In This Issue of the AHPA Report

The Official Publication of the American Herbal Products Association January 2011 www.ahpa.org Volume 26, Number 1

In this issue of the AHPA Report

You Need to Know 3

• Savings Opportunities for AHPA Members • New Members • Annual Call for Candidates to AHPA’s Board of Trustees

Legal & Regulatory 5

• Industry Joins FDA in Confronting Illegal Drug Spiking, by Michael McGuffin and Anthony L. Young, Esq. • FDA on Spiked Products, cGMP Small Entity Compliance Guidance Guide, More Warning Letters and Free Form Plant Phytosterols, by Anthony L. Young, Esq. • The 112th Congress: Outlook and Opportunities, by Pete Evich • AHPA Comments on FTC “Green Guides,” by Michael McGuffin • AHPA Comments on USDA’s Draft Guidance on Organic Wild Crops, by Michael McGuffin • U.S. Senate Succeeds on Second Attempt to Pass "Food Safety Modernization Act,” by Jennifer Denhard

Inside AHPA 14

• AHPA Looks Ahead to 2011, by Michael McGuffin • AHPA Trains Naturopaths in Quality Assessment of Dietary Supplements, by Jennifer Denhard

Special Science Feature 16

• Reanalysis of ConsumerLab’s Valerian Product Review; Many Questions Still Unanswered, by Michael McGuffin

Communications Update 19

• AHPA Media Scan: Notable “Herbal Headlines”

Calendar of Botanical Events 20

Table of Contents continues on page 2 Table of Contents continued from page 1

Botanical Science Update 20

• Meeting Attended • China Pharmacopoeia Delegation • Literature Citations Analysis • Fingerprint Analysis of Ginkgo Leaves and Supplements • NMR Fingerprint Analysis of Hoodia Species and Supplements • FTIR Screening for Adulterated Raw Materials by NOW Foods • FTIR Analysis of Astragalus Root for Origin and Adulteration • Tea and Herbal Tea Safe from Mycotoxin Exposure • Ginger Analysis: Measurement of Components in Products • Eugenol in Clove Oil: A Validated HPLC Analysis Clinical and Pharmacologic • Ginger Reduced Exercise Induced Pain, Just Not Right Away • Clove Oil Reversed Memory Impairment in Mice • Valerian Extract Did Not Sedate Mice In Vitro Studies • Clove Extract Kills Lettuce Leaf Pathogens • Essential Oils in Preserving Lettuce Leaves • Synergistic Action of Aerial Goldenseal Plant Extracts Reviews, Etc. • Immunological Activity from Medicinal Herbs • All About Olive Oil • Critical Review of Synephrine in Supplements • Assigning Causality in Botanical Adverse Events • Ayurveda Literature Searching • ESCOP Monographs Scientifically Valuable • Southwest US Guide to Herbal Practice • Upcoming Event • U.S. Pharmacopeia (USP) Nomenclature, Safety and Labeling Expert Committee

The AHPA Report, the official voice of the American AHPA Staff Send inquiries, comments or requests to: Herbal Products Association (AHPA), is published monthly as a service to AHPA members and friends Michael McGuffin, President American Herbal of the herbal products industry. The material [email protected] Products Association contained in this publication is for the information 8630 Fenton Street, Suite 918 Steven Dentali, PhD, Chief Science Officer of AHPA members. Although the information Silver Spring, MD 20910 [email protected] is believed to be correct, AHPA disclaims all Phone: 301-588-1171 responsibility for any damage or liability that Devon Powell, Chief Operations Officer Fax: 301-588-1174 may result from any reliance on the information [email protected] Email: [email protected] contained in this publication. Website: www.ahpa.org Articles may not be reproduced or reprinted Jennifer Denhard, Director of Communications without written permission from AHPA. [email protected] © copyright 2011, AHPA

January 2011 • Page You Need to Know Life Plus International is a manufacturer of dietary supplements and we sell our finished products, which include dietary supple- Savings Opportunities for AHPA Members ments, in tablet, capsule and powder form. Within the pages of this edition of AHPA Report, we are pleased to UST Corporation is a contract manufacturer of dietary supplements, provide our members with several valuable money-saving opportu- encapsulation, bulk powders, packeting, bottling, and stick packeting. nities. The following goods and services are offered at a discount National College of Natural Medicine (NCNM) is the oldest ac- for—or are uniquely available to—AHPA members this month: credited Naturopathic College in North America, with Graduate Programs in Naturopathic and Chinese Medicine. The college also  AuthenTechnologies, 10% off for AHPA members (page 4) markets Chinese and Western herbs, professional lines of nutraceu-  Guidance Documents (for the Manufacture and Sale of tical products, homeopathic remedies, Chinese patent medicines, Botanical Extracts), $30 discount for members (page 8) essential oils, and more through the NCNM Clinic Medicinary.  The Tan Sheet, $345 off of new subscriptions (page 11) This on-campus teaching clinic also offers complete naturopathic and Chinese medical services to the public.  CPG Jobs, 15% off for employers (page 13) AuthenTechnologies LLC is the first contract-testing laboratory spe-  First National Merchants, members-only offer (page 24) cializing in DNA botanical authentication and identity testing for  Herbs of Commerce, $20 discount for members (page 25)  natural products and herbal supplements. DNA is one of the most precise identification methods and can be used on any botanical, fungal, bacterial, or animal species raw material and select finished products. It New Members can reliably differentiate closely related substitutes as well as detect Bruker Corporation is a leading provider of high performance sci- adulterants, GMOs, and allergens. All tests are performed using GLPs entific instruments and solutions for molecular and materials re- with results verified by Ph.D. botanists. Visit their website above to search. We conduct NMR, MRI, EPR, MS, IR, Raman, GC, learn more about AuthenTechnologies’ IDNATM services. See their Analytical X-ray, AF, EDA, EBSD, and Elemental Analysis. DNA TestedTM quality seal for consumer products at www.id-na.com. It’s Time To Level the Playing Field Complying with regulatory laws, clearing your Amin Talati offers AFAs for: products from intellectual property infringement · FDA, FTC and Prop 65 compliance—ingredient claims, protecting your inventions and brand names and labeling compliance, advertising and claim and entering into solid business contracts are substantiation, GMPs, NDIs and GRAS crucial for sustainability but can be very costly. Moreover legal actions and disputes are often cost- · FDA, FTC, National Advertising Division (NAD) prohibitive because the odds and playing field can and State AG actions—FDA warning letters, be against you. detentions, recalls, FTC CIDs, false advertising, Prop 65 and class action disputes In response to these issues – whether you are seeking to comply, protect, enforce or defend – Amin · Patent and Trademark searches, registrations, Talati, LLC now offers Alternative Fee Arrangements freedom-to-operate clearance letters and (AFAs) to help level the playing field. Our AFAs infringement disputes include pure and blend contingency, fixed-capped, volume discount and merit-based arrangements that · Licensing, supplier, distributor and can help promote efficiency, cost-savings, favorable manufacturing agreements and breach of results and simply a better experience. contract disputes We invite you to contact us today. For more information email Rakesh Amin at [email protected] or call 312.286.3925. www.AminTalati.com

January 2011 • Page Annual Call for Candidates to ongoing functions of the organization. While trustees receive no re- AHPA’s Board of Trustees muneration for their services, the benefits to the companies represented, and the industry as a whole, are well recognized. The American Herbal Products Association (AHPA) announced on December 10 its annual call for candidates for elected trustees1 “With their individual experience, expertise and leadership, AHPA’s to the association’s Board of Trustees. The election for the 2011 board members create an essential guiding body as the association cycle will be held at AHPA’s annual meeting in Anaheim, CA on works to address challenges and opportunities facing this industry,” March 10, 2011. The association’s bylaws and election policies will said AHPA President Michael McGuffin. “All eligible companies govern this nomination process and election. This information is should consider nominating a representative and taking advantage available on our web site (www.ahpa.org), along with a list of trustee of the opportunity to become involved in this good work.” responsibilities. The deadline for submitting your intent to stand for election form A candidate for the board may be an owner, employee, consultant, is Feb. 8, 2011. All active AHPA members in good standing are or other designated representative of the company wishing to be qualified and encouraged to nominate a candidate. represented on the board. A candidate must be officially nominated If you have any questions about this process, or to request a copy of in writing by completing and returning an intent to stand for elec- the intent to stand for election form, please contact Devon Powell at tion form. 301-588-1171, ext. 102 or email [email protected]. The number of seats on the Board of Trustees consists of a mini- AHPA’s bylaws are available online at: http://www.ahpa.org/Portals/0/ mum of 22 seats. Two elected seats are reserved for “small business pdfs/04_11_AHPABylaws.pdf  members,” defined as those active members with $5 million or less in annual herbal revenues. The remaining elected seats are available 1 Association bylaws allow for any active member in good standing to all active members in good standing. The term of office for all to fill a seat on the Board of Trustees by appointment (an “ap- elected trustees is three years. pointed seat”) by paying dues within a single fiscal year to the association in an amount greater than or equal to the highest maximum The board generally meets three times each year, and trustees are ex- dues level for the association’s active members (currently $50,000). pected to adhere to the attendance requirements as defined by the Please contact Devon Powell if your company has an interest in AHPA bylaws. In addition, trustees are expected to participate in filling an appointed seat.

