US FDA Action On Benzene Levels In Acne Products Demanded By New Citizen Petition

Filed on 20 August by Pensacola, FL-based law firm Aylstock, Witkin, Kreis & Overholtz (AWKO) on behalf of an unnamed client, the petition points to benzene study data unconnected to Valisure on unheated benzoyl peroxide products, but is light on details of how it was conducted.

• Source: Shutterstock (Shutterstock)

A new citizen petition asking the US Food and Drug Administration to ban benzoyl peroxide products due to benzene exposure concerns cites a new study that detected excessive benzene levels in products tested at room temperature.

The petition follows objections raised by industry stakeholders regarding Valisure LLC’s similar petition filed in March, which relied on stability testing of 66 benzoyl peroxide products conducted at 50°C (122°F) to demonstrate high levels of benzene and drew criticism for relying on modified US Pharmacopeia methods and procedures

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

More from Regulation

More from Policy & Regulation

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

 
• By 

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.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By 

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

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

 

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.”