SUPPLEMENTS AND THE LAW
LAW ON DIETARY SUPPLEMENTS
When a dietary supplement is available in the store, it is naturally assumed that it is safe. Some government agency has checked to make certain it is not harmful, right? Not anymore.
In 1994, the Dietary Supplement Health and Education Act removed dietary supplements from premarket safety evaluations required of food ingredients and drugs. Drugs and food ingredients still undergo a lengthy Food and Drug Administration (FDA) safety review before they can be marketed, but the 1994 legislation eliminated the FDA’s authority to regulate the safety of nutritional supplements before they go on the market. Now, the FDA can intervene only after an illness or injury occurs.
Claims may not be made about the use of dietary supplements to diagnose, prevent, treat, or cure a specific disease. For example, a product may not carry the claim “cures cancer” or “treats arthritis.” The FDA can still restrict the sale of an unsafe dietary supplement when there is evidence that the product presents a significant or reasonable safety concern. But the agency must wait for complaints about a product before acting.
The legislation also changed guidelines for marketing supplements. Because the nutritional supplement industry is now largely unregulated, there is no guarantee of product purity or of the amount of active ingredient in a supplement—even from one package to the next of the same product.Tags: dietary supplemets, drugs, FDA