Regulation

Cosmetics Europe: Wastewater Directive Cost Imbalance Will Be Resolved In Court

 
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The European Commission’s recent environmental omnibus failed to address industry concerns on wastewater cost allocations, and legal pathways are expected to be the way forward.

US FDA Warns Private Labeler For Quality Violations

 
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Private Label Skin Care Inc. has violated Current Good Manufacturing Practice regulations for pharmaceuticals, according to the agency.

FDA Publishes Draft Guidance On Mandatory Cosmetic Recalls Under MoCRA

 

FDA’s draft guidance on mandatory cosmetic recalls under MoCRA signals how the agency plans to exercise its new recall authority and urges companies to strengthen compliance, recall readiness and rapid response procedures.

PFAS Data Gaps Hamper FDA’s Ability To Assess Exposure Risk In Cosmetics – Agency Report

 

The US FDA issued a report on PFAS, as mandated by Congress under the Modernization of Cosmetics Regulation Act, on Dec. 29, concluding that the safety of most PFAS cannot be established due to a lack of available data.


Can US FDA Balance Inspection Generalists And ‘Simple Reform’ With Need For Expertise?

 
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Former agency officials now representing industry worry that a deregulatory bent could be driving "Simple Reform" plan to merge all medical product and clinical research inspectorates and that specialist expertise gained in 2017 "Program Alignment" initiative will be reversed.

Colorado EPR Program Countdown Begins After State Approves Final Plan

 

The Colorado Department of Public Health and Environment approved Circular Action Alliance’s final plan for the state’s Extended Producer Responsibility program on Dec. 9.

Slow Burn For US Sunscreen Innovation While FDA Lights Lamp For Monograph Overhaul Deadlines

 

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.

US FDA Brings Rx Generics Marketers Up To Date On OTC Switch Regulatory Landscape

 

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.


FDA Withdraws Proposed Rule On Talc, Citing MAHA Priorities, ‘Complexity’ Of Asbestos Testing

 

The US FDA announces in a Nov. 28 Federal Register notice that it will withdraw its proposed rule under MoCRA for testing asbestos in talc-containing products, but remains committed to meeting its statutory requirements under the law.

Congress’ OMUFA Reauthorization A Win For Sunscreen Non-Animal Testing, Innovation – Industry

 

Congress’ reauthorization of OMUFA for five years includes measures that promote non-animal testing for sunscreen, a broadening of the evidence that can be used to support safety and additional funding for MoCRA.

EPR-Impacted Producers: Budget Early, Consider Other State Programs Before Repackaging

 

Consultants urge packaging producers to forecast and budget now for the fees of state EPR programs, particularly as fees from the Oregon program hit and surprise many firms and expose gaps in internal budgeting and planning. The topic was discussed at IBA’s Cosmetics Convergence 2025 conference.

US FDA’s Delay of Cosmetic GMP Rule, Communication Style Raises Litigation Concerns – Attorneys

 

The US FDA’s decision to move its long-awaited cosmetic GMPs rule to ‘Long-Term Actions’ under MoCRA likely delays a final rule for at least five years, raising the risk of increased state regulation and private litigation, say attorneys speaking during the 2025 PCPC Science Symposium & Expo


‘You Are Very Regulated’: Consumer Health And Beauty Industries’ Attention Needed In California

 

Regulations likely holding consumer product firms’ attention include the Plastic Pollution Prevention and Packaging Producer Responsibility Act, SB 54, scheduled to become effective by 2027. “Easily the most significant, extended producer responsibility law ever to pass in the world,” says lobbyist

US FDA Independence Questioned At CDC Oversight Hearing

 

A Senate committee is investigating leadership changes at the US Centers for Disease Control and Prevention. While the primary focus is vaccine policy, the first hearing suggested the probe could raise questions about FDA independence.

WA State Retailers Disposing Of TFCA Non-Compliant Beauty Items Must Abide By Waste Disposal Law

 

Retailers selling beauty products in the state of Washington who plan to dispose of unpurchased products by Jan. 1 must follow the state's Dangerous Waste Reduction law, which categorizes waste generators as small, medium or large.

US FDA Facility Inspections, Website Reviews Paused With FY 2026 Budget On Hold

 

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.


Washington State Urges Early Industry Input on Lead Rule to Avoid 1ppm Limit Fallback

 

The Washington Department of Ecology will begin collecting feedback for its rulemaking on lead limits for cosmetics under the Toxic Free Cosmetics Act early next year, and industry’s response throughout the process will be critical to determine the outcome.

US FDA Notes Honey Drops Eye Care, Nasal Spray Brain Boost In Recent Warning Letters

 

Recent FDA warning letters hit typical problems in consumer health space such as manufacturing quality control deficiencies, but also note honey offered for eye infections and nasal spray to enhance cognitive function.

Science Does Not Support TiO2 Carcinogenicity Measures In California, EU – Courts

 
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In separate cases in California and Europe, courts reached similar conclusions regarding the potential carcinogenicity of titanium dioxide in respirable form and its impact on regulations.

Washington State Adopts Nation’s Largest Ban On Formaldehyde-Releasing Chemicals In Cosmetics

 

Washington regulators announce restrictions on intentionally added formaldehyde releasers take effect Jan. 1, 2027, with retailers having until Jan. 1, 2028, to sell through existing stock.