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Is It Really FDA Approved?

FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations.

Cosmetic products and ingredients do not require FDA approval before they go on the market, with one exception: color additives (other than coal tar hair dyes.) Cosmetics must be safe for their intended use and properly labeled.

FDA field investigators inspect cosmetic companies, examine imports, and collect samples for analysis. FDA may take action against non-compliant products, or against firms or individuals who violate the law.

FDA does not approve medical foods.

A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs. An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder. A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine. A medical food is intended for use under the supervision of a physician.

Medical foods do not have to undergo premarket approval by FDA. But medical food firms must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.

FDA does not approve infant formula.

FDA does not approve infant formulas before they can be marketed. However, manufacturers of infant formula are subject to FDA's regulatory oversight.

Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers are required to register with FDA and provide the agency with a notification before marketing a new formula.

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.)

WebMD Public Information from the FDA