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)
