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 disclosure 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 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 organization, the weight consumers place on the reported results 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 identical to those of the sponsoring advertiser.” blog frequently seek his opinions about video game hardware 16 CFR 255.0(b) and software. As it has done in the past, the manufacturer of a newly released video game system sends the student a free New Media: Consumer-generated content as copy of the system and asks him to write about it on his blog. an “endorsement” He tests the new gaming system and writes a favorable re- The fundamental question here is whether, viewed objectively, view. Because his review is disseminated via a form of con- the relationship between the advertiser and the speaker is such sumer-generated media in which his relationship to the that the speaker’s statement can be considered “sponsored” by advertise is not inherently obvious, readers are unlikely to the advertiser and therefore an “advertising message.” know that he has received the video game system free of charge in exchange for his review of the product, and given Facts to consider:

the value of the video game system, this fact likely would  Whether the speaker is compensated by the advertiser or materially affect the credibility they attach to his endorse- its agent; ment. Accordingly, the blogger should clearly and conspicuously disclose that he received the gaming system free of  Whether the product or service in question was provided charge. The manufacturer should advise him at the time it for free by the advertiser; provides the gaming system that this connection should be  The terms of any agreement;

 The length of the relationship; USP Dietary Supplements  The previous receipt of products or services from the same or similar advertisers or the likelihood of future Compendium receipt of such products or services; Special Price $375*  The value of the items or services received. Regular price $425 Note that an advertiser’s lack of control over the specific statement made does not automatically disqualify that statement Approximately 400 official from being deemed an “endorsement.” USP 32–NF 27 monographs

More than 150 monographs Example 8 (16 CFR 255.0) from the FCC, Sixth Edition “A consumer who regularly purchases a particular brand Reference tables, charts, and of dog food decides one day to purchase a new, more ex- guidance documents from the pensive brand made by the same manufacturer. She U.S. FDA, U.S. FTC, APHA, and industry writes in her personal blog that the change in diet has made her dog’s fur noticeably softer and shiner, and that Approximately 350 pages of full- color chromatograms, diagrams, in her opinion, the new food definitely is worth the ex- and photomicrographs tra money. This posting would not be deemed an endorsement under the Guides… TO ORDER “Assume now that the consumer joins a network market- Contact USP Customer Service at +1-301-881-0666, 1-800-227-8772 ing program under which she periodically receives vari- (U.S. and Canada) or 00-800-4875-5555 (Select Europe), ous products about which she can write reviews if she or email [email protected] wants to do so. If she receives a free bag of the new dog

* Offer valid through December 31, 2009. food through this program, her positive review would be Mention promotion code GVU9ZN. ISO 9001:2000 Certified considered an endorsement under the Guides.”

DSC025A_AHPA ad Ä_0809.indd 1 8/24/09 4:49 PM November 2009 • Page disclosed, and it should have procedures in place to try to stantiation for the claim, in her review the blogger writes that monitory his postings for compliance.” the lotion cures eczema and recommends the product to her blog readers who suffer from this condition. The advertiser is New media: disclosure obligation and enforcement subject to liability for misleading or unsubstantiated representations made through the blogger’s endorsement. The Advertisers are subject to liability for false or unsubstantiated blogger also is subject to liability for misleading or unsub- statements made through endorsements, or for failing to disclose mate- stantiated representations made in the course of her endorse- rial connections between themselves and their endorsers. Endorsers ment. The blogger is also liable if she fails to disclose clearly also may be liable for statements made in the course of their endorsements. and conspicuously that she is being paid for her services. In the context of consumer-generated media, the endorser is the “In order to limit its potential liability, the advertiser should ensure that party primarily responsible for disclosing material connections with the advertising service provides guidance and training to its bloggers the advertiser.However, advertisers who sponsor these endorsers (either concerning the need to ensure that statements they make are truthful by providing free products—directly or through a middleman—or oth- and substantiated.The advertiser should also monitor bloggers who erwise) in order to generate positive word of mouth and spur sales should are being paid to promote its products and take steps necessary to establish procedures to advise endorsers that they must make the neces- halt the continued publication of deceptive representations when sary disclosures and to monitor the conduct of the endorsers. they are discovered.”  Example 5 (9 CFR 255.1): Anne V. Maher is a Partner at Kleinfeld, Kaplan and Becker “A skin care products advertiser participates in a blog adver- (Washington, D.C.). Prior to joining KKB, she was from 1922-2001, tising service. The service matches up advertisers with blog- the Assistant Director of the Advertising Practices Division in the FTC’s gers who will promote the advertiser’s products on their Bureau of Consumer Protection. In that role, she supervised law enforce- personal blogs. The advertiser requests that a blogger try a ment investigations and industry outreach efforts in such areas as food, new body lotion and write a review of the product on her dietary supplement, OTC drug, tobacco, alcohol, infomercial and on- blog. Although the advertiser does not make any specific line advertising. Prior to her appointment as Assistant Director, she claims about the lotion’s ability to cure skin conditions and served in the Office of the Director, Bureau of Consumer Protection, and the blogger does not ask the advertiser whether there is sub- as Attorney Advisor to an FTC Commissioner.

November 2009 • Page Legal & Regulatory Update

AHPA to FDA: “AHPA’s proposal is that FDA apply this same efficient and success- Provide Efficient Enforcement Against ful enforcement approach to illegal steroid products masquerading Illegal Steroid Products as dietary supplements,” added McGuffin. The American Herbal Products Association suggested Oct. 7 that The AHPA letter also notes that FDA’s testimony identified “several the Food & Drug Administration (FDA) adapt its current and suc- possible enforcement outcomes” against any product that contains a cessful enforcement program against fraudulent 2009 H1N1 prod- synthetic steroid, and that FDA did not need to identify in its testi- ucts and apply it to illegal synthetic steroid products. mony “a category of marketed synthetic steroids for which there is AHPA’s letter is addressed to Michael Levy, Esq., Director of the no possible enforcement outcome, because under current law, except Division of New Drugs and Labeling Compliance at FDA’s Center with respect to approved new drugs, all such marketing is unlawful.” for Drug Evaluation and Research and to Roberta Wagner, Director “At the same time,” commented McGuffin, “it is important to note, of the Office of Compliance at the Center for Food Safety and as did FDA in its testimony, that naturally-occurring steroids, such Applied Nutrition. Mr. Levy provided FDA’s testimony at a hearing as phytosterols and vitamin D, do not present significant regulatory last week before the U.S. Senate Committee on the Judiciary, issues, so the mere presence of steroidal saponins in an herb, for ex- Subcommittee on Crime and Drugs, at which illegal steroid prod- ample, is not of concern.” ucts were discussed (see the AHPA Update of Sept. 29, 2009). AHPA’s Oct. 7 letter to FDA is available here: http://www.ahpa. “AHPA is concerned that the net impression left by FDA’s testimony org/portals/0/pdfs/09_1007_AHPA_to_FDA_re_Illegal_synthetic_ before the Senate is that the agency cannot presently take effective steroids.pdf enforcement action with respect to synthetic steroids that are ille- The Sept. 29 AHPA Update on the hearing before the U.S. Senate gally marketed as dietary supplements,” stated Michael McGuffin, Committee on the Judiciary, Subcommittee on Crime and Drugs is AHPA’s president. “AHPA disagrees, and believes that FDA has all also online: http://www.ahpa.org/Default.aspx?tabid=69&aId of the authority it needs to shut down the marketers of any such =555&zId=1  product. We are today suggesting that the agency can do so effi- ciently by adapting its successful program for enforcing against fraudulent H1N1 products.” Warning Letter Review The AHPA letter notes that FDA’s current program for addressing For the benefit of our members, AHPA notifies members of new fraudulent 2009 H1N1 influenza products includes direct enforce- Warning Letters posted on FDA’s Web site. In this section, AHPA ment action, in the form of Warning Letters, and a prominently dis- General Counsel Anthony L. Young, Esq. (Kleinfeld Kaplan & played Web site list of marketers – of fraudulent air system products, Becker) reports on the significance of several recently-issued Warning shampoos, supplements, and other product forms – to whom FDA Letters. A list of recent H1N1-related Warning Letters is also pro- has sent these Warning Letters. AHPA also notes that FDA records vided. Warning Letters are first distributed to AHPA members who that the identified fraudulent claims have now been removed from subscribe to the AHPA Legal Alert service. For more information, 120 of the 136 products listed. email Katia Fowler, [email protected].

