Washington, D.C. – With school out soon and the summer sun season around the corner, a broad coalition of scientists, medical professionals, companies and public health groups has called on the federal Food and Drug Administration (FDA) to adopt regulations that assure safer, more effective sunscreens.
Ultraviolet-A (UVA) radiation, which does not cause sunburn, is suspected of causing skin cancer and premature aging. According to current statistics, about 1 million cases of skin cancer are diagnosed annually. Yet sunscreen makers are not required to substantiate marketing claims that their products offer protection from UVA rays.
“As a result, consumers may receive unexpectedly high UVA exposure when using products that actually provide low or no UVA protection,” the coalition wrote Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research.
The letter urged FDA to assess certain ingredients in sunscreens manufactured for markets outside the U.S.
“U.S. sunscreen manufacturers cannot use a number of active ingredients believed to be safer and more effective,” the coalition letter said. “…For instance, there are at least 29 ultraviolet filters approved for use in the European Union, compared to just 17 filters approved in the U.S. Newer active ingredients may offer manufacturers the capability to create safer products with superior UV protection.”
The FDA announced its plans to address sunscreen safety and effectiveness in 1978. The regulations contemplated at that time have never been put into force. In 2007 the FDA proposed a new set of regulations that, for the first time, would establish standardized measuring and labeling requirements for UVA protection in sunscreens.
“Despite this promising advance,” the coalition wrote, “ industry and consumers alike still await final standards to ensure that all sunscreens are as safe and effective as possible.”
The coalition, led by Environmental Working Group, dermatologist Steven Q. Wang of the Memorial Sloan Kettering Cancer Center and Alpha R&D Ltd., a research and product development company, has asked the FDA to finalize its sunscreen regulations this year and to expedite its review of new ingredients that could enhance the products’ sun protections.
A copy of the letter is attached.
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EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment. https://www.ewg.org
April 2, 2010
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration WO51-2201
10903 New Hampshire Avenue
Silver Spring, MD 20993
cc: Margaret Hamburg, M.D., Commissioner of Food and Drugs
Re: Final Monograph – Sunscreen Drug Products for Over-the-Counter Human Use
Dear Dr. Woodcock:
As professionals engaged in dermatology, product development, manufacture of sun care cosmetics and ultraviolet filters, academia and public health advocacy, we urge the U.S. Food and Drug Administration (FDA) to move quickly to issue enforceable sunscreen standards that include meaningful protection from ultraviolet-A (UVA) radiation. As well, we believe the FDA should complete its health and safety reviews of new active ingredients awaiting approval.
The FDA first announced its intention to publish such standards (the sunscreen “monograph”) in 1978 and has since refined its proposals. The most recent revision of the monograph, published Aug. 27, 2007, tackled for the first time the key question of UVA protection, specifying a uniform methodology for rating this property. Despite this promising advance, industry and consumers alike still await final standards to ensure that all sunscreens are as safe and effective as possible.
Sunscreens currently on the U.S. market have two major limitations. First, manufacturers do not have to substantiate claims of UVA protection. As a result, consumers may receive unexpectedly high UVA exposure when using products that actually provide low or no UVA protection. Damage associated with excessive UVA exposure is well known. In 2009, the International Agency for Research on Cancer (IARC) reaffirmed the carcinogenicity of solar radiation and noted that UVA radiation triggers the same mechanistic DNA damage as UVB radiation.
Second, U.S. sunscreen manufacturers cannot use a number of active ingredients believed to be safer and more effective, even though these ingredients are found in products sold in other countries. For instance, there are at least 29 ultraviolet filters approved for use in the European Union, compared to just 17 filters approved in the U.S. Newer active ingredients may offer manufacturers the capability to create safer products with superior UV protection.
More than 1 million Americans will be diagnosed with basal and squamous cell skin cancer this year, and another 60,000 will develop malignant melanoma. We commend the FDA for the many improvements to the sunscreen monograph outlined in 2007 and ask it to finalize enforceable standards in 2010. We further ask the agency to expedite review of new sunscreen active ingredients.
Thank you for your consideration.
