In this issue of the AHPA Report

The Official Publication of the American Herbal Products AssociationJuly 2008 www.ahpa.org Volume 23, Number 7

You Need to Know 2

•Update Your Address Book: We’ve Moved!

•New AHPA Members

• AHPA’s Key Points on JAMA’s St. John’s Wort for ADHD Study

Legal & Regulatory 3

• Suit Against FTC Reflects Tension Between First Amendment, Regulation of Advertising by Anthony Young, AHPA General Counsel

•Disclaimers Don’t Cut It: A Look at Recent Warning Letter by Anthony Young, AHPA General Counsel

•Quick Round-up

Communications Update 8

•DSEA Merges into Natural Products Foundation

• AHPA Media Scan: Notable “Herbal Headlines” and “AHPA in the News”

Calendar of Botanical Events 11

AHPA Scientific Update 13

•Meeting Attended

NCCAM 30th Advisory Council Meeting

• Presentation Given

Office of Dietary Supplements Research Practicum

• Literature Citings

St. John’s wort never was a treatment for ADHD New USP green tea (no cautionary statement) and bilberry extracts Japanese horse chestnut seeds appear to have weight loss potential

July 2008 • Page 2

You Need to Know

Update Your Address Book: We’ve Moved!

American Herbal Products Association 8630 Fenton Street

Suite 918Silver Spring, MD 20910

New AHPA MembersNutriCompliance is a Boca Raton, Fla.-based consulting company that provides compliance solutions for consumer health and dietary supplement businesses. The attorneys, consultants and medical professionals at NutriCompliance have years of experience helping supplement companies to navigate complex regulatory challenges and solve problems. The company can provide a wide range of solutions for small to medium companies and offers services in the following areas: adverse event reporting, good manufacturing practices, structure-function claims development, product development, brand protection strategies, risk management and strategic marketing and technical writing. Website: http://nutricompliance.com/

OVOS Natural Health, Inc. is a newly created nutraceutical business operating out of Laval, Quebec, engaged in the research, development and commercialization of branded natural health products. The company, a wholly owned sub-sidiary of BELLUS Health, Inc., is working to launch VIVIMIND™ (homotaurine), a natural health product that protects memory function, in 2008. OVOS Natural Health’s goal is to build a strong franchise with several products marketed to help brain function and subsequently expand to other conditions. Website: www.bellushealth.com

AHPA StaffMichael McGuffin, President mmcguffin@ahpa.org

Steven Dentali, PhD, Chief Science Officer sdentali@ahpa.org

Devon Powell, Chief Operations Officer dpowell@ahpa.org

Katia Fowler, Director of Communications kfowler@ahpa.org

The AHPA Report, the official voice of the American Herbal Products Association (AHPA), is published monthly as a service to AHPA members and friends of the herbal products industry. The material contained in this publication is for the information of AHPA members. Although the information is believed to be correct, AHPA disclaims all responsibility for any damage or liability that may result from any reliance on the information contained in this publication.

Articles may not be reproduced or reprinted without written permission from AHPA.

Send inquiries, comments or requests to:

American Herbal Products Association 8630 Fenton Street, Suite 918 Silver Spring, MD 20910 Phone: 301-588-1171 Fax: 301-588-1174 Email: ahpa@ahpa.org Website: www.ahpa.org

© copyright 2008, AHPA

AHPA’s Key Points on JAMA’s St. John’s Wort for ADHD StudySt. John’s wort rarely used for ADHD; Product seriously degraded by end of trial

The recent Journal of the American Medical Association (JAMA) study that finds St. John’s wort (Hypericum perforatum) comparable to placebo for attention-deficit/hyperactivity disorder in children and adolescents, has several crucial flaws, the American Herbal Products Association (AHPA) says.

The randomized and placebo-controlled trial published in the June 11, 2008 issue involved 54 children ages 6 to 17 years. The 27 chil-dren in the intervention group received 300 mg of H. perforatum three-times daily for eight weeks. Wendy Weber, ND, PhD, et al., found no significant difference between St. John’s wort and placebo with respect to improvement of the symptoms of ADHD.

According to Weber et al., the most common herbal treatments used by children with ADHD are St. John’s wort, Echinacea species, and ginkgo. However, as AHPA President Michael McGuffin points out, the marketing of St. John’s wort for ADHD is not common at all. In fact, the supporting reference for the authors’ assertion was a survey conducted in 2000-2001 that found five out of 117 children with ADHD had taken St. John’s wort at some time in their life. These five children had not necessarily taken St. John’s wort for ADHD and were not necessarily taking it at the time of the survey – hardly a supportive reference for the researchers’ assertion.

Furthermore, by the authors’ own admission, the product had seri-ously degraded by the end of the trial. The H. perforatum used in the study was reported to be standardized to 0.3% hypericin; however, at the end of the study the product contained only 0.13% hypericin and 0.14% hyperforin. “I don’t believe that this test material would pass muster if the proposal was submitted to NIH’s National Center for Complementary and Alternative Medicine (NCCAM) today be-

July 2008 • Page 3

AHPA in the News

To read a Reuters article on this study with comments from AHPA’s McGuffin point your browser here: http://abcnews.go.com/Health/wireStory?id=5039913

cause something as basic as ensuring the quality through the dura-tion of the trial was not assured,” said Steven Dentali, Ph.D., AHPA’s Chief Science Officer and past chairperson of NCCAM’s Product Quality Working Group.

