Dietary supplements are products containing ingredients meant to aid an individual's diet. The regulation of dietary supplements is under the jurisdiction of the FDA, a government agency responsible for ensuring the safety of many medications, foods, and other products. Under a government acted created in 1994, the FDA has created new rules and regulations in regards to dietary supplements.
Dietary Supplement Health and Education Act
Dietary supplement became an official term in 1994 as part of the Dietary Supplement Health and Education Act (DSHEA). Under this act, supplements were under the regulation of the U.S. Food and Drug Administration, or FDA, a government agency within the U.S. Department of Health and Human Services. The agency regulates a long list of products including medications, vaccinations, medical devices, cosmetics, tobacco products, food and dietary supplements. The FDA is divided into six product centers, each of which covers one field of products. Dietary supplements fall under the jurisdiction of the FDA's Center for Food Safety and Applied Nutrition.
According to the FDA, a dietary supplement is a product taken orally which contains an ingredient intended to supplement the diet. Most commonly, these ingredients are vitamins, minerals, or herbs. Supplements can come in many forms such as tablets, capsules, soft-gels, gel-caps, liquids or powders. The FDA categorizes all supplements separately and requires each product to be labeled as a dietary supplement.
Good Manufacturing Practices
Before 1994, dietary supplement regulations were the same as food. Under the DSHEA act, however, new laws were created regarding the safety and labeling of dietary supplements. The new act makes manufacturers responsible for determining the safety of a dietary product. Additionally, all claims made by manufacturers about the product must be true and substantiated.
Supplements do not need to be approved by the FDA before they are marketed. The exception is if there is a new dietary ingredient, in which case safety information is required.
While manufacturers do not need approval to market a supplement, they do need to record and investigate any claims of problems with the product. The results of these investigations must be forwarded to the FDA.
Labels
Certain information is required by law to appear on the label of all dietary supplements. This information includes a descriptive name, the name and address of the manufacturer, all ingredients and information stating that the product is a supplement. In addition, each product must have the nutrition labeling written on a supplement facts panel.
Consumer Warning
Because FDA approval is not needed to market a dietary supplement, the FDA advises consumers to become well informed about the products they are interested in. Consumers may want to contact the manufacturer with any questions. In addition, the FDA has several websites to help guide consumers through their purchases.
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