Welcome to Call to Decision 

July  2007

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 implanted.

Sincerely,