“It is possible that a product standard-ized to at least 3% hyperforin could benefit children with ADHD symp-toms if it were delivered in a method that limits oxidation,” Weber et al. note in the study.

“The degradation of the product to less than half the amount of the marker compound means the quality of this product was seriously impaired by the end of the study,” said McGuffin. “Overall, this is

a study of an uncommon use of St. John’s wort that used a poor quality product.”

The abstract of the JAMA study is available here: http://jama.a m a - a s s n . o r g / c g i / c o n t e n t / abstract/299/22/2633?etoc

Legal & Regulatory

Suit Against FTC Reflects Tension Between First Amendment, Regulation of Advertising By Anthony L. Young, Esq. AHPA General Counsel

In today’s electronic world, the library is only a click away from the marketer, and Native Essence Herb Company’s lawsuit against the Federal Trade Commission (FTC) reflects the tension that exists when published literature is used in connection with the sale and promotion of products.

The New Mexico-based herbal products marketer sued the FTC in United States District Court in Albaquerque, New Mexico after the commission wrote to the company and advised that the company’s website, www.allherbs.com, contained false, misleading, or unsub-stantiated information regarding some products.

The letter was accompanied by a draft civil complaint for an injunc-tion and money damages equal to the amount of sales of the product and invited the company to negotiate a consent decree. Instead, the company took the allegedly false, misleading and unsubstantiated material off of its website, posted a notice that “All truthful, tradi-tional and historic use information has been removed from our web-site due to FTC regulations” and filed its own lawsuit.

The company seeks a declaration that the FTC’s “Dietary Supplements: An Advertising Guide for Industry,” published in 1998, violates the First Amendment to the United States Constitution. The lawsuit also seeks a declaratory order from the Court that the company may quote or provide a link to information contained on any federal government website concerning herbs or herbal remedies.

In the Complaint, Native Essence states that it believes the Constitution provides consumers a First Amendment right to re-ceive information, and for a company to provide information re-garding the “documented historical use of [an herb] for a serious

disease like cancer.” The company alleges the FTC’s position is that it is never permissible for a company to do this and that this position “restricts consumers’ right to this information, [and] may also vio-late the privacy rights of citizens.”

This lawsuit reflects the tension between guides like the FTC’s 1998 Guide for Industry, where the FTC took steps to spell out how his-torical use information could be used to substantiate claims for products, and the FTC Act itself which is a broad statute applied to all types of products. After the Dietary Supplement Health and Education Act of 1994, first the FTC and then the FDA published documents and promulgated regulations and guides for an industry that wanted to know how to stay within the requirements of both

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July 2008 • Page �

the new law and other relevant statutes. These guides were wel-comed by the industry at the time and have served the industry and the FTC well over the years.

The devil is, however, in the details, and there has always been a question as to the distance necessary between a company’s market-ing activities and its efforts to provide First Amendment protected information to consumers. “How many clicks away must it be?” is a frequent question companies ask. And in the health food store, his-torically, there was also an issue of whether books could be sold right next to the products that they might describe. Is the information provided as part of the company’s efforts to sell its products? Or is the company providing the information to educate the public and its consumers? A wag would say that marketing companies market products and libraries and bookstores have or sell books and articles and provide educational material. On the Internet, the distance be-tween these businesses involves one or more slight moves of the finger.

Whether a lawsuit like this will resolve any of these issues is yet to be seen. In the meantime, the FTC and the FDA’s consistent position is that dietary supplements cannot be marketed for serious diseases like cancer. The FTC’s letter to this company and FDA’s actions on June 17, when Warning Letters were sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudu-lently claiming to prevent and cure cancer, teaches that this is a business that is bound to attract the attention of the government.

Disclaimers Don’t Cut It: A Look at Recent Warning LettersBy Anthony L. Young, Esq. AHPA General Counsel

Disclaimers about claims on products or websites don’t allow com-panies to make otherwise unlawful claims. The only claims dis-claimer that has any legal effect on a product or website is DSHEA’s, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” But this disclaimer and any other dis-claimer do not allow companies to make disease claims for their products.

FDA made this point to an internet marketer in a Warning Letter last month. The company’s website stated:

The success of Our Product is largely based on testimonials, accumu-lated over a period of 23 years from people who used Our Product. No Claims can be legally made about Our Product. The informa-tion has been prepared as narration of what users have reported to be the most effective way to use the products as an Herbal Remedy, and what some have reported as the results. It is not intended as a report of scientific studies, and it is not offered or endorsed by the AMA or the FDA. It is intended to be an honest report of what is known for those who are interested.

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FDA made clear to the company that “untrue or misleading infor-mation in one part of your site will not be mitigated by inclusion of such a “disclaimer.” Another company was using a similar gambit:

Yes! Here you will find the strongest and most effective ****** products, which we have formulated using only the best, natural sources on earth! There are many products out there that make claims but don’t produce the desired effect you have been searching for. Rest assured that our products are the real deal!

While historically, ******and *****have been used for melanoma, basal and squamous cell carcinomas. . . we at **** are not legally allowed to make such claims. Such claims made by companies would put these products into the category of “new drugs” based on the FDA definition. Again, we do not make such claims regarding our products.”

Since the Federal Food, Drug, and Cosmetic Act became law in 1938, companies have tried to use disclaimers to avoid the jurisdic-tion of the Food and Drug Administration and the Federal Trade Commission. Disclaimers do not work. You cannot make a claim and then disclaim it away. That has been the law now for sixty years.

