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FDA’s Sunscreen Regulatory Approach Misaligned With Its Public Health Messaging, Trade Groups Say

 
• By Eileen Francis and Ryan Nelson

The Personal Care Products Council and Consumer Healthcare Products Association say FDA’s tentative final sunscreen monograph and related communications have given rise to confusion that could lead to reduced sunscreen use and negative public health consequences. The groups go one further: FDA should reissue a tentative final monograph proposing that the 12 chemical UV filters currently in question are GRASE.

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Since the US Food and Drug Administration issued its tentative final monograph for OTC sunscreen drug products in February, designating 12 currently marketed chemical UV filters as Category III (additional data needed), the media has been awash with headlines reflecting various reads on the proposed rule’s significance.

Interpretations among public health advocates include “FDA Admits Most Sunscreens Are Probably Unsafe,” while the Environmental Working Group received...

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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.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

More from Policy & Regulation

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

 
• By Malcolm Spicer

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu