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Let the FDA Know What You Think About GMPs for Dietary Supplements >

The following letter to FDA will explain the issue and why many natural supplement users are opposed to FDA attempts to gain more oversight with respect to supplements. Please copy and paste the following into your email program and send to FDA with your name attached. We need to inundate FDA with objections to this illegal adoption of GMP regulation before AUGUST 11, the closing date for comments on this docket item. Jonathan Emord is an attorney representing the supplment industry interests, and the FDA is well aware of him. Invoking his name in the letter will demonstrate to FDA that the effort to oppose their tampering with DSHEA is coordinated and widespread. Together we can beat this!

p.s. if you want to try and use the FDA's website to send your comment (it wasn't working earlier), here is the LINK. Just hit the 4th "Sort" button over the heading "Comment Period Ends," and you'll see it's the third item from the top. Hit the "Go" button and respond to the prompts.

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Comment to FDA:

In support of Jonathan Emord's commentary regarding docket #96-0417 and the use of GMPs for dietary supplements, I wish to advise FDA that it risks certain litigation by consumers such as myself for its planned implementation of such regulations, which are contrary to existing law. As a user of supplements, I will not stand for site licensing as a tactic to spuriously remove dietary supplements from the market-place. FDA is required under the provisions of DSHEA to allow only FOOD-based GMPs with respect to these products. The following are additional reasons for my position on FDA's attempt to illegally extend its oversight of dietary supplements:

1. The dietary supplement Market is safer than the food and drug markets by several orders of magnitude.

2. Name recognition, private certification, and products liability already provide adequate safety and quality assurance in the supplement market.

3. The proposed CGMPs are a disproportionate response to a market in which safety is the norm and harm occurs only in rare and easily identifiable instances.

4. FDA adulteration and misbranding regulation, combined with state and local health laws, provide necessary and sufficient protection to the public.

5. The proposed CGMPs will disproportionately burden small supplement makers, thereby providing an advantage to larger supplement makers, due to the increased costs of compliance.

6. The proposed CGMPs will increase the cost of dietary supplements without increasing their relative safety and quality.

7. CGMPs propose to regulate supplements using a blanket approach that is not consistent with scientific fact and without consideration to economic impact.

8. The proposed CGMPs suffer from serious ambiguities that provide inadequate guidance to agency inspectors and invite arbitrary and capricious enforcement.

9. FDA lacks the resources to enforce the proposed CGMPs adequately.

10. Proposed CGMPs will not alter the practices of those few who currently violate the law by producing adulterated and mislabeled products.

11. DSHEA recognizes the inherent safety in natural supplements and appropriately alleviates manufacturers of a need to prove safety in the absence of evidence of harm.

Thank you.

(your name)

Follow Ups:

• Let the FDA Know What You Think About GMPs for Dietary Supplements (Archive.) Walt Stoll 08:30:47 8/07/03 (0)

In Reply to: Let the FDA Know What You Think About GMPs for Dietary Supplements > posted by peterb on August 06, 2003 at 18:20:18:

Thanks, PeterB.

NOW is the time!

Namaste`

Walt