Reported elsewhere in this issue of the AHPA Report is the lawsuit brought by the Native Essence Herb Company against the FTC. (See

previous story.) Here are the disclaimers they were using before the FTC invited them to enter into a Consent Decree or to be sued.

This information is to be used for educational purposes only and has been based solely on the traditional and historic use of a given herb, or on clinical trials that are generally not recognized by any US govern-ment agency or medical organization. This information has not been evaluated by the US Food and Drug Administration, nor has it gone through the rigorous double-blind studies required before a particular product can be deemed truly beneficial or potentially dangerous and prescribed in the treatment of any condition or disease.

Furthermore, the information presented here is not presented with the intention of diagnosing any disease or condition or prescribing any treat-ment. It is offered as information only, for use in the maintenance and promotion of good health in cooperation with a licensed medical practi-tioner. In the event that any individual should use the information pre-sented on this website without a licensed medical practitioner’s approval, that individual will be diagnosing for him or herself. No responsibility is assumed by the author, publisher or distributors of this information should the information be used in place of a licensed medical practitio-ner’s services. No guarantees of any kind are made for the performance or effectiveness of the preparations mentioned on this website.

Perhaps the pending lawsuit will determine whether what has been the law for sixty years has or should be changed.

July 2008 • Page �

Quick Round-upFor 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 at kfowler@ahpa.org.

Food Protection Rapid Response Team and Program Infrastructure Improvement Prototype Project

The Food and Drug Administration (FDA), Office of Regulatory Affairs(ORA), Division of Federal-State Relations (DFSR) in col-laboration with theCenter for Food Safety and Applied Nutrition (CFSAN) and Center forVeterinary Medicine (CVM), is announc-ing the availability of an Agreement of Limited Competition. … The goal of FDA’s ORA Cooperative Agreement Program is to en-hance, complement, develop and improve State manufactured food protection regulatory and surveillance programs. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0357-n.pdf

Cooperative Agreement to Establish and Support the Western Center for Food Safety

The Food and Drug Administration (FDA) is announcing a Request for Application (RFA) Number RFA-FD-08-004 and its intention to receive and consider a new sole source application for the award of a cooperative agreement in fiscal year 2008 (FY 2008) to establish and support the Western Center for Food Safety (WCFS). http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0360-n.pdf

Health Canada Warns Against a Number of Chinese Herbal Products

Health Canada issued a release June 25 advising consumers not to use several Chinese herbal products sold as treatment for erectile sexual dysfunction because the department found the products contained prescription drugs. http://canadianpress.google.com/article/ ALeqM5igdSpZOnx6iRGQqD-mpTObKAxSCQ

Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions

The Food and Drug Administration announced June 25 the avail-ability of a guidance for industry that explains FDA’s current think-ing on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives. http://edocket.access.gpo.gov/2008/pdf/E8-14397.pdf

Native Essence Herb Company Sues FTC

Taos, New Mexico-based Native Essence Herb Company announced June 25 it was suing the Federal Trade Commission, claiming FTC violates the company’s First Amendment right to “tell customers the historical use of herbs in treating serious diseases.” http://biz.yahoo.com/bw/080625/20080625006068.html?.v=1

United States and Viet Nam Sign Agreement on the Safety of Food, Medical Products

The United States Department of Health and Human Services an-nounced June 25 the U.S. and the Socialist Republic of Viet Nam signed a memorandum of understanding to enhance the safety of food, feed, drugs and medical devices traded between the two na-tions. http://www.hhs.gov/news/press/2008pres/06/20080624a.html

Energy Drink Safety Concerns Make Actions on Labels Imminent – Consultant

“The Tan Sheet” reports on Antonio C. Martinez’ argument urging marketers of energy drinks to disclose caffeine content on products labels and include warnings to “protect consumers and prepare for possible labeling regulations.” http://www.thetansheet.com/fdcreports/tan/showHome.do

Status of Certain Additional Over-the Counter Drug Category II Active Ingredients

The Food and Drug Administration (FDA) is proposing that cer-tain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbrand-

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ed. FDA is issuing this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA’s ongoing review of OTC drug products. http://edocket.access.gpo.gov/2008/pdf/E8-13826.pdf

Canada Considers Legislation to Distinguish Supplements from Drugs

Health News Daily reported June 17 that Canada will “propose cre-ating a distinct regulatory category for natural health products after opponents lobbied against imposing a pharmaceutical regulatory model on the products.” If you have a subscription to Health News Daily or “The Tan Sheet,” the complete story is available here: http://www.healthnewsdaily.com/fdcreports/story/printStory.do?targetGUID={0637729D-6804-479D-8D5B-60D50403CDF0} &AuthToken=-419823039

FDA Warns Individuals and Firms to Stop Selling Fake Cancer “Cures”

On June 17, the Food and Drug Administration announced it had sent warning letters to 23 U.S. companies and two foreign individu-als marketing products “fraudulently claiming prevent and cure can-cer.” http://www.fda.gov/bbs/topics/NEWS/2008/NEW01852.html

Online Pharmacy Ordered to Pay FTC $1�.8 Million

On June 4, a U.S. District Judge found Hi-Tech Pharmaceuticals and other companies liable for $15.4 million to compensate con-sumers for false advertising claims. The case is reported on in Law.com: http://www.law.com/jsp/article.jsp?id=1202422192464

