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Skin Care—Then and Now: Product and Professional Regulations

By: Myra Y. Irizarry
Posted: January 2, 2013, from the January 2013 issue of Skin Inc. magazine.

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Established in 1976 with the support of the FDA and the Consumer Federation of America (CFA), the Cosmetic Ingredient Review (CIR) expert panel was formed to determine the safety of ingredients under their intended conditions of use. The panel, comprised of seven members, including a dermatologist, toxicologist, consumer representative and an industry scientist, review and assess ingredient safety data, extensive research, literature and studies. The CIR safety assessments are available for public review and are published in the International Journal of Toxicology.

Cosmetic or drug?

Chemicals contained in a product, as well as the designated use of a product, help determine the product’s skin care category. Because skin care products can have the effects of both a cosmetic and a drug, the distinction between cosmetics and drugs may be blurred.

According to the FDA, a drug is defined as a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, AND is a substance (other than food) intended to affect the structure or function of the body. A cosmetic is intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.

Products that move past the cosmetic definition, such as a prescription acne treatment, are considered drugs under these definitions. But many drugs can have cosmetic properties—antiperspirant deodorants and dandruff shampoo, for example. Skin Protectant Drug Products is one of the most important over-the-counter drug categories. Other categories include medical devices, such as devices used for microdermabrasion services and hair removal.

The final Monograph, or detailed report/study, issued in 2003, confirmed that claims of “moisturizes, soothes, smoothing, rubbing, friction and lubrication” are cosmetic claims.