Concerns have lingered regarding the stability of benzoyl peroxide (BP) products and their potential to break down into benzene, a known carcinogen. Recent research underscores the importance of formulation in determining benzene levels. In a noteworthy finding, a weak but statistically significant correlation has been established between the days until expiration and benzene concentration. Furthermore, hot processing conditions appear to increase benzene concentrations, while the use of antioxidants like BHT is associated with decreased levels.
A study examining 111 over-the-counter BP products revealed a median benzene concentration of 0.89 parts per million (ppm), well within the US Food and Drug Administration's (FDA) limit of 2 ppm. Interestingly, leave-on products demonstrated significantly lower benzene concentrations compared to other types. The research indicates that each 100 days of storage at room temperature results in an increase of less than 1 ppm of benzene.
David Light, co-founder and president of Valisure, emphasized the role of formulation in benzene content, aligning with previous findings from his company. He stated:
"Benzoyl peroxide products are unstable and form benzene. Formulation is likely the strongest contributor to benzene content in benzoyl peroxide drug products."
- David Light, co-founder and president of Valisure
Valisure has taken proactive steps by filing patents on shelf-stable formulations of BP and methods for producing them. Despite these advancements, Light expressed concerns about the presence of benzene, advocating for its elimination or substantial reduction.
"We think the presence of benzene is extremely concerning and should be eliminated or at least substantially reduced."
- David Light, co-founder and president of Valisure
The research highlights that no significant association exists between BP concentration and benzene concentrations. Instead, the production process and ingredient composition play significant roles in benzene levels. Light reiterated:
"The idea that formulation has a big impact on benzene formulation, we absolutely agree with."
- David Light, co-founder and president of Valisure
In light of these findings, John S. Barbieri, MD, MBA, suggested that benzene is not forming at room temperature to any significant degree.
"That suggests benzene is not forming at room temperature at any meaningful degree."
- John S. Barbieri, MD, MBA
However, Barbieri believes manufacturers should reformulate with an aim to reduce benzene formation, although he notes a lack of substantial action from manufacturers or the FDA.
Henry W. Lim, MD, adds another perspective by acknowledging multiple factors that could cause a slight increase in benzene levels. Despite this, he reassures that dermatologists remain confident in recommending BP products.
"Most dermatologists are very, very comfortable to recommend these benzoyl peroxide products."
- Henry W. Lim, MD
Valisure researchers emphasized the potential risks associated with benzene exposure during BP product use, independent of starting concentrations.
"Results suggest that potential benzene exposure from formation during BPO drug product use poses significant risks independent of the starting benzene concentration."
- Valisure researchers
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