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FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands

 
• By Eileen Francis

OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.

Unfair advantage

Continuation of the “one size fits all” annual fee for facility registration and over-the-counter monograph order requests (OMORs) in the OTC Monograph Drug User Fee Program – without any small business considerations – may force out some small contract manufacturers, threatening to create a manufacturing bottleneck and fewer product choices, says the Independent Beauty Association.

IBA senior director of technical and regulatory affairs Meredith Petillo addressed the issue at a 28 September public meeting held...

More from Regulation

More from Policy & Regulation

House Bill Aims to ‘Modernize’ US FDA’s Review Process For Sunscreens

 
• By Eileen Francis

Four co-chairs of the House of Representatives’ Skin Cancer Caucus have introduced the Safe Sunscreen Standards Act to direct FDA to establish clearer, ‘more flexible’ standards for evaluating sunscreen ingredients.

Beauty Industry: Counter Impact Of State Legislation By Connecting With Lawmakers – IBA

 
• By Eileen Francis

Beauty stakeholders will undoubtedly feel the impact of new state laws targeting cosmetic ingredients and packaging and should therefore open lines of communication with state lawmakers.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.