FDA regulation of dietary supplements

The Food and Drug Administration FDA regulates drugs and medical devices to ensure they are safe and effective. Prior to 1994, the FDA regulated dietary supplements, vitamins, minerals, herbs, botanicals, amino acids, and nutraceuticals as foods. The Dietary Supplement Health and Education Act of 1994 DSHEA gave the FDA authority to establish specific standards for dietary supplements. The law provides that a dietary supplement is adulterated if it or any of its ingredients poses a significant or unreasonable risk of illness or injury when used as directed. DSHEA defines dietary supplements and outlines advertising and labeling requirements. Manufacturers can make nutritional support claims, which describe a dietary supplement’s effects on the structure or function of the body. There must be proof of such claims, but FDA approval is not required prior to making such claims. Under DSHEA, the FDA has the power to establish good manufacturing practices for dietary supplements. The FDA is authorized to remove a dietary supplement from the market if it concludes that the product poses a significant or unreasonable risk of illness or injury when used as directed.

In December 2003, the FDA notified dietary supplement companies marketing products containing ephedra that it planned to ban the sale of their products. The announcement was the first time the FDA had blocked the sale of an over-the-counter nutritional supplement. The FDA also advised consumers to stop using products containing ephedrine alkaloids (ephedra or Ma huang). Ephedra is a natural substance derived from plants. Its principal active ingredient is ephedrine. Products containing ephedra have been used for weight loss, enhancing sports performance and increasing injury. Ephedra was shown to raise blood pressure and stress the circulatory system. Ephedra use also increased the risk of heart palpitations, tremors and insomnia. The FDA had received a number of reports linking ephedra to heart attacks and strokes.

On April 12, 2004, the FDA issued a final rule prohibiting the sale of dietary supplements containing ephedra. Prior to the rule, the FDA reviewed evidence about the composition, safety and effectiveness of ephedra. The FDA also looked at reports of adverse drug events (any unexpected or dangerous reaction to a drug). Finally, the FDA considered a report about ephedra that had been complied by an independent scientific institute and reviewed public comments regarding the health risks associated with ephedra use.

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