Last week, the US Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously advanced S.2292, the Over-the-Counter Monograph Drug User Fee Amendments Act. The bipartisan bill includes provisions to accelerate the review of innovative over-the-counter (OTC) products, including sunscreen filters that are already approved in other countries but are currently unavailable to US consumers.
Industry and medical community welcome regulatory updates
The legislation, which reauthorizes FDA’s OTC Monograph User Fee Program (OMUFA), was met with strong support from cosmetics and personal care product industry stakeholders and public health advocates. emphasized the bill’s public health significance.
In a statement to CosmeticsDesign US, Jane Yoo, MD, Assistant Clinical Professor, Department of Dermatology at Icahn School of Medicine at Mount Sinai shared, “It’s clear that more needs to be done to address this pressing public health issue and making new sunscreen innovations accessible here in the US does just that.”
She added, “I’m encouraged by the proposed legislation and its recent revisions, [as] it holds great promise in improving patient outcomes and protecting the skin health of people, young and old, as well as those of diverse backgrounds and skin types across the country.”
Carl D’Ruiz, Head NA Beauty & Care Science Advocacy and Business Development at dsm-firmenich, highlighted the bill’s broader implications for global competitiveness.
“H.R. 4273 reauthorizes the FDA’s OTC user fee program, enabling more timely review of innovations, including advanced sunscreens that align with global standards,” he said. “These reforms will not only enhance product safety and efficacy, but also strengthen the US position in the global health and wellness market.”
Support for modern testing and faster sunscreen filter approvals
S.2292 includes language to expand FDA’s use of non-animal testing methods and allow historical data to be considered in sunscreen filter reviews, which are welcome changes for industry trade organizations.
“The Personal Care Products Council (PCPC) and our member companies applaud the…HELP Committee on the passage of S.2292,” PCPC stated in a press statement. “We also commend the committee’s commitment to advancing non-clinical testing methods… and moving away from outdated and inhumane animal testing requirements.”
The statement added, “These critical improvements will accelerate US consumers’ access to the most advanced, effective and safest sunscreen UV filters and strengthen global competitiveness.”
CHPA urges final clarification on GRAS/E standards
The Consumer Healthcare Products Association (CHPA) also praised the bill’s provisions, but urged lawmakers to include clarification on the “Generally Recognized as Safe and Effective” (GRAS/E) standard in the final version of the legislation.
“CHPA applauds Senators…and the Senate HELP Committee for advancing bipartisan policies that promote innovation, safety, and access across the self-care space,” the organization said in a media statement. “While today’s progress on this legislation in the Senate is meaningful, it’s imperative Congress take action to ensure this bill reaches its full potential by including clarification of the Generally Recognized as Safe and Effective (GRAS/E) standard.”
According to CHPA, the lack of regulatory clarity under the current GRAS/E framework continues to impede innovation in the OTC monograph system. The organization cited the withdrawn but noted amendment from Senator Andy Kim (D-NJ) as a signal that further action is expected during House-Senate negotiations.
With Senate committee approval secured, S.2292 now heads toward further congressional deliberation.