Nadim A. Shaath, Ph.D. Alpha R&D Ltd. |
Rebecca Sutton, Ph.D. Environmental Working Group |
Steven Q. Wang, M.D. Memorial Sloan Kettering Cancer Center* |
Bethany R. Albers Purple Prairie Botanicals |
Patricia Aikens, Ph.D. BASF* |
Humayoun Akhter, Ph.D. Pharmaceutical Specialties, Inc. |
Joe Albanese 3V* |
Gideon Andemichael Givaudan* |
Jeff Anshus Intelligent Nutrients |
Bill Basinsky CBI Laboratories |
Michael Boudjouk Medallion International, Inc. |
Ratan Chaudhuri, Ph.D. Sytheon Ltd. |
Catherine Chiou, Ph.D. L’Oreal USA* |
Sandra Conger CAC / Farpoint |
Cherylanne DeVita, Ph.D. DeVita International, Inc. |
Brian Diffey, Ph.D. D.Sc Institute of Cellular Medicine |
Vernell Dixon CAC / Farpoint |
Olga Dueva-Koganov, Ph.D. Integrated Botanical Technologies |
Frederick Flores International Flavors & Fragrances* |
Mike Frankenfield Shattuck-St. Mary's School* |
Adam Friedman, M.D. Albert Einstein College of Medicine* |
Helena Gonzales, M.D. Ph.D. Sahlgrenska University Hospital* |
Annette Graham Procore Labs |
Stephen Greenburg, Ph.D. Lipo Chemicals* |
Dr. Alan Greene, M.D. F.A.A.P. Lucile Packard Children’s Hospital at Stanford University* |
Brett L. Guinta Creative Concepts Corp. |
Kathryn Hatch, Ph.D. The University of Arizona* |
Robert Hendrickson Procore Labs |
Julian Hewitt Croda Suncare and Biopolymers* |
Bernd Herzog, Ph.D. BASF* |
Debbie Hicks Arbonne International |
Jose Huerta HEB* |
Ahmed Kamel, Ph.D. Strategic Expansion Partners |
Jarrod P. Kaufman, M.D. NJ State Chair, Commission on Cancer of the ACS |
Misbah Huzaira Khan, M.D. Northwestern University Hospital |
Ken Klein Cosmetech |
Christopher B. Kruse, M.D. Dermatology and Skin Cancer Center* |
Stanley P.L. Leong, M.D. California Pacific Medical Center* |
Anne Likimani, Ph.D. Arbonne International |
Regina Lim SBR Labs |
Karl Linter, Ph.D. Croda Intl. Enterprise Tech. & Sederma S.A.S* |
Dennis Lott Florida Suncare Testing, Inc |
Stephen H. Mason, M.D. The Dermatology Clinic* |
Peter Matravers Arbonne International |
Timothy Meadows CAC / Farpoint |
Hasan Mukhtar, Ph.D. University of Wisconsin* |
Nellam Muizzuddin, Ph.D. Estee Lauder Companies* |
Sergio Nacht, Ph.D. Riley-Nacht, LLC |
Adnan Nasir, M.D. UNC Chapel Hill* |
Irwin Palefsky Cosmetech Laboratories |
Jeffry Parks, M.D. Parks Dermatology |
Adam Perle Jean International Corp. |
Hillary Peterson Marie Veronique, Inc. |
Louis Posner Aruba Aloe Balm, Inc. |
Scott Prawer, M.D. Associated Skin Care Specialists* |
Elizabeth Quiggley, M.D. Memorial Sloan Kettering Cancer Center* |
Horst Rechelbacher Intelligent Nutrients |
Barbara Roman CAC / Farpoint |
Adriana Ros, D.O. Dermatology and Skin Cancer Center* |
Adam M. Rotunda, M.D. American Board of Dermatology* |
Julie C. Schultz, M.D. Affiliated Community Medical Center |
Koichi Shiozawa Aveda* |
Joe Stanfield Suncare Research Laboratories, LLC |
John Sottery, Ph.D. Enginuity PLM LLC |
Jack Surrette SkinHealth Technology, LLC |
Paul Thau, Ph.D. PaCar Tech. |
Roger Thomas E.T.Horn Company |
Koos Veel, M.D. Aruba Aloe Balm, Inc. |
Ismael Walele Phoenix Chemicals* |
Sheree Wiener Arbonne International |
Michael Zarkades Fragrance West |
Priya Swamy Zeikus, M.D. Swamy Clinic* |
* The views of these individuals do not necessarily represent the views of the affiliated companies or health care organizations.