In recent breaking news, concerns surrounding benzene contamination have resurfaced, sparking renewed health worries and heightened regulatory scrutiny.
Valisure LLC, an independent laboratory facility, has revealed the results of its extensive quality assurance testing on benzoyl peroxide (BPO), an FDA-regulated ingredient commonly found in products used to treat acne. According to their study, they found dangerously high levels of benzene, a known carcinogen, in numerous over-the-counter (OTC) and prescription skincare products containing BPO.
During their study, Valisure tested over 60 BPO products that are available for purchase over the counter or through prescription. These included creams, lotions, gels, and washes. The U.S. Food and Drug Administration (FDA) has previously imposed a limit on the concentration of benzene found in these products at 2 parts per million (ppm). The study, however, revealed that several on-market BPO products contain concentrations of benzene at over 12 times that limit.
Valisure also tested these products at higher temperatures in an effort to replicate how these products can break down over time. They found that when tested at higher temperatures, several products were found to contain over 800 times the FDA limit, which has sparked even higher levels of concern. According to their research, Valisure found that substantial amounts of benzene can form in a BPO product and leak outside the container into the surrounding air.
As a result of their findings, Valisure has issued a Citizen’s Petition to the FDA, demanding an investigation and market withdrawal of these BPO products with elevated levels of benzene. In the petition, they explain the decomposition of BPO into benzene and highlight their findings.
They revealed the results of their initial gas chromatography mass spectrometry (GC-MS) analysis on 175 acne treatment products with 99 containing BPO and 76 containing other ingredients (most commonly salicylic acid or adapalene). They found that all of the 76 non-BPO products had no detectable benzene or values below 2 ppm, but that 94 of the 99 BPO products did contain benzene. Upon further study of the stability of BPO products at 50°C over a period of 18 days, the products showed benzene levels ranging over 1,500 ppm in 2 of the products, over 100 ppm in 17 products, and over 10 ppm in 42 products.
LiVDerm Advisory Board Medical Chair, Christopher G. Bunick, MD, PhD, has stated,
"Dermatologists are waking up this morning to shocking news that the widely-used over-the-counter and prescription medicine benzoyl peroxide decomposes into the well-known carcinogen benzene. Benzene contamination has plagued numerous skin care products recently, but this time it is different. Millions of patients use over-the-counter or prescription acne products with benzoyl peroxide... Dermatologists will need to have serious discussions with their patients about the long-term safety risks of using these products having benzene."
Dr. Bunick goes on to say “There is not a safe level of benzene that can exist in any skin care product, over the counter or prescription. The current data on BPO degrading into high levels of benzene is extremely concerning given its prominent use in skin care, and this study should serve as another wake-up call for improved manufacturing and quality control of consumer healthcare products.”
As developments surrounding this more recent revelation on benzene contamination continue to unfold, we remain committed to keeping you informed with the latest updates and insights.
