Two recent articles from the Personal Care Products Council (PCPC) have highlighted the urgent need for improved testing of Benzoyl Peroxide products at this critical time.
The article titled “Statement by the Personal Care Products Council on Valisure Petition on Benzoyl Peroxide in OTC Personal Care Products” highlights that over-the-counter (OTC) drug products, including anti-acne treatments, are strictly regulated by the U.S. Food & Drug Administration (FDA). The FDA has reviewed and confirmed that benzoyl peroxide is a safe and effective ingredient for treating acne. These anti-acne products have been used safely by consumers for many years.
The article by PCPC acknowledges recent research that has identified trace amounts of benzene in certain personal care products. Benzene, a chemical commonly found in the environment, is not deliberately added to personal care products. It is a substance to which people globally are exposed daily through various sources such as air, drinking water, and food and beverages. Both the U.S. Food and Drug Administration (FDA) and product manufacturers recognize that trace amounts of benzene can occur in food and drug products, but these minimal levels are not considered a safety risk to consumers.
PCPC also mentioned that companies that produce personal care products do not introduce benzene into any over-the-counter (OTC) personal care items. The claims made in a petition by a Connecticut based testing laboratory rely on unverified, dubious methods that use unrealistic conditions, differing from typical storage practices for these products. In a letter from December 2022, the FDA pointed out several flaws in Valisure’s testing methods, emphasizing that the laboratory should adhere to the established testing procedures mandated for drug manufacturers.
The Personal Care Products Council (PCPC) and its member companies are dedicated to providing consumers with cosmetics and personal care products that contain ingredients rigorously tested for quality, efficacy, and safety, and that comply with all legal and regulatory standards. Safety is our top priority. Without the trust of our consumers in the safety of our products, nothing else is significant.
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Founders Science Group has successfully developed and validated a method according to USP <467> for testing benzene residual solvent limits in Benzoyl Peroxide products, ensuring compliance with the specified USP criteria of less than 2 ppb.
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If your company is looking for assistance in laboratory testing then give us a call at 508-258-8055. Located in eastern Massachusetts Founders Science Group has been New England’s trusted partner for laboratory testing services in cosmetics, personal care, pharmaceuticals, and more for many years. We offer precise analytical testing, tailored storage solutions, and expert development support. Our services include component testing (raw materials and packaging), release testing, and stability testing and much more. Simplify your stability challenges with our turnkey laboratory testing solutions.
The original articles can be found here:
Statement by the Personal Care Products Council on Benzene in Personal Care Products