November 2009 • Page FDA, FTC Warn Dr. Weil on Flu Claims

By Anthony L. Young, Esq., AHPA General Counsel for a response to FTC. Maher, who previously worked as FTC’s des- On Oct. 15 the Food and Drug Administration (FDA) and the ignated liaison with FDA and the U.S. Department of Agriculture, Federal Trade Commission (FTC) jointly issued a news-making also noted that FTC appears to be interested in more than simply Warning Letter to Weil Lifestyle, LLC, the eponymous company of receiving claim substantiation. FTC is showing an interest in stop- Dr. Andrew Weil, M.D., regarding flu claims being made on the ping the claims that is more akin to FDA’s approach to claim en- company’s Web site. FDA embraced the media and communica- forcement, she explained. tions opportunities surrounding an enforcement action against a ce- As reported by “The Tan Sheet” in its Oct. 12 issue, FDA and FTC lebrity by appearing on “The Today Show” the same day the letter have formed a working group to evaluate claims made by dietary was posted on the FDA site and issuing a Consumer Warning on supplements and other FDA-regulated products. The Warning unapproved and illegal H1N1 drug products (e.g., bogus Tamiflu) Letter to Dr. Weil is most likely a product of this cooperative effort, that are available for purchase online. Of course, FDA and FTC and it is most likely not the last joint Warning Letter industry will were also using Dr. Weil’s star power as a vehicle for communication see in the coming months. to industry. And what should industry take away? Finally, as I note below in my report on Mountain Meadow Herbs, It is notable that this letter was issued jointly by FDA and FTC. It a Warning Letter from the FDA causes an expectation from FDA is the first H1N1 Warning Letter, if not the first Warning Letter, to that all disease type claims will be removed from websites, labels and be co-signed by the two agencies. Even more notable is the change labeling. Companies making flu claims this year are risking more this letter represents for FTC. While FDA has set 48 hours as the than just a letter regarding one product and one claim, they are put- norm for responses to H1N1 Warning Letters, the tight timeframe ting all their products and claims under the FDA/FTC microscope. is unheard of for FTC. According to Kleinfeld Kaplan and Becker To do that to a public that now links flu claims with fraud may not Partner Anne V. Maher, at least two weeks is traditionally allowed be a wise business decision.

National and International PRODUCTS LIABILITY INSURANCE PROGRAM for Manufacturers & Distributors of Herbal & Health Food Supplements

Now you can take advantage of a casualty insurance program that is endorsed by the American Herbal Products Association (AHPA) and is available to AHPA Members. The program offers Commercial General Liability Insurance, which includes:  Products Liability  Vendors Legal Liability  Premises Liability  Employment Benefits Liability Excess Liability with limits to $50,000,000 with extensions over underlying coverages. The program is designed specifically for your industry and your unique needs. We work with manufacturers, importers, exporters, distributors, wholesalers, and multi-level marketers on a continuing basis. The result is a program for AHPA Members that thoroughly protects, yet still remains affordable. More than 150 companies nationally are now insured in the AHPA program. You can access the AHPA Program through your agent/broker by having them contact Richard M. Griffin, or you can call Dick direct: GRIFCON Enterprises, Inc. AHPA Insurance Program Manager at 916-434-8874 for details. www.dickgriffin.com • [email protected]

November 2009 • Page Lessons Learned: Responding to an FDA Warning Letter Recent H1N1 Warning Letters By Anthony L. Young, Esq., AHPA General Counsel Washington Homeopathic Products, Inc. 10/6/09 Product(s): The Food and Drug Administration’s (FDA) Sept. 21 Warning Influenzinum 08-09 Letter to Mountain Meadow Herbs offers several lessons, espe- Warning(s): cially to small businesses: If FDA makes observations about False or Misleading Information disease claims or implied disease claims during an inspection, “…For example, your website makes effectiveness claims, your company should take care to assure that the entire line of but it lacks adequate descriptions of the risks, warnings, products is reviewed for violative claims and further that any and contraindications of your product…” corrections made to claims will be acceptable to FDA. Failure to Require Prescription Mountain Meadow was inspected and made efforts to address “You have failed to require that your product be dispensed under a prescription from a duly licensed practitioner…” FDA’s subsequent warnings, but in the end the company received another Warning Letter from the agency. If you read the Letter: http://www.fda.gov/ICECI/EnforcementActions/ Warning Letter, you will see that some product names were WarningLetters/ucm187027.htm changed, e.g., from “Blood Pressure Formula” to “Herbal Cardio Care,” but with continuing claims of alleviating hypertension, www.novalistintegra.com 09/29/09 i.e., high blood pressure. Additionally, a number of additional Product(s): products and violative claims were cited by the agency in its Swine Flu Natural Immunization second letter. There are two takeaways here. Swine Flu Monitoring Cited Claim(s): First, never assume that FDA has noted all violative situations Examples when the agency visits or provides you with written • The names of your products themselves, “Free Swine observations. Indeed, just the opposite is true. FDA findings Flu Natural Immunization” and “Swine Flu Monitoring” and observations are a signal that there are problems with labels • “…Swine Flu Natural Immunization to maintain and labeling, and this extends to catalogs, Web sites, and every immunity….” other place where the company makes claims. FDA expects that • “It stimulates your immune system to naturally create any company that receives a Notice of Observation or a Warning resistance should you be exposed to the Swine Flu.” Letter will correct any additional problems. FDA also expects a • “the swine flu natural immunization is effective and safe.” company to do this itself, and not by sending materials to FDA • “the swine flu natural remedy not only prevents you from for review. getting the flu, but it also invigorates your immune system….” Second, small companies are sometimes not well equipped to Letter: http://www.fda.gov/ICECI/EnforcementActions/ evaluate claims because they lack adequate experience. If your WarningLetters/ucm186313.htm company finds itself in this situation, you should reach out to your trade association. Contacting AHPA for early guidance SKW Ventures, LLC 9/14/09 may help avoid wasted investments on new labels and labeling Product(s): that remain out of compliance. AHPA can provide some level of SkinWear Hand Sanitizers assistance during this process of bringing labels and labeling into Cited Claim(s): compliance, and the compliance matrix is not difficult once you Examples understand the “do’s and don’ts.” This is an AHPA service to its • “SkinWear can protect you and your family for up to 8 members that is well worth taking advantage of. It does not take hours from germs that may cause swine flu.” the place of having legal counsel if the circumstances warrant, • “SkinWear offers 8-hour protection against germs that but it does offer an AHPA benefit and sweat-equity investment may be associated with swine flu.” opportunity towards compliance. • “Don’t take a chance where the well-being of your family is concerned. Order SkinWear, your protective shield Companies with regulatory and legal questions should contact against germs that may be the cause of swine flu.” AHPA President Michael McGuffin at [email protected] or • “Because SkinWear is not alcohol-based, it not only kills (301) 588-1171 x201. 99.9% of all germs that can make people sick, including those that can cause swine flu . . .” Letter: http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/ucm184579.htm 