Citric Acid and Certain Citrates From Canada and China; Determinations

On June 11, the United States International Trade Commission determined that there is a reasonable indication that an industry in the United States is materially injured by reason of imports from Canada and China of citric acid and certain citrate salts that are alleged to be sold in the United States at less than fair value and subsidized by the Government of China. http://edocket.access.gpo.gov/2008/pdf/E8-11924.pdf

Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals

On June 10, the United States Patent and Trademark Office issued a final rule that amends the rules governing practice before the Board of Patent Appeals and Interferences in ex parte patent ap-peals. The rule is effective Dec. 10, 2008. http://edocket.access.gpo.gov/2008/pdf/E8-12451.pdf

July 2008 • Page 8

Metabolife Founder Sentenced for Lying to the FDA

Fox News covered the sentencing of Metabolife-founder Michael J. Ellis to six months in federal custody for lying to the FDA. According to the article, Ellis pleaded guilty to sending letters to FDA in 1998 and 1999 that falsely claimed his company’s ephedra weight-loss product had a “claims-free history.” http://www.fox6.com/news/local/story.aspx?content_id=0adc636d-7876-42f7-8c5c-85a96630b7e2

Import/Export User Fees

The Department of Agriculture’s Animal and Plant Health Inspection Service published a proposed rule June 4 that would amend the reg-ulations concerning user fees for import- and export-related services for animals, animal products, birds, germ plasm, organisms and vectors. http://edocket.access.gpo.gov/2008/pdf/E8-12376.pdf

Notice of Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Chemicals

The Environmental Protection Agency released a notice on June 4 announcing the initial filing of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. http://edocket.access.gpo.gov/2008/pdf/E8-12249.pdf

Food Labeling Workshop; Public Workshop

On June 3 the Food and Drug Administration, Office of Regulatory Affairs, Southwest Regional Small Business Representative Program, in collaboration with the University of Arkansas announced a public workshop entitled “Food Labeling Workshop.” http://edocket.access.gpo.gov/2008/pdf/E8-12301.pdf

Revision of Patent Fees for Fiscal Year 2009

On June 3 the United States Patent and Trademark Office published a proposed rule that suggests adjusting certain patent fee amounts for fiscal year 2009 to reflect fluctuations in the Consumer Price Index (CPI). Comments are due by July 3, 2008. http://edocket.access.gpo.gov/2008/pdf/E8-12364.pdf

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Communications Update

DSEA Merges into Natural Products FoundationThe Dietary Supplement Education Alliance (DSEA) has become part of the Natural Products Foundation in a move both organiza-tions feel will “strengthen efforts to focus the nation’s attention on the benefits provided by dietary supplements and other natural products,” the Natural Products Foundation announced June 20.

“DSEA’s Dietary Supplement Information Bureau (DSIB) and con-sumer and media outreach programs are highly regarded and will fit perfectly with the mission of the foundation, which is to enhance and promote the integrity of natural products through quality, sci-ence and education,” said Randy Dennin, chairman of the Natural Products Foundation. “This merger allows us to not only strengthen and expand the foundation’s education scope, it provides an estab-lished infrastructure that can be used to grow initiatives begun and planned by DSEA.”

As part of the affiliation and in order to take advantage of the Natural Products Foundation’s tax-exempt status, DSEA was dis-solved as a corporate entity. To ensure the programs DSEA contrib-utors have supported over the years are continued and the organiza-tion’s expertise are tapped, Elliott Balbert, DSEA’s founder and most recent president, along with past-president Jon Benninger, have joined the foundation’s board of directors. Long-time DSEA staffer Deb Knowles has also joined the foundation team.

The American Herbal Products Association, one of the founding organizations of DSEA, believes this merger is a positive step for both DSEA and the Natural Products Foundation. “AHPA is pleased to see these two good groups combine resources and talent,” said President Michael McGuffin. “Their combined energies should benefit the industry as a whole.”

Additionally, as part of the transition, the AHPA Foundation for Education & Research on Botanicals has received the copyright to “A Field Guide to Herbal Dietary Supplements.” This guide for

July 2008 • Page 9

consumers features the work of AHPA’s McGuffin and AHPA Award Winner Steven Foster, who contributed both text and photos for the booklet. A version of the guide reflecting this change in copyright should be released in the near future.

AHPA Media Scan: Notable “Herbal Headlines”These “herbal headlines” – and headlines of interest to the herbal indus-try – have been selected from the past few weeks of media activity. If you would like a copy of any of these articles, please email Katia Fowler kfowler@ahpa.org.

AHPA in the News

Read the following stories for comments from AHPA President Michael McGuffin:

June 10, 2008 – St. John’s wort doesn’t help ADHD, study finds Reuters

June 17, 2008 – FDA cautions consumers against cancer “cures” Reuters

June 29, 2008 – Trimming the competition: Diet-drug maker’s move could eliminate others The Star-Ledger

June 1, 2008 – Reinvent kava as a drink for export market Island Business

June 2, 2008 – Can Chinese remedy help women here? ABC 6

June 2, 2008 – U.N. Chief to Prod Nations on Food Crisis: Trade, Price Policies at Issue The Washington Post

June 3, 3008 – Bush Wants Sun to Set on Midnight Regulations Washington Post

June 3, 2008 – Tyson Pulls Antibiotic-Free Label Wall Street Journal

June 4, 2008 – China ingredient supplier gets life for killer drug Reuters

June 4, 2008 – Palmolive wins race to phosphorus limits The Spokesman Review

June 4, 2008 – Has stevia broken US dietary supplement shackles? Nutraingredients.com

