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Industry Seeks FDA Flexibility Around MoCRA Registration And Listing; Attorneys Discuss

 
• By Eileen Francis

Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.

• Source: Shutterstock (Shutterstock)

Stakeholders commenting on the US Food and Drug Administration’s draft guidance on registration and listing requirements under the Modernization of Cosmetics Regulations Act (MoCRA) will urge the agency to use enforcement discretion as concerns grow over the approaching year-end deadline.

Two attorneys who spoke with HBW Insight on 10 August, three days after the

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More from Regulation

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

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

European Commission’s Omnibus VII Bans Two Nail Care Ingredients Starting In September

 
• By Eileen Francis

Two nail care ingredients included in the European Commission’s Omnibus VII, which includes about two dozen ingredients overall, are banned in Europe in September.

More from Policy & Regulation

Cosmetics Consortium Shares Studies With FDA To Build Confidence In Animal Testing Alternatives

 
• By Lauren Nardella

By guiding regulators through case studies and mock dossier examples of how to utilize new approach methodologies, the International Collaboration on Cosmetics Safety hopes to counter hesitations in replacing animal tests.

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
• By Eileen Francis and Lauren Nardella

The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.

Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”