January 2011 • Page Legal & Regulatory

Industry Joins FDA in Confronting Illegal promoted for weight loss, sexual enhancement, and body building, Drug-Spiking and emphasized that some GMP procedures may be of particular relevance in these product classes. by Michael McGuffin, AHPA President “I know I speak for all marketers of legitimate products in the sports On December 15, the Food and Drug Administration (FDA) issued nutrition supplement category in expressing appreciation for FDA’s communications to consumers and to the dietary supplement indus- strong message,” commented Erica Stump, chair of AHPA’s Sports try to call attention to its concern about products that are “tainted” Nutrition Committee and General Counsel of Bodybuilding.com. with drug ingredients or other compounds, such as steroids. “AHPA will continue to provide a forum for companies in this cate- Although many of these products are labelled as dietary supple- gory to work together to implement FDA’s expressed guidance.” ments, FDA clearly stated that they are actually illegal due to the In the above-cited letter, FDA made clear its interest in continued presence of these ingredients, which FDA said are generally not de- input and collaboration from the dietary supplement industry’s clared on product labels. trade associations “to educate the industry about this problem and to FDA Principal Deputy Commissioner Dr. Joshua Sharfstein held a develop strategies to combat it.” AHPA was requested to share this press conference to call greater attention to this issue, and stated that letter with our members and “remind them of their responsibility to these tainted products pose “significant public health problems.” comply with the law and support their members in their efforts to do The American Herbal Products Association (AHPA) and other trade so.” In addition, FDA encouraged industry to report any suspected associations were in attendance to demonstrate support for FDA to tainted ingredients or finished products to FDA, and announced two use its full enforcement authority to remove these illegal products new tools to receive such information — via email to TaintedProducts@ from the marketplace. Dr. Margaret A. Hamburg, FDA’s fda.hhs.gov and/or via an anonymous reporting form “Report Commissioner, also delivered a letter to AHPA and other associa- Suspected Criminal Activity” located at: http://www.fda.gov/oci. tions to communicate the agency’s concerns directly to the trade. “AHPA applauds FDA for acting to protect consumer safety and for sending a strong message to those who would ignore the law by spiking products with undeclared and illegal ingredients,” noted Anthony L. Young, AHPA General Counsel. “We have consistently communicated our concerns to FDA about the need for active and well-publicized enforcement in this area and we will support the agency’s use of its significant authority to get these illegal goods out of the market.” Dr. Sharfstein focused attention on the need to keep consumers in- New: formed, and announced new tools to alert consumers when FDA U Full spectrum herbs, identifies tainted products. He stated that FDA will publish rapid including their salts notifications on its website and is making available a web widget and minerals that can be easily added to any web page. He also noted that the U Biodynamic quality government may initiate criminal investigations against individuals U Rhythmical and companies who violate the law and endanger the public health. processes FDA’s letter placed significant emphasis on the “role and responsi- U Non alcoholic tinctures, bilities” of the dietary supplement industry. It stated that companies vegetarian capsules, must “take appropriate steps to ensure that their products do not all natural cosmetics contain active ingredients that may cause the product to be an unap- proved new drug, a misbranded drug and/or an adulterated or misbranded dietary supplement.” It also noted that manufacturers are required under good manufacturing practice (GMP) rules for dietary supplement operations to establish specifications for contami- www.truebotanica.com nants that may adulterate finished dietary supplements. Further, it noted that FDA has found that these illegal products are often

January 2011 • Page AHPA is in complete agreement with FDA in recognizing the Associated AHPA communications that may be of interest include: significant public health risks presented by products that contain  AHPA Meets with FDA on Drug-Spiking Enforcement; undeclared and illegal ingredients and masquerade as dietary supple- Examines Consumer Education Ideas. AHPA Report, ments. We also appreciate FDA’s clear message that these products, November 2010; many of which are also sold beyond the U.S. borders, are illegal  AHPA Addresses Efficient, Effective FDA Enforcement. under current law. AHPA will continue to share our ideas with FDA AHPA Update. November 18, 2009; and to focus our resources on ensuring the quality of products  AHPA to FDA: Provide Efficient Enforcement Against Illegal manufactured and marketed by AHPA members. Steroid Products. AHPA Update, October 7, 2009. 

Why FDA’s “Tainted Products” Letter is a Big Deal by Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP, and AHPA General Counsel

In 35 years food and drug law, this is the strongest letter that 3. Addressing the Problem and (Perhaps) Liability with I and my partners have ever seen FDA send to any part of the Due Diligence. FDA makes several recommendations industry it regulates. Here are the notable points. as to what manufacturers and distributors can do to exercise due diligence, with emphasis on the three product 1. Undeclared ingredients. The letter lists the various sub- categories identified above. These should be read care- stances that FDA has found as adulterants in products fully and within the context of FDA’s dietary supplement labeled as dietary supplements and focuses on three pri- current good manufacturing practice (cGMP; i.e., 21 mary product categories: weight loss, sexual enhance- CFR 111) rule, and particularly where §§ 111.70 (b)(3) ment, and body building. The letter also lists other and (e) address “limits on those types of contamination substances not found in these product classes, including that may adulterate” a dietary supplement. Manufacturers lovastatin, a “statin” drug that also appears in very small may consider the specific substances identified in the amounts in red yeast rice, and warfarin, also known as FDA letter, and substances similar to them, to be such Coumadin, a blood thinning drug. The listing of any contaminants. If there is a problem with an undeclared drug substance in FDA’s letter is intended as fair warning ingredient despite taking FDA’s several recommended to supplement manufacturers and distributors that the steps, it is possible, but not certain, that strict liability ingredient should not appear in supplements at mean- may be avoided. ingful levels. And FDA promises more testing. 4. How the FDA and USDOJ Will Implement this 2. No Warning Letters and Criminal Consequences. Enforcement Program. If your company is found to When adulterated products are found, FDA will contact have distributed adulterated products, do not be shocked responsible firms to get the products off the market. if FDA, using its inspection powers and with search war- No warning letters will be issued. This means that FDA rants issued by US Magistrates and District Court Judges, will begin investigations and may seek to impose strict seizes products and copies records, and then begins a criminal liability upon responsible individuals in the detailed investigation to seek to prove a felony (inten- involved company or companies. Strict criminal liability tional crime). Companies and their responsible officials means that if it happened, and you are the boss, you take will then need to hire defense counsel, leading to large the fall, even if you claim “I knew nothing” and there is legal fees. This will create pressure for a resolution no solid evidence you knew you were selling adulterated that would include, in the usual course, a guilty plea products. Simply put, “but I did not know my supplier by the company and several responsible officials to crim- was shipping me adulterated products” and “I just inal misdemeanors. ordered the product and it sold well. That’s all I know,” are not good defenses. Guarantees from suppliers will not cut it.

January 2011 • Page FDA on Spiked Products, cGMP Small of dietary supplements are responsible for ensuring that their products Entity Compliance Guidance Guide, comply with the statutes and regulations FDA enforces.” More Warning Letters and Free Form The cGMP Small Entity Compliance Guidance follows the cGMP Plant Phytosterols which was promulgated on June 25, 2007. This cGMP rule became effective for all dietary supplement manufacturers on June 25 of this by Anthony L. Young, Esq. year. The Small Entity Compliance Guide is prepared as required by the Small Business Regulatory Enforcement Fairness Act (Public FDA educates through guidance documents and through enforce- Law 104-121) and is intended to restate the cGMP requirements in ment actions (Warning Letters). On December 15, FDA sent a plain language. Comments on this guidance may be filed at any letter to manufacturers of dietary supplements, as reported in the time, and manufacturers should read it and advise AHPA President two articles above. It was an important message to manufacturers, Michael McGuffin of any matters that require clarification or cor- distributors and retailers about spiked products masquerading as di- rection. Noteworthy in FDA’s Federal Register notice announcing etary supplements. Please read it and heed its teachings. the availability of this guidance, FDA noted that AHPA “submitted In a spiked product Warning Letter to dietary supplement manufac- a petition for reconsideration on July 25, 2007, under 21 CFR turer Prolatis, FDA warned that the Agency had found that 10.33, requesting reconsideration of certain provisions of the DS “’ProLatis’” contains sulfoaildenafil, an analogue of sildenafil, the CGMP final rule. FDA is currently considering this petition and the active pharmaceutical ingredient in Viagra, an FDA-approved SECG does not represent a response to such petition.” drug…” The Warning Letter follows an FDA Safety Alert on this The guidance is written in question and answer format. One issue it product and a recall by the company. This letter is noteworthy in addresses is “expiration” or “best if used by” dating of products. In that a copy of it was sent to the Director and Chief Executive Officer Part IX B and C, FDA discusses expiration dating as follows: of a major national retailer that carries this product line. This occurred two weeks prior to FDA’s industry letter, and is stark evi-  Does the DS CGMP rule require me to establish an dence that the FDA means what it says when it notes that “expiration date” (or a “shelf date” or “best if used by” date)? “[M]anufacturers, distributors, importers and others in the supply chain  No.

