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In This Issue of the AHPA Report The Official Publication of the American Herbal Products Association November 2009 www.ahpa.org Volume 24, Number 11 In this issue of the AHPA Report You Need to Know 2 • New AHPA Members • AHP Provides AHPA Members with Complimentary Access to QRS Special Topic 2 • FTC’s Revised Testimonial Guides Will Be the Law of the Land Dec. 1: Is Your Advertising and Labeling in Compliance? by Anne V. Maher, Esq., Partner, Kleinfeld Kaplan & Becker Legal & Regulatory 6 • AHPA to FDA: Provide Efficient Enforcement Against Illegal Steroid Products • Warning Letter Review FDA, FTC Warn Dr. Weil on Flu Claims by Anthony L. Young, Esq., AHPA General Counsel Lessons Learned: Responding to an FDA Warning Letter by Anthony L. Young, Esq., AHPA General Counsel Recent H1N1 Warning Letters • Quick Round Up Communications Update 12 • AHPA Media Scan: Notable “herbal headlines” and “AHPA in the News” Calendar of Botanical Events 13 Botanical Science Update 15 • Literature Citations Ginger: Measurement of Gingerols and Related Compounds Ginger: Enter the Finnish Health Authority Evira Evira: Chocolate Not for Children, and Cook Your Dried Beans! Separating Dried Beans by UV Spectral Fingerprints Finns Find Possible Pregnancy Problem from Loving Licorice Shelf Life of Cocoa Powder, Long Term Flavonoid Stability Planta Medica on Plant Analysis: Quality Control by NMR and MS Approaches to Analysis of TCM materials USP Considers Supplements in Convention White Paper You Need to Know Special Topic New Members FTC’s Revised Testimonial Guides Will Save Your World, a Clearwater, FL-based per- Be the Law of the Land Dec. 1: Is Your sonal care company, currently has a mission to Advertising and Labeling in Compliance? preserve 200,000 acres of rainforest in Guyana, By Anne V. Maher, Esq., Partner, Kleinfeld Kaplan & Becker South America, through the production and sale of their all-natural yerba maté and aloe vera- In January 2007, the Federal Trade Commission (FTC) began the process of based personal care products. The company reconsidering its Testimonial Guides, the guidelines that advertisers use with re- supports the conservation mission by donating a spect to using testimonials or “endorsements” of products. The final revised Guides portion of the proceeds from every product sold were published in the Oct. 1 Federal Register, and the new document becomes toward this goal. Save Your World’s product effective Dec. 1, 2009. Here Anne V. Maher, Esq., highlights the changes in the claim is “1 Product = 1 Acre of Rainforest Saved revised Guides that are most pertinent to your company: for 1 Year.” Website: www.saveyourworld.com DISCLOSURE REQUIREMENTS AHP Provides AHPA Members with Consumer endorsements/testimonials Complimentary Access to QRS When using consumer testimonials, 16 CFR 255.2 requires a clear disclo- sure of generally expected performance in the depicted circumstances when- The American Herbal Pharmacopoeia (AHP) has ever the testimonial itself is not representative of what consumers can graciously extended complimentary access to Herbal generally achieve with the advertised product in circumstances depicted. QRS Bulletin to all its fellow American Herbal Products (The provision removes the safe harbor for “results not typical” or similar Association (AHPA) members. The current issue, fo- disclaimers accompanying consumer testimonials that report non-typical cusing on Good Manufacturing Practice (GMP), is results.) Note, however, that an advertiser may be able to limit the scope of the available to members at http://www.ahpa.org/portals/0/ disclosure by limiting the circumstances depicted in the advertisement. members/AHP_QR_vol2_2009rev5.pdf. The disclosure need not be based on an exact mathematical average of users If your company has questions about GMP, please feel of the product.For example, substantiation for a “generally expected results” welcome to contact AHPA ([email protected]). Questions disclosure could be extrapolated from valid, well-controlled clinical studies will be directed to the appropriate AHPA staff member. of patients matching the profile of the persons in the ad, even though con- Additional support for complying with GMPs is also sumers’ real world results are not likely to match exactly the results in the available in AHPA’s Bookstore: http://www.ahpa.org/ clinical study. In some instances, advertisers may rely on generally accepted Default.aspx?tabid=68/. scientific principles (e.g., the average individual needs a net calorie deficit of 3,500 calories to lose 1 pound) to determine generally expected results. (The goal of the revision is to treat ads that use testimonials the same as all other ads, requiring substantiation for the messages that consumers reasonably take from the ads.) 