Earlier this month, an independent testing laboratory, Valisure, filed a petition with the FDA to recall various acne treatment products with the active ingredient benzoyl peroxide (BPO), as high levels of the highly carcinogenic ingredient benzene were detected. Spurred by concerns around the safety of hand sanitizers during the COVID-19 pandemic, attention has shifted to testing for the presence of benzene in other dermatology products, particularly those containing BPO, leading to this recent testing.
BPO products, whether available over-the-counter or via prescription, have long been considered safe within certain standards set by the FDA. However, recent findings from Valisure’s testing suggest that the presence of benzene in these products is a growing concern that requires immediate attention and action from all stakeholders involved.
In this article, we examine Valisure’s test results and discuss possible next steps for both dermatologists and patients while we await further investigations, testing, and regulatory guidance.
What Is Benzene?
Benzene is a chemical compound that is classified as a Group 1 human carcinogen. It is commonly found in industrial processes and products like gasoline, but its presence in consumer products, especially those intended for skin application, is highly concerning due to its cancer-causing properties.
Benzene exposure in skincare products can occur in two ways: by contamination of raw ingredients and by degradation. In the case of acne creams, benzoyl peroxide has been shown to degrade over time into benzene. Exposure to heat during manufacturing, shipping, and storage can greatly accelerate the degradation rate of this ingredient.
Valisure’s Findings
Valisure’s recent findings revealed elevated levels of the carcinogenic chemical benzene in various benzoyl peroxide (BPO) acne products from well-known brands. In their testing of 66 BPO products, including creams, lotions, gels, and washes, Valisure found benzene levels that greatly exceeded the FDA’s emergency permitted limit during the pandemic of 2 parts per million (ppm), with one popular BPO cream containing as much as 1761 ppm of benzene. Equally concerning is that after testing 66 BPO products, Valisure found that all products appeared to be generating benzene over time, though some faster than others.
In a recent podcast, Cofounder and President of Valisure David Light explains the importance of stability testing when examining the safety of BPO-containing products. While Valisure’s testing methods have been questioned due to the temperatures at which products were tested, Light explains that the aim of stability testing is to “look at the long-term stability of the shelf life of a product in a shorter amount of time,” which is achieved by using a standard temperature of 122°F (50°C) over a 169-day period. This mimics a three-year product shelf life at room temperature. Light also emphasized that these same products were also tested at 98.6°F (37°C), which is standard practice to mimic human body temperature.
Further, while these BPO products have been previously approved by the FDA at certain temperatures, those ideal temperatures do not always reflect real-life scenarios. For example, products that sit in a hot car or hot shower are routinely exposed to higher-than-normal temperatures, thus greatly accelerating the degradation rate of benzoyl peroxide into benzene.
What’s Next?
The FDA has commented that Valisure’s recent findings must be confirmed and able to be reproduced in order to substantiate the laboratory’s claims. Thus, no action to remove BPO products from shelves is being taken as of this writing. While we await further investigation, testing, and official regulatory guidance on the matter, there are some steps that can be taken to help minimize potential risks of benzene exposure related to BPO products.
Most notably, making sure BPO products are stored at low temperatures – from manufacturing to pharmacy shelves to consumers’ homes – can significantly slow down the degradation process of BPO into benzene, thus limiting potential exposure. At home, these products should always be stored in a cool, dry environment, so a shower or bathroom are not ideal storage areas. Those living in hot or humid climates can store BPO products in the refrigerator to ensure they do not reach dangerously high temperatures.
How Do I Know If a Product Contains Benzene?
Unfortunately, there is no way for a consumer to be able to look at a product label and tell whether or not it contains benzene. This is because benzene makes its way into personal care products as a contaminant of other ingredients or when ingredients like benzoyl peroxide break down into benzene. Thus, the responsibility lies with the manufacturer to properly test for the presence of benzene in its products in order to ensure product safety.
This, then, begs the question, “Should I still use benzoyl peroxide products?” The FDA has yet to determine the validity of Valisure’s testing and recent recall petition, so these products are still available for purchase. While other acne-treatment options are available, such as salicylic acid, retinoids, and others, BPO has long been touted for its effectiveness and ability to reduce antibiotic resistance. Thus, the best answer to this question is to work with your dermatologist to design a customized acne treatment plan that is best for your skin’s specific needs while we await more guidance from the FDA.
Bottom Line
The recent findings of potential benzene exposure in benzoyl peroxide products used to treat acne are certainly concerning and require further investigation. As we await further test results and guidance from regulatory organizations like the FDA, manufacturers, dermatologists, and patients are urged to take proactive measures to minimize health risks associated with benzene exposure by diligently storing these products at lower temperatures and ensuring they are never exposed to high temperatures.
If you have specific questions or concerns about BPO-containing products that you may be currently using or would like to discuss your current acne treatment regimen, please schedule a consultation with one of our board-certified dermatologists, who would be happy to answer your questions. Easily request an appointment online or make an appointment by calling our Delray Beach office at 561-692-6424 or sending a text message to 561-816-3197.