June 4, 2008 – Bisphenol A Under Scrutiny: Congress, media call into question safety of widely used plastics chemical Chemical & Engineering News

June 4, 2008 – New Hints Seen That Red Wine May Slow Aging New York Times

June 8, 2008 – A bitter fight over who can be called ‘doctor’ Star Tribune

June 9, 2008 – FDA Seeks $275M to boost food import protection USA Today

June 9, 2008 – China delivers pesticide residue detectors to quake zone Xinhua

June 10, 2008 – St. John’s wort doesn’t help ADHD, study finds Reuters

June 10, 2008 – NCCAM Launches Time to Talk Campaign CHIROeco.com

June 11, 2008 – Clash Arises on Safety of BPA in Plastic Items Wall Street Journal

June 11, 2008 – EU says China needs to invest in safety Associated Press

July 2008 • Page 10

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June 12, 2008 – Dial Debuts ‘Green Assurance Program’ for Cleaning Products GreenBizJune 12, 2008 – Report Faults F.D.A. Action for Safe Food The New York TimesJune 12, 2008 – Where’s the Food Safety Net? As a new salmonella crisis strikes, the FDA is stretched to “near breaking point” Business WeekJune 13, 2008 – Lawmakers to subpoena 9 companies over food test-ing USA TodayJune 15, 2008 – Herbalists to face strict regulations Telegraph (UK)June 16, 2008 – Regulate unorthodox therapy call BBC NewsJune 16, 2008 – Fruit-flavored placebo pill designed to comfort chil-dren raises health fears The Daily TelegraphJune 17, 2008 – HHS Secretary And Chinese Minister of Health Sign Memorandum of Understanding On Traditional Chinese Medicine Research Medical News TodayJune 17, 2008 – FDA cautions consumers against cancer “cures” ReutersJune 17, 2008 – FDA hopes to open China office by year end ReutersJune 17, 2008 – Chinese herbal gingko biloba remedy ‘doesn’t help’ Alzheimer’s victims Daily Mail (UK)

June 18, 2008 – Government insists on second public consultation before regulating complementary medicine British Medical JournalJune 18, 2008 – Chinese remedy seen beneficial after heart attack ReutersJune 18, 2008 – China to send food, product inspectors to US: official Agence France-PresseJune 18, 2008 – Red Wine A Weapon in Battle of the Bulge CBS NewsJune 19, 2008 – Japan’s Seven & I to start farming operations Reuters

June 20, 2008 – U.S. FDA seeks India post for food, drug checks ReutersJune 20, 2008 – Sino-US joint food safety test center starts operations China DailyJune 22, 2008 – Avoid the marketing misuse of ‘green’ Chicago TribuneJune 22, 2008 – Indonesia has 40,000 types of traditional medicine XinhuaJune 22, 2008 – The nutraceutical industry is at varying levels of maturity The Hindu Business LineJune 23, 2008 – China unveils anti-graft plan, warns task “arduous” ReutersJune 23, 2008 – Traditional healers opposed to policy move by Kenya government Africa Science News ServiceJune 24, 2008 – Vietnam, U.S. sign agreement to improve food and drug safety Houston ChronicleJune 25, 2008 – Beijing consumers are going organic Times NowJune 26, 2008 – China Launches Doping Inspection Nationwide Ahead of Olympic Games All Headline NewsJune 27, 2008 – Anheuser to Pull Caffeine Drinks The Washington PostJune 27, 2008 – Supplement maker sues plant supplier The Wichita EagleJune 27, 2008 – Chinese remedies gain popularity San Mateo County TimesJune 27, 2008 – Firms made to pay for deadly drug China DailyJune 29, 2008 – Trimming the competition: Diet-drug maker’s move could eliminate others The Star-Ledger June 30, 2008 – House bill backs organic farming GMA News (Philippines)

July 2008 • Page 11

July 9: Import Safety Summit, Grand Hyatt Washington. Washington, DC. The evolving global marketplace relies increasingly on imported goods, and maintaining product safety is the top priority for industry. This event brings together different industries and representatives of stages in the supply chain to share their current efforts and best practices in import safety with one another and the public. Website: http://guest.cvent.com/EVENTS/Info/Summary.aspx?e=e4bb898f-5e1f-4647-88cb-3ad41ffcfdb6

July 11: Partnering Western Medicine and CAM: An Evidence-Based Approach to Healing, Asheville, NC. Sponsored by MAHEC Interdisciplinary Education and co-sponsored by The School of Pharmacy, The University of North Carolina at Chapel Hill. The brochure is available here. Website: http://www.mahec.net/calendar/detail.aspx?eid=1634061&parentID=0

July 17-19: NPA Natural Marketplace, Sands Expo and Convention Center, The Venetian Resort Hotel, Las Vegas, Nevada. Each year more than 7,500 natural products industry retailers, suppliers and professionals gather at Natural Market-Place to connect with colleagues and friends, discover thou-sands of new products for stores and businesses, and learn from leading experts. See “AHPA on the Road” for more information Website: http://www.naturalproductsassoc.org/site/PageServer? pagename=tp_home

July 23-25: NBJ Summit, St. Regis Resort Monarch Beach, Dana Point, CA. Sponsored by New Hope Natural Media. Hosted by Nutrition Business Journal. AHPA Members may attend at a discounted rate of $1,695 (a $200 savings). Please contact Katia Fowler for AHPA’s promotion code. Website: www.nbjsummit.com

