Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.
Re: FDA Dietary Supplements Final Rule
Dear FDA:
I am responding to your June 22, 2007 news release requesting feedback on the
proposed Dietary Supplement Final Rule. The Dietary Supplement Final Rule
document and link were not available on the www.fda.gov management page for
consumer feedback and therefore I am writing you.
It is fact that the Dietary Supplement Industry has an established safety
record, which exceeds any safety record of the pharmaceutical industry.
Pharmaceutical drugs are regulated and tested and have injured and killed more
people than any dietary supplement by far.
Therefore, it is evident that the Dietary Supplement Industry, which uses GMP
(Good Manufacturing Practices) to ensure the quality and safety of their
product, is sufficient and does not warrant the regulation outlined in the FDA's
Dietary Supplement Final Rule cGMP. The FDA has not revealed what the
requirements are for the cGMP companion document for exemption of frequent
product testing.
Furthermore, the regulation outlined in the FDA's Dietary Supplement Final Rule
seeks to reclassify dietary supplements from a food to a drug category requiring
supplement manufacturers to operate like a pharmaceutical company. Such
requirements will increase the cost of the dietary supplement to the consumer
and force small dietary supplement manufacturers, which are without the
financial means to comply with the new regulations, to close.
Thus forcing the dietary supplement industry to acquire manufacturing and
testing processes similar to the pharmaceutical industry will not improve
quality and safety but will remove all but the largest and financially able
supplement manufacturers from existence. It appears that it is the goal of the
FDA to transfer the dietary supplement market into the hands of the
pharmaceutical industry.
Finally, I do not agree with the FDA's proposed Dietary Supplement Final Rule
and therefore ask that it not be finalized and implemented.
Sincerely,
Signature:
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Poster Comment:
A confirmation on the legitimacy of this claim is in order.
The link has this letter attached to a form to print out.