FDA places proposed order for over-the-counter sunscreens

Federal efforts to improve the quality, safety, and effectiveness of over-the-counter sunscreens have taken a step further today with the publication of two orders to update regulatory requirements for most sunscreen products in the United States.

“We see it as one of the top public health priorities and our regulatory obligation to ensure that sunscreen products available on the market offer protection from the effects of the sun and deliver on those promises made to consumers,” said Theresa Michele, MD, director of the Over-the-counter drug offices at the FDA’s Drug Evaluation and Research Center, said during a media briefing.

When the Coronavirus Aid, Relief and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of changing a sunscreen monograph through the previous rulemaking process, and the agency had issued a proposal for a sunscreen rule in February by 2019. The CARES Act has given the FDA new powers over OTC drugs, including sunscreens.

In addition, a final sunscreen order has been set which sets the current requirements for OTC sunscreen products that are marketed without application. The deemed final order, which was posted on September 24, “essentially preserves the marketing terms from the CARES law for these sunscreens,” explained Michele. “Prior to the passage of the CARES bill, sunscreens were marketed under almost identical terms and conditions enforced in an FDA discretionary guideline. As a result, the agency believes that most sunscreens on the market today are already in compliance with this regulation.”

The CARES Act also required the FDA to issue a proposed order by September 27 to change and revise what it deemed final. Michele described the proposed order, posted on September 24th, as “a vehicle to effectively transition our ongoing review of reasonable requirements for OTC sunscreens marketed without approved uses from the previous rulemaking process to this new ordering process in today The proposed order is therefore essentially the same as that outlined in the FDA’s proposed 2019 Sunscreen Regulation. With this proposed order, we are proposing new requirements to improve the quality, safety, and effectiveness of the sunscreens that Americans use every day. “

The ordinance provides for the generally recognized safe status (GRASE) to be updated for the 16 active substances listed in the final ordinance. It also suggests that GRASE dosage forms for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments and sticks, and suggests GRASE status for spray sunscreens that are subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, Professor and Chair of Dermatology at George Washington University, Washington, said in an interview that sun protection is “important for everyone, regardless of skin tone.” “Broad-spectrum sunscreens with a sun protection factor of 15 and higher play an important role here.

Changes between the accepted and proposed orders that he highlighted include a maximum sun protection factor of 60+ (although up to 80 could be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for a contribution from the community, ”he said.

Other changes between the accepted and proposed orders are that PABA and trolamine salicylate are not GRASE and that broad spectrum testing is mandatory. Additionally, Friedman said, “Sprays are considered for GRASS as long as they are properly tested [ultraviolet radiation]) and insect spray-sunscreen combinations are a no-go. “

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 consider any timely comments submitted in response to both the proposed February 2019 rule and the current proposed order,” said Michele.

Friedman reported that he worked as 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, part of the Medscape Professional Network.


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