FDA’s MUsT Draft Guidance Extends Challenge To Wider OTC Drug Industry

It’s known that challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors of late, but new draft guidance from the agency signals that MUsTs will be expected generally from companies looking to add topical ingredients to OTC drug monographs.

female scientist working with microscope

Newly released draft guidance from FDA underscores the agency’s increasing reliance on maximal usage trials (MUsTs) to support topical ingredients’ inclusion in OTC drug monographs.

More from Regulation

Beauty In 2025: Changes, Regulations, Trends Shaping The Year Ahead

 

Beauty industry insiders from trade associations and attorneys specializing in marketing law and/or cosmetics manufacturing look forward to a more business-friendly FTC in the US in 2025, while they expect industry to face an increasing number of challenges at the state level. Meanwhile, the EU beauty market is hopeful it will see reduced regulations this year.

OCAC Director Katz’ Legacy: Moving Cosmetics Regulation Into Modern Era

 
• By 

Linda Katz, director of the Office of Cosmetics and Colors at the US Food and Drug Administration, is credited with leading efforts toward modernization of cosmetics regulations as she retires after 22 years at the helm.

FDA Publishes Long-Awaited Talc-Testing Proposal Under MoCRA

 

FDA publishes the first proposed rule under the Modernization of Cosmetics Regulation Act – a testing method for detecting asbestos in talc-containing cosmetics.

MoCRA Education Deficit; Regulation Still Unknown To Many Small US Beauty Firms, Imported Brands

 

Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.

More from Policy & Regulation

FDA Publishes Long-Awaited Talc-Testing Proposal Under MoCRA

 

FDA publishes the first proposed rule under the Modernization of Cosmetics Regulation Act – a testing method for detecting asbestos in talc-containing cosmetics.

WA Regulators Open Rulemaking On Cosmetic Lead Limits; Provide Safe Harbor Under TFCA

 

The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’

MoCRA Education Deficit; Regulation Still Unknown To Many Small US Beauty Firms, Imported Brands

 

Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.