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Is It Really FDA Approved?

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FDA approves color additives used in FDA-regulated products.

This includes those used in food, dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.

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.