrying oxygen throughout the body. Iron may also see sales increases as women become more aware of today’s prevalence of iron deficiency. In fact, the World Health Organization (WHO) named iron deficiency the most common and widespread nutritional disorder in the world—more than 30 percent of the global population is anemic due to iron deficiency.

Achieving Success in the Market Understanding the hows and whys of women’s interest in health can help companies achieve their marketing goals. Nearly 75 percent of U.S. women believe it is important to live a healthy lifestyle, according to a 2013 study by the Natural Marketing Institute (NMI), and almost 70 percent said they “will take whatever means necessary” to control their own health. Most women also expressed they “are very concerned about their health and are actively

21 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKET TRENDS

managing it, and more women focus on “preventive wellness” rather than “managing illness.” Marketers should keep these viewpoints in mind to reach women today who are discerning, passionate about their health, and hungry for efficacious nutritional products. As with all natural product categories, research is key when marketing for women’s health. Women are especially likely to research products thoroughly before buying, so marketers must be sure to market brand products with honesty and integrity. “The more manufacturers invest in research, the more evidence they will have at their disposal to convince women around the world about the benefits of supplementation,” said Steve Siegel, vice president of Ecuadorian Rainforest. Dan Souza, vice president of Naturex’s DBS division, agreed, adding ingredient efficacy is key to building a sustainable brand. Along with investing in research to prove efficacy, companies should also find ways to distinguish their brands from the competition. Don Stanek, director of U.S. sales, Linnea, suggested women’s health marketers merchandize through the medical field whenever possible because women tend to hold their doctors’ opinions in high regard. In addition, online marketing and social media use is an important, low-cost way to market products and reach a widespread audience of women. Women make up a unique demographic within the world of natural products. Using the appropriate marketing techniques and staying up-to-date on women’s top health concerns can help companies ensure market success in the women’s health category. ¾

22 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com REGULATORY

Structure/Function Claims for Women’s Health by Anthony L. Young

nder the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may make statements that describe “the role of a Unutrient or dietary ingredient intended to affect the structure or function in humans,” but such statements “may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases.” DSHEA became law in October 1994, and in April 1998, FDA proposed a regulation with a more detailed description of claims FDA thought to be structure/function claims, as well as those the agency considers to be disease claims. In January 1999, FDA made the regulation final with a 50-page preamble of explanation. Within that preamble, FDA agreed, after originally proposed to the contrary, with what is so: that common conditions associated with women’s menstrual and menopausal functions are not diseases.

FDA said: “Common conditions associated with natural states or processes that do not cause significant or permanent harm will not be treated as diseases under the final rule. For example, hot flashes, common symptoms associated with the menstrual cycle, ordinary morning sickness associated with pregnancy … will not be treated as diseases under this provision. Uncommon or serious conditions like … toxemia of pregnancy, severe depression associated with the menstrual cycle … will continue to be treated as diseases under the final rule.”

This final structure/function claim regulation was immediately attacked by Public Citizen’s Health Research Group due to FDA’s allowance of dietary supplements for morning sickness during pregnancy (the drug Thalidomide, never approved in the United States, was a morning sickness drug that caused birth defects). FDA then held a public hearing and essentially asked the industry to take great care with products for moms. Following this hearing, FDA evaluated women’s health dietary supplements and sent warning letters to companies making claims for use in pregnancy where published literature and informed opinion cautioned against such use. The oldest and most established women’s health dietary supplement is the prenatal vitamin, a mainstay of the prescription drug and dietary supplement industry for decades. And with the passage of DSHEA, 1,000 mg/d of folic acid became acceptable for supplements as well as prescription drugs. That is because DSHEA put no regulatory upper limits on dietary IN THIS ISSUE ingredients, only that the product be reasonably expected to be safe. Market Trends p. 16 But it is with menses and menopause that women’s health Breast Health p. 26 dietary supplements have become most popular. These products Table of Contents p. 2

