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Proposed Sunscreen Rule, Final MUsT Guidance Jumpstart Next-Gen UV Filter Discussions

 
• By Lauren Nardella

CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.

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Four years after the US Food and Drug Administration said data was insufficient to support the safety of bemotrizinol for inclusion in the OTC sunscreen drug monograph, the agency is meeting with ingredient supplier DSM Nutritional Products to discuss the firm's time and extent application for the UV filter.

The Royal DSM NV business requested a non-public meeting and sought the agency’s assurance of confidentiality in January. Kaiseraugst, Switzerland-based DSM Nutritional's correspondence stating the request to the...

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More from 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.

US FDA Finds Banned Cosmetic Ingredient Methylene Chloride In Gel Polish Removers

 
• By Lauren Nardella

Testing conducted by the US Food and Drug Administration has found several cosmetic products on the market that contain high levels of methylene chloride, a banned ingredient.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

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More from Policy & Regulation

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.

Beauty Firms Confused By State EPR Laws Have New Resource: EPR Academy

 
• By Eileen Francis

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Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 
• By Malcolm Spicer

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.