Docket Management
Docket: 00P-1378 - Guidance on Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Gail Kincaide Date/Time 2002-12-11 05:28:46
Organization Association of Women's Health, Obstetric and Neona
Category Association

Comments for FDA General
1. General Comments December 11, 2002 Re: Docket # OOP-1378 On behalf of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN), I am pleased to submit comments on the draft guidance entitled, Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids (AHA) as Ingredients. AWHONN, a membership organization of 22,000 nurses, promotes the health of women and newborns. AWHONN members are registered nurses, nurse practitioners, certified nurse midwives, and clinical nurse specialists who work in hospitals, physicians’ offices, universities, and community clinics across North America as well as in the Armed Forces around the world. Because they interact with women at every stage of their lives, nurses play a critical role in health promotion. AWHONN supports the labeling of AHAs in cosmetic products. For the last ten years, cosmetic manufacturers have promoted the use of products containing compounds designed to stem the effects of aging. AHAs can be found in many popular skin care products, and while many extol the compound’s virtues, the evidence of its detrimental effects on skin is mounting. A recent article in the journal, Toxicology of Applied Pharmacology, showed that a 6 week treatment of a skin cream containing AHAs contributed to increased ultraviolet light sensitivity. (1) Such sensitivity increases the user’s short term susceptibility to sunburn. According to the American Cancer Society, most of the million cases of non-melanoma skin cancer diagnosed each year are sun-related (2); as result, there is a concern that the increased sensitivity caused by products containing AHAs may also increase susceptibility to skin cancers for long term users. Health providers have a responsibility to their patients to provide the best information available for making health related decisions. The inclusion of the recommended “Sunburn Alert” on skin care products containing AHAs is an important step in empowering health providers and consumers with valuable information about how to protect their skin while using these products. AWHONN strongly encourages the finalization of the draft guidance for the cosmetic industry and eagerly anticipates its implementation. Thank you for the opportunity to submit comments on this important health issue. Please contact Lisa M. Greenhill at 202-261-2402 or in the event you have questions regarding AWHONN’s submitted comments. Sincerely, Gail Kincaide Executive Director (1)Sams RL, Couch LH, Miller BJ, Okerberg CV, Warbritton AR, Wamer WG, Beer JZ, Howard PC. Effects of alpha- and beta-Hydroxy Acids on the Edemal Response Induced in Female SKH-1 Mice by Simulated Solar Light. Toxicology of Applied Pharmacology. 2002 Nov 1;184(3):136-43. (2)American Cancer Society,, Accessed on December 9, 2002.

EC -1