23 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com REGULATORY

offer an alternative to analgesic drug products, although this cannot be claimed (no comparisons to prescription drugs are permitted). Common symptoms accompanying menses, such as premenstrual syndrome, minor pain and discomfort, muscle cramps and low mood swings are fair claims for supplements. With respect to menopause, difficulty sleeping, hot flashes, frequent urination, decreased libido, mood swings and changes to the skin are common conditions where supplements may make claims. A frequent mistake that marketers make is to compare their supplement offerings to prescription drugs. This is not permitted because to do so is to make an implied disease claim. However, menopausal women are aware of their options, and marketers usually do not need to educate them with the Internet offering many educational options. Menstruation and menopause are important female conditions, and winning and maintaining consumers’ confidence in these categories creates the opportunity to market other women’s health dietary supplement products. Some of these include weight loss products with responsible claims and associated program discussions of diet and exercise. Also included is the growing category of skin health dietary supplements that proceed on the inside-out theory. Claims substantiation is important in the women’s health market, just as it is important for all dietary supplement claims. Accordingly, women’s health structure/ function claims should be substantiated by competent and reliable scientific evidence to assure their integrity and their capacity to withstand challenge. Menopause and PMS claims are appropriate for dietary supplements, but not for products labeled as food. This was pointed out by FDA in a warning letter to dōTERRA International LLC in September 2014, along with one to NAPRODIS Inc. in 2012. These companies market essential oil products, a product category that is growing in consumer acceptance. Labeled as dietary supplements, these products can make structure/function claims within the parameters of DSHEA. Consumer testimonials for women’s health products and social media marketing should be used with caution. FDA is watching company and product social media sites, and marketers need to be aware of that. FDA inspectors in some areas of the country ask for information about all such marketing and provide comments to management (usually comments that social media testimonials cause the products to be making disease claims). While FDA guidance on social media permits the use of consumer feedback, it requires the social media site be set up in a way where there is no manipulation of the messages received. Women’s health dietary supplements are a solid part of the dietary supplement category. With the increasing amount of information available on female health choices, there is no need to risk making disease claims by comparing dietary supplements to prescription or over-the-counter (OTC) drugs, leading to the unpleasant warning letter risk consequence. ¾

Anthony Young is a partner at Kleinfeld, Kaplan & Young LLP.

24 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com BREAST HEALTH

Formulating for Breast Health: Research, Ingredients and Therapeutic Targets by Isaac Eliaz

s the nutraceutical community doing enough to help prevent breast cancer? Data from BreastCancer.org indicates more than 230,000 cases of invasive Ibreast cancer will be diagnosed in American women. In addition, more than 40,000 will die from the disease, and one in eight women will develop invasive breast cancer in her lifetime. Quite simply, we need to do more. There are a number of tools within the vast pharmacopeia of nutraceuticals that can make an impact against the growth and spread of breast cancer. Certain botanicals and nutrients are shown to target carcinogenesis, invasion and metastasis of breast (and other) cancers, with a growing body of published data demonstrating their diverse mechanisms of action. As an integrative cancer physician, much of my research and focus has been on nutraceutical therapies, including botanicals and nutrients that work to prevent breast cancer growth, enhance conventional treatments and reduce side effects. For example, research presented at the American Academy for Cancer Research 2015 meeting showed that a botanical formula for breast health—containing eight targeted ingredients, including several I will discuss below—worked as well as, and also enhanced, the effects of against human breast cancer cells implanted into mice. From my clinical experience, it’s possible to prevent the growth and spread of breast cancer by using nutraceuticals as adjuncts to conventional and complementary therapies. The strategy is to “outsmart” the cancer with synergistic approaches that fight the disease, while also supporting the health of the patient. One of the central tactics within this approach is the use of compounds to target the interlocking cellular and genetic mechanisms and related physiological systems involved in breast cancer proliferation and metastasis.

