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User Fees Could Chafe Cosmetics In OTC Monograph Reform Proposal

 
• By Malcolm Spicer

Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.

Personal care and cosmetic product manufacturers should take note that legislation on reforming FDA's OTC drug monograph program with a user fee program might regain momentum, says regulatory consultant David Steinberg.

Steinberg, president of Plainsboro, N.J.-based Steinberg & Associates Inc., a consultancy specializing in the OTC drug and personal care industries,...

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More from Legislation

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.

Cosmetics Industry: Push Congress To Apply Pressure On MoCRA – Attorney

 
• By Eileen Francis

The US cosmetics industry, particularly small- and medium-sized businesses, should reach out to their representatives in Congress to encourage pressure on the US Food and Drug Administration to implement cosmetics reform, despite agency staff cuts.

No Longer Voluntary, MoCRA Drives Drastic Increase In Registered Companies, Products

 
• By Lauren Nardella

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

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

 
• By Eileen Francis

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.’

More from Policy & Regulation

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.

Beauty Industry Not Taking Advantage Of CBP’s Duty Drawback – IBA Conference

 
• By Eileen Francis

US Customs and Border Protection’s program allowing companies to recoup fees for imported goods that were destroyed or exported is applicable in the case of most of President Trump’s reciprocal tariffs. However, most cosmetic companies don’t make use of it.