The Food and Drug Administration today cautioned consumers about possible hazards associated with use of chemical skin peeling products. The agency also has begun an investigation to determine the seriousness of injuries reported to be associated with such products and the extent to which they occur.
"We are warning consumers about the use of skin peelers because they can cause serious injuries, particularly when not used under the supervision of a physician," said Commissioner David A. Kessler, M.D.
FDA issued the warning after it received reports of several injuries caused by skin peelers including four reports of skin burns from using a product called PeelAway. The agency said there may be other unreported injuries from PeelAway, as well as from other skin peeling products.
The products in question contain ingredients that purportedly remove wrinkles, blemishes, blotches and acne scars. They are often promoted with claims that they can restore youthful-looking skin.
FDA said such products can penetrate the skin too deeply, causing severe skin damage. In several cases, persons have been hospitalized for severe burns, swelling and pain. In one case, a California woman suffered seizure, shock and second degree burns after a mixture of skin peel chemicals was applied to her legs by a beautician. The case is under review by California State health officials.
Skin peeling products vary considerably as to their ingredients and strength. Also, skin reactions to the chemicals used in the products vary among individuals. Skin peeling products typically contain combinations and concentrations of several different acids such as resorcinol, phenol, lactic acid, trichloroacetic acid, salicylic acid, and glycolic acid and other alpha hydroxy acids.
They are ordinarily applied to the skin for a short time each day, usually for six to 12 days. The skin initially reddens, as with a sunburn, then darkens and finally peels away revealing what manufacturers claim will be "new skin." Treatments may be painful and leave permanent scars.
Skin peeling procedures used to be carried out only by plastic surgeons and dermatologists. However, they are now being done by a variety of non-medical professionals such as cosmetologists and beauticians, some using newly marketed preparations. Several of the products can be purchased through the mail. Many have inadequate instructions; none have been approved by FDA as being safe and effective.
In the course of conducting its investigation, FDA will review all products marketed with skin peeling claims. Dr. Kessler said FDA is working with state attorneys general who are also taking measures to stop the sale and use of hazardous skin peeling products.
In a warning letter sent to PeelAway manufacturer Global Esthetics of Seattle, Wash., May 14, FDA said that it considers PeelAway to be a new drug that cannot be legally marketed without FDA approval, and that the product is misbranded and presents a significant health hazard.
The actions being announced now are not directed at facial mask-type products intended for one-time or occasional use to cleanse the skin.
FDA is one of the eight Public Health Service agencies within HHS.
See also AHAs and BHAs.