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January 2011 • Page  Should I have data to support any expiration date (or The second letter was to New Life Alternatives and discusses their “shelf date” or “best if used by” date) that I will place on a Tongkat Ali product. Plainly, this inspection was predicated on product label? products in the sexual enhancement category. During the inspection, it was noted that the company received products via interna-  Yes. Although the DS CGMP rule does not require you to establish an “expiration date” (or a “shelf date” or “best tional parcel post, and that “none of your imported shipments were if used by” date), you should have data to support any declared” under the Bioterrorism Act. This is the first time we have such date that you place on a product label. seen a Warning Letter mention these prior notice provisions, and it is surprising that the products are not simply returned to the coun- At the outset of the guidance, however, there is an important caveat try from which they were sent. on page 5 – “The use of the word ‘should’ in Agency guidances means The enforcement discretion that allows the coronary heart disease that something is suggested or recommended, but not required.” health claim to appear on free form plant phytosterol dietary supple- AHPA members who are concerned about whether FDA has the au- ments has been set by FDA to expire on February 22, 2011. This re- thority to review data supporting “best if used by” dating should sults from an FDA decision to revoke the letter of enforcement keep this guidance and these references on hand if they would prefer discretion allowing such claims that was issued back in February not to volunteer supporting data to FDA inspectors. 2003. With respect to products on the market, this may mean noth- cGMP Warning Letters were sent to two companies. The first was to ing, but manufacturers and distributors may have substantial inven- Hain Celestial Group and it followed an inspection that occurred in tories that are impacted by this decision. You can expect that the March and April of this year. The letter contains many observations trade associations will be asking FDA for a more reasonable time and manufacturers should read it against their own procedures to frame to bring their products into compliance.  assure their own compliance. Be concerned that these letters make bold statements that can be used by competitors vying for precious retail shelf space. How would your sales staff answer a major account SPECIAL LOW PRICE that wants to know why FDA says, “Your quality control program is for MEMBERS not adequate”?

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January 2011 • Page The 112th Congress: means supplement skeptic Rep. Henry Waxman (D-CA) will no Outlook and Opportunities longer be at the helm of the House Energy and Commerce Committee. While Waxman didn’t take direct aim at DSHEA dur- by Pete Evich, Vice President, Van Scoyoc Associates ing his tenure as Chair of House Energy and Commerce, in the 2011 brings with it the start of a new Congress. As we know from 111th Congress he backed concerted efforts which would have the November election results, the congressional landscape will be heaped additional regulatory burdens on the supplement industry. undergoing a significant change. On January 5th, when the 112th Some examples of this include the onerous provisions contained Congress convenes, the House of Representatives will be Republican- within the House Food Safety legislation and his effort to expand controlled. The power shift from Democrat to Republican means the Federal Trade Commission’s authority as part of the House we will see a new set of leaders and federal priorities coming from Financial Reform package. the House. On the other side of the Capitol, while Senate Democrats Replacing Rep. Waxman as Chairman of the House Energy and will see their ranks slimmed from 59 to 53 seats, Democrats will re- Commerce Committee is Rep. Fred Upton (R-MI). What we know tain structural control of the upper chamber. of Rep. Upton is that he has a strong pro-business record during his An Obama White House, a Republican House of Representatives, a 24 year career in Congress and, as far as we know, has been support- Senate controlled by a modest Democratic majority, and a high ive of DSHEA. In short, the philosophies and outlooks espoused by stakes presidential election in 2012: all taken together, this translates Reps. Upton and Waxman on the role and size of government are into a perfect recipe for legislative stalemate over the next two years. night and day in their difference. Bringing it into focus for AHPA members, the question becomes: On the Senate side, long-time supplement champion Tom Harkin how are the pending political changes in Washington likely to im- will continue to chair the Senate Health, Education, and Pensions pact the issues that are important to the herbal supplement trade? Committee (HELP). Chairman Harkin scored a major victory at the end of the 111th Congress when the Senate version of the food Key Players of the 112th Congress safety bill (S. 510) was passed into law. Thanks to the advocacy of Let’s first examine who will be in charge of the key congressional Senator Harkin as well as Senator Hatch, the Senate food safety committees that have jurisdiction over Food and Drug Administration measure spared the supplement industry the most costly and bur- (FDA) policy. In the House of Representatives, the shift in power densome regulatory provisions found in the House food safety bill.

January 2011 • Page Also in the 111th Congress, we saw the Harkin-Hatch tandem effec- reform measure which would have expanded FDA’s jurisdiction, tively move to action when they helped the industry beat back Senator that effort is now considered off the table with the House Republican McCain’s legislation (S. 3002), which would have given the FDA ad- takeover. While supplements are not a part of PDUFA, that must- ditional powers to regulate supplements. The Hatch-Harkin interven- pass measure often carries FDA policy riders. The supplement in- tion resulted in Senator McCain pulling his bill and instead focusing dustry needs to pay attention to PDUFA reauthorization legislation on common-sense provisions (i.e. mandatory food recall authority) and the extraneous provisions that are often attached to it. that AHPA and the major supplement associations endorsed. The small business-friendly predisposition of the new Congress Senator Hatch should also be acknowledged for bringing a voice of might provide an opportunity for smaller supplement facilities to reason to the Senate Aging Committee hearing on supplements, voice concerns about regulations which potentially place an undue which took place last May, as well as for leading (along with Senator and unnecessary burden on their operations. Any regulatory relief Harkin) introduction of the Dietary Supplement Full Implementation petitions will need to be weighed against their potential impact on and Enforcement Act (S. 3414) which spotlighted the fact that FDA public safety. already has the appropriate regulatory tools to effectively oversee supplements. Will the Other Shoe Drop? Looking ahead to the 112th Congress, we know that Senator Hatch The FDA is appropriately concerned about the rise of illegal drug will be the top Republican on the Senate Finance Committee, and spiking of products which are often falsely labeled as dietary supple- every indication is that he will maintain his post on the Senate ments. These products are usually marketed for weight loss, muscle HELP Committee. While it would be foolhardy for the supplement growth, and sexual enhancement. AHPA and the major trades re- community to think that it need not worry about potential legisla- cently joined with the FDA in a renewed voluntary effort to assist tive threats emanating from the Senate in the 112th Congress, the the agency in identifying and helping them prosecute unscrupulous benefits of having our two most powerful champions in prominent actors who are illicitly marketing these dangerous products. positions in the U.S. Senate cannot be overstated. Despite the best intentions and FDA’s commitment to bring resources to bear on this issue, we know that it only takes one or two Congressional Action high profile tragedies to lead to congressional scrutiny, which will be So, what can we expect from the 112th Congress in terms of activity accompanied by misplaced calls to add further regulatory burdens to related to dietary supplements? First and foremost, we do not antici- the supplement industry. pate the 112th Congress to re-examine DSHEA. Another boost to As we have seen in the past, it’s the unpredictable and usually unpre- DSHEA came this past May from the Obama administration, when ventable events which throw the industry into defensive action in FDA’s Deputy Commissioner Dr. Joshua Sharfstein stated his belief Washington. The point of outlining this potential scenario is to in- that the law which governs dietary supplements struck the right bal- struct the herbal supplement community to remain vigilant and ance between regulation and access to supplements. avoid the trap of complacency when it comes to federal advocacy. The GOP-led House is expected to be aggressive and active in hold- ing oversight hearings on federal regulatory agencies. The House Time to Engage Energy and Commerce Committee will be probing FDA’s activities Starting this month, there will be 96 newly elected officials in the and actions. While we don’t know if FDA’s activities or regulatory House of Representatives and 16 new Senators. Last month, in ad- actions as it relates to supplements will be a factor in these pending dition to naming Rep. Fred Upton as the Chair of the House Energy hearings, we are certain to see a high level of scrutiny from House and Commerce Committee, House Republicans added 13 new Republicans who believe the FDA has received little accountability members to that committee. from the Democratic-controlled 111th Congress. This historic level of turnover in Congress provides a great opportu- As this industry well knows, warning letters and litigation against nity for AHPA members to seek out and engage their federal repre- drug and supplement companies have increased significantly over sentatives. The supplement industry is always in need of more the past two years as the Obama FDA has prioritized enforcement congressional champions and these next few months are a perfect and compliance with regulations. Some industry stakeholders have time to start this process. Building or fortifying relationships with expressed consternation that FDA has been overzealous in its en- one’s members of Congress entails effort and a time commitment, forcement scheme, allowing for only limited communication and but it’s a worthwhile endeavor. With no pressing or specific legisla- little or no give-and-take. It is possible that this is an area in which tive issue to address, “meet and greets” and general outreach meet- House Republicans will question the agency on its tactics. ings with congressional offices are very easy, and often more The Prescription Drug User Fee reauthorization legislation (PDUFA) fruitful. is due for consideration in the 112th Congress. While Reps. John In the next month, I will be providing AHPA President Michael Dingell and Henry Waxman had plans for a massive drug safety McGuffin with detailed profiles of the new members of Congress, as

January 2011 • Page 10 well as of those who will be serving on the congressional committees any manner that could be ruled as deceptive. They address claims which are important to the herbal supplement trade. For those such as recyclable, degradable, or refillable packaging, carbon off- AHPA members who have not already done so, I hope this informa- sets, renewable energy, and other environmental benefit claims. The tion will serve as a starting point to begin the process of building re- Guides were originally issued in 1992 and revised by FTC in 1996 lationships with your federal representatives. I would be happy to and again in 1998. assist any AHPA member with a congressional outreach plan, or any AHPA’s comments suggest that FTC recognize: other information that members might find helpful for engaging their congressional delegation.  Non-deceptive general claims. That there may be conditions under which an unqualified general environmental I look forward to working with AHPA over these next two years as benefit claim (e.g., "environmentally friendly") is not de- we educate the new Congress about the important role that herbal ceptive. AHPA provided as an example an organic farm supplements play in the lives of millions of Americans, as well as to that produces its own energy (or purchases carbon offsets) ensure access is not impeded by unnecessary and costly regulations. and uses only recycled packaging. As always, both challenges and opportunities lie ahead, but I am confident that in working together we will continue to be effective  Carbon offsets that include legally required emission re- and productive in our endeavors in Washington.  ductions. That a carbon offset claim can be truthful and not deceptive even if some of the offsets are related to le- AHPA Comments on FTC “Green Guides” gally required emission reductions, for example from renewable energy production in states that require its utilities by Michael McGuffin to produce some portion of its energy by renewable On December 10, the American Herbal Products Association (AHPA) means. communicated to the Federal Trade Commission its comments on  Commonly recyclable materials. That most consumers al- that agency’s proposal to revise its Guides for the Use of Environmental ready know whether commonly recycled materials, such as Marketing Claims (“Green Guides”). aluminum, glass, and plastic bottles, can be recycled in FTC identifies the Green Guides as helpful to marketers that make their communities, even without having this information environmental marketing claims to avoid making these claims in provided on package labeling. Analysis of the adequacy of

