Alpha Hydroxy Acids for Skin Care : Sun Sensitivity, Use with Care

by Food and Drug Administration (FDA)

(Page 2 of 2)

Sun Sensitivity

An additional concern arose as FDA prepared its 1996 report on AHA safety: Some people who had reported adverse reactions cited increased sun sensitivity. In addition, one industry-sponsored study found that participants whose skin was exposed to 4 percent glycolic acid twice daily for 12 weeks developed minimal skin redness with 13 percent less ultraviolet (UV) radiation exposure than normal. Three participants developed minimal redness with 50 percent less UV exposure than normal.

Another study that looked at the effects of glycolic acid on production of sunburn cells (markers for UV-induced skin damage) found that people who received the AHA product in the presence of UV radiation experienced twice the cell damage in areas where the AHA had been applied than those who were treated with the non-AHA product.

FDA's concern is that people who are sensitive to sunlight may be particularly susceptible to UV rays, which can damage the skin and, over a long period, can cause skin cancer.

In 1997, the Cosmetic Ingredient Review Panel — the cosmetic industry's self-regulatory body for reviewing and addressing safety of cosmetic ingredients — concluded that the AHA's glycolic acid and lactic acid and their related chemical compounds are safe for use in products intended for consumer use when:

• the AHA concentration is 10 percent or less
• the final product has a pH of 3.5 or greater (lower numbers indicate greater acidity)
• the final product is formulated in such a way that it protects the skin from increased sun sensitivity or its package directions tell consumers to use sunscreen products.

For AHA products used by trained cosmetologists, the Cosmetic Ingredient Review Panel concluded that formulations of glycolic acid and lactic acid at concentrations of 30 percent or less and a pH of 3.0 or greater intended for only "brief" use at one time followed by thorough rinsing and daily use of sun protection are safe.

The panel's conclusions actually serve as guidelines for cosmetic manufacturers, Bailey says. "This means that each manufacturer of an AHA product should conduct appropriate testing on their products to measure whether or not the product increases the sensitivity of the user to UV radiation and, if so, should add sun protection to their product and warn consumers to take extra steps to protect themselves at all times."

Meanwhile, FDA continues to study AHA safety. Later this year, scientists with the National Toxicology Program and FDA will use hairless mice to study the effect of AHAs on the risk of cancer associated with sunlight and UV radiation. The study will run for about three years.

Depending on the outcome of FDA's investigation, Bailey says, the agency may or may not take action against AHA products. "The absence of action by FDA to date doesn't mean that there won't be any in the future."

Use with Care

Considering the questionable safety status, FDA and dermatologists advise consumers who use AHA products to follow these precautions:

Always protect your skin before going out during the day. Use a sunscreen product with an SPF (Sun Protection Factor) of at least 15. Wear a hat with a brim of at least 4 inches (about 10 centimeters). Cover up with lightweight, loose-fitting, long-sleeved shirts and pants.

Buy products with adequate label information: for example, a list of ingredients to see which AHA or other chemical acids are in the product; the name and address of the manufacturer or distributor, which can serve as the contact if a problem or question arises; and a statement about the product's AHA concentration and pH level. The first two pieces of information are mandatory; the third is optional. Consumers can call or write the manufacturer, however, to get information about a product's AHA concentration and pH level.

Buy only products that comply with the Cosmetic Ingredient Review Panel's 1997 recommendations — that is, products with an AHA concentration of 10 percent or less and a pH of 3.5 or greater.

Do a skin-sensitivity test on a patch of skin if you are a first-time user of any AHA product or are using a different brand or a product with a different concentration or pH than you are used to.

Stop using the product immediately if you experience adverse reactions. Signs of adverse reactions include stinging, redness, itching, burning, pain, and bleeding or change in sun sensitivity. Even mild irritation is a sign that the product is causing damage, FDA's Bailey says, despite what the manufacturer may indicate on the product label. "Cosmetics shouldn't sting or cause irritation," he says.

If you have an adverse reaction, see a dermatologist. A dermatologist can tell you whether an adverse reaction is from the product or is an indication of an underlying disease, such as skin cancer. Dermatologists also can recommend appropriate skin-care products, and they will report your case, keeping your name confidential, to FDA's adverse reaction monitoring program.

You also can report your adverse reaction yourself to FDA. Reports can be made to local FDA offices, listed in the Blue Pages of the phone book or to FDA's Office of Consumer Affairs at 1-800-532-4440. Have the label and any other packaging information on hand. Be prepared to give the name of the product, the name and address of the manufacturer or distributor, and any identifiable product code numbers. Also be prepared to state where and when you bought the product, if you can remember, and whether you saw a doctor. "We'd like to know about it even if it's only a mild reaction," Bailey says.

Bailey adds that these precautions are important until AHAs' safety is better known. "We are told that AHAs are here to stay," he says. "But they are not reviewed for safety before they are put on the market. And we don't have enough information to say that they are safe."

Ingredient Terms

Here are some ingredient terms that indicate a cosmetic contains alpha or beta hydroxy acids.

Alpha hydroxy acids:

• glycolic acid
• lactic acid
• glycolic acid + ammonium glycolate
• alpha-hydroxyethanoic acid + ammonium alpha-hydroxyethanoate
• alpha-hydroxyoctanoic acid
• alpha-hydroxycaprylic acid
• hydroxycaprylic acid
• mixed fruit acid
• triple fruit acid
• tri-alpha hydroxy fruit acids
• sugar cane extract
• alpha hydroxy and botanical complex
• L-alpha hydroxy acid
• glycomer in crosslinked fatty acids alpha nutrium

Beta hydroxy acids:

• salicylic acid *
• beta hydroxybutanoic acid
• tropic acid
• trethocanic acid

Alpha and beta hydroxy acids:

• malic acid
• citric acid

From a chemist's perspective, salicylic acid is not a true BHA. However, cosmetic companies often refer to it as a BHA and, consequently, many consumers think of it as one.

Approved Treatments for Signs of Aging, Sun-Damaged Skin

These are the only products that have been studied for safety and effectiveness and approved by FDA for treating signs of sun-damaged or aging skin:

Renova (tretinoin emollient cream). This vitamin A derivative, available by prescription only, is approved for mitigating fine wrinkles and mottled darkened spots and roughness of facial skin in people whose skin does not improve with regular skin care and use of sun protection. Renova does not eliminate wrinkles, repair sun-damaged skin, or restore skin to its healthier younger structure. Also, the safety of daily Renova use for longer than 48 weeks has not been established, and it should not be used by women who are pregnant or trying to become pregnant. Renova has not been studied in people 50 and older or in people with moderately or darkly pigmented skin.

Carbon dioxide (CO2) and Erbium: YAG (Er:YAG) lasers. These medical devices are approved for treating wrinkles. The procedure requires removal of facial skin in a layer-by-layer manner. It is performed under anesthesia by a doctor in an outpatient surgical setting.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.