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Home :: Professional / Government Regulation / FDA Requirements and Programs / Inspection of Cosmetics

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 6, 1995

INSPECTION OF COSMETICS

FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public.

FDA cannot require companies to safety test cosmetics before marketing to ensure that they are safe. If, however, the safety of a cosmetic product has not been established, the product's label must read,

"WARNING: The safety of this product has not been determined".

FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. To keep abreast of such information, however, FDA maintains a voluntary data collection program. Cosmetic companies that wish to participate in the program forward their data on consumer cosmetic reactions to FDA.

FDA collects cosmetic product samples as part of its plant inspections, import inspections and follow-ups to complaints of adverse reactions. The agency does not function as a private testing laboratory. FDA is prohibited from recommending private laboratories to consumers for sample analysis. Consumers may consult their local telephone directory for testing laboratories.

FDA can inspect cosmetic manufacturers' laboratories, collect samples for examination, and take action through the Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufactures are subject to the same regulations. Foreign products that appear to be adulterated or misbranded may be refused entry into the United States.



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