November 2009 • Page Quick Round-up For the benefit of our members, AHPA keeps an eye on the many agencies that regulate the herbal products industry. Below are several recent regulatory developments that may interest you. They were first sent to those AHPA members who subscribed to the AHPA Legal Alert. For more information, email AHPA’s Katia Fowler, [email protected].

FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C The U.S. Food and Drug Administration sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient, FDA announces Oct. 30. The Warning Letter “concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error,” FDA states. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm188543.htm

FTC Charges Marketers with Making Baseless Weight-Loss Claims Despite Order to Stop The U.S. Justice Department, at the Federal Trade Commission’s request, filed suit Oct. 30 in federal court in a case affecting consumers nationwide. The government has charged three companies and two individuals with making advertising claims for their fat and weight-loss pills, Relacore and Akävar 20/50, that violate a 2006 FTC order barring them from making health or weight-loss claims without a reasonable basis. The defendants made claims such as “eat all you want and still lose weight” and, “And we couldn’t say it in print if it wasn’t true!” on product packaging, on the Internet, and in widely read magazines such as Redbook, Star, and Family Circle. The Commission seeks to stop the defendants from making such claims and make them pay civil penalties. http://www.ftc.gov/opa/2009/10/basicresearch.shtm

FDA, WebMD Expand Health Information Partnership The Food and Drug Administration (FDA) and WebMD Health Corp. have expanded their partnership to provide increased access to FDA’s consumer health information. The partnership’s second phase, announced on Oct. 29, 2009, gives consumers a larger selec- tion of timely information and multimedia tools at www.webmd. com/fda. One highlight of this new phase is the addition on WebMD of five new sections containing personalized FDA health information. These sections will initially focus on allergies and asthma, children’s health, diabetes, heart health, and vitamins and supplements. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm188226.htm

November 2009 • Page National Toxicology Program (NTP); Office of FDA Warns of Unapproved and Illegal H1N1 Liaison, Policy and Review; Meeting of the NTP Drug Products Purchased Over the Internet Board of Scientific Counselors The U.S. Food and Drug Administration Oct. 16 warned consum- Pursuant to Public Law 92-463, notice is hereby given of a meeting ers to use extreme care when purchasing any products over the of the NTP Board of Scientific Counselors (BSC). The BSC is a Internet that claim to diagnose, prevent, treat or cure the H1N1 in- Federally chartered, external advisory group composed of scientists fluenza virus. The warning comes after the FDA recently purchased from the public and private sectors that provides primary scientific and analyzed several products represented online as Tamiflu (oselta- oversight to the NTP Director and evaluates the scientific merit of mivir), which may pose risks to patients. the NTP’s intramural and collaborative programs. The BSC meet- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ing will be held on December 9-10, 2009. The deadline for submis- ucm186861.htm sion of written comments is November 25, 2009, and for pre-registration to attend the meeting, including registering to pres- New Zealand: Draft Guidance on the use of ent oral comments, is December 2, 2009. the term ‘Quantified by Input’ for Listed http://ntp.niehs.nih.gov/Ntp/PressCtr/FRN/2009/ complementary medicines (Consultation) 74FR204BSC20091023.pdf Since the implementation of the original QBI guidance document [Editor’s Note: Topics on the agenda for the Dec. 9-10 meeting include ‘Guidance on the Use of the Term ‘Quantified by Input’ for Listed a discussion of nominations and proposed research projects on butterbur, Complementary Medicines’ in January 2007, it has become evident evening primrose oil and valerian extract and oil. NTP’s Dietary that a number of issues central to its application require further Supplement and Herbal Medicines Initiative is also an agenda topic.] clarification. Therefore, after extensive consultation between New Zealand’s Therapeutic Goods Administration (TGA) and industry, User Fees for Agricultural Quarantine and revised documents have now been prepared. Inspection Services; Public Meeting http://www.tga.gov.au/cm/consult/cons-drqbi.htm We are informing the public of an upcoming meeting to address af- [Editor’s Note: A direct link to the Draft Guidance is available here: fected stakeholders’ questions and concerns regarding the agricul- http://www.tga.gov.au/cm/consult/cons-drqbi.pdf.] tural quarantine and inspection user fee increases scheduled to go into effect on November 1, 2009. The meeting is being organized by the Animal and Plant Health Inspection Service. The meeting will be held on October 27, 2009, from 9 a.m. to 1 p.m. Registration will begin at 8:30 a.m. http://edocket.access.gpo.gov/2009/pdf/E9-25548.pdf

Finland: Warning label to be added on food supplements containing ginger as well as on ginger tea, and corresponding drink powders The Risk Assessment Unit of the Finnish Food Safety Authority, Evira, has had its network of experts make an assessment of the safety of the consumption of food supplements containing ginger during pregnancy. Evira considers it appropriate in accordance with the precautionary principle that pregnant mothers be warned of the consumption of ginger products by separate labeling, the food safety authority announced in October. According to an Evira spokesper- son, the deadline for compliance with the rule is April 30, 2010. http://www.evira.fi/portal/en/food/control_and_entrepreneurs/ labelling_of_foodstuffs/warning_labelling_and_instructions_for_use/ warning_label_to_be_added_on_food_supplements_containing_ ginger_as_well_as_on_ginger_tea__and_corresponding_drink_powders/

