Multiple acne treatment products, including Clearasil, Proactiv and Clinique, have been found to have an “unacceptably high” level of the carcinogenic chemical benzene, according to a report from an independent laboratory.
Connecticut-based laboratory Valisure issued a statement saying that it found levels of benzene 800 times over the regulatory limit during an independent study.
Benzene is a colorless, or light yellow liquid at room temperature. According to the CDC, Benzene works by causing cells not to work correctly. The chemical can cause bone marrow not to produce enough red blood cells, which can lead to anemia. Benzene can also damage the immune system by changing blood levels of antibodies and causing the loss of white blood cells.
Valisure said the high levels are caused by benzoyl peroxide decomposing into benzene over time when combined with other ingredients in the medication, and is not caused by any contamination, reports Pennlive.com.
“This discovery of benzoyl peroxide’s fundamental instability and formation of benzene is substantially different than Valisure’s previous findings of benzene in sunscreens, hand sanitizers and other consumer products,” said David Light, Valisure’s co-founder and president, in a statement. “The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; however, the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself, sometimes at hundreds of times the conditional FDA limit. This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action.”
In a statement, Reckitt, manufacturer of Clearasil, said it is “confident” that when “used and stored as directed on their labels as intended,” its products are safe.
“The safety and quality of our products is our top priority and we work closely with regulators around the world to ensure our products are safe and effective for their intended use,” the company said in a statement. The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions. The findings presented by an independent lab today reflect unrealistic scenarios rather than real-world conditions.”
According to Pennlive.com, Valisure has issued a petition to the Food and Drug Administration, asking the agency to issue a recall of these products.
An FDA spokesperson told CBS News that it had received the petition, and that “the agency acts on information provided from a variety of sources, but such data must be verified as accurate and reproducible before it can be utilized to make regulatory decisions such as recommending product sale suspensions and recalls, reports Pennlive.com. The agency will continue to provide updates to the public regarding benzene in drug products, as appropriate.
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