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FDA Scorches Sunscreen Wipe Marketers With October Warning Letters

 
• By Ryan Nelson

Inspections conducted over the past year may have contributed to a wider FDA crackdown on unapproved sunscreen drug products – specifically those in dosage forms deemed ineligible under OTC drug review for inclusion in the sunscreen monograph – with five marketers targeted so far this month with warning letters.

FDA has issued at least five warning letters in October to marketers of sunscreen wipes and other dosage formats considered ineligible for OTC sunscreen drug review, making their offerings unapproved drugs.

Recipients include Colabs Intl. Corp., Diamond Wipes International, Inc., ITW Dymon, SCS Direct Inc. (the holding company of MD MOMS LLC) and PhytoCeuticals, Inc., according to the

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More from Regulation

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

 
• By Lauren Nardella

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

 
• By David Ridley

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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

 
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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.