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Dietary Supplement Regulation: FDA Public Hearing April 4, Written Comments Due May 4

By John S. James

March 17, 2000

On April 4 the FDA will hold a public hearing on regulation of claims for dietary supplements. While the technical issues involved do not directly affect AIDS treatment access, they are part of a larger issue which does. Anyone wishing to speak at this hearing must register in writing by March 28. But written comments can be submitted until May 4.

The hearing is to get public input on how the FDA should change its regulations in response to a court case which it lost. An appeals court held that "the First Amendment [of the U.S. Constitution] does not permit FDA to reject health claims that we [FDA] determine to be potentially misleading unless we also reasonably determine that no disclaimer would eliminate the potential deception" [FDA's summary in the Federal Register, March 16].

For background and more information, see "Food Labeling; Dietary Supplement Health Claims; Public Meeting Concerning Implementation of Pearson Court Decision and Whether Claims of Effects on Existing Diseases May Be Made as Health Claims," Federal Register, March 16, 2000 [page numbers not available as this article goes to press].


Comment

The larger issue is the regulation of "dietary supplements," such as the herbal products which are widely sold in the U.S. in health-food stores, and now in mainstream drugstores as well. There is widespread agreement that more regulation is needed than exists today. The appropriate kind of regulation is unclear.

The danger is that we will get the wrong kinds of regulation, just because the models are most readily available. If natural products become regulated like pharmaceutical drugs, most will be effectively banned since no company will pay for the large clinical trials which would be necessary for approval.

Even worse is the war-on-drugs model, which for decades has had a major impact on medicine in denying appropriate pain relief, because doctors reasonably fear trouble even when their prescribing is entirely legitimate and legal. The drug war has also greatly hindered the appropriate use of anabolic steroids in treating wasting, which causes many AIDS deaths -- and greatly impeded the use of needle exchange, although it has been clearly shown to prevent HIV infection without increasing drug use.

Fortunately there are more positive regulatory models from some European countries -- which have long allowed the sale of a large variety of natural products at reasonable prices, under effective but not prohibitive controls.

The U.S. is prone to destructive "moral" crusades -- which is why we have both the drug war, and the new mass imprisonment of the last 20 years. Because of the difficulty of making anything happen, this destructive spirit may be used as an ally by persons and institutions seeking legitimate safety measures for natural health products. Anyone interested in access to inexpensive or natural treatments should be paying attention at this time.



ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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