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While FDA action is awaited, dermatology clinicians can suggest BPO-free alternatives such as retinoids, salicylic acid, and more.
Valisure, an independent US laboratory, recently shed light on a concerning discovery regarding benzene levels in benzoyl peroxide (BPO) acne treatments across a wide range of brands and manufacturers. High levels of benzene were found in BPO products subjected to industry-standard accelerated stability testing, where they were incubated at 98.6°F, 122°F, and higher at 158°F. Benzene is a known carcinogen. As recently as 2022, there were several recalls of popular shampoo brands due to the presence of benzene in these products. What is different here is that in these BPO products, the presence of benzene is not as a contaminant but rather the result of direct chemical decomposition of highly concentrated active ingredients. Some products tested by Valisure exceeded the FDA limits by over 800 times, posing not only topical but also inhalation risks to users. These findings have prompted concerns about potential health risks associated with these products, leading Valisure to petition the FDA for a recall.
Further testing is needed to gauge the full extent of the issue and determine the real-world implications, but the concerns emerging from patients and dermatologists need to be taken seriously. Some experts have noted that the Valisure study has pointed out that BPO products are not subjected to 98.6°F let alone 122°F or 158°F the majority of the time. But, we should also note that these are 1) accepted industry standards for testing and ensuring product stability and shelf life, and 2) these products have significant reach in the marketplace with plausible real-world scenarios.
First, almost every cosmetic product on the market uses testing at elevated temperatures to test the stability of formulations. This is called Accelerated Stability Testing and generally uses temperatures ranging from 104°F or 122°F (and sometimes higher) to approximate how a product will degrade over time at room temperatures. This is a widespread and accepted standard that is used to establish shelf life estimates for products so that new products can be confidently advertised as safe and stable over the normal course of shipments, storage, and use by retailers and consumers.
Second, we must remember that BPO products are sold and used by millions of people every day but are not transported, sold, or kept in temperature-controlled environments. During transportation in the warmer months and climates, BPO products may be subjected to high temperatures on a ship, truck, or store shelf. Once purchased, many people may take their BPO products with them to school, work, or the gym where they can easily be left in a hot car. Others may keep their BPO products in the shower where they’re exposed to hot temperatures multiple times daily. These are plausible scenarios that underscore the need for further investigation by regulators to ensure consumer safety in regard to BPO products. Products that are used by millions of people need to consider edge cases.
The challenge is that there are millions of these kinds of personal care products out there and the FDA can’t be expected to test every single one. Thus, self-policing by manufacturers is always going to be necessary and expected. In 2023, the Personal Care Products Safety Act was passed which represented the first modernization of safety laws governing personal care products since 1938. While this is an important step, the benzene concern with BPO products shows that we need to continually strengthen our surveillance and oversight of these products. Simply because a product that you put only on your skin or in your hair does not require a prescription to buy does not mean it cannot lead to harm.
As dermatologists, BPO has been a long-standing staple in the treatment of acne. I recommend it all the time for my patients. We reach for it as part of a comprehensive regimen or as a suggestion for patients with mild acne where an over-the-counter (OTC) solution is both cost-effective and widely available. I’ve always warned my patients about some of its drawbacks like irritation, dryness, and bleached face towels. During my training, I never once thought about the risk of benzene degradation for BPO products. I never once warned my patients about this potential until now. I have to think twice now.
Am I telling my patients to throw out all of their BPO products? No. But I am bringing it up now with my patients. I tell them to make sure they are storing their BPO products in safe temperature-controlled environments. I ask them to be very mindful of the expiration dates and how long they have had their products on their shelf. It may be time for a refresh. I think twice about recommending BPO for high-risk patients; in the US there are more than 500,000 childhood cancer survivors. For patients with a history of skin cancer, I talk about alternative topical acne treatments that do not have any risk and which I feel will have the same results. Fortunately, there are alternatives to BPO for acne treatment with ingredients that have proven benefits and are available widely. Here are some examples of ingredients and brands that are widely available for patients who come with their concerns.
Retinoids
Salicylic Acid
Alpha-Hydroxy Acids
Azelaic Acid
Sulfur
When I prescribe acne therapies, combination therapy is more effective than monotherapy. We want to hit all the aspects of acne - the bacteria, the oil, the inflammation, and the follicular hyper-keratinization. Fortunately, there are also some combination therapies out there for acne that don’t have BPO, but are harder to find. While these may range in price, I often feel that the simplicity and improvement in results can be worth it to many patients. Below are some kits to consider without BPO with proven acne-fighting ingredients.
In conclusion, the concern over benzene degradation in a wide range of popular OTC BPO treatments for acne is real. It’s too early to abandon these products until more research is done and BPO remains a staple of effective acne care. However, for patients and dermatologists who are seeking other OTC alternatives without BPO, there are solutions out there that deliver results.
Steve Xu, MD, MSc, FAAD, is an assistant professor of translational dermatology research and pediatric dermatology in the department of dermatology and assistant professor at the McCormick School of Engineering at Northwestern Feinberg School of Medicine in Chicago, Illinois. He is also head of the medical advisory board at Geologie.
Disclosure: Xu founded Geologie in 2018 and launched a BPO-free acne regimen in February 2024, available at Target, prior to the Valisure report with the goal to offer gentler products for those interested.