November 2009 • Page 10 Draft Guidance for Industry: Ingredients FTC Publishes Final Guides Governing Endorsements, Declared as Evaporated Cane Juice; Availability Testimonials: Changes Affect Testimonial Advertisements, Bloggers, Celebrity Endorsements The Food and Drug Administration (FDA) announced Oct. 7 the availability of the draft guidance entitled ``Guidance for Industry: The Federal Trade Commission announced Oct. 5 that it has approved Ingredients Declared as Evaporated Cane Juice.’’ The intent of this final revisions to the guidance it gives to advertisers on how to keep draft guidance is to advise industry of FDA’s view that the common their endorsement and testimonial ads in line with the FTC Act. or usual name for the solid or dried form of sugar cane syrup is http://www.ftc.gov/opa/2009/10/endortest.shtm ``dried cane syrup,’’ and that sweeteners derived from sugar cane [Editor’s Note: A direct link to the Federal Register notice is here: http:// syrup should not be declared on food labels as ``evaporated cane www.ftc.gov/os/2009/10/091005endorsementguidesfnnotice.pdf.] juice’’ because that term falsely suggests that the sweeteners are juice. http://edocket.access.gpo.gov/2009/pdf/E9-24132.pdf Promotion of Food and Drug Administration- Regulated Medical Products Using the Internet Administrative Law Judge Dismisses Complaint and Social Media Tools; Notice of Public Hearing in Case Challenging Cancer Cure Claims The Food and Drug Administration’s (FDA’s) Center for Drug An Administrative Law Judge has dismissed a Federal Trade Evaluation andResearch (CDER), in collaboration with FDA’s Commission administrative complaint alleging that the respondents Center for Biologics Evaluation and Research (CBER), Center for were responsible for the deceptive advertising of an herbal remedy that Veterinary Medicine (CVM), and Center for Devices and was falsely advertised as a cure for cancer, FTC announces Oct. 2. Radiological Health (CDRH), announced Sept. 18 a public hearing http://www.ftc.gov/opa/2009/10/gemtronics.shtm to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, Bayer Sued Over Unsupported Prostate Cancer prescription biologics, and medical devices) using the Internet and Claims on One A Day: Drug Giant Tries to social media tools. FDA is seeking participation in the public hear- Silence CSPI With Threat of Libel Suit ing and written comments from all interested parties, including, but The Center for Science in the Public Interest announced Oct. 1 that not limited to, consumers, patients, caregivers, health care profes- it has sued the German drug company Bayer for falsely claiming sionals, patient groups, Internet vendors, advertising agencies, and that the selenium in Men’s One A Day multivitamins might reduce the regulated industry. the risk of prostate cancer. http://federalregister.gov/OFRUpload/OFRData/2009- http://cspinet.org/new/200910011.html 22618_PI.pdf 

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

November 2009 • Page 11 Communications Update Aug. 20, 2009 – Herbs, vitamins that can hurt you CNN Aug. 17, 2009 – Herbal supplements not always safe, says Mayo Clinic Nutraingredients-USA.com AHPA Media Scan: Aug. 12, 2009 – Customer spots poison stems in salad Reuters Notable “Herbal Headlines” Aug. 8, 2009 – Audit of organic program is ordered Washington Post Aug. 4, 2009 – Consultation on how to regulate complementary These “herbal headlines” – and headlines of interest to the herbal and alternative therapies Times Online industry – have been selected from the past few weeks of media Aug. 4, 2009 – Senate boosts food stamps as unemployment rises activity. If you would like a copy of any of these articles, please email Washington Post Katia Fowler [email protected]. July 31, 2009 – Will Uncle Sam Pay for Your Yoga? The Atlantic July 30, 2009 – House passes far-reaching food safety bill Associated AHPA in the News Press Oct. 26, 2009 – Sharfstein Says Spiked Products Top FDA July 30, 2009 – Americans spend $34 billion a year on alternative Supplement Enforcement Goals “The Tan Sheet” medicine USA Today Oct. 15, 2009 – Does Alternative Medicine Work for H1N1? July 28, 2009 – FDA warns against body-building products claim- Gannett ing steroids CNN Oct. 12, 2009 – AHPA Says H1N1 Enforcement Tactics July 27, 2009 – FDA flexes muscle as raid sends message to supple- Would Work To Find Hidden Steroids “The Tan Sheet” ment industry Daily News Oct. 10, 2009 – AHPA Urges FDA to Target Illegal Steroid July 24, 2009 – Senators seek coverage for alternative therapies Products Nutraceuticals World Boston Globe Oct. 9, 2009 – Swine flu tactics needed to fight hidden steroids July 17, 2009 – Medicinal herbs are becoming endangered Rodale Nutraingredients-USA.com July 6, 2009 – Overuse of energy drinks worries health pros USA Oct. 7, 2009 – AHPA Urges FDA to Move Against Illegal Today Steroid Products Natural Products Insider July 3, 2009 – Purity of Federal ‘Organic’ Label Is Questioned Oct. 4, 2009 – Specter Spares Supplements, Hammers DEA Washington Post Over Illegal Steroid Products “The Tan Sheet” July 2, 2009 – Pace says he took supplement ESPN June 29, 2009 – All natural. Not all safe. Boston Globe Oct. 27, 2009 – A dubious alternative Washington Post June 29, 2009 – Whatever works: Natural remedies and drugs New Oct. 27, 2009 – FDA sets sights on products that purport to fight Haven Register swine fluWashington Post June 24, 2009 – ‘Green’ claims by marketers go unchecked USA Today Oct. 26, 2009 – Alternative Health Care Offsets Cost Woes CBS June 16, 2009 – Multivitamins linked to 25 percent of supplement Oct. 18, 2009 – Student’s Research: Energy Drinks are Bunk CBS AERs Nutraingredients-USA.com Oct. 16, 2009 – Beware of Flu Scams The Today Show June 17, 2009 – AP IMPACT: Zicam not alone in side effect Oct. 14, 2009 – FDA chief: Regaining your trust Fortune reports Associated Press Oct. 14, 2009 – Chinese herbs show promise for diabetes preven- May 19, 2009 – You Don’t Have to Be Ayurvedic to Keep Your tion Reuters Doshas in Balance Washington Post Oct. 14, 2009 – FDA warns P&G over vitamin C in DayQuil and May 12, 2009 – Hoping to Make Food Safer, States Decide to Go NyQuil Reuters It Alone Wall Street Journal Oct. 13, 2009 – Green tea may curb risk of some cancers Reuters May 12, 2009 – Examining FDA Reports on Supplements Sports Oct. 13, 2009 – A Vigorous Push From Federal Regulators Illustrated Washington Post May 12, 2009 – The FDA, Making the World Safe — From Cheerios Sept. 30, 2009 – Hallucinogenic Herb Under Legislative Eye washingtonpost.com Washington Post May 14, 2009 – Study: Ginger Helps Chemo Nausea Associated Sept. 29, 2009 – Congress, Concerned About Steroids, Reviews Press Law on Dietary Supplements The New York Times May 5, 2009 – Mobile food-safety labs get FDA up to speed USA Sept. 9, 2009 – Harkin accepts chairmanship of HELP Committee Today The Hill May 5, 2009 – Warning against diet supplements for swine fluCNN Aug. 20, 2009 – Supplement Update: Oprah and Dr. Oz Sue April 10, 2009 – As Economy Is Down, Vitamin Sales Are Up New CBS News York Times 

