Cosmetics Q&A: Why are cosmetics not FDA-approved?

FAQs Main Page

If cosmetics are not FDA-approved, how are they regulated?

FDA-regulated does not mean FDA-approved. FDA does not have the legal authority to approve cosmetics before they go on the market, although we do approve color additives used in them (except coal tar hair dyes).

However, under the law, cosmetics must not be "adulterated" or "misbranded." For example, they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

FDA can take action against a cosmetic on the market if we have reliable information showing that it is adulterated or misbranded. FDA takes action within our legal authority, based on public health priorities and available resources.

To learn more, see   

• Compliance and Enforcement
• FDA Authority Over Cosmetics  
• FDA Recall Policy for Cosmetics
• FDA's Cosmetics main page
• Guidance & Regulation
• Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded"
• Labeling and Label Claims
• Products & Ingredients
• Resources for You: Consumers

FDA Basics Cosmetics Page