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 do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, 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, FDA maintains a voluntary data collection program. Cosmetic companies that wish to participate in the program forward data to FDA.
Recalls are voluntary actions taken by the cosmetic industry to call back products that present a hazard or that are somehow defective. FDA is not permitted to require recalls of cosmetics but does monitor companies that conduct a product recall. If FDA wishes to remove a cosmetic product from the market, it must first prove in a court of law that the product may be injurious to users, improperly labeled, or otherwise violates the law.
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, however, function as a private testing laboratory. FDA is prohibited from recommending private laboratories to consumers for sample analysis. Consumers may consult their local phone directory for testing laboratories.
FDA can inspect cosmetics manufacturing facilities, collect samples for examination, and take action through the Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufacturers must follow the same regulations. Foreign products that appear to be adulterated or misbranded may be refused entry into the United States.
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 3, 1995