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January 2011 • Page 11 recycling facilities is therefore not required in every com- tently serve as a disincentive to companies that might otherwise pro- munity where such materials are identified as recyclable. mote laws that mandate emission reductions in their municipalities or states. Similarly, AHPA calls attention to FTC’s position that  Compostable claims. That a compostable claim for a material for which facilities are not readily available for a sub- marketers should not make unqualified general claims under any stantial majority of consumers can be adequately qualified circumstances, and suggests that this could also disincentivize mar- either by describing the required capabilities for compost- keters from investing in making their products comply with more ing the material or with a statement that appropriate facili- strict environmental standards. ties may not be available. Both such statements, however, “While it is outside of the scope of FTC’s role to take actions that should not be needed. explicitly or implicitly encourage strict environmental standards or that advocate for laws that mandate emission reductions, neither  Organic claims for non-agricultural products. That AHPA should the agency take actions that might have the opposite effect,” agrees with FTC's decision to refrain from offering guid- AHPA went on to say in its comments. ance on organic claims for non-agricultural products. AHPA's comments note that significant expertise on this To read the full text of AHPA’s comments, click here.  topic exists at USDA's National Organic Program and on the National Organic Standards Board. AHPA Comments on USDA’s The Green Guides are a useful regulatory tool for marketers that Draft Guidance on Organic Wild Crops make environmental benefit claims. Enforcement of the principles set forth in these guidelines protects companies that have well sub- by Michael McGuffin stantiated claims from those who would be deceptive. AHPA’s com- On December 13, the American Herbal Products Association ments to FTC are provided to seek clarification on a few specific (AHPA) submitted comments to the USDA’s National Organic issues and to prevent unnecessary restrictions when not required. Program (NOP) in which it provided several suggestions on recently AHPA’s comments also request that FTC consider whether its posi- released draft guidance titled “Wild Crop Harvesting.” AHPA made tion that truthful carbon offset claims are necessarily deceptive if the following suggestions on subject areas addressed in the draft they are related to legally required emission reductions may inadver- guidance:

January 2011 • Page 12  That the guidance clarify that it is acceptable to produce unanimous consent. The move put an end to much of the uncer- organic wild crops and organic cultivated crops on the tainty that had surrounded the bill following its invalidation imme- same certified farm or site. diately after its passage weeks earlier based on a disallowed revenue-raising measure. According to media reports, a coalition of  That the presence of an endangered species in the same habitat where a wild crop is harvested restrict the wild crop groups supporting the bill sent a letter to Senate Majority Leader harvest only if the harvest is detrimental to that endangered Harry Reid (D-NV) and Republican Leader Mitch McConnell (R- species. KY) calling for its passage earlier the same day. The bill, which was passed by the House on December 21, will give  That a certifier's interviews with wild crop collectors be the Food and Drug Administration (FDA) authority to mandate a carried out by contacting a representative portion of recall of any food (including a dietary supplement) when there is a these collectors, as it is neither necessary nor pragmatic to attempt to interview all collectors. “reasonable probability [of] serious adverse health consequences or death” associated with such food. The American Herbal Products NOP’s guidance on organic wild crops should provide clear infor- Association has expressed support for this expanded recall power. mation to ensure that all wild-harvested plants identified as organic Under S. 510, FDA will also be provided with enhanced authority meet the same standards. Consistent implementation of the guid- on records inspections, administrative detention, imported foods, ance will provide consumers with confidence in the integrity of the and in numerous other areas. Other features of the legislation USDA organic brand, and companies that are making the extra effort to certify wild crops as organic with an even playing field. include: AHPA applauds NOP’s attention to this issue and hopes that our  a minimum schedule for FDA inspections of all food and few suggestions to clarify the draft will be well received. supplement manufacturers;

AHPA will report to members on the final content of the NOP  a requirement that food facilities re-register biannually; “Wild Crop Harvesting” guidance when it becomes available.  accountability of companies for expenses borne by FDA To read the full text of AHPA’s comments, click here. related to facility re-inspections, and

To read USDA’s Federal Register notice on its proposed revisions to  a requirement that food companies and dietary ingredient the NOP’s draft guidance on Organic Wild Crops, click here.  firms establish hazard analysis and risk-based preventive controls. U.S. Senate Succeeds on Second Supplement companies would be exempt from this last require- Attempt to Pass “Food Safety ment in recognition of their obligation to comply with the new di- Modernization Act” — Limited Effect etary supplement cGMP regulation. on Supplement Companies; “AHPA appreciates that the food safety bill exempts dietary More on Ingredient Manufacturers supplement manufacturers from the HACCP portion of the law, and is reviewing the final language to determine its full effect by Jennifer Denhard, AHPA Communications Director on ingredient manufacturers,” stated AHPA president Michael On Sunday, December 19, the U.S. Senate surprised observers McGuffin.  by passing S. 510, the FDA Food Safety Modernization Act, by

January 2011 • Page 13 Inside AHPA

AHPA Looks Ahead to 2011 by Michael McGuffin, AHPA President

Dear AHPA Members, In my holiday message last year, I predicted that Congress would, in 2010, pass some form of food safety legislation. Despite some procedural glitches after what appeared to be smooth sailing in the Senate, the FDA Food Safety Modernization Act (S. 510) was passed by the Senate on December 19 and by the House two days later. Once signed into law, it will give the FDA more power to detain potentially unsafe products, and to order recalls. AHPA has expressed support for this expanded recall power, in the belief that more rigorous enforcement will enhance the already high degree of trust that the public places in the herbal and dietary supplements industry. This year, as in earlier years, we faced down well-worn allegations by groups that purport to work on behalf of consumers (but seem more interested in confusing and frightening them). Neither PBS nor the Wall Street Journal—two media icons—missed the opportunity to do some unfounded generalizing. But consumers are apparently unimpressed, as evidenced by the consistently robust growth in sales of herbal and dietary supplements, even at the tail end of the current recession. While public opinion is important, our top priority is serving our members. In 2010, we sharpened our focus on education, offering new and varied opportunities for members to gain the knowledge necessary to survive and thrive in an envi- ronment that is as rich in opportunity as it is complex in detail. We offered training in cGMP and Proposition 65 compliance, microscopy, product quality assessment, material review, FDA inspections, and other subject areas. We also released two reference publications, “Good Documentation Practices: A Guide for the Dietary Supplement Industry” and another, “Primer on Products Liability Insurance for the Dietary Supplement Industry.” We are fortunate to be able to rely on some of the top experts in the industry to provide our members with the most authoritative information there is in all of our offerings. We plan to step up the pace on our educational programs even more intensely in the year ahead. In 2010, we also strengthened our relationships within FDA, and found particularly solid common ground on the issue of illegal drug spiking. We established AHPA as a resource and a partner in the effort to crack down on this practice--which is both insidious and harmful to our industry on many levels--and our efforts have been recognized. FDA has sought us out on a regular basis for the expertise we can provide from our “industry insider” perspective. The year ahead is bound to be no less exciting than the one we look back upon. I continue to take great satisfaction in the commitment of you, our members, to promote the well-being of the industry. Your active involvement in AHPA is a cor- nerstone of our success, and it is a privilege to be able to count on your continuing support. On behalf of myself and the entire AHPA staff, I wish you and your families a happy, healthy and prosperous new year! Sincerely,

Michael McGuffin President American Herbal Products Association

January 2011 • Page 14 AHPA Trains Naturopaths in Quality Assessment of Dietary Supplements by Jennifer Denhard

On December 4 and 5, the American Herbal Products Association (AHPA), in partnership with the Southwest College of Naturopathic Medicine & Health Sciences in Tempe, AZ, and sponsored by Metagenics, Inc., offered an unprecedented two-day course, titled “Evaluating Product Safety in Dietary Supplements.” The purpose of the course was to help prepare practicing and aspiring naturopaths to better evaluate marketplace products and make the best possible decisions when recommending dietary supplements to their patients. The course—for which currently practicing naturopathic doctors were eligible to receive twelve continuing education credits— provided an understanding of what defines quality in an herbal supplement. Students were taught how to develop a set of metrics in the form of a “Quality Questionnaire” to assist them in making decisions about individual products, and were given the tools to know how to interpret the answers manufacturers provide. Students benefitted from the expertise of instructor James Kinsinger, Ph.D., former Corporate Director of Regulatory Affairs at The Hain Celestial Group. Dr. Kinsinger has a strong practical and theoretical grounding in the manufacturing, regulatory and legal issues envi- ronments, and helped make sense of the many state and federal-level regulations and industry-developed “best practices.” Practitioner interest in making discerning decisions on supplements is evident. “The fact that this course drew so many practitioners is a clear sign that these professionals are aware of the need to gain as much new information as they can in order to prescribe the best possible supplements to their patients,” remarked Kimberly Volk, ND, RN, Director of Clinical Operations at Southwest Naturopathic Medical Center. “Courses like this one help practitioners ensure that their patients are making the best use of the natural supplements that are available to them.” “As a provider of dietary supplements exclusively dispensed by healthcare professionals as well as lifestyle medicine education and services, we were pleased to support this project. The industry only stands to gain by contributing to the greater understanding of naturopaths and others in assessing product quality,” said Lyra Heller, M.A., Co-founder and Category Manager of Metagenics, Inc. 

