Are Dietary Supplements Regulated for Safety and Efficacy?

The FDA has a different set of regulations for dietary supplements than those that cover conventional foods and medications. A 2003 investigation by the Office of the Inspector General revealed that most supplement labels are misleading, uninformative, and inconsistent, making it difficult for consumers to understand them. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for overseeing dietary supplements. For people with cardiovascular disease who don't eat fish regularly, taking a fish oil supplement is a reasonable option.

However, some of the harms associated with dietary supplementation can be attributed to heavy metals and other contaminants found in supplements, as well as higher doses that are naturally more toxic. The dietary supplement category generally excludes items approved as new drugs, authorized as biological products, or authorized for clinical research pursuant to an effective new investigational drug (IND) application (IND), unless the item was previously marketed as a dietary supplement or as a food. In most cases, scientific research on supplements begins with simple observational studies, in which researchers compare the health status of people who take a particular supplement with the health of people who don't. Companies do not have to provide the FDA with evidence of safety before or after marketing their products; however, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply.

The main mechanism for monitoring the safety of supplements is a voluntary reporting system established by the FDA Center for Food Safety and Applied Nutrition, called the AE Notification System of the Center for Food Safety and Applied Nutrition (CAERS). In addition, FDA regulations require that those who manufacture, package, or preserve dietary supplements follow current good manufacturing practices that help ensure the identity, purity, quality, concentration, and composition of dietary supplements. The predominant challenge in a passive post-marketing regulatory framework is the poor timeliness of the FDA's response and the laissez-faire attitude toward people whose lives are inadvertently sacrificed or seriously compromised in generating the tests needed to ban the product. More information on how to report adverse events related to the use of dietary supplements can be found in How to Report a Problem with Dietary Supplements.

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