CHPA Recognizes First OMOR Milestone Under OMUFA as FDA Advances Sunscreen Innovation Efforts

(WASHINGTON, D.C.) - The Consumer Healthcare Products Association (CHPA) today acknowledged a significant regulatory milestone following the U.S. Food and Drug Administration's (FDA) announcementto advance sunscreen innovation under the Over-the-counter (OTC) Monograph System. This development marks the first OTC Monograph Order Request (OMOR) to progress under the recently reauthorized Over-the-Counter Monograph User Fee Act (OMUFA), a long-anticipated step since the program was first established in 2020.

"The issuance of the first proposed administrative order based on an OMOR submission is an important regulatory milestone that demonstrates the modernized monograph process is beginning to produce the results that Congress intended when it enacted OMUFA in 2020," said CHPA President & CEO Scott Melville. "Today's action represents meaningful forward momentum toward bringing innovative sunscreen filters to U.S. consumers. And with OMUFA recently renewed by Congress for another five years, CHPA hopes this milestone signals a sustained period of OTC innovation, as a functioning and responsive monograph system is essential to ensuring Americans have timely access to modern, science-backed self-care options. CHPA and its member companies look forward to continued engagement with FDA as additional OMOR submissions move through the regulatory process and the promise of a reformed monograph system is realized."

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and OTC medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.