Hormones Certain hormonal imbalances, including an excess amount of estrogens, can dramatically increase risk of breast cancer development, proliferation and metastasis. Depending on a number of factors, estrogens in the body can be metabolized into cancer-promoting estrogen IN THIS ISSUE metabolites, such as 16-OH-estradiol, 4-OH and others. Regulatory p. 23 Conversely, they can be converted into less estrogenic Marketing p. 29 metabolites, such as 2-OH-estradiol. The ratio of 2-OH to 16-OH is often used as an indicator for risk. Most of these compounds Table of Contents p. 2

25 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com BREAST HEALTH

are metabolized by the liver, making liver support another important consideration in formulating for breast cancer and overall breast health. When selecting nutraceutical ingredients to support healthy estrogen breakdown, my first recommendation is diindolylmethane (DIM), a metabolite of indole-3-carbinol (I3C), which is formed when we eat cruciferous vegetables. DIM is shown to favorably modulate estrogen metabolism, and since it’s more bioavailable than I3C, it is well-suited as an oral supplement. Specifically, research shows DIM increases the expression of genes that help protect against breast cancer proliferation and metastasis. It also shows direct cytotoxic activity against breast and other cancers.1 Another beneficial nutraceutical is melatonin. Working through the pineal gland, melatonin is considered a “master hormone” that can help modulate other hormonal cycles. Studies show melatonin can counteract estrogen’s ability to fuel breast cancer growth; it also provides other protective benefits, including anti-inflammatory support and immune enhancement.2

Immune Therapy Immune therapy is one of the hottest areas in cancer research and treatment. To regulate immunity against cancer, I recommend the botanicals astragalus and ashwagandha, as well as certain medicinal mushrooms. Examples include reishi (Ganoderma lucidum), maitake (Grifola frondosa), coriolus (Trametes versicolor) and Phellinus linteus, which have been shown to inhibit breast cancer growth and metastasis in animal models.3,4 Shiitake (Lentinula edodes) also demonstrates activity against breast cancer.5

Hyper-viscosity and Inflammation The relationship between inflammation and cancer is well-documented. In breast tissue, one potential inflammation precursor is blood hyper-viscosity and lack of proper circulation. Ingredients such as extract from Magnolia bark, modified citrus pectin, curcumin, Salvia miltiorrhiza and nattokinase can enhance circulation. Also, several medicinal mushrooms are shown to improve circulation as well, such as oyster (Pleurotus ostreatus), caterpillar (Cordyceps sinensis) and reishi.6

Detoxification Because the breast is composed mainly of fatty tissue that absorbs DNA-damaging toxins, it’s important to bring detoxification into the equation. Use of botanicals that can help discharge toxins from cells, organs and tissues, and also help eliminate these toxins through the skin, lungs, urinary and gastrointestinal (GI) tracts, are important in the prevention and treatment of breast cancer.

26 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com BREAST HEALTH

Chinese salvia root, milk thistle seed, broccoli sprouts, dandelion leaf and root, and astragalus are examples of botanicals that can support detoxification processes. Modified citrus pectin (MCP), derived from citrus peels and modified for bioavailability and bioactivity, has been shown to safely remove toxic metals such as lead, mercury and arsenic from the body, without affecting essential minerals.7

Direct Cytotoxic Action Beyond supporting some of the underlying systems related to breast and overall health, we also need powerful agents that actively work to kill breast cancer cells safely. One of the most powerful cytotoxic botanicals now emerging is honokiol, a highly active polyphenol isolated from magnolia bark. Known for its potent anti-inflammatory, antioxidant, anxiolytic and neuroprotective abilities, honokiol has also been shown in numerous preclinical studies to inhibit breast cancer through multiple mechanisms at the cellular and genetic levels. For example, a Johns Hopkins study found that honokiol controlled breast cancer migration and invasion by targeting tumor-suppressing genetic pathway LKB1. In my clinic, honokiol is one of the most important tools we have in our arsenal of anti-cancer adjuvants.8 MCP can also play a significant role. In addition to Chinese salvia root, milk being a potent detoxifier, MCP has been shown to directly inhibit cancer growth and metastasis, induce thistle seed, broccoli apoptosis and modulate angiogenesis. MCP also sprouts, dandelion leaf binds and inhibits the pro-inflammatory, oncogenic protein galectin-3, now identified as a key driver not and root, and astragalus just in cancer, but in fibrosis as well. Other research are examples of botanicals shows that MCP can enhance the effects of certain chemotherapy drugs, including cisplatin, doxorubicin, that can support paclitaxel and others. Because of its powerful ability detoxification processes. to block galectin-3, MCP is also an important adjunct for protecting against radiation-induced organ ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| fibrosis, an all-too-common side effect of this standard cancer treatment.9 Mushrooms can also have a cytotoxic impact against breast cancer cells. One study showed a formula containing botanically-cultivated (grown on a substrate of botanicals) species Agaricus blazei, Cordyceps sinensis, Trametes versicolor and others, arrested the cell cycle and inhibited proliferation of breast cancer cells.10 Other direct anti-cancer compounds include curcumin, which reduces cancer cell proliferation, and , which can induce apoptosis.11,12

