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U.S. Department of Health and Human Services
Food and Drug Administration
P92-13: May 21, 1992
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
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
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
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.
Updated information is available on Alpha
Hydroxy Acids (AHA's).