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

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.

More from Regulation

California’s Landmark Recycling Law Back To Drawing Board, Placing Industry In ‘Prolonged Period Of Uncertainty”

 

Single-use packaging producers subject to California’s SB 54 recycling law, which implements a statewide EPR plan, should continue to prepare for its implementation, even as they enter a ‘prolonged period of uncertainty,’ says consultant Michael Washburn.

Beauty Counterfeit Market Continues Surging On Fast-Evolving Criminal Rings

 
• By 

Counterfeit beauty products cost the US industry an estimated $3bn in 2023, says a trade expert during the Personal Care Products Council’s Beauty Collective Summit.

Cosmetics Stakeholders Urged To Petition Lawmakers As Tariff Threats Loom

 
• By 

Cosmetics companies brace for the impact of Trump administration tariffs as industry experts seeing an opportunity for an exemption urge stakeholders to reach out to lawmakers. The issue was discussed during PCPC’s recent Beauty Collective Summit.

Washington State Publishes Formal Draft Rule Targeting 28 Formaldehyde Releasers For 2027 Ban

 

The Washington Department of Ecology releases its formal draft rule under the Toxic Free Cosmetics Act listing 28 intentionally added formaldehyde releasers, with plans to adopt the rule this summer.

More from Policy & Regulation

MoCRA Stakeholders Should Identify Products Requiring Fragrance Allergen Disclosure – Regulatory Expert

 

Cosmetic companies should conduct audits to identify products that will be required to disclose fragrance allergens and begin the work of adjusting labels, particularly for smaller packaging, says a director at Registrar Corp., during a 12 March webinar on MoCRA and labeling.

Cosmetics Stakeholders Urged To Petition Lawmakers As Tariff Threats Loom

 
• By 

Cosmetics companies brace for the impact of Trump administration tariffs as industry experts seeing an opportunity for an exemption urge stakeholders to reach out to lawmakers. The issue was discussed during PCPC’s recent Beauty Collective Summit.

European Commission Takes First Step For CPR Revision In New Institutional Cycle

 

The European Commission is issuing a call for data on the Cosmetic Products Regulation, the first step in a process to evaluate and potentially revise the regulation.