27 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com BREAST HEALTH

The clinical community has learned many lessons about cancer treatment during the past 50 years. Perhaps the most important is that single agents rarely generate lasting remissions. Cancers are driven by multiple complex mechanisms, and therefore must be addressed with a strategic, individualized integration of treatments that keep us ahead of the disease. By taking a holistic approach against breast and other cancers, we can create formulas that complement other therapies and give breast cancer patients the critical edge. ¾

Isaac Eliaz has been an expert in the field of integrative medicine since the early 1980s, with a specific focus on cancer, immune health, detoxification and mind-body medicine. He is a formulator, clinician, researcher, author and educator. As part of his commitment to the advancement of integrative medicine, Eliaz partners with leading research institutes and has co-authored numerous peer-reviewed papers on innovative therapies for immune enhancement, heavy metal toxicity, and cancer prevention and treatment. He is founder and medical director of the Amitabha Medical Clinic and Healing Center in Santa Rosa, California, where he and his team of practitioners pioneer individualized treatments for cancer and chronic illness.

References:

1. Ahmad A, Sakr WA, Rahmah KM. “Anticancer properties of indole compounds: mechanism of apoptosis induction and role in chemotherapy.” Curr Drug Targets. 2010 June;11(6):652-666. 2. Hill SM et al. “Melatonin: an inhibitor of breast cancer. Endocr Relat Cancer. 2015 Jun;22(3):R183-R204. 3. Loganathan J et al. “The mushroom Ganoderma lucidum suppresses breast-to-lung cancer metastasis through the inhibition of pro-invasive genes.” Int J Oncol. 2014 Jun;44(6):2009-15. DOI: 10.3892/ijo.2014.2375. 4. Eliza WL, Fai CK, Chung LP. “Efficacy of Yun Zhi (Coriolus versicolor) on survival in cancer patients: systematic review and meta-analysis.” Recent Pat Inflamm Allergy Drug Discov. 2012 Jan;6(1):78-87. 5. Shen J et al. “Effect of the culture extract of Lentinus edodes mycelia on splenic sympathetic activity and cancer cell proliferation.” Auton Neurosci. 2009 Jan 28;145(1-2):50-4. DOI: 10.1016/j.autneu.2008.11.004. 6. Bhardwaj N, Katyal P, Sharma AK. “Suppression of inflammatory and allergic responses by pharmacologically potent fungus Ganoderma lucidum.” Recent Pat Inflamm Allergy Drug Discov. 2014;8(2):104-17. 7. Eliaz I, Hotchkiss AT, Fishman ML, Rode D. “The effect of modified citrus pectin on urinary excretion of toxic elements.” Phytother Res. 2006 Oct;20(10):859-64. 8. Nagalingam A, Arbiser JL, Bonner MY, Saxena NK, Sharma D. “Honokiol activates AMP-activated protein kinase in breast cancer cells via an LKB1-dependent pathway and inhibits breast carcinogenesis.” Breast Cancer Res. 2012 Feb 21;14(1):R35. 9. Hossein G, Keshavarz, Ahmadi S, Naderi N. “Synergistic effects of PectaSol-C modified citrus pectin an inhibitor of Galectin-3 and paclitaxel on apoptosis of human SKOV-3 ovarian cancer cells.” Asian Pac J Cancer Prev. 2013;14(12):7561-8. 10. Jiang J, Silva D. “Novel medicinal mushroom blend suppresses growth and invasiveness of human breast cancer cells.” Int J Oncol. 2010 Dec;37(6):1529-36. 11. Shanmugam MK et al. “The multifaceted role of curcumin in cancer prevention and treatment.” Molecules. 2015 Feb 5;20(2):2728-69. DOI: 10.3390/molecules20022728. 12. Dhumale SS, Waghela BN, Pathak C. “Quercetin protects necrotic insult and promotes apoptosis by attenuating the expression of RAGE and its ligand HMGB1 in human breast adenocarcinoma cells.” IUBMB Life. 2015 May;67(5):361-73. DOI: 10.1002/ iub.1379.

