Regulation

Animal Testing Alternatives Need Central Office At US FDA, Science Board

Animal Testing Alternatives Need Central Office At US FDA, Science Board

 

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.

New Era For CIR: Expert Panel Meets As Mandatorily Reported Ingredient Data Pours In From FDA

New Era For CIR: Expert Panel Meets As Mandatorily Reported Ingredient Data Pours In From FDA

 
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Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines.

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Washington State TFCA Stakeholders: Don’t Hold Your Breath For Higher Lead Limit

Washington State TFCA Stakeholders: Don’t Hold Your Breath For Higher Lead Limit

 

Toxic-Free Cosmetics Act planner Shari Franjevic acknowledges the Washington State Department of Ecology is authorized to use enforcement discretion regarding the new law’s 1ppm limit on trace lead in cosmetic products, effective 1 January 2025, or raise the ceiling via rulemaking. But it does not seem inclined to do either based on data known to the department at present. 


EU’s Chemicals Strategy Demands Cosmetics Industry Transparency, Public Outreach

EU’s Chemicals Strategy Demands Cosmetics Industry Transparency, Public Outreach

 

Cosmetics Europe’s John Chave highlights the important role that industry must have in educating the public about chemicals used in cosmetic products. The association’s COSMILE Europe database launched last year is one such measure to combat misinformation while industry braces for potential impacts resulting from new hazard categories under the Classification, Labeling and Packaging (CLP) regulation.

EU Revision Of Cosmetic Products Regulation Uncertain In New Institutional Cycle

EU Revision Of Cosmetic Products Regulation Uncertain In New Institutional Cycle

 

Cosmetics Europe hopes a more “competitive” spirit will define the 2024-2029 regime. Director-general John Chave discusses the association’s outlook on planned revisions to REACH and the Cosmetic Products Regulation in the new EU institutional mandate.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

 

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.


EU’s Risk Assessment Committee Adopts Opinion Classifying Talc As 1B Carcinogen

EU’s Risk Assessment Committee Adopts Opinion Classifying Talc As 1B Carcinogen

 
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The RAC opinion begins the process of prohibiting use of talc in cosmetic products marketed in the EU. A consultation period will follow the Commission’s preparation of a delegated act.

Attention, Industry! Colorado EPR Registration Deadline For Packaging Producers Is Days Away

Attention, Industry! Colorado EPR Registration Deadline For Packaging Producers Is Days Away

 

Single-use packaging producers should heed the 1 October deadline in Colorado’s EPR law for paper and packaging to register with Circular Action Alliance lest they face enforcement action, said an advisor for that organization, which is leading the program’s administration, at IBA’s Cosmetics Convergence Fall 2024 Virtual Symposium.

Senate Hemp Regulation Bill Offers Option To House’s Blanket Limit On Levels Of All THCs

Senate Hemp Regulation Bill Offers Option To House’s Blanket Limit On Levels Of All THCs

 

Democrats Wyden and Merkley author Cannabinoid Safety and Regulation Act to limit sales to consumers 21 and older and authorize FDA to order recalls and impose bans on cannabis products with dangerous chemicals or additives. It also would establish regulatory structure for using cannabinoids found naturally in hemp and allowing “semi-synthetic” ingredients while prohibiting artificial or fully synthetic cannabinoids.

Asking For More: Supplement MPL Authority For FDA, Agency Results For Congress, Industry

Asking For More: Supplement MPL Authority For FDA, Agency Results For Congress, Industry

 

Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.


2024 US Presidential Election: Implications For Beauty Industry

2024 US Presidential Election: Implications For Beauty Industry

 

The US' approach to international trade and potential for new tariffs on China or other partners could be the most significant issue for the beauty industry ahead of the presidential election in November, experts suggested at the Independent Beauty Association’s Cosmetics Convergence Fall 2024 Symposium.

‘We Aren’t Nibbling Around The Edges’: FTC’s Sam Levine On Taking Big Bites Out Of National Challenges

‘We Aren’t Nibbling Around The Edges’: FTC’s Sam Levine On Taking Big Bites Out Of National Challenges

 

The Federal Trade Commission’s Consumer Protection head Sam Levine says bipartisan leaders at the state and federal levels are taking on consumer protection issues like never before and using the FTC’s approach as a model for legislation.

Fresh From The CHPA Regulatory Conference Stage

Fresh From The CHPA Regulatory Conference Stage

 

In addition to commentary and information about the OTC drug, dietary supplement and cosmetic industries, speakers offered candid remarks on subjects well known across the consumer health industry or well recognized by consumers.

US FDA Action On Benzene Levels In Acne Products Demanded By New Citizen Petition

US FDA Action On Benzene Levels In Acne Products Demanded By New Citizen Petition

 
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Filed on 20 August by Pensacola, FL-based law firm Aylstock, Witkin, Kreis & Overholtz (AWKO) on behalf of an unnamed client, the petition points to benzene study data unconnected to Valisure on unheated benzoyl peroxide products, but is light on details of how it was conducted.


In Largest FDA Reorg, More Help Available For Supplement Programs’ ‘Little Tiny Workforce’

In Largest FDA Reorg, More Help Available For Supplement Programs’ ‘Little Tiny Workforce’

 

Reorganization creating in Human Foods Program makes the work of additional staff available for dietary supplement office programs. FDA’s “got a little tiny workforce” for “a huge industry,” says Commissioner Robert Califf.

Post-MoCRA, US Cosmetics Legislative And Regulatory Footprint Goes On Expanding

Post-MoCRA, US Cosmetics Legislative And Regulatory Footprint Goes On Expanding

 

The Independent Beauty Association says the towering demands posed by new, diverse legislation and regulations – especially at the US state level – have led it to partner with a consultancy that specializes in policy and global intelligence to provide industry-critical insights to the organization and help track bills.

Keeping Score In Drug Development And Innovation Game? Look To US FDA As The Referee – Califf

Keeping Score In Drug Development And Innovation Game? Look To US FDA As The Referee – Califf

 

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

California DTSC Proposes Narrow Focus For 1,4-Dioxane Listing, Alignment With NY Threshold

California DTSC Proposes Narrow Focus For 1,4-Dioxane Listing, Alignment With NY Threshold

 
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Present as a contaminant in some personal care and cleaning products, 1,4-dioxane continues to be a concern for California’s Department of Toxic Substances Control under the state’s Safer Consumer Products regulation despite limits already imposed on 1,4-dioxane content in those product categories by New York.