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US Petition Claims Benzene Forms In Benzoyl Peroxide, Requests Market Removal Of Acne Drugs

Petition Asks For US Market Removal Of Widely Used OTC Acne Remedy Benzoyl Peroxide

 
• By Malcolm Spicer

Valisure recommends FDA request recall and halt sales of products containing benzoyl peroxide due to its propensity to form the benzene. Products include numerous OTC monograph topical formulations as well Rx drugs with an acne indication available through approved applications.

Valisure presented this diagram in its 2024 citizen petition to FDA emphasizing its argument benzoyl peroxide is "well known to decompose into benzene." • Source: Valisure

The active ingredient in dozens of OTC topical acne remedies is the latest drug that an analytical laboratory which tests for potential carcinogens in finished pharmaceutical products is asking the Food and Drug Administration to remove from the US market.

Valisure LLC on 5 March submitted a citizen petition recommending the FDA request a recall and halt sales of products containing benzoyl peroxide due to the drug’s propensity to form the known human carcinogen benzene. The products include numerous topical formulations for acne treatment available through the agency’s

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• By Lauren Nardella

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• By David Ridley

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

 
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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.

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• By Eileen Francis and Lauren Nardella

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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.”