Consumer Alert—Is Your OTC Benzoyl Peroxide Product Safe?

 

 

 

Consumer Alert—Is Your OTC Benzoyl Peroxide Product Safe?

By Susan Massick, MD

In January 2024, the AAD updated its 2016 clinical guidelines for the treatment of acne with evidence-based treatment recommendations based upon a working group’s comprehensive and systematic review of current data (Reynolds). Benzoyl peroxide (BPO), a longstanding mainstay of acne treatment, remained a strongly recommended therapeutic intervention for both mild and moderate-severe acne. For many dermatologists and clinicians who regularly treat acne, BPO is efficacious, cost-effective, well-tolerated, and readily available for patients to use as an initial intervention as well as for maintenance therapy. Thus, a published report on March 6, 2024, regarding unacceptably high levels of benzene detected in over-the-counter BPO products, came as a surprise to many dermatologists.

According to the CDC’s website, benzene is a colorless, flammable carcinogenic liquid that evaporates when exposed to oxygen. It is found naturally in crude oil and forest fires as well as manmade in the form of cigarette smoke, motor vehicle exhaust, and industrial emissions. It is used as a solvent but can also be emitted as waste by-product in the industrial manufacturing of products such as plastics, resins, dyes, and rubbers. Benzene is in the environment with measurable concentrations at gas stations, in homes from cigarette smoking, and in manufacturing plants. Exposure can be through direct contact, in the air through inhalation, and ingested in contaminated food or well water (CDC).

On March 5, 2024, Valisure, an independent testing agency whose discovery of benzene contamination in products ranging from sunscreen to dry shampoo led to significant product recalls, submitted a Citizen’s Petition (click here) to the FDA noting levels of measurable benzene in OTC BPO products when tested at various temperatures (37^o C, 50 ^o C, and 70 ^o C, or the equivalent of body temperature, standard stability testing temperature, and high heat, ie hot car, temperature) over periods of incubation. In the petition, Valisure claimed that not only were there high levels within the BPO product itself, but also in the air around the products, creating a possible inhalation risk. Valisure also noted that unlike its prior sunscreen studies, where benzene was considered a contaminant from the manufacturing process, the benzene in the BPO products was related to the breakdown of the presumed unstable BPO product itself, particularly when exposed to sustained high temperatures. Valisure suggested the need for a recall and sales halt of BPO products in order for further testing given their findings (Light).

Whether you consider the announcement shocking and concerning or inaccurate and misleading, it does raise valid questions. You can draw your own conclusions based upon facts and accurate interpretation of data.

Fact: Benzene is a carcinogen, and it is important to avoid exposure. Consumer safety should be paramount. Keep in mind that your gas stove, your car exhaust, and secondhand smoke emit benzene. At this time, there are no known cases of cancer that can be directly attributed to the use of topical OTC BPO.

Conclusion: Minimizing exposure and potential risk are always a priority. But quantifying risk and determining cause and effect, namely whether the exposure from these products constitutes harm to a patient, have yet to be determined. For now, consumers can continue to use benzoyl peroxide products with recommendations for storage and usage. As Yale’s Dr. Christopher Bunick recommends for BPO products, avoid leaving in hot temperatures for extended periods of time; store in cool location/refrigerate; and replace products frequently (Bader). If patients have any concerns, then suggest alternative treatment options that do not contain benzoyl peroxide.

Fact: Valisure’s report was a citizen petition, not a peer-reviewed study subject to scrutiny regarding methods and data analysis. The data and Valisure’s conclusions need to be consistently replicated and substantiated by other independent labs. The most compelling data on benzene levels were a result of products incubated at very high and sustained temperatures that may not be consistent with typical usage or storage.

Conclusion: As with any scientific hypothesis, additional studies and more data are needed to make definitive conclusions. For the time being, if a patient is concerned, then encourage the use of alternative products.

Fact: In March 2023, Valisure’s President David Light and Scientific Advisor Kaury Kucera submitted an international patent application (click here) as inventors with company Blue Hill Technologies, LLC, which shares the same business address as Valisure. The patent application is for a “shelf-safe” benzoyl peroxide product. The initial U.S. patent application was submitted in March 2022. No conflict-of-interest disclosure was noted in Valisure’s Citizen Petition findings.

Conclusions: New cosmeceutical products that address a challenging condition or fulfill a niche are constantly entering the market. They will thrive based upon efficacy, impact, price point, and consumer need.

Final Conclusions

Benzoyl peroxide is an effective acne treatment that is best stored away from prolonged high heat/high temperatures. The FDA may call for additional testing to validate and replicate Valisure’s findings and to determine whether current BPO formulas are unstable leading to benzene emission and whether that poses any risk to consumers. If consumers or your patients have any concerns, then review alternative treatment options since there are many other potential treatment interventions available.

 

References

Bader, Kaitlyn. “Updates on benzene found in benzoyl peroxide-containing acne products.”  Dermatology Times Vol 45: Issue 4, April 2024.

Blue Hill Technologies, LLC. “Shelf-Stable Formulations of Benzoyl Peroxide and Methods of Producing Same.” International Patent, filed March 13, 2023, published September 21, 2023. https://patentimages.storage.googleapis.com/db/86/9b/1c939b442aaa18/WO2023177625A1.pdf. Accessed 04/03/2024.

CDC Emergency Preparedness and Response. Facts about Benzene. April 14, 2018. https://emergency.cdc.gov/agent/benzene/basics/facts.asp#:~:text=Where%20benzene%20is%20found%20and%20how%20it%20is,plastics%2C%20resins%2C%20and%20nylon%20and%20synthetic%20fibers.%20. Accessed April 23, 2024.

David Light, Wolfgang Hinz, Kaury Kucera. “Valisure Citizen Petition on Benzene in Benzoyl Peroxide Drug Products. www.valisure.com/valisure-newsroom/fda-citizen-petition-8-benzene-in-benzoyl-peroxide-products 

https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf

Accessed online 4/3/24.

National Toxicology Program. Benzene, Report on Carcinogens, Fifteenth Edition. Triangle Park, NC: National Institute of Environmental Health and Safety, 2021. https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/benzene.pdf. Accessed April 23, 2024.

Rachel V. Reynolds, Howa Yeung, Carol E. Cheng, Fran Cook-Bolden, Seemal R. Desai, Kelly M. Druby, Esther E. Freeman, Jonette E. Keri, Linda F. Stein Gold, Jerry K.L. Tan, Megha M. Tollefson, Jonathan S. Weiss, Peggy A. Wu, Andrea L. Zaenglein, Jung Min Han, John S. Barbieri. “Guidelines of care for the management of acne vulgaris.” JAAD. https://doi.org/10.1016/j.jaad.2023.12.017. Published online January 30, 2024.