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.
A copy of Schumer and Gillibrand’s letter from last week can be found below.
Margaret A. Hamburg, M.D. Jacob J. Lew
Commissioner Director
U.S. Food and Drug Administration Office of Management and Budget
5600 Fishers Lane 725 17th Street, NW
Rockville, MD 20857 Washington, DC 20503
Dear Dr. Hamburg and Mr. Lew:
Once again, the summer months are upon us and millions of Americans will be spending time outdoors without adequate protection from the sun. It has now been nearly four years since the Food and Drug Administration (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). We strongly urge you to finalize this regulation without further delay so that Americans will no longer be deceived into thinking they are truly protected from the sun when that isn’t the case.
The FDA first looked into the deceptive practices of 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.
We continue to be disappointed that the FDA has not prioritized the implementation of meaningful, enforceable standards for sunscreen products and products containing sun protection that includes standards for both UVA and UVB protection. Millions of Americans purchase and use over-the-counter sunscreen products and assume they are protected from harmful UVA and UVB rays. But the current protection that they are afforded by these products could be misleading or worse inaccurate.
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. Clearly and accurately labeled sunscreen products, containing comprehensive information that includes UVA and UVB protection would help keep Americans safer from the sun’s harmful rays.
In the past, when Congress inquired about the status of the final regulation, we were told that the number of written comments that the agency received to the proposed rule delayed its finalization, but that it would be released in the fall of 2010. That time frame has come and gone, and now we need action.
As such, we urge you to issue these regulations immediately. Once again, we look forward to hearing from you about when this proposed rule will be finalized and when consumers will be able to purchase sunscreen products and products containing sun protection with the knowledge that they meet FDA’s enforceable standards.
Thank you for your prompt attention to this matter. We look forward to your reply.
Sincerely,
Charles E. Schumer Kirsten Gillibrand
United States Senator United States Senator