Organizations respond to citizen petition regarding benzene findings
Independent lab Valisure recently reported its findings from a study on how benzene can format in high levels of benzoyl peroxide acne treatment products. As a result, the company launched a citizen petition urging the FDA to take action on the products currently sold on retail shelves.
Since then, various organizations and the American Academy of Dermatology Association have shared their thoughts on the matter, issuing statements and showcasing next steps consumers can take if concerned about the findings.
USP, an independent scientific organization that works with experts in health and science, issued a lengthy statement on the matter.
USP’s response:
“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously. Full transparency around the testing methods is also needed to understand the accuracy of these results. Only results from validated methods applied appropriately should be used to judge the quality of a medicine. As noted in USP’s recent white paper, results from non-validated tests may be misleading, have negative impacts on the behavior of health plans and patients, and can result in drug shortages and reduced patient adherence to their treatment regimens.”
“The third-party laboratory used a practice known as accelerated thermal degradation in its study, which is when the storage temperature of the product is increased to greater than label-indicated conditions to simulate degradation over a longer period. Accelerated thermal degradation may be an acceptable study. However, we cannot confirm that the elevated temperatures chosen in the study design (50 to 70° Celsius for a period of up to 18 days) reflect the changes expected to occur in the drug products under conditions of use and storage per the label.”
“If excessive temperatures are used, the degradation may differ from what occurs under the recommended conditions of the label. The third-party laboratory demonstrated that stressed storage conditions outside the labeled recommendations can prompt product degradation, which is well-known and why manufacturers indicate storage conditions for products. Limited stability studies under labeled conditions should be used to confirm the validity of temperatures chosen for accelerated degradation and determine if benzene would still appear in the drug products above the USP pharmacopeial limit of NMT 2 ppm. The petition does not provide details of such study.”
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The Consumer Healthcare Products Association, an educational foundation that offers information and guidance on how to safely use, store and dispose of OTC products, also chimed in on the topic.
CHPA’s statement:
“Consumers can be confident that over-the-counter (OTC) acne products containing benzoyl peroxide (BPO) are stable and safe under the specified storage conditions on their labels. The findings presented in the Citizen Petition were based on unrealistic situations created in a laboratory that are inconsistent with storage conditions provided on product packaging. CHPA and our manufacturer members are committed to consumer safety and preventing the presence of contaminants and impurities, including benzene, in OTC medicines. OTC medicines, and the active pharmaceutical ingredients they contain, are FDA-regulated and are held to high quality standards for safety and efficacy.”
“Benzene is not intentionally added to any consumer product, and it is important that proper quality control measures are in place to both detect impurities and reduce potential contamination during the manufacturing process. Manufacturers take potential quality issues seriously by testing, reviewing data and, if necessary, implementing corrective action. Consumer trust is a responsibility our member companies take very seriously, and their commitment to ensuring consumer safety remains the top priority.”
The Personal Care Products Council, an advocate for 600 member companies representing the global cosmetics and personal care products industry, shared its own response to the matter.
PCPC’s statement reads:
“Over-the-counter (OTC) drug products such as anti-acne treatments are highly regulated by the U.S. Food & Drug Administration (FDA), which has reviewed and determined benzoyl peroxide is a safe and effective anti-acne ingredient. Consumers have safely used anti-acne products for decades.”
“Personal care products companies do not add benzene to any OTC personal care product. The findings in the most recent Valisure petition are based on unproven, questionable methods applying unrealistic conditions which are inconsistent with the way the product would be stored normally. In a December 2022 letter, the FDA highlighted multiple deficiencies in Valisure’s analytical methods, stating that the lab should follow the same testing methods that drug manufacturers are required to use.”
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Lastly, the American Academy of Dermatology, a sister organization to the Academy, is a resource for government affairs, health policy and practice information for dermatologists.
The AAD’s president, Terrence A. Cronin Jr., MD, FAAD, stated:
“The American Academy of Dermatology Association is aware of a recent petition filed with the FDA describing formation of benzene in products containing benzoyl peroxide that are exposed to elevated temperatures. The American Academy of Dermatology Association and its members are committed to the health and safety of the public and is reviewing the petition and awaiting more information from the FDA to determine next steps. If you are concerned about using acne products containing benzoyl peroxide, opt for other options such as topical retinoids, salicylic acid, or azelaic acid, or speak with a board-certified dermatologist.”
