Posted: March 15, 2007

Nutrition: Can Supplements Be Trusted?

From Vegetarian Sports Nutrition by Enette Larson-Meyer Although the practice of medicine is, for the most part, grounded in science, the same cannot necessarily be said for supplements. For a medical treatment to become an accepted practice or standard of therapy, there must be evidence, supplied by human clinical trials, that the treatment is likely to benefit rather than harm the people who receive it. If a treatment shows no benefit, it will not make it into the standards of care manual or to the shelves of your local pharmacy. For a prescription or over-the-counter drug, the U.S. Food and Drug Administration (FDA) requires that pharmaceutical companies conduct clinical trials in adults before seeking approval. During these trials, the participants’ response, side effects, and established doses are monitored and documented. The study results are then reported to the FDA and likely submitted for publication in peer-reviewed scientific journals. Although not perfect, this process, lasting approximately 15 years from discovery to consumer use, reduces the likelihood that ineffective and unsafe drugs reach the market. Once a drug is released, the FDA mandates that information pertaining to the drug’s active ingredients, safety, dosage, and expected reactions be available and also expects physicians to report any ill effects experienced by patients taking the drugs. The drug may then later be removed from the market. This recently happened with the weight-loss drug Redux. Supplements, on the other hand, require much less regulation before they are available to the consumer. Clinical trials documenting efficacy, safety, and dosage are not required and are exempted from evaluation by the FDA by the 1994 DSHEA act. As a result, supplements are released on the market sooner. The manufacturers are required to supply only a single scientific report as supporting evidence and that report need not even pertain to that specific product. For example, if Supplement X is a caffeine herbal cocktail and one report documenting the possible effects of generic caffeine is available, Supplement X can be released even if its mixture is ineffective or produces side effects. Once a supplement reaches the shelves, the FDA can remove the product only if it can be proven unsafe when taken as directed. Furthermore, whereas the FDA has the authority to inspect the facilities of any drug manufacturer and to verify that the ingredients are pure, this safeguard does not apply to supplements. In the past, contaminated supplements have produced adverse reactions that were difficult to treat because the source of the contaminant was not easily identified. One such example occurred a few years ago when an herbal “cleansing system” was found to be contaminated with the heart medication digitalis. This caused life-threatening cardiovascular reactions in two women. That said, however, it is also important to mention that the seemingly lax regulation of dietary supplements by the FDA does not mean that all supplements are unsafe or that their effects are poorly documented. Herbs are in fact regulated by Germany’s Commission E, the equivalent of the FDA. Any herb that is widely used in Germany or other parts of Europe, where herbal remedies are an accepted part of medical practice rather than being considered “alternative medicine,” is likely to be accompanied by reports from studies concerning its effectiveness and safety. These reports are typically published in German medical journals, and summaries of specific herbs are available to the public. Some are translated and available through scientific databases such as Medline. As a result of growing interest, it is becoming easier to find herbal remedies in the United States from reputable companies in standardized extracts that are equivalent to those used in Germany and to be reasonably certain of their effects. Unfortunately, there is much less supporting evidence for nonherbal supplements and ergogenic aids, including enzymes, prohormones, hormones, and amino acids. From Vegetarian Sports Nutrition by Enette Larson-Meyer. Copyright © 2007 by Human Kinetics Publishers, Inc. Excerpted by permission of Human Kinetics, Champaign, IL. Available to order from Human Kinetics Canada at www.humankinetics.com or by calling 1-800-465-7301.