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Is It Really FDA Approved?

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FDA does not approve dietary supplements.

Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.

The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.

FDA does not approve the food label, including Nutrition Facts.

FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and non-misleading, and must comply with any special requirements for the type of claim.

Manufacturers are required to provide the serving size of the food and information about the nutrient content of each serving on the "Nutrition Facts" panel of the food label (or on the "Supplement Facts" panel for dietary supplements.)

FDA does not approve structure-function claims on dietary supplements and other foods.

Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is "calcium builds strong bones."

Dietary supplement firms that make structure-function claims on labels or in labeling must submit a notification to FDA. This notification must be submitted no later than 30 days after marketing the dietary supplement with the structure/function claim. Additionally, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier. FDA does not require conventional food manufacturers to notify FDA about their structure-function claims.

Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Conventional foods are not required to carry such a disclaimer.