Tuesday, November 25, 2008

FDA's Latest Threat to Dietary Supplements Defies DSHEA

For Immediate Release:

U.S. Contact: Gretchen DuBeau,
ph 800-230-2762
International Contact: Dr Robert Verkerk,
ph +44-1306-646-600

November 25, 2008


Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), jointly submitted comments to the US Food and Drug Administration (FDA) in response to its request for comments from industry and consumers to help them interpret recent changes to Section 912 of the Amendments Act of 2007 (FDAAA). The submission was accompanied by comments from 700 concerned citizens and practitioners exasperated over the latest threat to supplements from the FDA. The FDA’s unprecedented, controversial, and ambiguous changes to Section 912, specifically the addition of Section 301 (ll), may mean that all food products, including dietary supplements, could be barred from being marketed if they have been the subject of published clinical studies. AAHF and ANH point out that this provision is so far-reaching that a very large number of commonly consumed foods could be impacted by the new regulation and hence barred from interstate trade.

“If the FDA determines that Section 301 applies to dietary supplements, this would strangle innovation. It would create a ‘Catch 22’ situation in which supplement producers who undertake scientific research on new supplements will find that their very research will lead to a ban on the proposed supplement. This is totally senseless. This is too senseless even for the FDA,” said Gretchen DuBeau, AAHF Executive Director.

At the crux of the issue is whether the new Section 301 applies to dietary supplements, which are already covered by Section 201 (ff) of the Federal Food, Drug, and Cosmetic Act (FDCA). This means that Section 301 is in direct conflict with Section 201 of the FDCA that already governs dietary supplements through the Dietary Supplements Health and Education Act (DSHEA). DuBeau added:

“This conflict—which is supported by influential case law— gives Section 301 of the FDAAA no legal basis. Congressional language has already made clear and unambiguous that the FDAAA, currently under consideration, shall not affect the regulation of supplements under DSHEA.”

Section 201 currently also prevents the marketing of dietary supplements which have been subject to published clinical studies—but only when they have also been the subject of a Investigational New Drug (IND) application.

Dr Robert Verkerk, executive and scientific director of the ANH emphasized:

“Unlike Section 201 of the FDCA, the proposed new Section 301 of the FDA Amendments Act doesn’t just limit the ban to supplements that have been subject to drug applications, it applies a ban to some of the best researched and most useful supplements and ingredients on the market today. This is clearly nonsensical and if enforced, would represent one of the most severe restrictions seen in any country at any time.”

“There will be no shortage of big corporations that will exploit this situation to their benefit unless the scope of Section 301 is both clarified and narrowed”, commented Gretchen DuBeau, “one such company is already trying to use it to ban the natural zero-caloric sweetener stevia, given that stevia has been subject to scientific research and has been a thorn in the side of the sugar and artificial sweetener giants for years.”

Since the FDA’s call for comments issued on July 28, 2008, the AAHF sent an alert to its members, including professional, integrative medicine organizations, apprising them of the threat posed by the FDAAA’s Section 912. More than 700 concerned doctors and citizens emailed comments to AAHF, which accompanied the AAHF’s joint submission with ANH. Among the prestigious groups opposing the FDA’s erroneous interpretation are the International College of Integrative Medicine (ICIM), the American College for Advancement in Medicine (ACAM), The American Holistic Medical Association (AHMA), the Certification Board for Nutrition Specialists (CBNS), and the American College of Nutrition (ACN).


Friday, November 21, 2008


U.S. Contact:
Gretchen DuBeau,
ph 800-230-2762

International Contact:
Dr Robert Verkerk,
ph +44-1306-646-600

November 18, 2008

Finding of No Cardiovascular Protection Was Predictable

Today, the American Association for Health Freedom (AAHF) and its international affiliate, the Alliance for Natural Health (ANH), have together sharply criticized defective and misleading research published earlier this month in the Journal of the American Medical Association (JAMA). The research triggered headlines around the world suggesting that neither vitamin E nor vitamin C supplements protect against cardiovascular disease in older men.

