In late 2014, Congress passed the Sunscreen Innovation Act (SIA) to speed the approval of innovative new sunscreen ingredients and formulations, many of which have long been available in Europe, Asia, and Latin America. While the SIA requires FDA to take concrete steps to more quickly review submissions regarding OTC sunscreen ingredients, the SIA does not promise a quick cure-all to speed these formulations to market. And FDA’s first tentative steps toward implementing the new law demonstrate that it is still far from clear whether the SIA’s actual impact will measure up to Congress’s goals. Until FDA publishes guidance on review criteria—which it is required to issue by November 26, 2016—and a few ingredients utilize the new timelines and guidelines, it is unclear how many ingredients will actually be approved through this “improved” review process.
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