July 26–30: Botany 2008, University of British Columbia. The Joint Annual Meeting of Canadian Botanical Association/L’Association Botanique du Canada, American Fern Society, American Society of Plant Taxonomists, and the Botanical Society of America. Conference website: www.2008.botanyconference.org/

August 3–8: 7th Joint Meeting of AFERP, ASP, GA, and PSE (49th Annual Meeting of the American Society of Pharmacognosy): “Natural Products with Pharmaceutical, Nutraceutical, Cosmetic, and Agrochemical Interest,” Athenaum Intercontinental Hotel, Athens, Greece. The official language of the Congress will be English. Abstract Deadline: March 15, 2008. Registration and Info online at: www.jointmeeting.2008athens.gr. Preliminary program brochure: www.phcog.org/AnnualMtg/Athens.pdf

August 11–15: 2008 International Training Program on Natural Products: Botanicals, Nutraceuticals and Medicinal and Aromatic Plants, “From Sourcing and Production to Processing and Product Development, And from Quality Control to Health Applications,” Rutgers University, New Brunswick, New Jersey with part of the course held (transpor-tation provided) at the New York Botanical Garden, Bronx, New York City, NY. This intensive training program for those seeking in-depth knowledge and expertise in natural products, including their historical roles and applications to their modern uses; from the genetics and actual production of the plant, to the processing and extraction of plant products; from the basic chemistry and biochemistry of the plants to their relevance in the commercialization of the final processed botanical product, essential oils, herbal teas, spices, phytomedicinals and dietary supplements. Full course description and registration informa-tion online: www.aesop.rutgers.edu/~newuseag/itp2008.htm

AHPA on the Road

Calendar of Botanical Events

Many more listings are online at www.ahpa.org.

July 17-19: NPA Natural Marketplace, Sands Expo and Convention Center, The Venetian Resort Hotel, Las Vegas, Nevada. Stop by and visit AHPA at booth B-439 and don’t forget that all AHPA members are welcome to attend any of the committee meetings held during the show. This is a great time to find out what the committees are working on and help develop new projects. A complete meeting schedule is below:

Education / Small Business Committee 8:30 – 10: 00 a.m. / July 18, 2008 / Venetian Hotel / Room 2804 Staff Liaison: Devon Powell (dpowell@ahpa.org)

Government Relations Committee 10:15 – 11:45 a.m. / July 18, 2008 / Venetian Hotel / Room 2804 Staff Liaison: Michael McGuffin (mmcguffin@ahpa.org)

Animal Products Committee 12:00 – 1:30 p.m. / July 18, 2008 / Venetian Hotel / Room 2804 Staff Liaison: Katia Fowler (kfowler@ahpa.org)

Analytical Labs / Botanical Raw Materials / Standards 1:45 – 4:15 p.m. / July 18, 2008 / Venetian Hotel / Room 2804 Staff Liaison: Steven Dentali, PhD (sdentali@ahpa.org)

Public Relations Committee 4:30 – 6:00 p.m. / July 18, 2008 / Venetian Hotel / Room 2804

Staff Liaison: Katia Fowler (kfowler@ahpa.org)

July 2008 • Page 12

August 13-16: Embody Nature, Redefine Health, the 23rd annual convention and exposition of the American Association of Naturopathic Physicians, Arizona Biltmore Resort & Spa, Phoenix, Arizona. Website: www.naturopathic.org

August 21-24: International Grand Centennial Convention on Ayurveda & Arogya 2008, Codissia Trade Fair Complex, Coimbatore, India. Co-organized by the Arya Vaidya Pharmacy and the Ayurvedic Drug Manufacturers’ Association. Website: www.ayurvedaconvention.com.

September 24-26: U.S. Pharmacopoeia Annual Scientific Meeting, Westin Crown Center, Kansas City, Missouri. The USP Annual Scientific Meeting 2008 is your opportunity to directly contribute to USP’s standards–setting processes. Website: http://www.usp.org/meetings/asMeeting/

September 26-October 5th: Botanical Medicines from the Amazon and the Andes, Travel in Peru includes Reserva Amazonica in the rainforest, Machu Picchu, the Sacred Valley and Cusco. For the itinerary, click here. An exploration of traditional and modern uses of plant based medicines from the Amazon and Andes for health promotion, symptom manage-ment and disease treatments. For the course outline, click here.Sponsored by the ACEER (Amazon Center for Environmental Education and Research) Foundation, American Botanical Council (ABC) and West Chester University. Cost: $3,109 (From Lima) Contact: Mary Ann Robinson mrobinson@wcupa.edu and 610-738-0477. Website: http://www.aceer.org/workshops.php

October 11: HerbDay, everywhere! Website: www.herbday.org

October 11–14: 23rd Annual Conference of the American Holistic Veterinary Medical Association, John Ascuaga’s Nugget Casino Resort, Reno, Nevada. Deadline for their call for papers is November 1, 2007: www.ahvma.org/associations/4062/files/CALLFORPAPERS.pdf

October 22–24: SupplySide West, The Venetian and Sands Expo, Las Vegas, Nevada. Manufacturers that are members of AHPA receive a $50 discount. See ad this page for more details. Website: www.supplysideshow.com

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July 2008 • Page 13

AHPA Scientific Update

by Steven Dentali, PhD AHPA’s Chief Science Officer

MEETING ATTENDED

NCCAM 30th Advisory Council Meeting

I attended the open session of the 30th meeting of the National Advisory Council for Complementary and Alternative Medicine on June 6, 2008. The meeting did not specifically address botanical issues but did provide interesting information. For example, it was reported that the large human ginkgo trial (GEMS) and the human glucosamine and chondroitin imaging trial (GAIT II) will be released this summer, and that the botanical research centers are up for renewal. This process is expected to be a competitive one.

