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FDA Sunscreen Rules Too Little and VERY Late

(202) 667-6982
For Immediate Release: 
Tuesday, June 14, 2011

Washington, D.C. –The federal Food and Drug Administration’s new sunscreen rules, released today after nearly 33 years of deliberations, fall short.

“FDA's action offers some noticeable improvements for consumers, such as limiting misleading claims” said David Andrews, Ph.D, a senior scientist with Environmental Working Group. “However, it is clear that FDA caved to industry and weakened its safety standards. Its earlier draft proposed stronger health protections.”

According to Andrews, the agency’s final rule for UVA protection has been substantially watered down from a draft circulated in 2007.

“The agency's weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” Andrews said. “FDA’s rule will allow most products on the U.S. market to use the label ‘broad spectrum sunscreen,’ even though some will not offer enough protection to assure Americans they can stay in the sun without suffering skin damage from invisible UVA radiation. For that reason, about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.”

The FDA continues to allow oxybenzone, retinyl palmitate and several other ingredients in sunscreens despite scientists' concerns about their toxicity.

One bit of good news is the agency's bar on the misleading terms “waterproof” “sweatproof” and “sunblock.” But it is seeking further comments about the additional protection offered by SPF values above 50.

“FDA’s new standards don’t go far enough to protect you from the sun,” Andrews said. “Consumers will have to turn elsewhere, like EWG’s online guide, to find the safest, most effective sunscreens. After 33 years of delay, it is evident people just can’t trust FDA on this issue.”

NOTE: To speak with EWG’s research staff, please call Alex Formuzis at 202.667.6982 or email:

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