January 2011 • Page 15 Special Science Feature

Reanalysis of ConsumerLab’s Valerian do not need to meet standards that are assigned by some third party Product Review; Many Questions and that go beyond the promises made to consumers on product Still Unanswered labels. by Michael McGuffin Valerenic acids levels depend on ingredient form Some of the products selected by CL specify the level of valerenic ConsumerLab.com* (CL) announced on November 10 that “only acids while others list only the amount of valerian root. In the latter 22%” of valerian products tested and reported upon had passed the case, CL states that a product was passed if the amount of total company’s “tests for quality.” The American Herbal Products valerenic acids detected was at least 0.17% of the amount of valerian Association (AHPA) issued an analysis of this study on November root in the product. Although CL does not provide a reference for 23 and called into question some of ConsumerLab’s procedures and this 0.17% standard, it matches the European Pharmacopoeia (EP) conclusions. CL released a response the following day in which it for whole, dried or fragmented underground parts of Valeriana offi- branded AHPA’s statement as “false” and took issue with three of the cinalis (i.e., the rhizomes, roots, and stolons; hereinafter “root”) for many points made in AHPA’s analysis while ignoring others. sesquiterpenic acids calculated as the sum of valerenic and ace- This revised AHPA statement takes into account the issues raised in toxyvalerenic acids. The EP standard for valerian root in cut form, CL’s November 24 response and reaffirms AHPA’s view that CL’s re- however, is 0.10% sesquiterpenic acids. liance on arbitrary criteria for measuring valerian products misrep- “ConsumerLab appears to have arbitrarily chosen to apply the resents the quality of some tested products. 0.17% standard to finished products made from any form of AHPA makes no defense of products that fail to meet claims that valerian root in their attempt to determine product quality,” stated appear on their labels. But herbal products that comply with all laws Steven Dentali, Ph.D., AHPA’s Chief Science Officer. “This is a

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January 2011 • Page 16 misapplication of this EP standard for products made with cut or The INA method quantifies four compounds: valerenic acid, ace- fresh valerian root, since that 0.17% standard is for dried, whole va- toxyvalerenic acid, hydroxyvalerenic acid, and valerenal. CL’s second lerian root,” he added. “In addition, unless a company claims to “similar” method counts at least three of these. It is not clear how comply with the EP or another compendial measure, it may use CL uses this information to approve or not approve products if they other quality standards in the sourcing and manufacture of its vale- relied on the EP standard for whole, dried valerian root for all tested rian products.” products, since, as CL pointed out in their November 24 response, the EP levels are sums of only two of these compounds. Authoritative references vary in qualifying valerian root ingredients Re-analysis of data One other such compendial standard is the United States CL identifies four products that had acceptable levels of valerenic Pharmacopoeia-National Formulary (USP-NF), which is published by acids by its selective criteria, and classes five others as “not approved.” the U.S. Pharmacopoeia (USP). According to USP, its standards are CL claims that three of these did not contain the amount of valeren- “recognized and used in more than 130 countries around the globe.” ic acids identified on product labels, and AHPA notes that such The current edition of the USP-NF includes monographs for un- products would be mislabeled if CL’s analysis is correct. processed dried valerian root and powdered valerian root. The USP- But two of the “not approved” products do not make any claims as NF describes whole valerian root as containing not less than 0.05% to the amount of valerenic acids in their products. CL nonetheless valerenic acid, and powdered valerian root as containing not less holds these to its own standard, which assumes that the level of than 0.04% of this same single compound. valerenic acids in finished products should be 0.17% of the declared Questions on analytical methods used quantity of valerian root. This approach apparently applies the EP standard for whole, dried valerian root, irrespective of the form of CL identifies their initial assay method as an HPLC method “devel- the root used in each product. One of these “not approved” products oped by the Institute for Nutraceutical Advancement’s (INA) is made with fresh valerian root. Method Validation Program to specifically test for the presence for these substances.” CL also states that a “similar” method was used to “Any assumption that the levels of valerenic acids set by the USP re-test products that did not pass the first assay but provides no ad- or the EP for dried valerian ingredients should apply to a product ditional information to identify this second method. made with fresh valerian root completely ignores the fact that

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January 2011 • Page 17 neither organization has established a fresh root standard,” observed grams per maximum daily serving (mcg/day), and specifically at Dr. Dentali. amounts of 1.15 and 3.5 mcg/day. CL’s limit of 0.5 mcg/day is the For another product that made no quantitative claim for valerenic level above which products sold in the state of California are re- acid, CL measured 0.04% valerenic acid and 0.10% total valerenic quired to bear warning labels. acids, resulting in a “not approved” classification. The manufacturer But this California standard is inconsistent with other established of this product has communicated to AHPA that its product is made limits on lead. For example, Health Canada allows up to 20 mcg/ with dried, cut valerian root in a manner that intentionally includes day of lead in natural health products (the Canadian equivalent of a broad spectrum of the naturally-occurring compounds found in dietary supplements in the U.S.). And while the Food and Drug valerian root. The company notes that its product contains exactly Administration (FDA) has not issued a regulation to provide quan- the amount of valerenic acid prescribed by the USP for dried valeri- titative limits for lead or other heavy metals in supplement products an root powder, but believes this to be of lesser importance than its (or in most conventional foods), FDA’s Principal Deputy intention to produce a broad spectrum extract. The company states Commissioner Joshua Sharfstein, M.D. referenced 6 mcg/day as that its product meets its internal quality specifications for this broad “FDA’s tolerable daily intake” for lead in testimony before Congress spectrum extract. earlier this year, referring to the agency’s long-established provisional total tolerable intake (PTTI) of lead in the most sensitive popula- Valerenic acids not a “magic bullet” tion of children under 7. CL apparently relies on valerenic acids as the sole indicator of valeri- ConsumerLab has again chosen an arbitrary reference to determine an quality, implying that the level of valerenic acids is the only factor whether products meet its self-assigned quality standards. While that can be used to determine whether a valerian product has any AHPA has been active in providing information to assist companies benefit. to comply with the California law, the lead levels in these products But one of the products that was “not approved” by CL is a clinically do not represent adulteration under federal law. tested valerian-hops combination. CL completely ignores the fact that this product has been shown in a double-blind placebo controlled study to provide significant sleep benefits with a single dose. “While valerenic acids are useful markers for identifying a valerian ingredient, you can’t ‘test in the quality’ of a valerian product simply This space could be yours by measuring these compounds,” noted Dr. Dentali. “This narrow approach has in at least one case caused ConsumerLab to classify a ADVERTISE product with proven efficacy as ‘not approved.’” IN THE AHPA REPORT In CL’s November 24 response to AHPA’s analysis, Dr. Tod Cooperman, CL’s president, accurately noted that this clinical study “was not independently conducted, but was funded by the product’s easy manufacturer and co-authored by one of its employees.” Dr. Cooperman’s comment, which seems to imply that he thinks cost effective it is a bad thing for companies to conduct clinical trials on their products, is confusing. Drug trials are routinely paid for by the de- veloping drug company and conducted by scientists employed by targeted audience that company. There should be nothing suspect when an herbal company does the same. Non- CL also stated that the description of the clinically tested product “is inconsistent with the product tested” by CL, so that any comparison Members Members is “impossible.” This statement ignores, however, that the company has publicly announced the positive results of its clinical study for Half Page $200 $300 this specific marketed product. Quarter Page $100 $150 Lead levels under FDA threshold Two valerian products were confirmed by CL to contain the claimed contact: [email protected] or expected amount of valerenic acids but are nonetheless classed as “not approved” due to the presence of lead at levels above 0.5 micro-

January 2011 • Page 18 In its November 24 statement CL states that the California limit is “the only limit in the U.S.”except for FDA’s limit for candy. But this Communications Update ignores the fact that FDA considers its PTTI levels to represent the agency’s current thinking on lead limits, and that FDA in fact used the 6 mcg/day level to set its lead limit for candy (and to be most AHPA Notable “Herbal Headlines” precise, for candy “likely to be consumed frequently by small children”) at 0.1 ppm. It is also important to note that the only enforce- These “herbal headlines” – and headlines of interest to the herbal ment action taken to date by FDA against a supplement due to the industry – have been selected from the past few weeks of media and presence of lead was for a product that contained 12 mcg/day at its public affairs activity. maximum dosage. Clove Oil Reverses Learning and Memory Deficits in Still unanswered Scopolamine-Treated Mice, Thieme eJournals, December 22. In its November 24 response CL addressed three of the issues raised Goldenseal (Hydrastis canadensis L.) Extracts by AHPA’s initial analysis of its valerian product review, but ignored Synergistically Enhance the Antibacterial Activity of others. Their response also raised some new questions. The follow- Berberine via Efflux Pump Inhibition, Thieme eJournals, ing issues are as yet not addressed: December 22.  What is the reference for CL's selection of its 0.17% stan- U.S. Spending Millions to See if Herbs Truly Work, dard? Is it the EP standard for whole, dried valerian root? U.S. News, December 16.  Why should products made with cut or powdered valerian FDA Scrutinizing Hain Celestial Teas, Boulder County root contain 0.17% valerenic acids instead of the 0.10% Business Report, December 22. EP standard for cut valerian root or the USP standard for dried valerian root powder of 0.04% for just valerenic ESCOP’s role in defining a scientific foundation for acid? herbal medicinal products, Phytomedicine, December 15.

 Why should products made from fresh valerian root con- US Looks to India to Strengthen Co-Operation in tain 0.17% valerenic acids, as the EP standard does not Ayurveda-Siddha-Unani Herbal and Botanical Products of apply to fresh valerian root? Global Standard, Pharmabiz.com, December 9, 2010.

 Why shouldn't an herb company conduct and pay for Ginseng for cognition, Cochrane Reviews, December 8. clinical trials for its products? If they should not, then who Food Labeling; Health Claim; Phytosterols and Risk should conduct and pay for such studies? of Coronary Heart Disease, U.S. Food and Drug  Has any company that participates in CL's Voluntary Administration (Federal Register), December 8. Certification Program ever requested or permitted CL to NMR Fingerprinting for Analysis of Hoodia Species and  post the results of a product that failed its tests? Hoodia Dietary Products, Planta Med, December 2.

Introduction to the special issue: The changing use and * ConsumerLab.com (CL) is a for-profit business that identifies misuse of khat (Catha edulis)-Tradition, trade and itself as a provider of “independent evaluations of products that tragedy, Journal of Ethnopharmacology, December 1. affect health and nutrition.” The company claims to offer two testing programs: “Product Reviews” and a “Voluntary Certification Two-Thirds of Canadians Use Natural Products, IPSOS, Program.” In the former, products to be tested are “selected” and December 1. “purchased independently” by CL, and “results ... are available on- Safety of botanical ingredients in personal care products/ line to subscribers.” On the other hand, the Voluntary Certification cosmetics, Food and Chemical Toxicology, November 24. Program is described as testing “conducted in the same manner” as Product Reviews, but in this program test results “are proprie- Plant-derived medicines: A novel class of immunological tary to the manufacturer,” which pays “a testing fee.” Thus, in the adjuvants, ScienceDirect, November 5, 2010. voluntary program it is up to the manufacturer to decide whether CL should publish its test results. AHPA is not aware of any case Fingerprint Analysis of Ginkgo biloba Leaves and Related Health Foods by High-Performance Liquid in CL’s 11 years in business in which a manufacturer in the volun- Chromatography/Electrospray Ionization-Mass tary program has had CL post the results for a product that failed Spectrometry, AOAC International, November issue. its tests.

January 2011 • Page 19 Calendar of Botanical Events Botanical Science Update

 Feb. 7-11, 2011: First International Symposium on Papaver, by AHPA Chief Science Officer, Steven Dentali, Ph.D. Lucknow, India. The opium poppy as a source of food, flow- ers, medicine and human conflict has never before received so MEETING ATTENDED much public attention. But the contribution Papaver som- niferum to health, culture, food and horticulture is not nearly China Pharmacopoeia Delegation so well known and indeed is often wrongly presented in the press. Please join your colleagues from around the world for a I represented AHPA at a U.S. Department of Commerce workshop multidisciplinary conference devoted to this ancient crop. The that hosted a China Pharmacopoeia delegation on December 15 in meeting is hosted by the Central Institute for Medicinal and Washington, DC. The delegation came to the U.S. by invitation of Aromatic Plants (CIMAP) and the International Society for the U.S. Pharmacopeia (USP) who asked for this meeting that in- Horticulture Science (ISHS). cluded representatives of other dietary supplement associations, http://www.sciencejobs.co.in/conference-training/460 Department of Commerce officials, and representatives from U.S. pharmaceutical companies and associations. Topics addressed in-  Feb. 18-20, 2011: 15th Annual Conference and First cluded cooperation on the regulation of dietary supplements and International Convention of Society of Pharmacognosy, health foods, the impact of globalization on the pharmaceuticals in- KLE University and Indian Council for Medical Research, KLE dustry, and cooperation in combating the commerce in counterfeit University, Belgaum, India. The convention brochure can be medications. downloaded at http://isp2011ic.kleuniversity.edu.in. I presented an overview of the mission and scope of AHPA and pro-  July 10-15, 2011: 27th International Symposium on the vided a historical background on the U.S. herbal industry. I ad- Chemistry of Natural Products, Brisbane, Australia. The dressed standards set by AHPA with regard to heavy metal and world class scientific program is being assembled together with microbial limits, issues that the Chinese Pharmacopoeia apparently an International Advisory Board and will include topics such takes very seriously. Zhou Fucheng, Deputy Secretary General of as: discovery of new metabolites, isolation and structure the Chinese Pharmacopoeia Commission, stated that pesticide resi- elucidation, neglected diseases, biosynthesis, chemical ecology, due and heavy metal contaminant limit tests have been added to the new methodology, and biodiversity. There will be plenary new English-language 2010 edition of the Chinese Herbal sessions, invited talks, and contributed oral presentations, while Pharmacopoeia. He also reported on the overall modernization of poster sessions will be linked to the individual scientific themes. this text including the addition of chromatographic, microscopic, http://www.ccm.com.au/home-welcome.php and other quality tests. 

If Latin is not your native language …

Add AHPA’s new custom dictionary to your computer and finally trust that you have the correct spelling of the Latin names listed in AHPA’s Herbs of Commerce, 2nd edition.

If you are responsible for the accuracy of product labels, technical or scientific writing or regulatory affairs, then loading this file on your computer will ensure the correct spelling of your taxonomic terms.

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January 2011 • Page 20 Further discussion addressed the impact of the China Food Safety inappropriate. In this study, researchers report the use of HPLC-MS law of 2009, which requires product registration and manufacturer- for the analysis of ginkgo (Ginkgo biloba) leaves pointing out the ad- provided information on product “potency” levels. The law also de- vantage over UV detection of being able to also quantify ginkgo’s fines the role of scientific evidence and addresses allowable functional terpene trilactones. They analyzed 15 leaf samples from different claims, among other provisions. In addition, it creates a functional Chinese habitats, one commercial leaf sample, and five commercial food category. According to Mr. Zhou, the Chinese government is ginkgo products. also placing an increased emphasis on pesticide residues and heavy The researchers reported 27 peaks and definitively or tentatively metal limits, apparently with an eye toward improving exports to identified most of them. Complex flavonol glycosides were the most the U.S. abundant class of compounds seen, mostly derivatives of kaempferol and quercetin. The figure below shows the relative percentages of LITERATURE CITATIONS each peak for the 21 samples tested, producing a qualitative assessment tool. It is notable that peak 3 (rutin) in sample S05 (the white Analysis bar in the far right sample) is very high compared to the other samples. The large light blue bars (peak 17) representing trilactones, Fingerprint Analysis of Ginkgo Leaves and were fairly consistent throughout the leaf samples except for samples Supplements L13-15. Song J, Fang G, Zhang Y, Deng Q, Wang S. Fingerprint Correlative coefficients were calculated to evaluate similarities between analysis of Ginkgo biloba leaves and related health foods by the different results. The commercial leaf sample (L16) closely high-performance liquid chromatography/electrospray ion- matched the fingerprints of L1-12 as did S01, a commercial tea prod- ization-mass spectrometry. J AOAC Int. 2010 Nov;93(6): uct made from leaves. Products S02-4 (a tablet and two soft gels) also 1798-1805. closely matched in comparison with leaf samples L1-12, indicating Fingerprint analysis has become a popular approach to analyzing a probable authentic match. The researchers suggest that the results Traditional Chinese Medicines (TCM) because of their inherent obtained from S05 are indicative of adulteration by addition of rutin. complexity that makes a quality evaluation based on a few constituents Additional impurities were also observed in this sample.

January 2011 • Page 21 NMR Fingerprint Analysis of Hoodia Species This study reports the use of FTIR and data manipulation in the and Supplements analysis of astragalus (Astragalus membranaceus var. mongholicus) root. Extracts prepared with different solvents were analyzed in Zhao J, Avula B, Joshi VC, Techen N, Wang Y-H, Smillie TJ, order to pick the one best able to produce a simpler spectrum than Khan IA. NMR Fingerprinting for analysis of Hoodia species that obtained from analyzing unextracted material. Astragalus sam- and Hoodia dietary products. Planta Med. Accepted manu- ples from five different agricultural regions were evaluated. While script online: 2010 Dec 2. doi:10.1055/s-0030-1250583. subtle differences could be observed in comparing spectra, mathe- This report from Dr. Khan’s group at the University of Mississippi matical treatment of the data (discriminant partial least squares examined the use of NMR technology on differentiation of Hoodia in this case) was needed to be able to differentiate the geographic species showing it “could be a promising and efficient tool for the origin of the various samples. authentication of botanicals.” The researchers had previously devel- Hedysarum (Hedysarum polybotrys) root, sometimes called red oped sophisticated TLC and HPLC methods of analysis for hoodia astragalus, was used as the adulterant in this study. Mahalanobis and were able to identify and quantify the oxypregnane glycoside distances were calculated from the data and used to indicate the P57, as well as several other closely related compounds. However, probability of sample adulteration. The authors suggested which they were not able to easily distinguish various Hoodia species from regions of the IR spectra are likely the most data rich for detection those results alone, as a few other species contain the same of adulteration. This paper, and the one before it, provide good ex- compounds. amples of critical approaches to the challenge of detecting botanical Multivariate data analysis (a mathematical treatment of the data) al- ingredient adulteration. lowed this group to visually separate H. gordonii from H. parviflora. When the NMR analysis was applied to the analysis of ten market- Tea and Herbal Tea Safe From Mycotoxin place products, the researchers were able to separate materials that Exposure were consistent with the presence of H. gordonii from those that Monbaliu S, Wu A, Zhang D, Van Peteghem C, De Saeger were not. Their results were confirmed by HPLC-UV-MS though S. Multimycotoxin UPLC-MS/MS for tea, herbal infusions the NMR results, which allowed them “to get a holistic view about and the derived drinkable products. J Agric Food Chem. 2010 the chemical composition of the products. In addition, the method Dec 22;58(24):12664-71. was simple, rapid, and easy to conduct.” This study reported on the development, validation, and applica- FTIR Screening for Adulterated Raw Materials tion of a method of analysis designed to measure multiple mycotox- by NOW Foods ins in tea (Camellia sinensis) and herbal tea materials. Mycotoxins are produced by certain species of molds and are not likely destroyed Champagne AB, Emmel KV. Rapid screening test for adul- by the tea brewing process. Only one sample of 91 tested, a Ceylon teration in raw materials of dietary supplements. Vibrational melange, was found to be contaminated. Although 76 μg/kg of fu- Spectroscopy. Accepted manuscript online: 2010 Dec 2. monisin B1 was reported in this sample, none was recovered from doi:10.1016/j.vibspec.2010.11.009. the drinkable product. Based on this, the authors concluded that in- This paper by AHPA member company NOW Foods describes the take of tea and herbal infusion products are unlikely to result in high use of FTIR (Fourier transform infrared spectroscopy, which uses levels of mycotoxins. the mid-IR region) to detect the intentional adulteration of supplement ingredients with melamine, erectile dysfunction drugs, and Ginger Analysis: Measurement of Components steroids. Their tests were designed to mimic adulteration of “men’s in Products specialty,” sports nutrition, and diet/weight management products. Shao X, Lv L, Parks T, Wu H, Ho CT, Sang S. Quantitative Assignments of individual spectral absorptions to molecular features analysis of ginger components in commercial products using of the adulterants were identified, something that cannot be done liquid chromatography with electrochemical array detection. with the use of NIR (near infrared spectroscopy). J Agric Food Chem. 2010 Dec 22;58(24):12608-14. This international group briefly reviewed the advantages and disad- FTIR Analysis of Astragalus Root for Origin vantages of HPLC ginger analysis beginning from twenty years ago and Adulteration and “developed a very sensitive HPLC method coupled with elec- Zhang L, Nie L. Discrimination of geographical origin and trochemical array detection for the quantitative analysis of [6]-, [8]-, adulteration of radix astragali using fourier transform infra- and [10]-gingerol, [6]-, [8]-, and [10]-shogaol, [6]-paradol, and [1]- red spectroscopy and chemometric methods. Phytochem dehydrogingerdione, and quantified their levels in eleven different Anal. 2010 Nov;21(6):609-15. commercial ginger products.” The method optimization and validation are described.

January 2011 • Page 22 The improvements in results obtained from this method demon- The amount of eugenol in the various samples varied more than six- strate a potential to analyze ginger constituents and metabolites in fold. I agree with the authors that “this quantitative analysis method can biological fluids collected from in-vivo and clinical studies. The au- provide a scientific and technical platform for QC to the manufac- thors recognize that gingerols, the major pungent components in turers of herbal preparations containing clove” and suggest that this fresh ginger, “generate the dehydration products, shogaols” during model is instructive of a general approach that should see more use in drying, and point out that shogaols are the “predominant pungent the botanical industry to help establish minimum quality standards constituents in the ginger oleoresin from dried ginger.” I believe that connected to scientifically valid methods of analysis where appropriate. they are correct in stating that “it is important to standardize ginger products used in in vivo study using both gingerols and shogaols as Clinical and Pharmacologic marker compounds.” Ginger Reduced Exercise Induced Pain, Eugenol in Clove Oil: A Validated HPLC Analysis Just Not Right Away

Yun S-M, Lee M-H, Lee K-J, Ku H-O, Son S-W, Joo Y-S. Black CD, O’Connor PJ. Acute effects of dietary ginger on Quantitative analysis of eugenol in clove extract by a validated muscle pain induced by eccentric exercise. Phytother Res. 2010 HPLC method. J AOAC Int. 2010 Nov;93(6): 1806-1810. Nov;24(11):1620-6. This paper describes the development of a method to measure the This study examined the effect of 2 gm of dried ginger (Zingiber of- amount of eugenol in clove (Syzygium aromaticum) buds and serves ficinale) extract provided by the McCormick Science Institute, in a as an example of a straightforward approach to the industrial estab- placebo controlled, double blind, randomized experiment involving lishment of an important quality parameter for a botanical com- 28 subjects in whom short term muscle damage was induced through modity, partly because eugenol is recognized as the main bioactive of eccentric exercise. The authors thought that the anti-inflammatory clove oil. Improvements over earlier methods were made as sample activity of ginger might lessen the experimentally caused muscle pain. preparation and chromatographic conditions were optimized. The They found that inflammation, muscle dysfunction, or pain was not method was then subjected to validation in a single laboratory and initially altered in this study by ginger consumption, but that pain applied to 15 samples from Singapore, Indonesia, and China. was reduced in the interval between one and two days after exercise.

Support Safety by Supporting the Botanical Safety Handbook Revision

AHPA’s Botanical Safety Handbook is a reference book that provides safety information on more than 600 species in trade as ingredients in dietary supplements. An essential reference for healthcare providers, consumers, retailers and manufacturers of herbal products, its safety classifications are frequently cited in other publications.

Time for an update v Significant herbal research has been published since the BSH was published in 1997 v A number of new ingredients are now on the market.

The revision will be based upon comprehensive literature reviews for each herb, historical uses and traditional knowledge, and case reports of adverse reactions and herb-drug interactions, herb-drug interaction studies, metabolism studies, toxicology studies and clinical trials. The BSH revision is to be completed over a three-year period, and seed money for the project has been pledged by the Office of Dietary Supplements at the National Institutes of Health, the University of Massachusetts, and individual and corporate contributions to the AHPA-ERB Foundation.

Pledge your tax-deductible contribution today! Contact Michael McGuffin at [email protected].

January 2011 • Page 23 Clove Oil Reversed Memory Impairment in Mice eral. The authors suggest that future studies should focus on other valerian flavonoid constituents as sleep-inducing agents. The also Halder S, Mehta AK, Kar R, Mustafa M, Mediratta PK, point out that their results indicate that valerian could be effective Sharma KK. Clove oil reverses learning and memory deficits in reducing the time it takes to fall asleep. in scopolamine-treated mice. Planta Med. Accepted manuscript online: 2010 Dec 14. doi:10.1055/s-0030-1250605. Clove (Eugenia caryophyllata) oil obtained from clove buds is known In Vitro Studies for its antiseptic activity, is used to treat toothaches, and has also been reported to have antiepileptic and anticonvulsant activities. Clove Extract Kills Lettuce Leaf Pathogens Many drugs used to treat epilepsy also affect mental function. This Kim S-Y, Kang D-H, Kim J-K, Ha Y-G, Hwang JY, Kim study evaluated the effects of clove oil on memory and learning in T, Lee S-H. Antimicrobial activity of plant extracts against mice that had been treated with scopolamine, an alkaloid known to Salmonella Typhimurium, Escherichia coli O157:H7, and impair memory, though in minute amounts is employed to treat Listeria monocytogenes on fresh lettuce. J Food Sci. Accepted motion sickness. Their results suggested that clove oil could reverse manuscript online: 2010 Dec 1. doi:10.1111/j.1750- memory deficits. Although they found a reduction in lipid peroxides 3841.2010.01926.x. (indicators of oxidation), further research is needed to establish a This research studied the antimicrobial activity of ethanolic extracts mechanism of action. of 12 herbs against three pathogenic bacteria associated with food poisoning. Extracts of lightyellow sophora (Sophora flavescens) root, Valerian Extract Did Not Sedate Mice rosemary (Rosmarinus officinalis) leaves and branches, hemp Chow NK, Fretz M, Hamburger M, Butterweck V. (Cannabis sativa) seed, myrrh (Commiphora molmol) stem, and clove Telemetry as a tool to measure sedative effects of a valeri- (Syzygium aromaticum) bud were the most active in inhibiting the an root extract and its single constituents in mice. Planta growth of all three microbial pathogens, with clove being the most Med. Accepted manuscript online: 2010 Dec 10. doi:10.1 effective microbial reduction agent. Treatment of lettuce leaves with 055/s-0030-1250589. 5% or 10% solutions of clove extract significantly reduced the levels of pathogens without compromising the color of the lettuce. This This study reported the use of radiotelemetry in an attempt to mea- work indicates that clove extracts may offer an alternative to the use sure the sedative effects of a 70% ethanolic valerian (Valeriana offici- of chemical sanitizers in food processing. nalis) extract, as well as three valerian constituents (valerenic acid, and flavonoids linarin and apigenin), in mice. The researchers did not find significant sedative effects from any of the test materials Essential Oils in Preserving Lettuce Leaves over the three hours of telemetry measurement. However, positive Ponce, A., Roura, S. I. and Moreira, M. d. R. Essential oils short-term effects were found for a high dose of the extract (1000 as biopreservatives: different methods for the technologi- mg/kg) and lower doses of linarin (12 mg/kg) and apigenin (1.5 cal application in lettuce leaves. J Food Sci. 2010 Accepted mg/kg). manuscript online: 2010 Nov 4. doi:10.1111/j.1750- Valerenic acid produced no significant effect in this study. These 3841.2010.01880.x. findings do not support the use of valerian in sleep disorders in gen- This study examined the efficacy of clove (Syzygium aromaticum), tea tree (Melaleuca alternifolia), and rosemary (Rosmarinus officinalis) essential oils in preserving lettuce leaves post-harvest. The oils were applied to lettuce leaves at full strength, half strength, and one-tenth the strength needed to inhibit 90% of the microbial population growth. The oils were applied by spray, im- mersion and embedded in lactose capsules. The treated leaves were also subjected to sensory evaluation. Unlike previous studies, the required higher concentrations of essential oils to be effective was at the minimum inhibitory concentration. Essential oils embedded in lactose capsules were most effective in controlling microbial growth but also scored lowest in the sensory evaluations.