The study by Howard Sesso and colleagues from Harvard, entitled the “Physicians’ Health Study II”, included over 14,600 male physicians over a ten year period, used the least potent form of vitamin E and incorrect dosages of both vitamins C and E , according to an analysis conducted by ANH experts, Dr Steve Hickey, Dr. Damien Downing, and Dr. Robert Verkerk.

The ANH analysis, “Designed to Fail: A Trial Without Meaning”, criticized the Sesso et al. study for using synthetic dl-alpha-tocopherol, which is less effective than the natural and more complete forms of vitamin E and is thus more likely to not reveal any benefit. Additionally, the vitamin E dose in the study (400 IU every other day) is far below the dose taken by many who supplement making the findings irrelevant to older supplement consumers who are aware of extensive research and clinical evidence on higher dose vitamin therapy.

The JAMA paper included a 500 mg daily dosage of vitamin C, which is only half of a typical one-gram tablet of the type popular with supplement users. Evidence suggests that dynamic flow levels of vitamin C, which may prevent heart disease, begin at daily intakes above about 3g per day, best delivered in divided doses.

Additional complaints about the JAMA study include the use of an unidentified placebo, which may have included beneficial nutrients such as magnesium, failure to control diet for synergistic nutrient interactions that may have skewed test results, and the relevance, or otherwise, of applying these findings among physicians (the study group) to all men across the population.

“Considering that the methodologies were significantly biased against finding a positive result from vitamins C and E as determined from both available research and clinical evidence, one has to ask who stands to benefit from these findings? How, for example, would the pharmaceutical industry be impacted from diminished sales of their vitamins if people, under the belief that vitamins provided no benefit in the treatment and prevention of cardiovascular disease, instead chose pricey prescription drugs,” asked Gretchen DuBeau, AAHF Executive Director.

Dr Damien Downing, ANH Medical Director, President of the British Society of Ecological Medicine and Editor-in-Chief of the peer reviewed journal, the Journal of Nutritional and Environmental Medicine, on reading the Sesso et al. paper independently responded, saying it was “an intervention designed to fail”!

ANH Scientific & Executive Director, Dr Robert Verkerk added, “With three of the world’s largest drug companies, namely BASF, Wyeth and DSM—formerly Roche—supplying the low dose synthetic vitamins for the study, it’s perhaps not surprising that the outcome is made to look bad for vitamins. A trial like this costs a huge amount of money and is a waste of much needed research funds. Why don’t they ask the people who work with nutrients on a daily basis—integrative medicine doctors—what nutrient forms, combinations and dosages are most likely to work?”

The ANH analysis, “Designed to Fail: A Trial Without Meaning”, is available at: http://www.anhcampaign.org/files/081117_Sesso_PHSII_ANHrebuttal.pdf.



About the American Association for Health Freedom (AAHF)

The American Association for Health Freedom (AAHF) is a 501©4 nonprofit organization serving as the politically active voice at federal and state levels to protect Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislature and crafting legislation; acting as a government watchdog and filing comments on proposed rulings; educating the public, press, and decision-makers on integrative medicine; initiating legal activities and joining and forming significant coalitions.

About the Alliance for Natural Health (ANH)
The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to protect and promote natural healthcare, using the principles of good science and good law.
The ANH’s overriding goal is to help develop appropriate legal and scientific frameworks for the development of sustainable approaches to healthcare. As in the fields of energy and agriculture, sustainable healthcare invariably requires use of natural products which are inherently compatible with human biochemistry and physiology. Within this setting, consumers and health professionals should be able to make informed choices about a wide range of health options, and in particular those that relate to diet, lifestyle, traditional medicinal and non-drug-based or natural therapies, so that they may experience their benefits to the full while avoiding unnecessary risks.