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In March 2024, Valisure,[1] an independent, Connecticut-based laboratory, reported that it had found high levels of benzene — a known human carcinogen — in topical prescription and over-the-counter drugs that contain benzoyl peroxide. These drugs are commonly used to treat acne due to their bactericidal activity. Examples include ACANYA, BENZAMYCIN, CABTREO, DUAC, EPIDUO, EPSOLAY, ONEXTON, TWYNEO and generics.
Therefore, Valisure petitioned the Food and Drug Administration (FDA) to request...
In March 2024, Valisure,[1] an independent, Connecticut-based laboratory, reported that it had found high levels of benzene — a known human carcinogen — in topical prescription and over-the-counter drugs that contain benzoyl peroxide. These drugs are commonly used to treat acne due to their bactericidal activity. Examples include ACANYA, BENZAMYCIN, CABTREO, DUAC, EPIDUO, EPSOLAY, ONEXTON, TWYNEO and generics.
Therefore, Valisure petitioned the Food and Drug Administration (FDA) to request a recall and suspension of sales of benzoyl peroxide products in the United States, among other actions.[2]
Benzene has been linked to leukemia and other blood cell cancers.[3] It can enter the body through inhalation or ingestion of (or skin or eye contact with) products that contain this substance. Therefore, the FDA has determined that pharmaceutical products should not contain benzene.[4] However, the agency has stipulated that if benzene’s use is unavoidable in the production of a drug “with significant therapeutic advance,” its benzene content should not exceed two parts per million.
Valisure reported that it analyzed samples from 99 benzoyl peroxide acne products and 76 acne products with other active ingredients (such as salicylic acid or adapalene). All products were purchased from major retailers or licensed pharmaceutical wholesalers. At normal temperatures, 95% of the benzoyl peroxide products tested positive for benzene, often with values well above the FDA’s permissible limit. In contrast, the other 76 tested acne products had either no detectable benzene or had levels that were below the FDA’s permissible limit.
Moreover, Valisure reported that when stored for two weeks at less than 122 degrees Fahrenheit, some benzoyl peroxide acne drugs formed benzene at over 800 times the FDA’s permissible limit. Importantly, formed benzene can leak outside of intact benzoyl peroxide containers into the surrounding air, increasing the toxic reach of benzene and creating a serious inhalation risk.
The presence of benzene in benzoyl peroxide drugs does not appear to result from a contamination problem with other materials in these drugs, according to Valisure. Instead, the cause seems to be the inherent instability of these drugs, which break down into benzene.
The FDA should expeditiously respond to Valisure’s petition. Removing benzoyl peroxide products from the U.S. market would protect consumers from benzene-related cancer risks.
References
[1] Valisure. About us. https://www.valisure.com/about. Accessed July 9, 2024.
[2] Valisure. Valisure Citizen Petition on Benzene in Benzoyl Peroxide Drug Products. March 5, 2024. https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf. Accessed July 9, 2024.
[3] Ibid.
[4] Food and Drug Administration. Q3C — Tables and list: Guidance for industry (revision 4). August 2018. https://www.fda.gov/media/133650/download. Accessed July 9, 2024.
