1. HBW Insight
  2. >>Beauty
  3. >>Policy & Regulation
  4. >>Regulation

MoCRA Check-In: Postscript To My Three Minutes At US FDA's Cosmetics GMP ‘Listening Session’

 
• By John Bailey

EAS Consulting Group’s John Bailey is checking in with HBW Insight periodically in 2023 to offer his views on developments under the US Modernization of Cosmetic Regulations Act of 2022. Here he provides his experience with, and takeaways from, the US FDA’s 1 June virtual “listening session” on good manufacturing practices for cosmetic products.

MoCRA Check-In
• Source: Shutterstock

Among the many provisions enacted by the Modernization of Cosmetics Regulations of 2022 (MoCRA) is the requirement that FDA promulgate regulations that establish Good Manufacturing Practices (GMPs) specifically for cosmetics.

This is a long, multistep process that will be challenging for FDA to complete by the required deadline. It is important to understand that, as with drugs and foods, GMP regulations impose a heavy burden on the regulated industry. FDA will enforce the new GMPs regulation primarily through establishment inspections

MoCRA GMP Provisions

Under MoCRA, FDA is directed to do the following:

  • By regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards;

  • Ensure that the regulations protect the public health and ensure that cosmetic products are not adulterated;

  • Inspect records necessary to demonstrate compliance with GMPs during an inspection conducted under section 704 (establishment inspections);

  • Include simplified GMPs for smaller businesses;

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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

US Fragrance Firms Should Identify Domestic, Non-Tariff Sources Now – Fragrance House CEO

Firms in the US facing tariff costs should identify US-based, non-tariff sources and lobby local government officials and DC when foreign-sourced ingredients cannot be substituted in the US.

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.