FDA Definition of Cosmetics

The FDA assigns a definition for cosmetics

According to the Food and Drug Administration, whether a product is classified as a drug or as a cosmetic is determined by the product's intended use. The Federal Food, Drug and Cosmetic Act defines cosmetics as products that are to be "rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body" in order to clean, beautify, promote attractiveness, or alter the appearance.

What Are Cosmetics?

The term cosmetics covers some interesting products, including shampoos, deodorants, and toothpastes, in addition to skin moisturizers, cleansers, lipsticks, eye and face makeup, perfume, fingernail polishes, hair dye and permanent waves. Materials used as components of cosmetic products are also classified as cosmetics.

Some Cosmetics Are Drugs

A number of common products are classified as both cosmetics and drugs. For example, shampoo is a cosmetic because it is intended to clean hair; a dandruff treatment is a drug, since it treats a medical condition; as a result, a dandruff shampoo is both a cosmetic and a drug. Similarly, toothpaste is a cosmetic; sodium fluoride (used to reduce cavities) is a drug; so fluoridated toothpaste is both.

Cosmetics Regulations

FDA regulation of cosmetics differs from FDA regulation of drugs in a number of ways. The FDA does not have to approve cosmetics with the exception of color additives before they are marketed.

Safety Testing

It is up to the manufacturer to test the safety of cosmetics and their components. If it fails to do so and does not state on the product label), the product is considered to be misbranded and is subject to FDA action.

Possible FDA Actions

The FDA cannot order a manufacturer to recall adulterated or misbranded cosmetics from the marketplace, although it does monitor the recall process. The FDA can, however, take action through the judicial process to remove adulterated or misbranded cosmetics, and may request a court issue restraining order to stop the manufacturer from selling the adulterated or misbranded cosmetics. Finally, the FDA can initiate criminal proceedings against violators of the FD&C Act.

References

• Food and Drug Administration: Cosmetics: Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
• Food and Drug Administration: Cosmetics: FDA Authority Over Cosmetics
• Food and Drug Administration: Cosmetics: Key Legal Concepts: "Interstate Commerce," "Adulturated," and "Misbranded"