Schumer, Gillibrand Announce FDA Agrees to Call for More Accurate Labeling on Sunscreen Products

Press Release

Researchers Found That Many Sunscreen Labels Promise Protection from the Sun But Instead Leave Beachgoers Vulnerable to Skin Cancer; in 2011 Alone, One Million Americans Will Be Diagnosed With The Disease

FDA Had Not Issued New Rules in 30 Years, Leaving Consumers in the Dark About Safe, Effective Sunscreens; New Labeling Rules Will Provide Consumers With More Information to Better Protect Themselves from Skin Cancer

Senators: Parents and Consumers Can Make More Informed Decisions About the Products They Use to Protect Themselves and Their Kids from Harmful UV Rays

U.S. Senators Charles E. Schumer and Kirsten E. Gillibrand today announced that the U.S. Food and Drug Administration (FDA) has agreed to their call to implement new and more accurate labeling rules for sunscreen products. Schumer and Gillibrand have been pressuring the FDA to issue comprehensive regulations for the sunscreen industry, regarding formulation, labeling and testing requirements for over-the-counter sunscreen products, to protect consumers from dangerous ingredients and inaccurate labels. With summer just around the corner, one million more Americans are expected to be diagnosed with skin cancer this year alone. Schumer and Gillibrand said that the FDA has been dragging its feet to issue rules that would require sunscreen companies to provide clear and accurate sunscreen labels. After threatening legislation earlier this month with Senator Jack Reed (D-RI), that would have imposed a hard deadline on the agency to implement the new rules, the FDA announced today that it has finalized action. Schumer and Gillibrand sent a letter to FDA Commissioner Margaret Hamburg and Director of the Office of Management and Budget Jacob Lew a week ago, urging them to finalize the FDA's proposed comprehensive standards for sunscreen products. The new regulations will become effective for most manufacturers within a one year time frame and all manufacturers with annual sales less than $25,000 will be given two years to comply.
"Parents, those who work outdoors and those who love the sun need and deserve these new rules to better protect themselves and their kids from the harmful, and potentially fatal, effects of sun exposure. These new rules will provide even greater protection to consumers by letting them know the full scope and breath of protection they may or may not be getting when they purchase sunscreen," said Schumer. "The FDA has finally come to its senses and put in place rules that will provide consumers with greater information, which in the end, will save lives."

"As more New Yorkers head to the beach, this is a commonsense step to tell consumers just what they're getting from their sunscreen," Senator Gillibrand said. "I am pleased the FDA is taking the proper steps to bring transparency and accuracy to sunscreen labeling, giving consumers the information they need."

The FDA first considered establishing safety, effectiveness and labeling requirements for sunscreen products over 30 years ago. Since then, the rate of melanoma in this country has doubled. This year, 1 million individuals will be informed that they have a preventable form of skin cancer. Millions of Americans purchase and use over-the-counter sunscreen products and assume the products are safe and they are protected from harmful UVA and UVB rays. But the current protection that they are afforded by these products could be misleading or the products could contain harmful ingredients.

Researchers have found significant variability in the numbers, words, ratings, colors, and symbols that sunscreen products and products containing sun protection use to make consumers believe that they are being protected from the sun. For example, one product with a Sun Protection Factor (SPF) of 30 was found to protect against 98 percent of the sun's UVB rays, while a product labeled with a SPF of 100 may protect against 99 percent of the sun's rays. The larger the SPF number doesn't always result in significantly better protection. Additionally, there is currently no confirmed method of determining if a product protects against UVA rays, and claims that a product is "waterproof" or provides "all day protection" from the sun are unsubstantiated. In the face of this overwhelming evidence, in 2007 the FDA proposed comprehensive standards for sunscreen products and products claiming to contain sun protection in Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph (72 Fed. Reg. 49070).

Despite proposing these new rules nearly four years ago, the FDA had not yet finalized them, leaving the industry dangerously unregulated. In the past, when Congress inquired about the status of the final regulation, the FDA said that the written comments that the agency received to the proposed rule delayed its finalization, but that it would be released in the fall of 2010. Schumer and Gillibrand said that as that time frame has come and gone, now is the time for action.

Schumer has also been pushing the FDA to act on studies that have suggested a possible link between skin cancer and retinyl palmitate, a common ingredient found in sunscreen. Retinyl palmitate is a form of vitamin-A found in 41% of U.S sunscreens, including popular brands such as Coppertone, Banana Boat, Hawaiian Tropic, Neutrogena and Panama Jack. In the FDA's announcement the agency noted that it is also currently reexamining the safety information available for active ingredients included in sunscreens marketed today.

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