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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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