AHA product status – Alpha Hydroxy Acids

Some in the cosmetic industry have suggested that AHA products are more than simple cosmetics, coining the term “cosmeceutical” to describe them instead.

Under the 1938 Federal Food, Drug, and Cosmetic Act, cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Drugs are defined as products intended for treating or preventing disease and affecting the structure or any function of the body. They are subject to premarket review and approval; cosmetics are not.

“The term ‘cosmeceutical’ is not recognized by law,” Bailey says. “These products, depending on their intended use, would be regulated either as cosmetics, drugs, or both as cosmetics and drugs.”

FDA has a particular concern about AHAs because, unlike traditional cosmetics, AHAs seem capable of penetrating the skin barrier. In reviewing the limited data on AHAs, FDA concluded in a 1996 report that certain formulations of AHA products can affect the skin in a manner similar to that of chemical peels–that is, increasing cell turnover rate and decreasing the thickness of the outer skin. The effect depends on the product’s pH level (a measure of its acidity), the AHA concentration, and the AHA vehicle cream, as well as how the product is used (for example, frequency of use and where on the skin it is applied).

Source: U. S. Food and Drug Administration

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