FDA Announces Action on Sunscreens

FDA took its first steps geared toward improving the quality, safety, and efficacy of sunscreens as a part of its implementation of new authorities for certain over-the-counter (OTC) drugs, according to its press release.¹

Currently, the new authorities keep the marketing conditions for these sunscreens the same, but the FDA did propose revisions and updates to the requirements related to the maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other changes. 

Janet Woodcock, MD, acting commissioner for the FDA in Washington D.C., stated that sun safety is important for all people and Americans can reduce sun exposure risk by using sun protection such as a broad-spectrum sunscreen with SPF values of at least 15.  

“Today’s activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products,” Woodstock said. “We are committed to using our new authorities to help meaningfully advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.”  

The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed the way unapproved applications for sunscreens are marketed in the U.S. by deeming a final order for sunscreens. Requirements of this Act, alongside the final order, set the current requirements for marketing OTC sunscreen products. The deemed final order includes requirements on active ingredients from the 1999 final monograph regulation for OTC sunscreen products, however, the monograph did not ever take effect, along with labeling and effectiveness requirements from a 2011 labeling and effectiveness testing rule. 

It’s important to note that the CARES act did not change the scientific standards for determining whether a sunscreen may be marketed legally without an approved application. OTC orders establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE), so long as they comply with all other applicable requirements, according to the release.  

The press release explained that the deemed final order perseveres the pre-CARES act status quo condition for these sunscreens, making sunscreens marketed according to nearly identical terms described in an FDA enforcement discretion policy. The FDA thus believes most sunscreens currently on the market follow the order and the order will remain in effect until the FDA issues another final order to revise it.  

The CARES Act did require the FDA to issue a proposed revised order by September 27, 2021 and the FDA has made the order available today. The FDA used the order to transition the ongoing consideration of the requirements for OTC sunscreens marketing without approved applications from past rulemaking processes to this current order process. 

“The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens and are aimed at bringing sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective sunscreen products,” according to the press release wrote.  

The order included a proposal to update the GRASE status for the 16 active ingredients listed in the deemed final order. Also, that dosage forms that are considered GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and GRASE status for spray sunscreens, subject to testing, and labeling requirements were proposed. 

The order’s proposals on SPF and broad spectrum were created to confirm the public have access to sunscreens with proper ultraviolet A rays (UVA) protection, as a growing number of research has linked UVA exposure to skin cancers. The label of the products was also proposed to change, to help make it easier for consumers to see important product information. 

Christopher Bunick, MD, PhD, associate professor of dermatology, Yale University and Dermatology Times® editorial advisory board member, commented on the FDA’s proposed changes. 

"It is encouraging to dermatologists and our patients that the FDA is taking steps toward improving sunscreen quality by addressing issues such as active ingredients, product labeling, and SPF and broad-spectrum testing procedures,” Bunick said. “This is a step in the correct direction, and I hope the FDA will continue to do more with sunscreen safety in the future, especially regarding the more recent data showing batch contaminations, chemical breakdown of certain ingredients, and blood absorption." 

There will be a 45-day public comment period in which the FDA will consider comments before then issuing a revised final order (and is considering all comments timely submitted to the 2019 proposed rule to be constructively submitted to the proposed order), according to the release. 

The CARES Act specifies the effective date for the revised final order cannot be earlier than 1 year after its issuance.  

Reference

 1. FDA takes steps aimed at improving quality, safety and efficacy of sunscreens. FDA. Published September 24, 2021. Accessed September 24, 2021. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-aimed-improving-quality-safety-and-efficacy-sunscreens