November 2009 • Page 12 Calendar of Botanical Events

Many more listings are online at www.ahpa.org.  Nov. 17-19: Natural Ingredients 2009, co-located with Upcoming Meetings and Events Food Ingredients Europe 2009, Frankfurt, Germany. Don’t miss the global business platform that offers you the AHPA President Michael McGuffin delivers his biannual opportunity to drive your product development initiatives “State of the Industry” presentation at SupplySide West forward. Whether you are looking to control costs, reformu- Fri., Nov. 13. late existing products, or develop products in your pipeline, Natural ingredients 2009 is the event of 2009.  Nov. 2-6: Codex Committee on Nutrition and Foods for Website: http://ni.ingredientsnetwork.com/home. Special Dietary Uses, Duesseldorf, Germany.  http://www.codexalimentarius.net/web/current.jsp?lang=en Nov. 23-24: Natural Beauty Summit Europe, Hotel Pullman Rive Gauche, Paris, France. Topics to be covered in Natural  Nov. 9-11: International Conference & Exposition on Beauty Summit Europe will include ethical ingredient & raw Traditional Medicine (ICTM) 2009, will be co-hosted by material sourcing, sustainability best-practices, natural & fifteen Ministries of P.R.C and the People’s Government of organic standards update, retailing & distribution issues, Guangdong Province in Guangzhou, China. During this product development & formulation challenges, and corporate conference, experts will open new insights and discussions into social responsibility & business ethics. The summit will debate the hot topic in the development of Traditional Medicine and and discuss these major issues in a high-level forum. A half day Traditional Chinese Medicine. Website: www.ictm.org.cn workshop will be conducted on Nov. 25. Website: http://www. naturalbeautysummit.com/NewYork2009/en/Main.aspx?Id=8  Nov. 11-13: COSMOPROF Asia, Hong Kong. As the leading trade event in Asia, the Cosmoprof Asia 2009 will once again  Dec. 3-4: Tea and Health Dubai 2009: Nutraceutical and provide exhibitors the opportunity to meet with key buyers Pharmaceutical Applications—Last Advances, Controver- from over 100 countries and regions in one single venue. sies & Innovations, Dubai. The aims of Tea Conference 2009 Seventeen countries and regions had already confirmed their are to discuss the latest advances in tea and health and high- participation to the 2009 Fair, it proved at one time the light the recent innovations and applications of tea, tea extracts importance of the show in this uncertain market conditions, and tea polyphenols in nutraceutical, cosmeceutical and and the strength of the Asian market within the beauty and pharmaceutical products. Website: www.dubai-tea.com wellness industry. Website: http://www.cosmoprof-asia.com/  Dec. 4: “The role of natural products in drug discovery  Nov. 11-13, SupplySide West, Las Vegas, SupplySide is the and development in the new millennium’’. The symposium world’s largest trade show and conference for healthy and will take place at Royal Pharmaceutical Society of Great innovative ingredients. Thousands of decision makers from Britain, London, on December the 4th, 2009. It aims to bring the global food, beverage, dietary supplement and cosmeceuti- together both academics and industrial scientists, and form a cal industries converge to learn, network, source and create. useful platform for discussing the present and the future of Your next big idea is just a show away. AHPA members, use natural product research in the 21st century, as we are ap- promo code AHPA8 and receive $50 off registration if you proaching to the end of the first decade of the new millennium. are a manufacturer of finished products. Royal Pharmaceutical Society of Great Britain. Website: www.supplysideshow.com Email [email protected] for more information.

 Nov. 13: Traditional Herbal Medicines Masterclass –  Dec. 7-9: 7th Middle East Natural & Organic Products Practical advice on registering a traditional herbal Expo (MENOPE) 2009. Dubai World Trade Centre, Dubai, medicinal product (THMPD), This masterclass will bring U.A.E. The event is organized under the patronage of Ministry together those scientists who have much experience in the of Health & Ministry of Environment & Water, United Arab herbal medicines sector and the regulators at the health Emirates and supported by International Federation of authority with an aim to provide advice on a practical level to Organic Agriculture Movements (IFOAM), Korea Health those registering a traditional herbal medicine; Share the Supplement Association (KHSA), International Competence experience of the UK MHRA in the assessment of applications, centre for Organic Agriculture, Chamber of Herbal Industries and; Allow delegates to consider and learn from real-life scenarios of the Philippines (CHIPI) etc. MENOPE 2009 is the only through interactive sessions. http://www.thmpd.eu/workshops/ exhibition in the region for natural & Organic Products and by

November 2009 • Page 13 participating at this b2b event, the exhibitors can meet  Jan. 21-24: 7th Annual Natural Supplements: An Evidence- the Importers, Exporters, Distributors, Wholesalers, Trading Based Update, Paradise Point Resort, San Diego, Calif. houses, Business groups, Collaboration and Joint Venture During this informative and comprehensive CME confer- seekers, Manufacturers, Producers, Overseas buyers, Agents, ence, renowned faculty will present a concise, clinically Consultants and Franchisees who deal with the above products. relevant overview of natural supplements in evidence-based http://www.naturalproductme.com/exhibitor_profile.php practice, with an emphasis on disease states. This medical education event is a must-attend for anyone wanting  Dec. 8-10: Cairo, Egypt - Euro-Med Symposium *Plant to acquire the knowledge and expertise for addressing and Natural Products: from Biodiversity to Bioindustry*. managing dietary supplement use. Website: http://www.scripps. Aims to bring the scientists to point out the state of art on org/events/natural-supplements-an-evidence-based-update plant secondary metabolisms and natural products including vitamins, carotenoids and flavonoids, anti-nutrients, toxins,  Feb. 17-20: BioFach 2010, Germany. Where Organic metabolic network and metabolomics. Attention will also People Meet - World Organic Trade Fair. devoted to the traditional and non-traditional utilization of Website: http://www.biofach.de/en/default.ashx medicinal plants, phytopharmaceuticals, and antioxidant  activity of plant compounds as well as comparison of plant March 21-25: 239th ACS National Meeting & Exposition, extracted medicinal and synthetic drugs. This gathering will San Francisco, CA. For further information, please contact the also provide a tool to establish interdisciplinary network symposium organizers or the AGFD program chair (Michael  between Italian, Egyptian and the international scientists to Appell 309 681-6249 [email protected]). foster the research on secondary metabolism and natural products in the Mediterranean region. http://www.estc.sci.eg/event.php?event_id=6 SPECIAL LOW PRICE for MEMBERS

You Manufacture Herbal Extracts? Then Your Company Needs AHPA’s Guidance Documents for the Manufacture and Sale of Botanical Extracts, the Standardization of Botanical Products, and Manual for Alcohol Tax Drawbacks developed by the American Herbal Products Association’s Botanical Extracts Committee A collection of five documents that set forth guidelines for procedures and issues encountered in the manufacture, sale and labeling of herbal extracts: • Guidance for the Manufacture and Sale of Bulk Botanical Extracts • Guidance for the Retail Labeling of Dietary Supplements Containing Soft or

Powdered Botanical Extracts • Use of Marker Compounds in Manufacturing Labeling Botanically Derived Dietary

Supplement • The White Paper on Standardization of Botanical Products describes the many factors that contribute to the proper standardization of a botanical product. This document is intended to foster a heightened awareness of the complexities associated with standardization and to facilitate informed discussions between raw material suppliers, product manufacturers, practitioners, clinicians, regulators and consumers. • The Manual for Alcohol Tax Drawbacks assist manufacturers to understand and conform to the Federal Regulations that govern the drawback of prepaid excise tax on alcohol used in the production of non-beverage products.

