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 elements.
In keeping with the invoice, the proposed requirements would:
- “guarantee the security of shoppers based mostly on a complete analysis of scientific proof”;
- “permit for the usage of real-world proof, observational research, and different scientifically legitimate approaches rather than, or to complement, conventional scientific checks”; and
- assist “nonprescription advertising and marketing and use” by 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 fulfill regulatory necessities.
Business implications
The SAFE Sunscreen Requirements Act instantly addresses long-standing issues amongst US cosmetics and private care product producers and ingredient suppliers concerning delays in FDA approval of recent UV filters. The FDA has not authorized a brand new sunscreen lively 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, advised CosmeticsDesign US that “we now have 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 international and home regulatory progress: “The FDA’s present evaluate course of for approving new sunscreen elements hasn’t saved tempo with international innovation, which is holding the US magnificence trade again from growing extra secure, efficient merchandise for all pores and skin sorts and tones.”
Concentrate on 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 “take into account… every other various to animal testing that the Secretary deems acceptable” when reviewing sunscreen lively elements.
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 powerful, 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 numerous wants.”
Regulatory and market affect
For producers and suppliers, the SAFE Sunscreen Requirements Act may doubtlessly unlock a sooner path to marketplace for UV filters which can be already authorized overseas, notably within the EU and Asia-Pacific areas. It may additionally cut back improvement prices by validating non-animal testing alternate options.
Underneath Part 5 of the Act, the Secretary of Well being and Human Providers shall be mandated to submit an annual report back to the Committee on Power and Commerce of the Home of Representatives and the Committee on Well being, Schooling, Labor, and Pensions of the Senate detailing “the standing of implementation of proof and testing requirements for sunscreen lively elements… and the progress of the Meals and Drug Administration in permitting nonclinical testing alternate options to animal testing for the consideration of sunscreen lively elements.”
These stories intention 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 potential changes to FDA evaluate procedures and formulation guidelines.
