1. HBW Insight
  2. >>Beauty
  3. >>Policy & Regulation
  4. >>Regulation

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

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.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

French SME association COSMED will push the European Commission for a “clear checklist” and criteria on how substances in the Cosmetic Products Regulation are assessed by Member States, as well as more clarity on the exemption process and timelines.

US FDA Expert Panel Paints Bleak Picture For Future Of Talc In Cosmetics

 
• By Eileen Francis

The US FDA’s 20 May expert panel on talc discussed science behind the potential carcinogenicity of the cosmetic, food and drug ingredient, the importance of ‘good science’ in evaluating the substance and the need to find alternatives in each industry.

More from Policy & Regulation

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.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

IBA Interactive Policy Map Is Call To Action As Cosmetics Industry Braces For Myriad Of State Bills

 
• By Eileen Francis

The Independent Beauty Association has launched an interactive Policy Map tracking state and federal bills and filtering by state or topic, pinpointing bills of great priority.