(ATN) Regulation of Nutritional Supplements: Letter to FDA

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(ATN) Regulation of Nutritional Supplements: Letter to FDA

AIDS Treatment News #181 - Aug 20 1993
John S. James


AIDS TREATMENT NEWS sent the following letter to the U. S. Food and Drug Administration in response to its request for public comments on its plans to increase regulation of nutritional supplements and related compounds. This particular public comment period has now passed (see AIDS TREATMENT NEWS #178, July 9, 1993, and #180, August 6, 1993), but the issue will be with us for some time.

* * *

People with HIV are concerned that amino acids, certain herbs, and other substances may become difficult to get, without very good safety reasons. They care much less about regulation of labels and claims. Patients want treatment options, not treatment promotions.

Especially in the last few months, leading AIDS researchers have agreed that so much is still unknown about AIDS that nobody can be confident that any particular scientific approach will be productive. We need to maintain openness so that many avenues can be explored. In addition to high-tech treatments like gene therapy and protease inhibitors, low-tech approaches based on nutritional substances like amino acids, or on herbs or other generally available substances which are already in wide human use, also need to be considered.

The problem is getting these substances researched. Making amino acids prescription drugs would make them more expensive and scarce, but how long would it take for this higher cost and easier monopoly to bring about trials and drug approvals? AIDS -- and perhaps cancer and other life-threatening diseases -- might well be last in line, as entrepreneurs seek their fortunes on approvals for minor ailments, where success is easier.

Top-down drug development, which starts when some corporation decrees a project, is only part of the picture. Until the last few decades, most drugs throughout human history have been developed bottom up. Individual physicians, "outsider" experts, or even patients, took the initiative and did informal testing. Momentum built gradually, only later bringing the treatments to serious mainstream attention. The example of antioxidants as potential cancer preventives shows that this development path is still active.

But few physicians are willing to prescribe a drug in the early stages of bottom-up development, because of professional risks to them. Most, however, are willing to monitor and advise their patient on the use of the same substance, if the patient can obtain it elsewhere. Therefore, making amino acids prescription drugs, or otherwise making substances now available illegal or difficult to obtain, could choke off bottom-up research (the only kind we are likely to get, in many cases) in its beginning.

The history of epidemics suggests that it is impossible to predict where important treatment advances will come from. The experts are often surprised. Let's not create a system so highly controlled that the unexpected becomes impossible.


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AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1993. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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