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Physicians, Makers and Advocates Press For Safer Sunscreens

For Immediate Release: 
Tuesday, April 6, 2010

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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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.