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Guidance: Labeling for Cosmetics Containing Alpha Hydroxy Acids
January 10, 2005
Guidance for Industry
Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients
Additional copies are available from:
Office of Cosmetics and Colors, HFS-100
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-1130
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
January 2005
Cosmetics Labeling
Table Of Contents
1. Introduction
2. AHAs in Cosmetic Products
3. Citizen Petition from the Cosmetic, Toiletry, and Fragrance Association
4. Safety Reviews of AHAs
5. "Sunburn Alert" AHA Labeling Statement
6. Function of "Sunburn Alert" AHA Labeling Statement
7. Requested Restriction of CTFA's Alert Statement to Exfoliant Use
8. Use Conditions for "Sunburn Alert" AHA Labeling Statement
9. Statutory Basis
10. Significance of Guidance
11. Electronic Access
12. References
Guidance for Industry(1)
Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.
I. Introduction
FDA has considered evidence that suggests that topically applied cosmetic products containing alpha hydroxy acids (AHAs) as ingredients may increase the sensitivity of skin to the sun while the products are used and for up to a week after use is stopped, and that this increased skin sensitivity to the sun may increase the possibility of sunburn. The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs as ingredients and to educate manufacturers to help ensure that their labeling for cosmetic products containing AHAs as ingredients is not false or misleading. As an interim measure, while FDA continues to review the data on AHAs to address the potential for this increased skin sensitivity to the sun, FDA is recommending that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane bear a statement that conveys the following information. The information in the AHA labeling statement is consistent with FDA's current thinking on sun protection.
Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
Alpha hydroxy acids are organic acids with a hydroxyl group on the carbon adjacent to the carboxylic acid group. The predominant AHAs present in cosmetic products are glycolic acid and lactic acid. Other AHAs used in cosmetic products include citric acid, ?-hydroxyoctanoic acid, and hydroxydecanoic acid (Reference 1).
Starting in 1994, the Cosmetic, Toiletry, and Fragrance Association's Cosmetic Ingredient Review Expert Panel, FDA's AHA Review Committee, and FDA reviewed the safety of topically applied AHAs in cosmetic products (References 2 through 4). The reviewers evaluated human clinical studies that investigated the effects of ultraviolet (UV) radiation on the skin after exposure to AHAs. The studies demonstrated that topically applied AHAs increase skin sensitivity to UV radiation during application and that this increased skin sensitivity to UV radiation diminishes after discontinuing application for a week.
Sensitivity to UV radiation is the main reason for the skin's sensitivity to the sun (Reference 5). Short-term exposure to the sun may cause sunburn and chronic long-term exposure to the sun may increase risk of premature skin aging (Reference 5). Experimental and epidemiological studies have demonstrated that prolonged exposure to the UV radiation in sunlight is a primary risk factor for certain types of skin cancer (References 6 through 8).
The human clinical studies reviewed by the Cosmetic Ingredient Review Expert Panel, FDA's AHA Review Committee, and FDA provided data for the effects of UV radiation on the skin after short-term (up to 12 weeks) topical exposure to AHAs. The evidence from the clinical studies suggests that increased skin sensitivity to UV radiation may increase the possibility of sunburn for consumers. Adverse experience reports by consumers of increased sunburn after AHA use support this conclusion (Reference 2). The increased skin sensitivity to UV radiation also may result in other harmful effects to the skin, but the data currently available to FDA's Center for Food Safety and Applied Nutrition (CFSAN) are still inconclusive on this point at this time.
This guidance applies to cosmetic products that contain an AHA as an ingredient and that are intended for topical application to the skin or mucous membrane. Most AHAs used as cosmetic ingredients are formulated into products that are intended for topical application to the skin or mucous membrane.
Certain products may not be intended for topical application of AHAs to parts of the skin or mucous membrane that are exposed to the sun, but such application may be unintentional (e.g., shampoos, deodorants). This guidance also applies to cosmetic products that contain an AHA as an ingredient and that are intended for application to areas of the body that may result in unintentional topical application to the skin or mucous membrane that are exposed to the sun.
However, AHAs can be present in cosmetic products that are applied to areas of the body that are not sun exposed (e.g., mouthwashes, breath fresheners, and douches). This guidance does not apply to cosmetic products that contain an AHA as an ingredient and that are intended for application to non-sun exposed areas of the body.
AHAs can be present in products that also are labeled to contain a sunscreen. This guidance does not apply to drug-cosmetic products that contain an AHA as an ingredient and also are labeled to contain a sunscreen for sun protection. FDA intends to address labeling for such products in a future document.
AHAs can be present in cosmetic products as incidental ingredients. As defined in section 701.3(l) of the Code of Federal Regulations (21 CFR 701.3(l)), incidental ingredients are ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic. Incidental ingredients are not required to be declared in the ingredient lists on the labels of cosmetic packages. This guidance does not apply to cosmetic products that contain an AHA as an incidental ingredient.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.
