The law does not require cosmetic labeling to have FDA approval before cosmetic products go on the market, and FDA does not have a list of approved or accepted claims for cosmetics. However, there are limits that apply to cosmetic labeling claims.
Under the law, information on cosmetic labeling, including claims, must be truthful and not misleading. In addition, if a product is marketed with claims for purposes such as treating or preventing disease, or affecting the structure or function of the body—including the skin—it’s a drug according to the law, and it must meet the requirements for drugs, even if it affects the appearance.
Because FDA does not have the authority to approve claims before cosmetics go on the market, you may see cosmetics with claims that go beyond what the law permits. FDA monitors cosmetics on the market, and we can take action against companies that break the laws we enforce. For example, FDA has issued warning letters to cosmetic firms that have made unapproved drug claims for products marketed as cosmetics.
In addition, while FDA regulates cosmetic labeling claims, the Federal Trade Commission regulates advertising claims.
The following resources answer some common questions about claims and cosmetic labeling:
- Alcohol Free
- Consumer Update: Are Some Cosmetics Promising Too Much?
- Cruelty Free/Not Tested on Animals
- Hypoallergenic Cosmetics
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- "Organic" Cosmetics
- Thigh Creams (Cellulite Creams)
- Wrinkle Treatments and Other Anti-aging Products
Related Regulatory and Enforcement Information
- Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics
- Warning Letters Highlight Differences Between Cosmetics and Medical Devices
- Country of Origin Marking: From U.S. Customs and Border Protection
- "Made in U.S.A.": From the U.S. Federal Trade Commission
- Are your "all natural" claims all accurate? From the U.S. Federal Trade Commission