The latest federal spending package delivers a long-awaited shift in how the United States regulates over-the-counter sunscreen ingredients. Folded into H.R. 5371, which President Trump signed on November 12, are new mandates that broaden the evidence FDA can rely on, require progress reporting on nonclinical testing alternatives and set the parameters for the forthcoming sunscreen final administrative order.
For manufacturers and suppliers, the changes signal movement on issues that have stalled UV-filter innovation for more than a decade.
New federal requirements for OTC sunscreen oversight
H.R. 5371 revises FDA’s annual reporting timeline for monograph activity. The statute directs that “Not later than 120 calendar days after the end of each fiscal year” the agency must issue its report, the legislation stated, “by striking ‘section 3861(b) of the CARES Act’ and inserting ‘section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments’.”
Beginning in fiscal year 2026, FDA must expand the detail included in these reports. The act requires disclosures on the number of proposed and final orders across Tier 1, Tier 2, specified safety and GRASE finalization categories, as well as “the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year,” the text stated.
The report must also include updates on adverse event surveillance, analytical tool development, facility registrations and fee payments.
The law establishes new evidence and testing standards for topical active ingredients. It directs that the Secretary shall “utilize standards that allow for the use of real-world evidence, as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients,” according to the legislation.
FDA must also consider alternatives to animal testing, and the act notes that the Secretary shall “consider the types of nonclinical tests described in paragraphs (1) through (4) of the first subsection (z) of section 505, or any other alternative to animal testing that the Secretary determines appropriate,” the bill stated.
For sunscreen, the forthcoming final administrative order must “account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States,” the legislation added, while incorporating evidence standards consistent with SPF 15 and higher broad-spectrum protection.
Industry reactions
Implications for nonclinical testing
Stakeholders across safety science say the updates could make sunscreen development more feasible for US manufacturers. CosmeticsDesign spoke to industry expert Dr. Jane Yoo, who said the change is notable because “FDA now has to issue annual reports regarding the agency’s progress in allowing non-clinical testing alternatives to animal testing for the consideration of sunscreen active ingredients,” adding that companies have faced substantial cost and feasibility concerns when relying on legacy testing requirements.
The timing of implementing alternative methods is also drawing attention. Dr. Yoo said, “within a year of the law’s enactment, FDA must issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards for sunscreen products,” noting that several laboratory platforms, including skin-on-chip technologies, are already available.
Dr. Yoo said the law also strengthens expectations for how FDA evaluates sunscreen ingredients. She said “the new law must now: (i) account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States; (ii) account for the role of broad spectrum sunscreens with a SPF of 15 or higher in effective skin cancer prevention; and (iii) incorporate the certain evidence and testing standards for sunscreen active ingredients, including real world evidence.”
Trade group perspective
In a statement, industry association Personal Care Products Council (PCPC) said the legislation reinforces the importance of a modernized regulatory framework. The organization and its member companies “applaud the passage of H.R. 5371, which includes full-year funding for the U.S. Food and Drug Administration (FDA),” the statement said, adding that the measure supports the agency’s ability to safeguard public health while fostering innovation.
PCPC also highlighted the evidence flexibility introduced under the updated OTC monograph program. The organization said “the OMUFA reauthorization includes critical language enabling FDA to consider broader evidence when evaluating the safety and efficacy of topical products such as sunscreen,” adding that this contributes to ongoing work toward acceptance of non-animal methods.
The group also pointed to broader industry regulatory priorities supported in the bill. PCPC said H.R. 5371 includes dedicated funding for FDA to continue MoCRA implementation, along with a requirement for a congressional report on Good Manufacturing Practices and fragrance allergen labeling rulemaking.
Advocacy groups push for rapid adoption
Advocacy groups focused on animal-free testing say Congress’ direction to FDA reflects rising expectations for nonclinical science. Jeffrey Brown, a PETA scientist, said in a press statement that the vote demonstrates that “Congress agrees with PETA and tens of thousands of PETA supporters.”
Brown continued: “the FDA must prioritize non-animal test methods for evaluating sunscreens and must expand access to modern, effective sunscreens to enhance protection against skin cancer,” adding that the group met with lawmakers earlier this year.
Noting that scientific tools needed for such a shift are already established, he said, “we have sent multiple letters to the agency, urging it to act swiftly by collaborating with sunscreen manufacturers and other scientific experts who have spent decades developing reliable cell- and computer-based test methods to assess sunscreen safety,” adding that human-relevant approaches could reduce reliance on outdated animal models.
The legislation further reinforces expectations for the agency, and the FDA “must fulfill its responsibility to use the best, most human-relevant science to protect the public, rather than insisting that companies conduct decades-old animal tests that have been shown not to protect human health,” he asserted.