Special Member Price: $49.99 U Non-Member Price: $79.00 To order, call: 301-588-1171 or buy online at: http://www.ahpa.org/bookstore.htm

November 2009 • Page 14 Botanical Science Update

complicate data interpretation” are relevant or not. The equipment by Steven Dentali, Ph.D. used to carry out the analysis is expensive and not likely to be available in most manufacturing in-house labs for routine quality control. LITERATURE CITATIONS, ETC. The method presented reduces ginger to a series of related compounds that can be identified and quantified in a single run. It is Ginger: Measurement of Gingerols and practical as a research and quality assessment tool. It was validated Related Compounds with regard to linearity, limits of detection, limits of quantitation, accuracy and precision. Intraday relative standard deviation, relative Identification and quantification of gingerols - andre lated compounds in ginger dietary supplements using error, and interday relative standard deviation, and recoveries were high-performance liquid chromatography-tandem mass also determined for the analytes. The method was then employed in spectrometry. Tao Y, Li W, Liang W, Van Breemen RB. the analysis of three commercial ginger supplements to measure 6-, J Agric Food Chem. 2009 Oct 9. [Epub ahead of print, 8-, and 10-gingerol and 6-, 8-, and 10-shogaol. Two of the samples DOI:10.1021/jf9020224] were found to be comparable with regard to these measurements with a third reported as having less of each of these compounds. Metabolic profiling and phylogenetic analysis of medicinal Zingiber species: Tools for authentication of ginger (Zingiber The second citation above is an earlier study done at the University officinale Rosc). Jiang H, Xie Z, Koo HJ, McLaughlin of Arizona that compared the genetics of ginger and closely related SP, Timmermann BN, Gang DR. Phytochemistry. 2006 species. The researchers found that regardless of different geographi- ug;67(15):1673-85. cal locations, the ginger samples were genetically indistinguishable while other species differed significantly. Chemical investigations of Reasonable chemical consistency of botanical materials is needed in ginger showed the presence of the same major volatile compounds order to conduct reliable and reproducible clinical trials using them. with significant differences in the amounts of 6-, 8-, and 10-gin- Although the human volunteers are not identical, reducing the vari- gerol present. ation in the study material can allow for clinical trial results to be compared to each other and to finished products. Determining the chemical profile of extract constituents can allow distinctions to be ® made between extracts when significant differences are found. In the American Herbal Pharmacopoeia first citation above researchers from Bristol Myers-Squibb, Novartis, and the University of Illinois at Chicago teamed up to identify and quantify specific compounds in ginger Zingiber( officinale) root. New Release Gingerol-related compounds are some of the major ginger constitu- “All the analytical and technical ents with anti-nausea and anti-inflammatory activity. (The anti- American Herbal Pharmacopoeiainformation needed for botanical and ingredient GMP compliance” nausea activity for ginger in pregnancy is an accepted safe practice as will be covered in the upcoming 2nd edition of AHPA’s Botanical herapeutic Safety Handbook). The major recognized groups of gingerol-related ompendium compounds are the very closely related gingerols, shogaols, paradols, gingerdiones, and gingerdiols. Each group has related compounds Stinging Nettle Herb ® Urtica dioica or homologues that are created by differing lengths of the hydrocar- Standards of Analysis, Quality Control, Associate Editor & and Therapeutics L. Urtica urens bon side chain. Monograph Coordinator

Funded jointly by the Office of Dietary Supplements, the National L. PRODUCTS & SERVICES Center for Complementary and Alternative Medicine, the Office Pharmacopoeial Standards for Research on Women’s Health, and the National Institute for Herbal QRS (Quality, Research, General Medical Sciences, the researchers used HPLC with two mass and Safety) Bulletin AHP-Verified Botanical and spectral detectors (tandem mass spectrometry) in order to selectively Chemical Reference Standards Quality Control Training detect and measure most gingerol-related compounds. The results Programs can be used to authenticate and fingerprint ginger extracts or ginger containing dietary supplements. The assumption was made that the 95 95 gingerol-related compounds are the significant ones to measure. It is PDF $39. Print Edition $44. AHPA MEMBERS RECEIVE AN EXTRA 10% OFF! not known if the non-gingerol-related compounds “which may American Herbal Pharmacopoeia

November 2009 • Page 15 Ginger: Enter the Finnish Health Authority Evira recommended for pregnant women” and such products may not be advertized or marketed in a way that targets pregnant women. While not exactly literature citation, an AHPA Legal Alert sent out on October 21, 2009 reported on the Finnish Food Safety Authority’s The same reasoning was applied to teas containing ginger and cor- (Evira) decision to require a warning label to be added to food sup- responding drink powders, which must bear the same warning and plements containing ginger as well as to ginger tea and correspond- advertisement limitations. It is possible that the potential benefit for ing drink powders in Finland by April 30, 2010. This came about reducing pregnancy induced nausea and vomiting from ginger in- due to the recognition by the Risk Assessment Unit of Evira that gestion (that has been the subject of clinical trials) may not have ginger 1) contains compounds that could be harmful to a develop- been adequately considered. While is it true that all of the risks from ing fetus because they can cause cell death and 2) that the scientific ginger consumption during pregnancy aren’t known neither do we evidence on the consumption of ginger during pregnancy is limited have any serious signals that any actual risk is present. Borrowing a and somewhat inconsistent. This led to an assessment producing line from the most recent Cohen brother’s movie, perhaps Evira in “indications suggesting that the consumption of ginger products as attempting to deal with uncertainty while crafting appropriate pub- well as the abundant or long-term consumption of ginger tea should lic health statements should “just accept the mystery” in cases where be avoided during pregnancy” (emphasis added). harm is not likely, certain, or expected to result. The implementation of the precautionary principle (avoid any chance of harm while simultaneously avoiding any chance of bene- Evira: Chocolate Not for Children, fit, therefore potentially causing harm – this is solely my interpreta- and Cook Your Dried Beans! tion) here resulted in the determination “that pregnant mothers be While reviewing the above rational for the Finnish warn- warned of the consumption of ginger products by separate labeling on ginger and pregnancy available at http://www. ling.” The reasoning was that food supplements sold in small por- evira.fi/portal/en/food/control_and_entrepreneurs/labelling_ tion sizes of capsules, tablets, and pills can be consumed in large of_foodstuffs/warning_labelling_and_instructions_for_use/ quantities. Evira goes on to say that because “(i)t is not possible to warning_label_to_be_added_on_food_supplements_containing_gin- scientifically establish a safe limit for the consumption of ginger ger_as_well_as_on_ginger_tea__and_corresponding_drink_powders/ during pregnancy” products must carry the following warning “Not I chanced to discover the instructions for use of foodstuffs containing

