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FDA Urges More Industry Sun Protection Research

Sun exposure

(Yuval Y, Flickr)

23 May 2018. The head of the U.S. Food and Drug Administration is asking companies making sunscreen to conduct more research on the safety of products that protect against harmful sun rays. FDA administrator Scott Gottlieb made the request yesterday for companies to study new ingredients in sunscreen and implications of greater sunscreen use in an agency statement.

FDA’s regulatory authority over non-prescription sunscreen is based on the Sunscreen Innovation Act, signed into law in 2014. Gottlieb notes that over-the-counter, or OTC, sunscreen was once a product used occasionally at the beach, but is now applied by many people any time they venture out in the sun to protect against ultraviolet rays implicated in skin cancer. Thus, FDA is asking sunscreen manufacturers to learn more about the consequences of increased sunscreen use.

Another concern is absorption of sunscreen through the skin. When sunscreen first came on the market, says Gottleib, sunscreen was thought to stay on the skin surface, but new evidence suggests some active ingredients penetrate the skin. “This combination of a large increase in the amount and frequency of sunscreen usage,” says Gottlieb, “together with advances in scientific understanding and safety evaluation methods, has given rise to new questions about what information is necessary and available to support general recognition of safety and effectiveness of active ingredients for use in OTC sunscreens.”

The Sunscreen Innovation Act, adds Gottlieb, provides new processes for evaluating sunscreen products and the agency issued a draft of proposed guidance yesterday for authorizing a new analytical technique with sunscreen. That technique, called a maximal usage trial, is designed to help understand the implications of topical non-prescription sunscreen, and if more data are needed to evaluate the safety of these products.

FDA also took action yesterday against makers of dietary supplements that claimed to protect against harm from exposure to the sun. The agency sent warning letters to makers of pills and capsules marketed under the brand names Advanced Skin Brightening Formula, Sunsafe Rx, Solaricare, and Sunergetic. These products, says Gottlieb, “are putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer.”

FDA says the companies were told to correct the specified violations, including claims made in their literature and on their web sites, to ensure they’re in compliance with the law. “There’s no pill or capsule that can replace your sunscreen,” notes Gottlieb.

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