CANADA HOME PAGE USA CONTACT US LINKEDIN TWITTER FACEBOOK

COSMETICS


LABEL AND INGREDIENT REVIEW

Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both: the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). Labeling mistakes result in more than 22% of all detentions in the United States. MEDERA Consulting helps companies modify their cosmetic labeling to comply with U.S. FDA regulations.

FDA regulates cosmetic labeling under the authority of both: the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act. FDA has an Import Alert in effect for cosmetics labeled with drug claims.

If a product is an over-the-counter (OTC) drug as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling. The drug ingredients must appear according to the OTC drug labeling requirements.

To learn how U.S. FDA cosmetic labeling regulations apply to your product(s) please contact us or to receive a free copy of our white paper on marketing a healthcare product in U.S. click here.