New law aims to streamline FDA sunscreen-approval process


The newly minted Sunscreen Innovation Act (SIA) is being hailed as a godsend-a long overdue one-by the dermatologic community. Read to learn more.

The newly minted Sunscreen Innovation Act (SIA) is being hailed as a godsend-a long overdue one-by the dermatologic community.

The bill, signed into law Nov. 26, is designed to cut through regulatory red tape that has denied U.S. consumers access to state-of-the-art sunscreens that have long been available in other countries. If it works as planned, the SIA will speed up the Food and Drug Administration’s plodding review process for sunscreen ingredients that have been used in Canada, Europe and elsewhere for years.

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The FDA last approved an over-the-counter sunscreen ingredient two decades ago. Eight sunscreen applications have been filed since 2002-they remain in FDA-review limbo.

Dermatologists are applauding the new law.

“At long last, Americans will have access to safe and more effective sun-protection products that have only previously been available outside the United States,” Ronald Wheeland, M.D., Columbia, Mo., tells Dermatology Times. “Hopefully this will not only stress the importance of using sunscreens on a routine basis, but also help reduce the epidemic of skin cancers that is occurring in the United States.”

“It’s high time that the U.S. is catching up with European sunscreen technology,” says Helen M. Torok, M.D., Medina, Ohio. “With the passage of this act we can now work on technology that will be more effective in combating skin cancers.”

In addition to calling for a speedier approval mechanism, the new law requires the FDA to periodically report to Congress on the agency’s progress in reaching that goal. The new law also orders the FDA to produce guidelines that clarify how sponsors can get their sunscreen products approved. Finally, the SIA asks the FDA to issue a new sunscreen monograph within five years. Once that’s done, a new sunscreen product will be allowed to bypass some of the FDA’s more arduous approval procedures if it meets the monograph’s criteria.

“The passage of the SIA is a huge step in the right direction,” says Omaha, Neb. dermatologist Joel Schlessinger, M.D. “It’s a dirty little secret that most dermatologists go on vacation to Europe and the Caribbean for one thing only-to pick up contraband sunscreen! Now we can go for more esoteric reasons if these fabulous concoctions come stateside.

“This is also going to save lives in the long run, which is a terrific accomplishment. The American Academy of Dermatology Association, which lobbied for this important bill, and all the dermatologists who wrote to their congressmen deserve a round of applause.”

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