In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results on over-the-counter brands from various retailers as well as prescription acne products.
The petition alleged that benzene formed in these products as a result of the degradation of the original formulation, not as a contaminant or added ingredient. Valisure requested that the Food and Drug Administration (FDA) recall the products tested, conduct its own investigation and testing of these products and update its guidance on safe benzene levels.
Also in March 2024, the first class action complaints were filed claiming that plaintiffs would not have purchased certain acne products or would have paid substantially less if they had known the products contained benzene. The complaints use many of the same scientific arguments that were laid out in the Valisure petition. Overall, 35 putative class actions were filed in 10 districts across the United States. These lawsuits remain ongoing.
After receiving the Valisure citizen petition, FDA initiated its own testing of benzoyl peroxide products. In March 2025, FDA announced that, contrary to the claims in the citizen petition, more than 90% of the 95 products tested had undetectable or extremely low levels of benzene. FDA’s testing found only six products with elevated levels of benzene. These products are being voluntarily recalled by their manufacturers. However, FDA reassured consumers that “even with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low.”
In its announcement of the results of the benzene testing, FDA noted its concern that “use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion. Specifically, such methods may result in much higher reported levels of contaminants such as benzene than are actually present in tested products. It is critical that third-party laboratories reporting their results to consumers use validated methods so their results are reliable.”
This public rebuke may indicate an eventual denial of Valisure’s citizen petition.
The results of FDA’s testing are likely to be protective for defendants in the pending class action litigation. Validation from regulators that personal care and beauty products meet required limits for certain chemicals of concern is helpful in preventing unfounded lawsuits from the plaintiffs’ bar.
Conversely, detection of chemicals of concern by independent labs or watchdog organizations can spur action from the plaintiffs’ bar, even when the results are questionable. These lawsuits often allege economic damages to avoid having to link the presence of an alleged contaminant to a negative health outcome.
While eliminating brand targeting by citizen advocate publications is not possible, manufacturers and owners of beauty and personal care brands can take certain steps to mitigate this regulatory risk in their overall strategy, including:
- Clearly understanding product formulation and what chemicals of concern may be linked to the ingredients used to make products.
- Especially for products that use claims such as “clean,” “vegan,” “100% natural,” “free of,” “organic” or other claims that connote purity and safety, scrutinizing formulations to understand the risk of using certain ingredients in combination with these types of claims.
- Ensuring that the safety substantiation required under the Modernization of Cosmetics Regulation Act is complete and up-to-date and that the laboratory used to perform the safety substantiation is reputable.
- Reviewing agreements with ingredient or packaging suppliers to ensure that regulatory requirements, representations and warranties, and indemnification provisions account for risks related to chemicals of concern.
- Regularly testing products, including conducting stability testing, to account for degradation.
- Tracking state law changes. In addition to California’s Prop 65 (the most common law that generates issues for beauty and personal care products), other states such as Maryland, New York and Washington have passed laws related to chemicals in cosmetics.
Proactively planning to prevent potential regulatory issues associated with beauty and personal care products can be important for business strategy, especially for smaller brands that may be pursuing partnerships, an acquisition or a liquidity event in the future.
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.