US : Congress Aims to Expedite Approval of New Sunscreens
US : Congress Aims to Expedite Approval of New Sunscreens

US : Congress Aims to Expedite Approval of New Sunscreens

Congress is reviewing the Sunscreen Innovation Act, a bill that may speed up the process of approving new innovations for sunscreen ingredients under US Food and Drug Administration (FDA) standards.

Michael J. Werner, a member of the Public Access to SunScreens Coalition, a multi-stakeholder group formed to advocate for a regulatory pathway to market for new, safe and effective sunscreen ingredients, said the coalition favors the legislation. He said the legislation is a “win-win-win.”

“It is a win for the FDA because they are administering a process that works and they can have confidence that when they approve a product it is safe and effective,” Werner told TIME magazine.

“It will be a win for manufacturers because they will know that their products will be reviewed in a timely manner. And of course consumers will win because we will have more safe and effective sunscreens to choose from.”

Better ingredients exist and are being used in other countries, skin experts said, it has taken years for the FDA to have the ingredients go through the drug-approval process. New sunscreen ingredients are being used in other countries because they were approved as a cosmetic.

The FDA said it, too, is frustrated with the process.

“The FDA is actively considering alternative regulatory and administrative approaches to a over-the-counter monograph process,” an FDA spokesperson told TIME.

In 1972, the FDA began reviewing OTC products already on the market, but not covered by new drug applications, the coalition’s website said.

“The FDA established review panels to evaluate OTC drugs on the market pre-1972 by category and developed monographs for each category of drug product,” the website said.

“If an OTC drug meets the criteria established in a monograph, it is considered ‘generally recognized as safe and effective’ and does not need independent pre-market approval. The existing OTC drug monographs are codified in 21 C.F.R. Part 330. Although several versions of a final monograph for sunscreen products have been developed, no final regulations have ever been implemented.”


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