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 [email protected] of the herbal products industry. The material Products Association contained in this publication is for the information Steven Dentali, PhD, Chief Science Officer 8630 Fenton Street, Suite 918 of AHPA members. Although the information [email protected] Silver Spring, MD 20910 is believed to be correct, AHPA disclaims all Devon Powell, Chief Operations Officer Phone: 301-588-1171 responsibility for any damage or liability that [email protected] Fax: 301-588-1174 may result from any reliance on the information Email: [email protected] contained in this publication. Katia Fowler, Director of Communications [email protected] Website: www.ahpa.org Articles may not be reproduced or reprinted without written permission from AHPA. © copyright 2009, AHPA November 2009 • Page 2 Example 4 (16 CFR 255.2) the depicted circumstances (e.g., ‘most women who use “An advertisement for a weight-loss product features a for- WeightAway for six months lose at least 15 pounds’).” merly obese woman. She says in the ad, ‘Every day, I drank 2 Material connections between endorser and seller WeightAway shakes, ate only raw vegetables, and exercised vigorously for six hours at the gym. By the end of six months, When there exists a connection between the endorser and the seller I had gone from 250 pounds to 140 pounds.’…Because the of the advertised product that might materially affect the weight or endorser clearly describes the limited and truly exceptional credibility of the endorsement (i.e., the connection is not reasonably ex- circumstances under which she achieved her results, the ad is pected by the audience), such connection must be fully disclosed. not likely to convey that consumers who weigh substantially This disclosure requirement also applies to sponsorship of clinical less or use WeightAway under less extreme circumstances trials conducted by outside research groups. Consumers reasonably will lose 110 pounds in six months. (If the advertisement can be more skeptical about research conducted by outside entities simply says that the endorser lost 110 pounds in six months but funded by the advertiser than about studies that are both con- using WeightAway together with diet and exercise, however, ducted and funded independently, because financial interest can this description would not adequately alert consumers to the create bias. truly remarkable circumstances leading to her weight loss.) Example 1 (16 CFR 255.5) The advertiser must have substantiation, however, for any “A drug company commissions research on its product by an performance claims conveyed by the endorsement (e.g., that outside organization. The drug company determines the WeightAway is an effective weight loss product). overall subject of the research (e.g., to test the efficacy of a “If, in the alternative, the advertisement simply features ‘be- newly developed product) and pays a substantial share of the fore’ and ‘after’ pictures of a woman who says ‘I lost 50 expenses of the research project, but the research organiza- pounds in 6 months with WeightAway,’ the ad is likely to tion determines the protocol for the study and is responsible convey that her experience is representative of what consum- for conducting it. A subsequent advertisement by the drug ers will generally achieve. Therefore, if consumers cannot company mentions the research results as the ‘findings’ of generally expect to achieve such results, the ad should clearly that research organization. Although the design and conduct and conspicuously disclose what they can expect to lose in of the research project are controlled by the outside research November 2009 • Page 3 organization, the weight consumers place on the reported re- sults could be materially affected by knowing that the adver- Definition of Endorsement tiser had funded the project. Therefore, the advertiser’s “Any advertising message (including verbal statements, payment of expenses to the research organization should be demonstrations, or depictions of the name, signature, disclosed in this advertisement.” likeness or other identifying personal characteristics of Example 7 (16 CFR 255.5) an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, “A college student who has earned a reputation as a video beliefs, findings, or experiences of a party other than the game expert maintains a personal weblog or ‘blog’ where he sponsoring advertiser, even if the views expressed by that posts entries about his gaming experiences. Readers of his party are
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