Considerable attention was given to evaluating and tweaking the NCCAM Development Centers for Research on CAM (DCRC) that have supported CAM practitioners in the past. It was recog-nized that there should be more collaborative projects with built in mentoring and research building capacity at CAM institutions. The proposed concept of Centers for CAM Research and Capacity Building (C3B) would take a five-year approach instead of the four currently in place for DCRD. Other changes would support a shift in focus from practice and training to CAM research itself. The main difference would be to help provide institutional support for individuals instead of just developing them as practitioners.

NCCAM’s director, Josephine Briggs, MD, provided an update in her process of getting acquainted with the requirements of her job explaining that she has a strengthened conviction of NCCAM’s mis-sion, and is aware of research challenges and the limitations of exist-ing research designs. She is also cognizant of the complaints that NCCAM isn’t answering practical questions. She spent time attend-ing Australia’s 3rd International Congress on Complementary Medicine, was part of a China delegation that spent a day in the Shanghai College of Traditional Medicine, visited the NCCAM funded Purdue University Botanical Research Center, and attended the Ole Miss Conference on the Science of Botanicals/Pharmacognosy conference as reported in the May 2008 AHPA Report (Vol. 23, No. 5, p. 17-19).

Dr. Briggs likened the botanical research process to a drug develop-ment pipeline with greater emphasis being placed on how CAM practices work in the outside world. The questions that she and staff will be considering include how can NCCAM more effectively focus their study of herbals and other biological remedies, which interventions are most promising, what are the needed resources, and how should NCCAM approach priority setting. The evident intention is to build a portfolio of research that tests “real world” CAM effectiveness questions and to determine which conditions

July 2008 • Page 1�

Following my talk, Bill Gurley, Ph.D. covered supplement drug in-teractions and explained the mechanism by which St. John’s wort increases metabolism of approximately 50% of prescription drugs. Goldenseal root was found to have similar but opposing properties in that it reduces the activity of a couple of drug metabolizing en-zymes, which effectively increases the blood levels of many prescrip-tion drugs. This effect appears to be clinically relevant. The after-noon saw presentations by three ODS staff, Joseph Betz, PhD, Marguerite Klein, and Christine Swanson, PhD, who covered iden-tity and quality, good manufacturing practices for supplements and evaluating supplement quality, and how supplements should be characterized when reporting in journal articles.

The third day of the practicum took a break from the NIH campus to meeting the stakeholders in Washington, D.C. just off the National Mall. Organizations represented comprised the American Herbal Products Association represented by President Michael McGuffin, the American Society for Nutrition, the Food and Nutrition Board at the Institute of Medicine, the American Dietetic Association, the Council for Responsible Nutrition, Nutramax Laboratories, the Center for Science in the Public Interest, Public Citizen’s Health Research Group, and the Washington Post.

The fourth day of the practicum dealt with measuring food and supplement intakes and the concepts and measurement of safety and efficacy. The afternoon sessions covered relevant databases while the final day presented information on conducting studies with

and CAM modalities are ready for this type of study using which best methods.

NCCAM also announced their public education and outreach pro-gram called “Time to Talk” that will be employed partly through outreach with the American Association for Retired People (AARP). It appears to be a very nice program that mirrors what has been an AHPA guidance since 2001. AHPA’s Disclosure of Herb Use to Health Care Providers reads as follows: “AHPA recommends that con-sumers of herbal supplements inform their healthcare provider(s) of such use. In the interest of seeing this recommendation broadly accepted by consumers, AHPA encourages healthcare providers to receive such com-munication with respect for the consumers’ healthcare choices. In addi-tion, AHPA encourages healthcare providers to seek out accurate and truthful information about herbs.”

Additional information on the NCCAM’s Time to Talk program, including ordering of toolkits and patient packets is available at http://nccam.nih.gov/timetotalk/.

PRESENTATION GIVEN

Office of Dietary Supplements Research Practicum

The NIH Office of Dietary Supplements (ODS) conducted a week long practical intensive “to provide fundamental knowledge of dietary supplements to faculty, PhD students, and post-docs at aca-demic institutions; healthcare practitioners; and other professionals with biomedical degrees.” The intent of the practicum was to provide a fundamental overview of the field that would allow partic-ipants to provide instruction at their academic institutions, and to foster interest in carrying out research in this area.

Over one hundred participants were exposed to about 30 speakers over 8 sessions that included a review of who takes supplements and why by ODS staff, the regulatory environment pre- and post-DSHEA, and an introduction to what the FDA and FTC do by Vasilios (Bill) Frankos, PhD, and Michelle Rusk, respectfully. Supplement labeling and claims on supplements and foods were covered by Kenneth Fischer, PhD, and Paul Thomas EdD, consul-tants at ODS.

Day two reviewed the different paths and requirements for drug, supplement, and food development. I spoke about botanical supple-ments emphasizing the history of safe use and the resurgence of his-torically viable preparations that followed the shift in pharmacog-nosy from categorizing medicinal plants by how they look and what they to, to the bioactive constituents they create. I explained the European Union system of extract categorization and the concept of botanical standardization that applies to all phases of botanical ac-quisition, ingredient preparation, and final product manufacture. I completed the presentation with the example of how adulterated bilberry can be detected with simple chemical tests posted on the AHPA website.

