April 13, 2015
Stephen Ostroff, M.D.
Acting Commissioner
Food and Drug Administration
U.S. Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: FDA-2008-N-0474; Over-the-Counter Sunscreen Drug Products-
Regulatory Status of Ecamsule
FDA-2003-N-0196-0060; Over-the-Counter Sunscreen Drug Products —
Regulatory Status of Enzacamene
Dear Dr. Ostroff,
On behalf of the 13,500 members of the American Academy of Dermatology
Association (Academy), I am writing to provide comments regarding the regulatory status of ecamsule and enzacamene as published in the Federal Register on
February 25, 2015. The Academy appreciates the opportunity to provide comments to the Food and Drug Administration (FDA or Agency). We hope the
Agency will consider our comments as you continue your consideration and determination of sunscreen products, including ecamsule and enzacamene.
Sunscreen as a Component of Skin Cancer Prevention
Skin cancer rates continue to rise, particularly in young adults ages 15-29 years.
1
Sadly, more and more Americans are being diagnosed with melanoma or nonmelanoma skin cancers. In 2015, it is estimated that one in every fifty
Americans will be diagnosed with melanoma, the most deadly form of skin cancer, in his or her lifetime.
2 In short, skin cancer is an epidemic in the U.S. that requires strong and swift action on the part of public health entities, including the FDA.
Fortunately, healthy skin behaviors can help prevent the incidences of skin cancer.
The Academy has been a leader in promoting skin cancer prevention and smart skin decisions with the hope of curbing the alarming incidence of skin cancer.
Among the cornerstones of healthy skin behaviors is proper use of broad-spectrum
UVA/UVB sunscreen with an SPF of 30 or higher. The Academy believes that improved formulations of sunscreens will be advantageous for our patients.
1 Melanoma of the Skin, Cancer Fact Sheets, National Cancer Institute, SEER database,
2007. http://seer.cancer.gov
2 Rigel DS, Russak J, Friedman R. The evolution of melanoma diagnosis: 25 years beyond the ABCDs. CA Cancer J Clin. 2010 Sep-Oct;60(5):301-16.

Sunscreen Ingredients
Sunscreens provide safe and effective protection against ultraviolet rays (UVR) . Recognizing the need for continuous improvement in sunscreens, the Academy supported the principles of the Sunscreen Innovation Act (Pub. L. 113-195). We are disappointed to see that the FDA has neglected to review the time and extent applications (TEAs) for eight sunscreen ingredients until now. Specifically, the TEA for enzacamene was submitted to FDA in 2002 and the TEA for ecamsule was submitted in 2007. Since 2008, FDA has not issued a TEA feedback letter or otherwise responded to these TEAs until forced to do so by the SIA’s tight timeframes.
Consumers have used sunscreens with enzacamene and ecamsule safely and effectively across the world, including in Europe, South America, Asia, and the rest of North America.
Ecamsule, for example, has been available in European consumer products for over twenty years.
The Academy is very concerned about t he limited number of filters that are available in sunscreens in the U.S. market. Oxybenzone remains the most common photosensitizer among
UV filters, despite being a common allergen; in fact, it is included in the benzophenones class, which was selected as “Allergen of the Year” by the American Contact Dermatitis Society in
2014. Additionally, oxybenzone is the source of significant questions from the lay public about its other side effects in animal models. Moreover, avobenzone is the only long wave UVA filter currently available in the U.S. Its efficacy and use is limited by the fact that it is photolabile.
Nevertheless, without the availability of new filters, avobenzone is difficult to replace.
Public health and skin cancer patient groups have been frustrated by the lack of guidance on the data requirements for the FDA to make a s ound decision on the safety and effectiveness of sunscreen ingredients in an expedited manner. Recognizing the need for the most advanced sunscreens to prevent skin cancer and ensure public safety, the Academy urges the Agency to issue guidance on the clinical data needed to allow the FDA to review and decide if an ingredient is generally recognized as safe and effective (GRASE). While the Academy recognizes that FDA has to follow its regulations on GRASE, we strongly encourage the FDA to move forward on these TEAs in an expeditious manner that takes into account the global safety record of these filters as well as the public health need for more effective sunscreen products.
Despite these frustrations, the Academy respects and supports the
Agency’s guiding principles to ensure that all products are safe and effective. While we urge the FDA to review sunscreen ingredients and other sun safety products in an expeditious manner, we recognize and strongly support the Agency ’s mission to ensure that all sunscreen products are safe and effective.
The Academy applauds the FDA’s continued efforts to help curb the incidences of skin cancer and urges the Agency to allow safe and effective products to enter the market after careful review in a reasonable timeframe. The Academy looks forward to working with the FDA as the
Agency continues discussions and deliberations on the safety and effectiveness of new sunscreen ingredients. In this respect, we would like to make Dr. Henry Lim, a board-certified dermatologist, C.S. Livingood Chair, and Chairman of the Department of Dermatology at Henry
Ford Hospital in Detroit, available to your staff as they continue to work in this area. Dr. Lim has extensive experience with, and knowledge of, sunscreen products and is a recognized authority on photodermatology, having published over 280 articles and edited several textbooks including the Clinical Guide to Sunscreens and Photoprotection. Please contact Amanda Pezalla, JD,
Manager of Regulatory Policy, at apezalla@aad.org
or (202) 842-3555 should you have any questions or would like to be put in touch with Dr. Lim.

Sincerely,
Mark Lebwohl, MD
President, American Academy of Dermatology Association
CC: Elaine Weiss, JD, Executive Director
Barbara Greenan, Senior Director, Advocacy and Policy
Leslie Stein Lloyd, JD, Director, Regulatory and Public Policy