US Home invoice targets modernization of FDA sunscreen ingredient approvals

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 substances.

In keeping with the invoice, the proposed requirements would:

1. “guarantee the security of customers primarily based on a complete analysis of scientific proof”;
2. “enable for the usage of real-world proof, observational research, and different scientifically legitimate approaches rather than, or to complement, conventional medical checks”; and
3. assist “nonprescription advertising and use” by means 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 options to fulfill regulatory necessities.

Trade implications

The SAFE Sunscreen Requirements Act instantly 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 authorised 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 Govt Vice President of Authorities Affairs, instructed 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 would modernize sunscreen regulation.”

Ross emphasised the hole between international and home regulatory progress: “The FDA’s present overview course of for approving new sunscreen substances hasn’t stored tempo with international innovation, which is holding the US magnificence trade again from growing extra protected, efficient merchandise for all pores and skin varieties and tones.”

Deal with scientific innovation and humane testing

A key element 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 different to animal testing that the Secretary deems acceptable” when reviewing sunscreen energetic substances.

Ross commented on this characteristic, stating, “The act’s authors clearly perceive the significance of non-animal testing strategies and the important position 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 offers customers with entry to a broader vary of efficient sunscreen choices that meet their numerous wants.”

Regulatory and market impression

For producers and suppliers, the SAFE Sunscreen Requirements Act might doubtlessly unlock a sooner path to marketplace for UV filters which can be already authorised overseas, notably within the EU and Asia-Pacific areas. It might additionally cut back growth prices by validating non-animal testing options.

Below 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, Training, Labor, and Pensions of the Senate detailing “the standing of implementation of proof and testing requirements for sunscreen energetic substances… and the progress of the Meals and Drug Administration in permitting nonclinical testing options to animal testing for the consideration of sunscreen energetic substances.”

These studies intention to boost visibility into the company’s dealing with of sunscreen ingredient evaluations underneath the up to date framework.

The invoice is now with committee and awaits additional motion. Corporations within the cosmetics and private care sector ought to monitor its progress and be prepared for potential changes to FDA overview procedures and formulation guidelines.