November 2009 • Page 16 caffeine in Finland. AHPA has developed certain disclosures regard- Make no mistake; chocolate contains small amounts of caffeine. In ing the labeling of caffeine containing supplements. This position fact the National Institute of Standards and Technology Standard can be found in part XII of the AHPA Code of Ethics & Business Reference Material 2384 contains approximately 100 mg of caffeine Conduct available here http://www.ahpa.org/Default.aspx?tabid=224. per 3.2 ounce bar of baking chocolate. I nibbled on baking chocolate Evira determined that the most sensitive individuals (pregnant as a child. Children can easily eat a bar of chocolate, most of which women and children) were not adequately protected by their ex- will likely have considerably less than 100 mg of caffeine per bar, isting regulations and require separate warnings and information which is about the amount of caffeine contained in a cup of coffee. regarding maximum daily intake so that marketing of caffeine- To my amazement Evira has decided that labeling on packages of containing products takes into account these groups and people products that contain caffeine, this includes chocolate, must bear the sensitive to caffeine. following labeling: “Not recommended for children, pregnant women This sounds well and good however Evira, in my opinion, again errs or people sensitive to caffeine” (emphasis added). in the assumption that a minor amount of compounds of potential The US Halloween tradition would be odd indeed if all chocolate concern should receive warnings consistent with possible gross containing candy given to trick or treaters bore this warning replete overconsumption. This is exemplified not with energy drinks with with the maximum amount to be used daily. Unless you think I’m tens of milligrams of caffeine per serving, but with chocolate. needlessly picking on Evira there is another warning that caught my Drinks with more than 150 mg/l of caffeine from any source, attention, which is to cook dried raw beans before eating them. except coffee or tea, will require a warning of high caffeine content Though it sounds like an Onion spoof, Evira is requiring packaging with the amount of caffeine stated per 100 ml and a warning with a of raw beans to carry the following warning and instructions for use: statement of maximum daily amount to be consumed. This makes “The beans must not be eaten uncooked. They must be soaked over- sense; it’s the handling of chocolate bars, listed with confectionary, night, rinsed and cooked for at least…” and they provide a chart of chewing gums, and other similar products that seems, well, foreign how many minutes each type of bean is to be cooked. No mention to me. is made regarding the use of pressure cookers, which should change the recommended cooking times considerably.

The AHPA NDI Database Your key to future botanicals

The AHPA NDI Database helps companies that have invested in new dietary ingredients increase their knowledge how to submit NDI notifications and speed their time to market. Cut through the confusion

The AHPA NDI Database is the most complete listing and analysis resource for NDI filings, often posting information well in advance of the FDA website. No need to review lengthy or numerous documents to try to determine the outcome of an NDI submission. “Outcome statements” for each notification summarize FDA’s response.

Easily locate notifications by searching for such key terms as the generic names, brand names, Latin names, the submitting firm or their counsel or other consultant, or the report number assigned by FDA.

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But wait! There’s more … AHPA also offers a practical guidance document to help companies increase their success in filing NDI notifications. AHPA’s Interim Guidance for New Dietary Ingredient Notifications for Manufacturers of Distributors of New Dietary Ingredients explains the NDI regulations, details what information to include (and exclude) in a notification, and provides three practical hands-on worksheets: ♦ Determination of Requirement to Submit ♦ Submission of NDI Notification ♦ Cover Letter Template for Notification Submission

Available for purchase via the AHPA online bookstore www.ahpa.org

November 2009 • Page 17 Separating Dried Beans by UV Spectral amount of “glycyrrhiza” in licorice candy consumed by pregnant Fingerprints Finnish women was determined and provided researchers with an opportunity to see if effects of a proposed prenatal glucocorticoid Variance in the chemical composition of dry beans deter- mechanism might have been at work. mined from UV spectral fingerprints. Harnly JM, Pastor- Corrales MA, Luthria DL. J Agric Food Chem. 2009 Oct While glucocorticoids are needed for brain development fetal levels 14;57(19):8705-10. of cortisol are normally 2 – 10 times lower than maternal levels due to the placental enzyme 11b-hydroxysteroid dehydrogenase type 2. This Speaking of dried beans, Jim Harnly of the Food Composition and enzyme inactivates maternal cortisol by catalyzing its transformation Methods Development Laboratory at the Beltsville Human to cortisone. Research suggests that the deficiency of this enzyme Nutrition Research Center of the US Department of Agriculture would expose the fetus to abnormally high cortisol exposure and is and company analyzed simple extracts of nine varities of beans associated with defective brain function later in life. The researchers grown in eight rows each in three states by simple UV spectropho- defined glycyrrhiza as 3b-D-diglucuronyl-18b-glycyrrhetinic acid. tometry. This analysis is HPLC-UV without the benefit of HPLC Glycyrrhizin (or glycyrrhizic acid or glycyrrhizinic acid) is the more separation! The data obtained were analyzed by a variation of re- accurate name for this naturally occurring sweet compound because ported analysis of variance (ANOVA) followed by principle compo- “glycyrrhiza” is the name of the genus to which licorice belongs. nent analysis (PCA). PCA is often described as chemometric analysis as it is a way of manipulating data to indirectly measure compounds Probably naïve to licorice compound nomenclature, the authors and can be used to differentiate material one from another. nevertheless appear to have designed and conducted a good study examining 211, 46, and 64 children of mothers who recorded inges- In this research, supported by the Agricultural Research Service of tion of low, medium, and high (0-249, 250-499, and > 500 mg/ the USDA and the Office of Dietary Supplements at the NIH, dif- week, respectively) glycyrrhizin consumption during pregnancy. ferences between individual plants were at least seven times greater The children were followed up with 8 later and tested for cognitive than differences between varieties. However when eight or more abilities and psychiatric symptoms. Some significant differences plants were combined differences between varieties could be were found between the groups. No differences were found with re- discerned. Statistically significant differences could also be seen gard to birth weight or length of gestation, but maternal glycyrrhi- between beans grown from each of the three locations. zin “consumption was significantly and linearly associated with poorer performance in the vocabulary and the narrative memory Finns Find Possible Pregnancy Problem from tests.” Risk for “attention problems, rule-breaking behavior prob- Loving Licorice lems, aggressive behavior problems, attention deficit hyperactivity Maternal licorice consumption and detrimental cognitive disorder, and somatic complaints/problems” were increased in chil- and psychiatric outcomes in children. Räikkönen K, Pesonen dren of mothers who consumed high amounts of licorice. AK, Heinonen K, Lahti J, Komsi N, Eriksson JG, Seckl JR, The results of this study are not conclusive because the reported as- Järvenpää AL, Strandberg TE. Am J Epidemiol. 2009 Nov sociation is not the same as proving a causal connection; in fact the 1;170(9):1137-46. authors examine several possible mechanisms that could explain In contrast to the situation with ginger, Finnish researchers have what they observed. While further research could illuminate what discovered what may be an adverse association with material inges- might be at work here it is probably prudent for pregnant women tion of large amounts of licorice during pregnancy, and cognitive not to consume large amounts of glycyrrhizin containing materials. deficits and behavioral problems of their children later in life. The The amount of glycyrrhizin in the confections consumed was not

