On June 3, 2025, Consultant John Joyce (R-PA) launched the Supporting Accessible, Versatile, and Efficient Sunscreen Requirements (SAFE Sunscreen Requirements) Act. The bipartisan laws seeks to amend Part 505G of the Federal Meals, Drug, and Beauty Act by establishing new requirements for evaluating the security and efficacy of those components.
In keeping with the invoice, the proposed requirements would:
- “guarantee the security of shoppers primarily based on a complete analysis of scientific proof”;
- “enable for using real-world proof, observational research, and different scientifically legitimate approaches instead of, or to complement, conventional scientific checks”; and
- assist “nonprescription advertising and use” by way of streamlined, science-based evaluations.
If enacted, the invoice would require the FDA to situation steering inside 180 days on how sponsors can use non-animal testing alternate options to satisfy regulatory necessities.
Trade implications
The SAFE Sunscreen Requirements Act immediately addresses long-standing issues amongst US cosmetics and private care product producers and ingredient suppliers relating to delays in FDA approval of latest UV filters. The FDA has not accredited a brand new sunscreen energetic ingredient since 1999, regardless of Congress passing the Sunscreen Innovation Act in 2014 to expedite the method.
We spoke to the Private Care Merchandise Council (PCPC), which welcomed the brand new laws. Karin Ross, PCPC’s Government Vice President of Authorities Affairs, informed CosmeticsDesign US that “we’ve been deeply dedicated to this situation for greater than 20 years, so it’s encouraging to see the proposed bipartisan laws that might modernize sunscreen regulation.”
Ross emphasised the hole between world and home regulatory progress: “The FDA’s present evaluate course of for approving new sunscreen components hasn’t stored tempo with world innovation, which is holding the US magnificence business again from growing further protected, efficient merchandise for all pores and skin varieties and tones.”
Deal with scientific innovation and humane testing
A key part of the laws is the endorsement of different testing fashions, together with real-world proof and nonclinical, non-animal strategies. The invoice instructs the Secretary of Well being and Human Providers to “contemplate… another different to animal testing that the Secretary deems applicable” when reviewing sunscreen energetic components.
Ross commented on this characteristic, stating, “The act’s authors clearly perceive the significance of non-animal testing strategies and the important function sunscreen performs in stopping pores and skin most cancers.”
If handed, she affirmed that the PCPC is “able to work with the FDA on creating a robust, trendy regulatory framework that helps innovation, is extra humane, and gives shoppers with entry to a broader vary of efficient sunscreen choices that meet their various wants.”
Regulatory and market impression
For producers and suppliers, the SAFE Sunscreen Requirements Act may doubtlessly unlock a sooner path to marketplace for UV filters which might be already accredited overseas, notably within the EU and Asia-Pacific areas. It may additionally cut back growth prices by validating non-animal testing alternate options.
Beneath Part 5 of the Act, the Secretary of Well being and Human Providers can be mandated to submit an annual report back to the Committee on Vitality and Commerce of the Home of Representatives and the Committee on Well being, Training, Labor, and Pensions of the Senate detailing “the standing of implementation of proof and testing requirements for sunscreen energetic components… and the progress of the Meals and Drug Administration in permitting nonclinical testing alternate options to animal testing for the consideration of sunscreen energetic components.”
These stories goal to reinforce visibility into the company’s dealing with of sunscreen ingredient evaluations beneath the up to date framework.
The invoice is now with committee and awaits additional motion. Firms within the cosmetics and private care sector ought to observe its progress and be prepared for doable changes to FDA evaluate procedures and formulation guidelines.
