“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.”
* Supplementary Note: Please also see this statement from the U.S. Pharmacopeia (USP) noting the lack of validation of Valisure's test methods and lack of transparency: (Excerpt) “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.”
