High levels of the cancer-causing chemical benzene were found in various benzoyl peroxide (BPO) acne products from major brands, including Proactiv, Clinique, Clearasil, and more.1
Valisure LLC, an independent testing laboratory, filed a petition with the US Food and Drug Administration (FDA) on Tuesday, requesting a recall of treatments affected by elevated levels of the carcinogen in order to allow regulators to investigate.2
Valisure tested 66 BPO products, including creams, lotions, gels, and washes that are available over the counter from main retailers or in prescription form. Currently, FDA guidelines allow up to 2 parts per million of benzene, and Valisure found acne products that contain up to 12 times the allowed amount. Additionally, the parts per million of benzene significantly increased when the acne products were tested at higher temperatures that were designed to replicate how the products can break down over time.
Affected Products
- La Roche-Posay 5.5% BPO cream
- Sandra Lee MD 2.5% BPO lotion
From its testing, Valisure found that Proactiv's 2.5% BPO cream, manufactured by Taro Pharmaceuticals, contained 1761 parts per million of benzene. Target's Up & Up 2.5% BPO cream had 1598 parts per million; Estee Lauder's Clinique 2.5% BPO cream had 401 parts per million; Reckitt Benckiser Group's Clearasil 10% BPO cream had 308 parts per million, and Walgreens 10% BPO cream had 114 parts per million, as some of the products with the highest parts per million.1
From the Citizen's Petition sent to the FDA, Valisure also found detectable levels of benzene in La Roche-Posay's BPO cream, PanOxyl BPO cream, Sandra Lee MD BPO lotion, Oxy's BPO cream, Galderma's BPO cream, Equate's BPO cream, and many more.3
As acne is one of the most common skin conditions in the US, especially among teenagers and young adults, it will be crucial for dermatologists to discuss the recent findings with their patients.
"Dermatologists are waking up this morning to shocking news that the widely-used over the counter and prescription medicine benzoyl peroxide decomposes into the well-known carcinogen benzene. Benzene contamination has plagued numerous skin care products recently, but this time it is different," Christopher Bunick, MD, PhD, associate professor of dermatology and physician-scientist at the Yale University School of Medicine, exclusively told Dermatology Times. Bunick, Dermatology Times' Editor in Chief, has been closely involved in benzene contamination research and education.
"Here, it is not contamination, rather benzoyl peroxide breaks down into benzene, stimulated to do so by the formulation of the products themselves. What is concerning is that nearly all benzoyl peroxide-containing products tested formed benzene (even the new triple combination topical), often at levels 2 to 1000X higher than the emergency/conditional FDA limit of 2 ppm," he said. "To make matters worse, benzoyl peroxide breakdown into benzene was accelerated by exposure to elevated temperatures equivalent to a hot bathroom or car, meaning that patients and consumers must be mindful of how to store their benzoyl peroxide-containing product (not in a car!). Even more concerning, as benzoyl peroxide breaks down into benzene, the gaseous form of benzene was found to penetrate through sealed packaging at levels nearly 1000X higher than EPA lifetime exposure limit (0.4 ppb) for the increased risk of 1 cancer per 100,000 people. Thus, benzoyl peroxide-containing acne products unsuspectedly are also an inhalation risk."