Use of Nonprescription Alpha-Hydroxy Acids

W. Steven Pray, Ph.D., R.Ph.

Disclosures

US Pharmacist. 2002;27(5) 

In This Article

Regulatory Status of AHAs

Products that affect only superficial skin or terminal hair are classified by the FDA as cosmetics.[1] Cosmetic status has allowed AHAs to avoid the premarket approval and review processes that are required of all drugs.[5] However, some in the cosmetic industry have questioned this designation, suggesting that AHAs instead be classified as "cosmeceuticals," a term not currently recognized by the FDA.[6]

The FDA is aware, however, that AHAs may penetrate the dead cells of the epidermis to affect living cells, which would change their status to that of drugs. One dermatologist states that long-term use of AHAs can increase collagen and elastin synthesis, as well as boost protein regeneration. These actions imply that AHAs have an effect on living tissues, thereby negating their status as cosmetics.[2]

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