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For Review & Comment - FDA Requests for Comments
November 25, 2008
Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Via Online Submission Request: www.regulations.gov
Re: Request for Comments on Section 912 of FDAAA (FDA-2008-N-0389)
To Whom It May Concern:
The American Association for Health Freedom (AAHF), in partnership with the Alliance for Natural Health (ANH) and Integrative Medicine Consortium Members including the American College for Advancement in Medicine (ACAM), the American Academy of Environmental Medicine (AAEM), the International College of Integrative Medicine (ICIM), the American Holistic Medical Association, the American Association of Naturopathic Physicians (AANP), and the Institute for Functional Medicine (IFM), provides these comments on behalf of our collective integrative medicine practitioner and consumer members who utilize natural healthcare options, including dietary supplements and medical foods.
These comments are limited specifically to the particular questions outlined in the FDA’s request for comments on Section A in relation to foods.
As a U.S. association representing in particular integrative medicine practitioner and consumer interests, the AAHF has not given specific examples of commercial products that could be impacted by the proposed prohibition, as these will undoubtedly be provided by manufacturers and distributors.
Question: What types or categories of food would likely be subject to the prohibition of section 301(II)?
Answer: Presently the prohibition could be interpreted to apply to all categories of food, including dietary supplements, since dietary supplements are regarded as a sub-category of food, as defined under section 201(f). It is not clear as to whether the prohibition would be applied to products that are presently marketed as ‘medical foods’, but do not necessarily fully comply with C.F.R. Section 101.9(j)(8). AAHF argues that dietary supplements and medical foods should be exempted from the prohibition, and it should be applied to conventional foods only.
Question: What is the likely impact of applying section 301 (II) to dietary supplements?
Answer:
The prohibition, if applied to dietary supplements, could potentially have a devastating impact on some natural product companies, given that they would be prevented from going to market with products that include one or more ingredients backed by solid scientific research (“substantial clinical investigations”).
The prohibition may also be applied to products currently marketed in the U.S. as medical foods, which may include complex combinations of natural (or nature-identical) ingredients. Just a single ingredient with extensive clinical testing would be sufficient, under a literal interpretation of section 301(II), to invoke the prohibition in the case of dietary supplements or medical foods.
Since the passage of DSHEA in 1994, the natural products industry in the U.S. has dramatically increased the amount of scientific research conducted on the therapeutic effects of dietary supplements and ingredients contained within. Companies which have invested in such research would be massively penalized if products containing ingredients in which they had invested research funds were subjected to the prohibition.
Some of the most useful ingredients, from a health perspective, are those that have been subject to substantial clinical investigation, and it would be contrary to the purpose of the DSHEA to prevent sale of natural ingredients as dietary supplements, whether they had been subject to extensive clinical investigation or had been subsequently licensed as drugs.
The prohibition effectively grandfathers ingredients that were previously sold as foods or dietary supplements, but its implementation would substantially interfere with innovation.
Additionally, the prohibition imposes a barrier to interstate trade, and would have disproportionate impacts on citizens in some states in which there is no or limited presence of dietary supplement manufacturers or distributors. By example, California supports a wide diversity of dietary supplement manufacturers and distributors, so that residents outside this state would be limited in their choice and access to dietary supplements, as compared with residents of California.
Concluding comment
There is a real risk, given the existing legal uncertainty surrounding section 301(II), that the provision would contravene DSHEA, deny consumers access to dietary supplements, as well as massively impact companies which have invested in clinical research, or those wishing to market new products based on substantiated evidence.
Additionally, the imposition of barriers to interstate trade would differentially impact residents of different states, thereby interfering with equal rights to access dietary supplements and related products, such as medical foods.
In order to avoid such inequalities and adverse impacts, it is of paramount importance that dietary supplements and medical foods be exempted from the prohibition.
Sincerely,
Gretchen DuBeau, Esq.
Executive Director
American
Association for Health Freedom
Dr. Robert Verkerk BSc MSc DIC PhD
Executive
and Scientific Director Alliance
for Natural Health
(International Affiliate of the American Association for Health Freedom)
November 14, 2008
November 13, 2008
New ACAM calendar ready for download
ACAM has created a one-page calendar with conference dates highlighted. Download below!
November 12, 2008
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