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Possible
future FDA regulations
January 1999
The
FDA regularly proposes new regulations for dietary supplements.
Regulations proposed in 1998 sought to further restrict structure/function
claims by classifying conditions such as pregnancy and aging as
disease, thus subjecting such claims to regulations set forth in
NLEA (which requires claims to be preapproved by the FDA). They
also sought to prohibit use of supplements to treat disease - even
if no such claims are made by the manufacturer on the label or in
any product literature - if consumers are found to use the supplement
for such purpose.
Many
consumer groups and producers opposed these proposed regulations
during the comment period for this proposal which ended in September
of 1998. More traditional health care providers and groups favored
it. The FDA issued its final rule in January 2000 -- which did not
classify "normal conditions" such as pregnancy, menopause
or aging as diseases.
FDA
Good Manufacturing Practices (GMPs)
The
Dietary Supplements Health and Education Act (DSHEA) authorizes
the FDA to establish good manufacturing practices, or GMPs, for
dietary supplements. In a February 1997 advance notice of proposed
rulemaking, the agency said it would establish dietary supplement
GMPs if, after public comment, it determined that GMPs for conventional
food are not adequate to cover dietary supplements. FDA is reviewing
comments on the 1997 notice.
A
coalition of industry trade associations -- the Council for Responsible
Nutrition (CRN), the National Nutritional Foods Association (NNFA),
the American Herbal Products Association (AHPA), and the Consumer
Health Products Association (CHPA) -- developed a draft version
of GMPs that they submitted to the FDA in 1995. FDA is reviewing
these GMPs as it considers whether to pursue mandatory industry-wide
GMPs.
Because
of strong ties between the FDA and large pharmaceutical companies,
government standard GMPs run a high risk of imposing unnecessary
yet costly mandates on manufacturers, particularly smaller ones.
They would also preempt other GMP standards which may be more effective
and more tailored to applicable manufacturing operations. Once forced
to comply with a government-mandated GMP, it is unlikely that any
manufacturer would be able to afford the time, or have any incentive,
to comply with a self-regulatory GMP.
For
more information about GMPs, click on one of the following topics:
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