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Letters to the Editor

FDA's Latest Power Play to Regulate Dietary Supplements with Only 90 Day Notice

From Bill Sardi
July 10. 2011

(Forward courtesy of Dr Louise)

FDA's Latest Power Play to Regulate Dietary Supplements with Only 90 Day Notice (July 10, 2011)


By Bill Sardi
Knowledge of Health, Inc.

July 10, 2011

The dietary-supplement industry has only 90 days to comment on the FDA's new dietary ingredient guidelines,[1] which would require many supplements currently on the market (since 1994 when the Dietary Supplement Health & Education Act was passed) to undergo onerous and expensive safety testing.

Some of the animal testing would require three years to complete. It is difficult to ascertain the cost of meeting these new requirements but it appears to be in the millions of dollars for each ingredient. It would take three years before any new dietary ingredient could be introduced as well. Essentially, the only way these natural medicines would remain on the market is to make them expensive prescription drugs. You are talking about many well-known supplements such as resveratrol, hyaluronic acid, piperine, curcumin, etc.

Some companies with broad product lines would have to spend $20 million to $100 million in order to keep existing products on the market. All this to just get paperwork in order as there is no clear and present danger to consumers posed by dietary supplements.

The entire 47-page document issued by the FDA is so overwhelming as to throw a mortal blow to the supplement industry. It is not known whether public outcry will influence the FDA as it is an aloof organization that is obviously responsible for protecting America's pharmaceutical industry to the point of recklessly approving prescription drugs that, like Vioxx, have killed thousands.

The supplement industry is recoiling, ready to make pleas to politicians. In other words, beg for mercy. The supplement industry could be forced to take 17 steps backward in time, to 1994, and utilize only those molecules and processes that were in existence then. The fact that the FDA dropped this guidance upon the industry like a bomb instead of gaining their input prior to its writing suggests the FDA knows what it is doing ? creating a doomsday document. RIP dietary supplements unless something is done soon.

Bill Sardi

[1] The FDA Draft Guidance for Industry on New Dietary Ingredients may be read at:


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