28 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKETING

Thinking Outside the Pink Box: Brand Strategies

in Women’s Health by Heidi Rosenberg

ccording to Nielsen/Net Ratings, women control more than 80 percent of all consumer spending, representing US$7 trillion in A the U.S. economy. In the natural health industry, the number is even more significant, where women represent more than 90 percent of the spending. In either case, the women’s health market is rich with opportunity. However, it is no longer sufficient to slap a product into a pink box to suggest it is targeted to women. Today’s female consumers demand personalized, targeted solutions, and they require high levels of engagement from brands. This provides a unique opportunity for brand strategies that target women’s health. Women strive to maintain a healthy lifestyle for many different reasons. A number of key lifestyle factors are motivating growth in the women’s health category:

Strength Comfort and Youthfulness and Energy Contentment and Image

Strength and Energy Women want to have the energy and strength to accomplish what needs to be done in a day and remain physically active. The energy category continues to expand, and many women are looking for natural options, including caffeine alternatives, for boosting energy. Women also continue to play a significant role in the shift of focus from sports nutrition to active nutrition for the mainstream consumer.

Comfort and Contentment Many women seek solutions to help support positive emotions and reactions to stress. Just look at the masses that turn to yoga, IN THIS ISSUE meditation and other forms of relaxation and stress management. Breast Health p. 25 Women want to feel balanced and at-ease, and that involves Takeaways p. 32 ensuring optimal health both physically and mentally. Table of Contents p. 2

29 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKETING

Youthfulness and Image Women of all ages want to feel confident, comfortable and accepted, and they look for brands that support both feeling good and looking good. Many women are turning to products with natural ingredients they recognize and trust. Youthfulness is not only reflected in how a woman looks, but also in staying active and alert.

How to Leverage the Purchasing Power of Women Women tend to be astute consumers willing to invest the time and energy to research and compare options. They demand that brands provide relevant and clear information to help them feel good about the product choices they make. Women want to have meaningful contact, and want to be heard. To leverage the purchasing power of women, there are a number of strategies brands can employ to strengthen customer engagement.

Emphasize Allow for Build a Make a Personal Personalization Community Difference Empowerment

Emphasize Personal Empowerment The buzz of “women’s empowerment” continues to gain momentum. We are witnessing female-empowerment campaigns from brands like LUNA Bar’s promotion of LUNAFEST and Sport England’s “This Girl Can.” Women want brands that make them feel like a “hero.” They want to feel confident and empowered in the health choices they make.

Allow for Personalization It is important to make your female There is rising customers feel special and unique. They do not want to feel like they are simply consumer involvement “lumped” together in one group. For in personal health, and example, women from teens to those in their mid-30s all belong to the Millennial a growing expectation generation. However, messages for each of personalization for segment within this group may vary widely. There is rising consumer involvement in virtually all services personal health, and a growing expectation of personalization for virtually all services and products. and products. Women expect personal |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

30 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com MARKETING

engagement, and demand options. Listening to the real feedback from individual consumers helps drive brand success.

Build a Community A sense of belonging is critical for well-being. For brands specifically targeting women, it’s important to provide opportunities to share information and experiences. Many women are motivated by social validation and peer acceptance of the purchase choices they make. Giving women the ability to voice their opinions and interact with peers can influence attitudes toward the brand.

Make a Difference A recent study from Nielsen reveals that 55 percent of respondents would pay extra for products and services from companies that are committed to positive social and environmental impact. Women are particularly interested in brands they perceive as making the world a better place somehow. However, they do not want just lip service, and can see right through it when brands claim philanthropy that isn’t really genuine.

We Belong Together Women are exerting more influence over brand decisions. Successful brands empower women with the information and resources they need to make informed purchase decisions. Encouraging an open dialogue and creating a sense of community helps instill confidence in the health choices women make, and generates positive feelings about purchase decisions to drive enduring brand loyalty. ¾

Heidi Rosenberg serves as senior PR counsel at BrandHive, a healthy lifestyle branding agency. She brings over 25 years of public relations, business and marketing expertise, having served organizations ranging from small businesses to global enterprises within the natural products, wellness, technology, healthcare and environmental markets.

