Does FDA pre-approve cosmetic product labeling?
No. FDA does not have the authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer's and/or distributor's responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product.
For an overview of cosmetic labeling requirements, see "Cosmetic Labeling and Label Claims."
For a "how-to" guide to cosmetic labeling, including answers to common questions, with examples, see the "Cosmetic Labeling Guide."
For links to the cosmetic labeling regulations, see "Labeling Regulations Applicable to Cosmetics."
For information on cosmetic vs. drug claims, "organic," aromatherapy, shelf life, and more, see "Label Claims and Expiration Dating."
For FDA responses to industry requests on the international harmonization of cosmetic ingredient names, see "Industry Requests and FDA Responses."
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