New, Improved Sunscreen Ingredients Are Given a Legal Push

At least on paper, it looks like Americans may soon finally be able to slather on more effective sunscreen ingredients – compounds already used in Europe, Canada and Latin America for years. In November of 2014, President Obama signed the Sunscreen Innovation Act (SIA) into law, mandating that the US Food and Drug Administration (FDA) step up its approval process for new sunscreen ingredients, a process long stuck in neutral. Several new ingredients providing significantly better ultraviolet A (UVA) filters than those currently available in the US have awaited FDA review for more than a decade. Since 2000, not a single new sunscreen ingredient has been added to the FDA’s approved list.

As a charter member of the PASS (Public Access to SunScreens) Coalition, a group of organizations that was instrumental in developing and promoting the SIA, The Skin Cancer Foundation applauds passage of the law. But while the new law expedites the review process, it does not guarantee that any new sunscreens will be approved.

“Previously companies had to wait 10 years for a response from the FDA, and this at least speeds up...response. They’re not in limbo anymore,” says Riette van Laack, an attorney specializing in FDA regulatory issues with the Washington D.C.-based firm Hyman, Phelps, & McNamara, P.C.  

Second Try

This isn’t the first attempt at accelerating approval of sunscreen ingredients. In 2002, the FDA introduced the time and extent application process (TEA), in hopes of fast-tracking approval of over-the-counter products already proven safe and effective and in wide use overseas. But years passed, with the FDA neither approving nor denying these ingredients. Explaining the delay, the FDA cited understaffing and lack of sufficient safety data. 

The new law revises the TEA process, setting a specific timeline for review and approval of new sunscreen ingredients: the FDA will have to rule on new ingredient applications within six months. However, the process can stall again whenever the FDA claims insufficient data and calls for additional information. After the passage of the SIA, six sunscreen applications on the backburner for years were officially ruled to have insufficient data. 

Nonetheless, PASS coalition policy adviser Michael Werner is confident the SIA will improve Americans’ access to superior sunscreens and help prevent future skin cancers. “This law... has helped answer the U.S. Surgeon General's Call to Action to Prevent Skin Cancer,” Werner said in a recent press release. The focus now, he said, is working with the FDA to implement the new law as quickly as possible.

Published on March 6, 2015