31 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com TAKEAWAYS

Takeaways for Your Business

hether it’s concern for a healthy pregnancy, a desire to reduce stress, or the goal of battling post-menopausal bone loss, women’s W health needs are of great importance. For any stage of life, women can supplement with natural ingredients to address these concerns and others; plus, many ingredients can help reduce the unwanted symptoms that come with various conditions. For example, James Frame, CEO of Natural Health International, said peri- and post-menopause can lead to less well-known health issues, such as increased cholesterol and triglycerides, brain fog or memory issues, increased body weight and reduced bone density. “All of these symptoms are either directly or indirectly related to the loss of or imbalance of hormones,” he said. Frame also cited research showing the benefits of maca, a root that grows in the Peruvian mountains, to help balance hormones. “Clinical studies show that maca impacts the endocrine system in many ways, including supporting increased libido and sexual well-being in both men and young women,” he said. “Maca has also been shown to affect the adrenal glands and ovaries in young women.” When marketing products to women, companies should ensure they understand the hows and whys of women’s interests in health. Nearly 75 percent of U.S. women believe it is important to live a healthy lifestyle, according to a 2013 study by the Natural Marketing Institute (NMI), and almost 70 percent said they “will take whatever means necessary” to control their own health. Most women also expressed they “are very concerned about their health and are actively managing it, and more women focus on “preventive wellness” rather than “managing illness.” Marketers should keep these viewpoints in mind to reach women today who are discerning, passionate about their health, and hungry for efficacious nutritional products. Marketers must also note the importance of claims substantiation in the women’s health market. Women’s health structure/function claims must be substantiated by reliable science to assure product integrity. Also, companies should use consumer testimonials and social media marketing with caution, as FDA is closely monitoring company and product social media sites. While FDA guidance on social media permits the use of consumer feedback, it requires the social media site be set up so there is no manipulation of the messages received. Companies must take heed in all phases of product development, from the research stage, to product IN THIS ISSUE formulation, to marketing. Female consumers are interested Marketing p. 29 in quality products backed by sound research, and FDA will INSIDER Contacts p. 33 certainly step in with a warning letter for any company whose Table of Contents p. 2 product falls short. ¾

32 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com ® NATURAL PRODUCTS INSIDER CONTACTS naturalproductsinsider.com

Natural Products INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry. INSIDER boasts the largest magazine and web audience in the industry delivering news, analysis and features to executives involved in the expanding market of global nutrition. The Natural Products INSIDER brand includes a print magazine, a website, e-newsletters, reports, digital summits, whitepapers, digital issues and image galleries.

Vice President, Sales, Health & Nutrition Vice President, Marketing Services Danielle Dunlap Danica Cullins [email protected] Creative Director Joseph DiPastena Strategic Account Director Amy Bix Art Director, Health & Nutrition Andrew Rosseau Senior Account Executives Ioana Neacsu Media Operations Manager Melissa Ewing Anthony Arteca Karen Salas Program Manager Kristin LaBarbera [email protected] Editor in Chief Sandy Almendarez Senior Editor Steve Myers Events Department Legal and Regulatory Editor Josh Long Senior Vice President, Events Dana Hicks Managing Editors Kate Lloyd Event Director Marisa Freed Rachel Adams Education Director Shilo Lusson Custom Content Editor Lauren Joyner Education Coordinator Alyssa Sanchez Vice President, Content, Health & Nutrition Heather Granato Informa Exhibitions LLC Vice President, President John Siefert Health & Nutrition Jon Benninger Chief Financial Officer Kelly Ridley Marketing Manager Katie Egley Human Resources Director Sabrina Wolf Audience Marketing Director Katherine Jackson Audience Marketing Manager Amanda Saye

Published by Informa Exhibitions LLC 3300 N. Central Ave. #300, Phoenix, AZ 85012 Phone (480) 990-1101 ■ Fax (480) 990-0819 Website: naturalproductsinsider.com

33 • Women’s Health Digital Issue • September 2015 | naturalproductsinsider.com