Kirsten Gillibrand United States Senator for New York

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Schumer, Gillibrand: New FDA Delays Will Allow Misleading Sunscreen to Be Sold Throughout Summer – Senators Blast Delays and Call on FDA to Protect Consumers as Summer Begins

Many Sunscreen Labels Promise Protection from the Sun But Instead Leave Beachgoers Vulnerable to Skin Cancer – FDA Told Senators New Standards Would Be In Place By Summer 2012

May 21, 2012

Washington, DC -- In an effort to ensure sunscreen labels are clear, accurate, and provide consumers with the information they need to protect themselves, U.S. Senators Charles E. Schumer and Kirsten Gillibrand urged the Food and Drug Administration (FDA) to abandon their recently announced timeline for new standards that would allow manufacturers to continue to put products on the shelf this summer without updated labels. Last year at the request of Senators Schumer and Gillibrand, the FDA announced that they were ordering a comprehensive overhaul of sunscreen regulations and that new policies would be in place by June of this year. The Senators are pushing for new regulations because the current regulations leave numerous loopholes that allow sunscreen companies to claim protections and safety that they fail to achieve. This month, the FDA announced that it was giving sunscreen makers an additional 6 months to make label changes, which means consumers will be in the dark on the safety of their sunscreen for another summer. Smaller companies have an even more generous deadline of December 2013. 

“On the eve of the summer, it is unacceptable that the FDA wants to keep consumers in the a dark and allow the sunscreen companies, for yet another year, not to provide the most up-to-date information available on the effectiveness of their sunscreens,” said Senator Schumer. “Skin cancer affects millions of Americans every year, and New Yorker families deserve to know exactly how safe and effective their sunscreen is. The FDA needs to end these delays immediately, and put new standards in place this summer before beach season gets into full swing.” 

“As the summer season begins, New Yorkers deserve clear information on which sunscreen products are safe and effective so that they can guard themselves and their families against skin cancer,” said Senator Gillibrand. “FDA’s decades-long delay only puts more New Yorkers’ health at-risk and allows manufacturers to get away with misleading claims. Adequate sunscreen labeling and testing are long overdue and must be immediately put in place.” 

Since sunscreens have been considered a cosmetic, they have largely avoided government oversight and the FDA hasn't changed its recommendations for sunscreen standards in over 30 years. In June of 2011, the FDA told manufacturers they had until this June to revise their sunscreen labels in order to distinguish brands that could be labeled as “broad spectrum,” meaning they protect against both ultraviolet A and ultraviolet B rays, which contribute to skin cancer and early skin aging. The new guidelines also state that sunscreen manufacturers cannot claim their product to be sweatproof or waterproof on their labels without proving it, and that the label must include an alert that users must reapply the products. 

This week, Senators Schumer, and Gillibrand sent a letter asking the FDA to “reverse the recent decision to delay these critical regulations and to do more to ensure that consumers can purchase sunscreen products and products containing sun protection with the knowledge that they meet FDA’s enforceable standards.”  

Among the changes FDA is supposed to make: 

  • In order for sunscreens to be labeled as "Broad Spectrum" they must block both UVA and UVB rays.  UVA rays cause skin aging; UVB rays cause sunburn. Both can cause cancer.
  • Products with SPFs below 15 must display a warning that it has not been shown to help prevent skin cancer or early skin aging.
  • The terms "sunblock," "sweatproof," and "waterproof" will no longer permitted.  Sunscreens may claim to be "water-resistant," but must specify whether they protect skin for 40 or 80 minutes of swimming or sweating, based on standard testing.
  • Products may no longer claim to provide sun protection for more than two hours without submitting test results to prove it.
  • All sunscreens must include standard "Drug Facts" information on the back or side of the container. 

Text of the letter follows:

Dear Commissioner Hamburg: 

We write to express our disappointment in a recent decision by the Food and Drug Administration (FDA) to delay compliance with the sunscreen regulations released last summer.   Once again, the summer months are upon us and millions of Americans will be spending time outdoors without adequate protection from the sun.  FDA’s decision is a major step backward, and we strongly urge you to reverse it. 

FDA’s announcement last year that new sunscreen testing and labeling standards would be implemented this summer was a positive signal to Americans that they would not go another summer without critical protection from the sun.  Unfortunately, delaying the implementation of these standards by six months (for some manufacturers and 18 months for others) will allow the deceptive practices of the industry to continue.   Americans will continue to think they are truly protected from the sun, that a product is “waterproof” and “sweatproof,” and provides “all day protection,” when that isn’t likely the case. 

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.  According to the American Cancer Society, over two million individuals will be informed that they have a preventable form of skin cancer in 2012.  When Americans purchase and use over-the-counter sunscreen products they 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, according to the Environmental Working Group.  Has FDA determined the effect that the delay in the new regulations will have on public health?  Has FDA analyzed the potential for confusion among consumers due to conflicting announcements? 

FDA’s decision to delay the implementation of these critical regulations also draws attention to the agency’s unfinished business regarding proposed regulations regarding the use of Sun Protection Factor (SPF) numbers over 50, as well as the testing and labeling of aerosol spray sunscreens.  As you know, researchers have found significant variability in the SPF numbers listed on sunscreen products and products containing sun protection that make consumers believe that they are being adequately protected from the sun.   For example, one product with an 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.  Similarly, aerosol-based products are becoming more popular among consumers, but may not provide the same level of protection from the sun as lotion-based products.  It is critical that consumers have access to accurate information in order to know they are purchasing a product that provides adequate protection from the sun. 

Once again, we urge you to reverse the recent decision to delay these critical regulations and to do more to ensure that consumers can 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.