How does FDA regulate cosmetics?
FDA regulates cosmetic labeling similarly to most other products under FDA's jurisdiction, based on intended use. Congress authorized FDA's jurisdiction over cosmetics and the FDA regulations can be found in the Federal Food, Drug and Cosmetic Act as well as the Fair Packaging and Labeling Act. The intent of these regulations is to protect consumers from health hazards and deceptive practices so that they might make informed decisions.
What is a misbranded cosmetic?
A cosmetic may not be misbranded. Some examples of misbranding including (1) labeling that is false or misleading; (2) labeling that fails to provide the mandatory information under FDA regulations; (3) labeling that does not properly display the mandatory information; and (4) labeling that violates the Poison Prevention Packaging Act.
Does FDA Approve Cosmetic Labels?
FDA does not approve cosmetic labeling, however FDA does provide guidance documents for labeling. It is the responsibility of the manufacturer or the private labeler to ensure that the cosmetic labeling complies with all regulations.
What are the mandatory labeling requirements for cosmetics?
All cosmetics must have a (1) statement of identity; (2) net quantity of contents; (3) name and place of business; (4) distributor statement; (5) warnings and caution statements; and (6) ingredients. How and where these mandatory labeling requirements are displayed will vary depending on the size of the labeling and the method of selling.
Are there any additional labeling regulations?
Customs and Border Patrol (CBP) and Federal Trade Commission (FTC) have regulations regarding labeling a product with its country of origin. FTC issues regulations about when a product can claim that it is Made in USA. CBP has regulations about how and when to place a foreign country of origin on a product labeling. In addition, FDA has regulations about placing foreign language statements on labeling. FDA regulations require all mandatory labeling to be in English and if the labeling contains any foreign language all mandatory labeling requirements must also appear in the foreign language, this does not apply to Puerto Rico or other Territories where the predominant language is not English.