The FDA announced its goals of enhancing the quality, safety, and efficacy of sunscreens as a component of its implementation of new authorities for certain nonprescription drugs. The press release stated that in the short term, these new authorities basically maintain status quo marketing conditions for these sunscreens. However, in the press release, the agency proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions.
The FDA stated that the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed and modernized the manner in which sunscreens marketed without approved applications are regulated in the U.S. The Act establishes a deemed final order for sunscreens, which, along with other requirements established by the CARES Act, sets the current requirements for marketing these OTC sunscreen products.
It is important to note that the CARES Act did not change the scientific standards for determining whether a sunscreen may be legally marketed 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.
The deemed final order for sunscreens includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect. It also includes labeling and effectiveness requirements from a final 2011 labeling and effectiveness-testing rule.
The press release explained that the deemed final order essentially preserves the pre-CARES Act status quo condition for these sunscreens, as previously sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. The FDA therefore believes that most sunscreens currently on the market are in compliance with the order, which will remain in effect until the FDA issues another final order to revise it.
According to the press release, the FDA stated, "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 product."
The order included a proposal to update the GRASE status for the 16 active ingredients listed in the deemed final order. Also, the order stated 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, was proposed.
The order's proposals on SPF and broad spectrum were designed to ensure public access to sunscreens with proper ultraviolet A rays (UVA) protection, as an increasing amount of research has linked UVA exposure to skin cancers. It was also proposed to change the labeling of the products to help make it simpler for consumers to recognize important product information.
Acting FDA Commissioner Janet Woodcock, MD, stated, "Sun safety is important for everyone, regardless of your skin tone. Americans can reduce risks from sun exposure with continued use of sun protection measures including 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. 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 content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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