Is There an FDA Enforcement Bias?

A Healthnotes Newswire Opinion

November 21, 2002—The U.S. Food and Drug Administration (FDA) recently ordered the seizure of a dietary supplement that the agency said was falsely being claimed to be beneficial for people with autism. U.S. marshals raided an Oregon company and removed hundreds of bottles of taurine, an amino acid that occurs naturally in the body and in many foods. According to the FDA, the product was seized because its labeling violated the Federal Food, Drug, and Cosmetic Act, which requires that “all dietary supplement products’ labeling must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease.” The claim that the product can be used to treat autism resulted in the FDA classifying it as “a misbranded food and an unapproved new drug.”

While protecting the public from false and misleading claims is a worthwhile goal for a government agency, the recent FDA action heightens a long-standing concern that current law, or the FDA’s interpretation of the law, is biased against natural substances that can’t be patented.

There is some reason to believe that taurine may be beneficial for people with autism, although the evidence is largely theoretical and not particularly strong. One might debate whether it is appropriate for a manufacturer to promote taurine for autism. However, the strength of the scientific evidence is somewhat beside the point, when one considers the FDA’s history with respect to nutritional supplements. In the past, even health claims that were strongly supported by research have resulted in products being pulled from the shelves. That is because, with a few exceptions (such as calcium for osteoporosis prevention, or folic acid for preventing birth defects), supplement manufacturers are not allowed to tell people what diseases their products can be used for, no matter how strong the evidence.

In the case of taurine, controlled studies have shown that it can improve heart function in people with congestive heart failure. Other research suggests that this amino acid may help prevent complications of diabetes, reduce seizure activity in people with epilepsy, and slow the progression of visual loss in individuals with macular degeneration. But companies that sell this amino acid are not allowed to tell potential customers about the research. This restriction of the free flow of information keeps the public (and many medical practitioners) in the dark about safe and effective alternatives to prescription drugs.

In addition, the FDA’s enforcement policies appear to favor the pharmaceutical industry over producers of natural substances. During the past several years, there have been numerous instances in which the agency cited drug companies for misleading advertising. However, none of the medicines in question were removed from the market. Moreover, the “punishment” was typically limited to a cease-and-desist order, often coming after the public had already “gotten the message” from an intensive advertising campaign. The FDA should have expressed its dissatisfaction with the taurine distributor in a similar manner.

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Alan R. Gaby, MD, an expert in nutritional therapies, testified to the White House Commission on CAM upon request in December 2001. Dr. Gaby served as a member of the Ad-Hoc Advisory Panel of the National Institutes of Health Office of Alternative Medicine. He is the author of Preventing and Reversing Osteoporosis (Prima, 1994), and co-author of The Natural Pharmacy, 2nd Edition (Healthnotes, Prima, 1999), the A–Z Guide to Drug-Herb-Vitamin Interactions (Healthnotes, Prima, 1999), Clinical Essentials Volume 1 and 2 (Healthnotes, 2000), and The Patient’s Book of Natural Healing (Prima, 1999). A former professor at Bastyr University of Natural Health Sciences, in Kenmore, WA, where he served as the Endowed Professor of Nutrition, Dr. Gaby is the Chief Medical Editor for Healthnotes, Inc.

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