Cosmetics : Cosmetics That Are Also Drugs

by Food and Drug Administration (FDA)

(Page 2 of 3)

Cosmetics making therapeutic claims — that they may affect the structure or function of the body — are regulated as drugs and cosmetics and must meet the labeling requirements for both. One way you can tell if you're dealing with such a product is if the first entry in the ingredient list says "Active Ingredient." (The active ingredient is the chemical that makes the product effective, and it must be safe for its intended use.) However, active ingredients are not legally required to be identified by this term. The law does require the active ingredient(s) to be listed first, followed by a list of all inactive cosmetic ingredients.

Examples of products that are both cosmetics and drugs are shampoos that treat dandruff, fluoride toothpastes to prevent dental decay, and sunscreens and sun-blocking cosmetics, including foundations that contain sunscreens. (See "Dodging the Rays" in the July-August 1993 FDA Consumer.)

A product with a drug and cosmetic classification must be scientifically proven safe and effective for its therapeutic claims before it is marketed. If the product is not, FDA considers it to be a misbranded drug and can take regulatory action.

Preventing Problems

Under FDA's good manufacturing practice guidelines, even cosmetic products that are not regulated as drugs should be thoroughly tested for safety and subject to quality control during manufacture. But the law does not require the agency to review these tests before the cosmetics are marketed. Nevertheless, FDA does require safety warnings when problems become apparent.

Misuse of some cosmetic products can cause problems that range in severity from a mild rash to skin burns, or from burning eyes to blindness.

Look for warnings about the consequences of misuse required on products that could be hazardous, in addition to the detailed directions for use that appear on almost all cosmetics.

For example, products containing halocarbon or hydrocarbon propellants, such as aerosol hairsprays or deodorants, must bear the exact wording: "Warning — Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal."

All cosmetics in self-pressurized containers, such as shaving creams, must have specifically worded warnings against spraying near the eyes, puncturing, incinerating, storing, and intentionally misusing.

"Keep out of the reach of children" is also required for all products in pressurized containers. In the case of products intended for use by children, such as foaming soap, the phrase "except under adult supervision" may be added.

Other products requiring specific wording include:

Detergent bubble bath products — may irritate skin and the urinary tract through excessive use or prolonged exposure. The labeling instructs users to discontinue the product if rash, redness or itching occur, to consult a physician if irritation persists, and to keep out of reach of children. These adverse reactions reportedly occur mostly with prolonged soaks. According to some studies, the adverse reactions either subside or disappear with discontinued use. In 1987, FDA started requiring all foaming detergent bath products not labeled as intended for exclusive adult use to display the caution statement in addition to directions for use.

Feminine deodorant sprays intended for use in the genital area — are for external use only and should not be applied to broken, irritated or itching skin. A physician should be consulted if persistent, unusual odor or discharge occurs. The statement instructs users to discontinue immediately if rash, irritation or discomfort develops. Labeling on self-pressurized containers must state that the product should be sprayed at least 8 inches from the skin.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.