6/14/2011 — 

WASHINGTON, DC – After years of prodding by U.S. Senator Jack Reed (D-RI), the Food and Drug Administration (FDA) today announced new sunscreen regulations that will for the first time require comprehensive testing and prevent misleading labeling of sunscreen products.

The new FDA requirements mean that sunscreen products sold in the U.S. will be appropriately tested and labeled for both UVA and UVB protection.  They will also prevent manufacturers from marketing their products with unproven, misleading labels that claim their products are “waterproof” and “sweatproof,” and offer “all day protection.”  Products that meet the new standards will explicitly state on their label that using the product “as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun.”  Products that don’t meet the comprehensive standards for UVA and UVB testing will have to warn consumers: “Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not [in bold font] skin cancer or early skin aging.”

“This is a victory for consumers that is long overdue.  It will help prevent more Americans from getting burned.  These new sunscreen standards are going to give consumers better, more accurate information.  By next summer products that don’t meet these standards will be taken off the shelves, or exposed for offering inadequate protection,” said Reed, the author of the proposed Sunscreen Labeling Protection (SUN) Act, which sought to require the FDA to implement a clear, standardized sunscreen labeling system in a timely manner.

The FDA had been considering such regulations since 1978 and finally released a proposed rule in 2007.  Today’s announcement means the FDA regulations will take effect next summer.

Currently, the FDA only requires sunscreen testing and labeling for sun protection factors (SPF), which mostly measures UVB rays, known for causing sunburns.  But there is no consistency in the SPF number and the protection it provides from UVB rays and under the current system, manufacturers have been free to use increasingly high SPF numbers, leaving consumers confused and/or with the false impression that they are getting total protection from the sun.   And, there are no current labeling standards that apply to UVA protection, which are a major cause of skin cancer and premature aging. 

“This is a public health issue and a situation where consumers deserve to know that the sunscreen products they purchase are safe, effective, and easy to understand so they may better protect themselves and their children from the sun’s harmful rays.  These new rules outlined by the FDA today are a positive step in the right direction, and I will continue to monitor this process closely to ensure they are implemented in a timely manner,” concluded Reed.

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