Drugs

FDA Proposes New Sunscreen Rule

FDA has issued a proposed rule to update regulatory requirements for most sunscreen products in the U.S. The proposed rule is intended to bring nonprescription, over-the-counter sunscreens that are marketed without agency approved applications up to date with the latest science to better ensure that consumers have access to safe and effective preventive sun care options, according to an agency news release.

Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

The release says that the proposed rule includes several proposals for sunscreens marketed without FDA-approved applications involving two ingredients that are generally recognized as safe and effective (GRASE), two ingredients that are not GRASE due to safety issues, and 12 ingredients for which there are insufficient safety data to make a GRASE determination and for which FDA is asking industry and other interested parties for more data.

The proposal also addresses dosage forms, SPF values, labeling information, agency expectations for testing and record-keeping by entities conducting sunscreen testing, and a proposal that sunscreens combined with insect repellants are not GRASE.

CDER director Janet Woodcock says in a staff e-mail the proposed rule does not require any sunscreen products to be removed from the market at this time. “Manufacturers will be able to provide comment and submit data on the proposals contained in the proposed rule, including safety data for active ingredients for which insufficient data exist,” she says.

The rule will put into effect final monograph regulations for OTC sunscreens as required by the Sunscreen Innovation Act. Woodcock says the rule outlines the process for deferring GRASE decisions at the final rule stage on active ingredients for which manufacturers have agreed to generate the needed data within a certain timeframe. The Sunscreen Innovation Act calls for the final OTC sunscreen monograph rules to be effective by 11/26/19. Ingredients deferred from the final rulemaking will be able to remain on the market as the data are being generated, she says.

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