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November 2009 • Page 18 stated so it is difficult to state with assurance what the high dose and 1929 sample results were within one standard deviation of the glycyrrhizin translates to with regard to candy consumed. mean of the 2004 results and the 116 year old sample found to have ORAC, total polyphenols, and catechin and epicatechin levels “well Shelf Life of Cocoa Powder, Long Term within the levels expected for cocoa beans.” This was not an unex- Flavonoid Stability pected result as the second study above on dry green tea leaves showed a reduction in the levels of epigalloepicatechin gallate Stability of cocoa antioxidants and flavan-3-ols over time. (EGCG) and epicatechin gallate (ECG) over time while the amount Hurst WJ, Payne MJ, Miller KB, Stuart DA. J. Agric. Food of epicatechin was conserved. Chem. 2009, 57, 9547–9550. Stability of green tea catechins in commercial tea leaves dur- Planta Medica on Plant Analysis: Quality Control ing storage for 6 months. Friedman M, Levin CE, Lee SU, by NMR and MS Kozukue N. J Food Sci. 2009 Mar;74(2):H47-51. Recent advancements and applications in the analysis of tra- The first study above, performed at the Hershey Center for Health ditional Chinese medicines. Ganzera M. Planta Med. 2009 and Nutrition, evaluated the content of the flavan-3-ol monomers Jun;75(7):776-83. catechin and epicatechin, and ORAC antioxidant activity along Quality control of herbal material and phytopharmaceuti- with total phenols and total procyanidins, in two milk chocolates cals with MS and NMR based metabolic fingerprinting. van bars over the course of a year. Cocoa powder and dark chocolate der Kooy F, Maltese F, Choi YH, Kim HK, Verpoorte R. were also assessed for total polyphenols and antioxidant activity, Planta Med. 2009 Jun;75(7):763-75. which were remarkably constant over a period of 800 days. This is the fourth and final monthly AHPA Report coverage of se- Even more remarkable were the results for analysis of cocoa powders lected articles from the June 2009 issue of Planta Medica (free from from 2004, 1982, 1929, and a fermented Guatemala cocoa bean http://www.thieme-connect.com/ejournals/toc/plantamedica/94429). sample exhibited at the 1893 Chicago Exposition. The 2008, 1982,

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 es- sential 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 Massa- chusetts, and individual and corporate contributions to the AHPA-ERB Foundation.

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

November 2009 • Page 19 The first review above (available at http://www.thieme-connect.com/ USP Considers Supplements in Convention ejournals/pdf/plantamedica/doi/10.1055/s-0029-1185686.pdf) exam- White Paper ines recent developments in the analysis of Traditional Chinese White Paper: Access to Good Quality Dietary Supplements. Medicine (TCM) preparations. This current review focuses on un- Council of the Convention Section on the Quality of common and innovative analytical approaches and will be of inter- Food Ingredients and Dietary Supplements. September 23, est to analytical chemists. The second review above also attends to 2009. Available at http://www.usp.org/pdf/EN/members/ the analysis of TCM preparations in an analytical approach that fo- dietarySupplements.pdf. cuses on nuclear magnetic resonance (NMR) and mass spectral (MS) fingerprinting. In preparation for the 2010 USP Convention, a series of white pa- pers have been published by USP in order to provide background Approaches to Analysis of TCM materials information and advance proposals for consideration by the Convention membership, to which AHPA belongs. The white Harmonization of monographic standards is needed to en- paper on dietary supplements is introduced with this paragraph: sure the quality of Chinese medicinal materials. Chan K, “While stakeholders debate stronger regulatory oversight of dietary Leung KS, Zhao SS. Chin Med. 2009 Sep 22;4:18. Available supplements and express unease about broader global sourcing of as Open Access at http://www.cmjournal.org/content/4/1/18. ingredients and products, are there other measures and mechanisms Traditional Chinese medicine and separation science. Liu S, available to help manufacturers and practitioners protect consum- Yi LZ, Liang YZ. J Sep Sci. 2008 Jun;31(11):2113-37. ers?” It presents six opportunities “for possible USP Convention action and improvement in the regulation of dietary supplements.” Improved quality assessment of proprietary Chinese medicines based on multi-chemical class fingerprinting. Chen D, The first topic concerns public monographs and reference materials Zhao SS, Leung KS. J Sep Sci. 2009 Sep;32(17):2892-902. whereby it is suggested that USP, where feasible, expand their docu- mentary standards and reference materials to cover all dietary sup- The first article cited above approaches harmonization issues from plements. The second suggests consideration for USP to engage in the standpoint of Chinese medicinal materials, recognizing that ad- discussions with Congress about requiring conformation with USP- equate quality control standards include “standards for harvesting, NF standards while acknowledging that it’s unclear that industry collecting, processing and packing of the crude herbs and final prod- would support such mandatory standards. The third topic, which is ucts.” This paper provides a very general overview of regulations and much more likely to receive industry support, would be for USP to pharmacopoeial status of Chinese medicinal materials in several cooperate with organizations such as the Canadian Natural Health countries suggesting that harmonized standards are needed to meet Products Directorate, the European Directorate for the Quality of the growing demand for these substances. Medicines and HealthCare (EDQM), the WHO, and the Indian The second citation above is a review of separation technologies for and Chinese Pharmacopoeia Commissions to promote standards isolating bioactive compounds from traditional Chinese medicines. for traditional medicines that are also dietary supplements in the Examples of dozens of compounds isolated using high speed coun- US. ter current chromatography are listed with the source material, sol- The fourth topic offers consideration for the development of vent system, percent purity, and reference. Macroporous absorptive Pharmacopeial Education courses for practitioners and consumers resin separation is also included and applied to the separation of fla- on the use of dietary supplements and “additional courses on com- vonoids, alkaloids, and glycosides. This practical overview article pendial approaches to quality standards for dietary supplements to also covers supercritical fluid chromatography, and the use of well help manufacturers, testing labs, and regulators understand the val- known instrumental methods such as HPLC-MS, as well as a dis- ue of USP public standards and reference materials.” The fifth topic cussion of chemical fingerprinting. This article was cited in the discusses the potential value in the broad implementation of USP’s Planta Medica review article above by Ganzera as an informative and Verification Programs for dietary supplements including interna- excellent review. tional applications, while the final one gives brief consideration of The final citation here uses sophisticated instrumentation (LC-ESI- product registration or pre-market notification, which would re- MS) to chromatographically fingerprint nineteen chemical markers quire amendment of the Federal Food, Drug, and Cosmetic Act. belonging to eight chemical groups from a traditional Chinese med- The white paper ends with the Council of the Convention Section icine composed of nine herbal ingredients. The method was validat- on Food Ingredients and Dietary Supplements welcoming input on ed as to linearity, precision, and accuracy, and was used to analyze the proposals as well as additional comments on how USP can con- various marketplace samples of this particular preparation. This very tinue its efforts to help assure the quality and appropriate use of di- impressive work is probably outside the ability of most manufactur- etary supplements. Comments are requested to be sent to CoC@usp. ers to implement in-house. org. Please let me know if you do. 

November 2009 • Page 20