Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under this law, cosmetics must not be adulterated or misbranded. ... If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products.

What does FDA consider a cosmetic?

The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

What does the FDA not regulate?

Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices. Unlike animal drugs, animal devices do not have to be approved by FDA before they can be marketed.