January 2011 • Page 24 Synergistic Action of Aerial Goldenseal when used in an aerial extract than a root extract and state that fol- Plant Extracts low up in vivo research should investigate the toxicity and antibacterial activity of golden seal extracts made from below ground verses Ettefagh KA, Burns JT, Junio HA, Kaatz GW, Cech NB. above ground materials. Goldenseal (Hydrastis canadensis L.) extracts synergistically enhance the antibacterial activity of berberine via efflux pump inhibition. Planta Med. Accepted manuscript online: Reviews, Etc. 2010 Dec 14. doi:10.1055/s-0030-1250606. Immunological Activity From Medicinal Herbs Berberine, the major alkaloid in goldenseal, and what makes goldenseal root yellow, has been considered to be primarily responsible Licciardi PV, Underwood JR. Plant-derived medicines: A for the antibacterial activity of goldenseal. Antibacterial activity novel class of immunological adjuvants. Int Immunopharmacol. from the above ground (aerial) portions of goldenseal was found to Accepted manuscript online: 2010 Nov 5. doi:10.1016/j. be stronger than would be expected from their berberine content intimp.2010.10.014. alone. In this study researchers investigated the alkaloid content This review covers the modulation of human immune factors by from the aerial and below ground portions of 6 goldenseal plants, botanical materials. Effects on dendritic cells, B-lymphocytes, and evaluated the samples’ antibacterial activity in combination with T-lymphocytes by herbs are discussed, as are the activities on com- berberine, and determined if the extracts acted as inhibitors of bac- ponents of the immune system by plant-derived compounds from terial efflux pumps. Efflux pumps are used by methicillin-resistant Astragalus spp., ginseng (Panax spp.), Echinacea spp., milk thistle (MRSA) bacterial to actively excrete toxins Staphylococcus aureus (Silybum marianum), and others. from bacterial cells, reducing the effectiveness of antibacterial agents. Inhibiting that pump would render antibacterial agents more effec- All About Olive Oil tive in killing the bacteria. Garciìa-Gonzaìlez DL, Aparicio R. Research in olive oil: The below ground materials were found to contain about 5 times challenges for the near future. J Agric Food Chem. 2010 Dec the berberine of the aerial materials but when adjusted for berberine 22;58(24):12569-12577. content the latter exhibited synergistic antibacterial activity in combination with berberine. This research indicates that the above This overview of research in olive oil covers five fields that are ground portions of goldenseal leaf, which can be harvested sustain- applicable to most botanical products, namely 1) growing and pro- ably, are a good source of antibacterial compounds. The researcher’s cessing, 2) sensory quality, 3) authentication and traceability, in vitro work showed that berberine is effective in lowers dosages 4) consumers, and 5) health and nutrition. Manufactures that

What’s In a Name? Herbs of Commerce, 2nd Edition by Michael McGuffin, John Kartesz, Albert Leung and Arthur Tucker

This revised edition, published in 2000, lists 2,048 separate species, including 25 fungi and 23 seaweeds, by their Standardized Common Names and Latin binomials, and includes Indian Ayurvedic names for more than 300 plants and Chinese (pinyin) names for 500 herbs. Also, 639 botanical synonyms are included; older botanical names no longer accepted can be cross-referenced. AHPA published the first edition in 1992 to reduce confusion by establishing “standardized” common names. It was recognized and codified when FDA adopted the original edition in 1997: the common names may be used instead of Latin binomials to identify herbal ingredients in dietary supplements.

Special Member Price: $79.99 U Non-Member Price: $99.00 To order, call: 301-588-1171 or buy online at: http://www.ahpa.org/bookstore.htm

January 2011 • Page 25 employ olive oil in their manufacturing processes may want to be- sored by a grant from the Indian government’s Department of come familiar with this paper that describes the recent changes in Science and Technology maps databases in which Ayurvedic publi- olive oil production to meet growing world demand, and some of cations are likely to be found. Using vitiligo as an example, the au- the technical challenges involved in the production and quality thors searched 41 databases for relevant studies. evaluation of this important commodity. The most productive search was of the Annotated Bibliography of Indian Medicine (ABIM accessible at http://indianmedicine.eldoc. Critical Review of Synephrine in Supplements ub.rug.nl/), which returned 28 articles, eight of which were deemed Rossato LG, Costa VM, Limberger RP, Bastos MD, eligible for inclusion. In contrast, PubMed returned nine articles Remião F. Synephrine: From trace concentrations to mas- with only one deemed eligible. The authors succinctly describe the sive consumption in weight-loss. Food Chem Toxicol. 2010 situation as follows: “Comprehensive searches for Ayurveda articles Jan;49(1):8-16. for the purpose of literature reviews are never going to achieve authoritative results, if restricted to journals listed in MEDLINE This review article covers the pharmacology of synephrine with a fo- (PubMed). It is essential to look at Indian databases, because these cus on its use in weight loss supplements. Reports of cardiovascular contain the majority of Indian articles, whereas PubMed does not.” toxicity are reviewed, with the authors suggesting a potential for toxicity from synephrine ingestion, especially when consumed with ESCOP Monographs Scientifically Valuable other stimulants such as caffeine, while recognizing the factors that confound most case reports. Bilia AR, Frater-Schröder M, Krenn L, Steinhoff B. ESCOP’s role in defining a scientific foundation for herbal medicinal Assigning Causality in Botanical Adverse Events products. Phytomedicine. 2010 Dec 15;18(1):88-89 (free download). Lai JN, Hsieh SC, Chen PC, Chen HJ, Wang JD. Should herbs take all the blame? Causality assessment of a serious This editorial discusses the role that the European Scientific thrombocytopenia event. J Altern Complement Med. 2010 Cooperative on Phytotherapy (ESCOP) plays in the regulatory Nov 8;16(11):1221-4. recognition of herbal medicinal products in Europe and the overall scientific value of the ESCOP medicinal plant monographs. The This article reports the implementation of an active safety surveil- second edition of the ESCOP monographs was published in 2003 lance system applied to the use of herbal products in Taiwan. The and contains 80 monographs. The 2009 supplement includes updated system was tested by evaluation of a single serious adverse event, a information on eight monographs and adds an additional 27. case of acute thrombocytopenia (very low platelets in the blood) that occurred in one of 136 patients in a clinical trial for treating Southwest US Guide to Herbal Practice symptoms of menopause with a formula made from 21 herbs. In the evaluation of this event, it was discovered that the patient was also Yu S, Wang ZJ. Herbal Medicine: Trends and Traditions, C.W. taking conventional medicines and other herbs. The patient was not Kane, Lincoln Town Press (2009) ISBN 097713332X 325 subjected to a re-challenge of any kind. pp., Soft cover, $24.95. Phytomedicine. 2010 Dec 15;18(1):90 (free download). The authors proposed only one necessary criterion for a causal rela- tionship from herb ingestion and the serious adverse event (SAE), This book is written in the style of the late of Michael Moore, and that of temporality. Other criteria “only incrementally adding credi- covers a location where he lived, wrote, and taught. Charles W. Kane bility to the inference of causality. Because the SAE happened well appears to have produced a practical text in the trade school tradi- after 28 days into the study, the authors state that the temporal con- tion for which Michael was so well known. I plan on adding a cou- clusion can be drawn that the herbal formula alone was unlikely to ple of books by this author to my library.  be the cause of an acute event. Four days prior to the SAE, the patient was taking continuous prescribed doses of drugs that have been UPCOMING EVENT reported to cause, or have been associated with, thrombocytopenia. I will be attending the U.S. Pharmacopeia (USP) Nomenclature, Safety and Labeling Expert Committee meeting as a committee mem- Ayurveda Literature Searching ber at USP Headquarters in Rockville, MD on January 12-13, 2011. Narahari SR, Aggithaya MG, Suraj KR. Conducting literature USP’s Pharmacopeial Forum is the publication through which searches on Ayurveda in PubMed, Indian, and other databases. USP communicates proposed changes in the USP-NF to stakehold- J Altern Complement Med. 2010 Nov 8;16(11):1225-37. ers. It is now available online at no cost, which should contribute to Because many of the journals in which articles on Ayurveda appear industry’s ability to access and respond to issues of importance un- are not referenced in PubMed, the authors of this article developed der consideration and development by USP. See http://www.usp.org/ a literature search strategy for Ayurveda topics. The article, spon- USPNF/pf/pfRedesign.html for further information. 

January 2011 • Page 26