FDA Commissioner Dr. Scott Gottlieb issued a press release on May 22nd, announcing new FDA actions that it says will keep consumers safe from the harmful effects of sun exposure, and to ensure the long-term safety and benefits of sunscreens.
First, the Commissioner's statement announced that the FDA sent warning letters to companies illegally marketing pills and capsules labeled as dietary supplements making unproven drug claims about protecting consumers from the harm of sun exposure. According to the FDA, these companies marketed their products without meeting the FDA’s standards for safety and effectiveness and put consumers' health at risk by creating a false sense of security that their products could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer.
Second, the Statement noted that the FDA is encouraging industry to conduct research on additional active ingredients for sunscreens. The Statement notes that there have been "important changes to how sunscreens are used and delivered, including recommendations on use." Because consumers are now encouraged to use sunscreens liberally whenever they are out in the sun, their exposure to sunscreens themselves has greatly increased, raising questions about how the active ingredients in sunscreens may be absorbed through the skin.
Accordingly, the Statement also announced that as part of the Sunscreen Innovation Act of 2014, which provided an alternative process for the FDA to review the safety and effectiveness of sunscreen active ingredients, the FDA has issued another draft guidance for industry regarding "Maximal Usage Trials (MUsT)" for topically-applied active ingredients being evaluated for inclusion in an OTC monograph (under which the vast majority of sunscreens available in the United States are marketed).
Finally, the Commissioner's Statement also announced the issuance of guidance describing its enforcement approach with respect to OTC sunscreen products marketed without approved applications during the period before a final OTC monograph becomes effective. In the interim, unless the failure to pursue regulatory action poses potential health hazards to consumers, the FDA says that it does not intend to object to the marketing of OTC sunscreen products that have all of the characteristics outlined in the guidance, even without an approved application.
Finally, the Commissioner exhorted us all to "enjoy the summer — and protect [ourselves] and [our] loved ones from sun damage, knowing the FDA is continuing to take actions to ensure the products [we] use are safe and effective."
Consumers should be watchful for unscrupulous companies making unproven claims. When the FDA sees companies taking advantage of people’s desire to protect themselves from the harmful effects of the sun — we’ll step in. There’s no pill or capsule that can replace your sunscreen.