Valisure urges FDA action over cancerous benzene found in Clinique, CeraVe, Galderma acne treatments

07 Mar 2024 --- Valisure finds that benzene, a known human carcinogen, can form at high levels in benzoyl peroxide (BPO) acne treatment products. The independent quality assurance provider is petitioning the FDA “to issue a regulation, revise industry guidance, request a recall and suspend sales of benzoyl peroxide from the US market.”

Test results from the company show benzene levels in BPO products on the market can reach 800 times the FDA’s conditionally restricted limit of 2 parts per million (ppm). The “substantial” levels of benzene were detected inside BPO products and in the air around unopened BPO products, which Valisure says poses a “significant” inhalation risk.

Products examined
Out of 175 acne treatment products, 99 over-the-counter and prescription acne treatments contained BPO as a significant ingredient, according to Valisure. The chemical is considered a drug product regulated by the FDA.Benzoyl peroxide forms benzene.

“This discovery of BPO fundamental instability and benzene formation is substantially different from Valisure’s previous findings of benzene in sunscreens, hand sanitizers and other consumer products. The benzene we found in sunscreens and other consumer products was impurities from contaminated ingredients. However, the benzene in BPO products comes from the BPO itself, sometimes at hundreds of times the conditional FDA limit. This means the problem broadly affects BPO products and necessitates urgent action,” underscores David Light, Valisure’s co-founder and president.

All other acne treatment products that contain salicylic acid or adapalene did not appear to have this issue, according to the study.

Benzene was detected at various levels in the 66 BPO products analyzed, including: Proactiv 2.5% cream, Target’s Up & Up 2.5%, Estee Lauder’s Clinique 2.5% cream, Reckitt Benckiser’s Clearasil 10% cream, Walgreens 10% cream, La Roche Posay 5.5% cream, PanOxyl 10% cream, Galderma 5% cream and CeraVe 4% cream.

Manufacturing investigation and tighter regulation
In addition to halting sales of BPO acne treatments, Valisure requests the FDA investigate the products, their manufacturing processes and submissions.When handled or stored by consumers at higher temperatures, BPO products may produce benzene levels that are too-high.

The company also demands the public be given access to product information and that the FDA develop guidance for analyzing benzene in BPO products.

In addition, it would like the FDA to revise “Q3C — Tables and List, Guidance for Industry” to include recommendations regarding the permissible benzene concentration for pharmaceutical products, like those containing BPO.

Valisure suggests the FDA work with the US Environmental Protection Agency (EPA) to address benzene contamination and cement their partnership in future collaborations. It also wants the agency to support the rise of independent drug quality testing programs and “promulgate regulations requiring robust independent chemical testing and verification of pharmaceuticals.”

Temperature and cancer-risk
According to Valisure’s analysis, BPOs are essentially unstable the way they are currently manufactured. When handled or stored by consumers at higher temperatures, the products may produce benzene levels that are too-high. Benzene levels in BPO products on the market can reach 800 times the FDA’s conditionally restricted limit of 2 ppm.

At 50°C, a lower temperature used for pharmaceutical stability testing, benzene levels were detected at significant levels in some products, reaching over 1,500 ppm.

In one case, Valisure found benzene in the air volume of a car after a Proactiv product was incubated at 70°C, which is roughly 1,270 times higher than the EPA’s calculated threshold for increased cancer risk from long-term benzene inhalation exposure.

“As stated by the EPA and numerous global regulatory agencies, ‘benzene can cause leukemia.’ The long-established epidemiological data in humans is utilized by EPA to determine that a lifetime exposure of 0.4 pp billion, or 0.0004 ppm, of benzene in air can lead to one additional cancer case in 100,000 exposed persons,” warns Valisure.

The company suggests a potential solution based on its previous research on 10% BPO in glycerol. The findings suggested that adding an antioxidant alone can significantly lower the production of benzene by more than 98%.

Benzene contamination
Previously, personal care companies unintentionally released batches of products laced with benzene and had to recall their products due to health risk.

Last year, Edgewell Personal Care modified its announcement to recall its Banana Boat hair and scalp sunscreen spray SPF 30 with three batches of additional sunscreen found to be contaminated with benzene. It was the company’s second voluntary nationwide recall in two years. Edgewell said benzene was not a component in its sunscreen spray. Rather it was detected as a result of the propellant spraying the product from the container.

A similar case was observed at Unilever for its Bed Head, Dove and Tresemmé dry shampoo aerosol products.

By Venya Patel