FDA issues prescription proposal for over-the-counter sunscreens

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Federal efforts to improve the quality, safety and effectiveness of over-the-counter sunscreens took a step forward today with the release of two orders to update regulatory requirements for most of the products. sun protection in the United States.

“We see this as a key public health priority and our regulatory obligation to ensure that marketed sunscreen products provide protection against the effects of the sun and deliver on their promises to consumers,” Theresa Michele, MD, Director of the Office of Non-Prescription Drugs. at the FDA’s Center for Drug Evaluation and Research, said at a press briefing.

When the CARES (Coronavirus Aid, Relief, and Economic Security) law was passed in 2020, the FDA was amending a sunscreen monograph through the previous rulemaking process, and the agency had released a proposed rule for sunscreens in February. of 2019. The CARES Act gave the FDA new authority over over-the-counter drugs, including sunscreens.

It also established a well-known final order for sunscreens, which set out the current requirements for over-the-counter sunscreen products marketed without an app. The decree deemed final, made public on September 24, “essentially preserves the conditions for the marketing of the status quo before the CARES law for these sunscreens,” explained Michele. “Prior to the passage of the CARES Act, sunscreens were marketed under almost identical terms that were outlined in an FDA discretion policy. For this reason, the agency believes that most sunscreens on the market today already comply with this order. “

The CARES Act also required the FDA to issue a draft order by September 27 to vary and revise the deemed final order. Michele described the proposed order, which was released on September 24, as “a way to effectively pass our ongoing review of the appropriate requirements for over-the-counter sunscreens marketed without approved applications from the previous rulemaking process. to this new ordering process. The provisions in today’s proposed order are therefore essentially the same as those described in the proposed FDA 2019 rule on sunscreens. With this proposed order, we are proposing new requirements for improve the quality, safety and effectiveness of the sunscreens Americans use every day. “

The order proposes to update the status generally recognized as safe (GRASE) for the 16 active ingredients listed in the order deemed to be final. It also proposes that GRASE dosage forms for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments and sticks, and offers GRASE status for aerosol sunscreens, subject to requirements. testing and labeling.

Adam Friedman, MD, FAAD, professor and president of dermatology at George Washington University, Washington, stressed that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad spectrum sunscreens with an SPF of 15 and above play an important role in this. This should not be lost in the proposed order.”

The changes between the alleged prescription and the proposed prescription that he highlighted include a maximum SPF of 60+ (although up to 80 may be allowed) and that both zinc oxide and titanium dioxide are GRASE. “The FDA did not say that the nanoparticle formulations of these, which are easier to use, are not GRASE; they seek community input,” he said.

Other changes between the alleged prescription and the proposed prescription are that PABA and trolamine salicylate are not GRASE and broad spectrum testing will be mandatory. Additionally, Friedman said, “sprays will be considered for GRASE as long as they are properly tested, the labeling should be clearer (and a warning will be applied to sunscreens not shown to prevent all the bad stuff with UVR. [ultraviolet radiation]), and insect-sunscreen combos are prohibited. “

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we will review all comments submitted in a timely manner in response to both the proposed February 2019 rule and the current proposed order,” Michele said.

Friedman has indicated that he is a consultant and / or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma and Janssen.

This story originally appeared on MDedge.com, which is part of the Medscape Professional Network.


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