North American Research Conference on

Complementary Integrative Medicine&

Call for Abstracts/Sessions Submissions due September 30, 2008

July 2008 • Page 1�

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 health-care 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, toxicol-ogy 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 mmcguffin@ahpa.org.

uct as reported in the study.

JAMA also published an editorial holding up this study as an example of a properly designed and conducted randomized, placebo controlled, double blind clinical trial. Unfortunately the editors and reviewers apparently failed to question the appropriateness of using St. John’s wort in treating ADHD or have knowledge of basic re-porting for studies that contain botanical ingredients. The research-ers clearly did not obtain information from the source ingredient supplier and their knowledge about product integrity requirements for a clinical trial appears to be lacking.

AHPA’s letter to the editor stated that researchers and journals should be aware of and follow the CONSORT statement for herbal interventions, and NCCAM’s product quality guidelines for studies that employ botanical materials (see http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html). Had this been done there would not be any question about the integrity of the material used in the study as the authors reported a marker compound concentra-tion at the end of the study that was half that measured before the study began. The authors should know that the implementation of different analytical methodologies can give different results for hy-pericin levels in St. John’s wort.

This trial is yet another example of inadequate expertise brought to bear on botanical study materials before a trial begins and inade-quate characterization of the product in the final study report. There

supplements, science and policy issues, communicating information about supplements to consumers, and the resources of ODS. I think the audience was well served throughout the week with practical information that should expand and further inform their view of supplements and supplement research.

LITERATURE CITINGS

St. John’s wort never was a treatment for ADHD

Weber W, Vander Stoep A, McCarty RL, Weiss NS, Biederman J, McClellan J. Hypericum perforatum (St John’s wort) for attention-deficit/hyperactivity disorder in children and adolescents: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2633-41.

Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 2006 Mar 7;144(5):364-7.

This study has been the subject of an AHPA Update (See p. TK)) and a letter to the editor of JAMA. Our main criticisms are the inappropriate indication of using St. John’s wort to study attention-deficit/hyperactivity disorder (the originally proposed work was to study depression) and the apparent change in strength of the prod-

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July 2008 • Page 1�

was no question in my mind that most any material could be sub-jected to a proper clinical trial, but doubts remain as to when the choice of treatment and the proper identification of botanical mate-rial employed will become the rule instead of the exception.

New USP green tea (no cautionary statement) and bilberry extracts

Powdered Decaffeinated Green Tea Extract, USP31–NF26 Supplement: No. 2 Page 3797, and Powdered Bilberry Extract, USP31–NF26 Supplement: No. 2 Page 3793.

USP dietary supplement monographs for USP powdered decaffein-ated green tea extract and USP powdered bilberry extract have been published in the second supplement to the current USP-NF. They will become official on December 1, 2008. The green tea extract monograph does not contain USP’s previously proposed cautionary labeling statement that was opposed by AHPA (see the AHPA Report, February 2008, volume 23, number 2, pages 5-7).

The identification portion of the bilberry extract monograph speci-fies a thin-layer chromatographic test, and a qualitative evaluation of the HPLC test. These analyses should provide adequate differen-tiation between genuine bilberry extracts and raw materials adulter-ated with red dye. AHPA previously notified its member of this is-sue and provided approaches for industry on our website (see http://www.ahpa.org/Default.aspx?tabid=164).

Japanese horse chestnut seeds appear to have weight loss potential

Kimura H, Ogawa S, Katsube T, Jisaka M, Yokota K. Antiobese Effects of Novel Saponins from Edible Seeds of Japanese Horse Chestnut (Aesculus turbinata Blume) after Treatment with Wood Ashes. J Agric Food Chem 2008 doi: 10.1021/jf800340s ASAP article, Epub: May 31.

When used as food, acorns must be leached of their tannins in order to be edible. Leaching Japanese horse chestnuts (Aesculus turbinata)

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also removes their bitterness and was done for this study prior to the isolation and testing of its saponins. The common horse chestnut (Aesculus hippocastanum) seed contains saponins known as escins (or aescins) that are used for treating chronic venous and lymphatic in-sufficiency, and have recognized anti-inflammatory and antiedemic activities. This report mentions that A. turminata also has tradition-al food uses after processing with wood ashes.

Previously the authors isolated saponins from Japanese horse chest-nut seeds. This time they focused on anti-obesity effects of these compounds in mice on a high-fat diet and on their ability to inhibit pancreatic lipase (a fat metabolizing enzyme from the pancreas) in vitro. (The article mentions that the weight loss drug orlistat, which is marketed as Xenical or Alli is a pancreatic lipase inhibitor.) The saponins evaluated were actually different escins and deacetylescins. The mice were fed up to 0.5% saponin fraction in their high fat diet (40% beef tallow!) over 8 weeks.

Results indicated a significant suppression weight gain among the mice receiving the saponin fraction supplemented material com-pared to the high fat diet controls. The high fat diet saponin supple-mented diet also showed lowered triglycerides compared to those on the saponin unsupplemented diet while total cholesterol was not significantly affected, except for one supplemented group that did show an increase in total cholesterol.

In short, Japanese horse chestnut saponins were shown to inhibit pancreatic lipase in vitro and in mice to suppress the digestion and absorption of fats. Considerably more study is needed too draw any conclusions with regard to the actions of these materials in humans, but it is intriguing information as the mechanism of action appears to be the same as that for the only U.S. FDA-approved drug for weight loss.

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