FDA Confirms Low Benzene Levels in Most BPO Products Tested

The US Food and Drug Administration (FDA) has identified a limited number of benzoyl peroxide (BPO) acne products for retail-level recall because of elevated benzene levels, but more than 90% of tested products have very low or undetectable benzene levels, according to an FDA statement.

The agency conducted independent testing on 95 benzoyl peroxide acne products in the wake of third-party tests showing concerns about elevated benzene levels, according to the March 11 statement.

Several companies have agreed to recall certain products at the retail level, meaning that they will instruct retailers to remove these products from stores and online marketplaces, but consumers need not discard products they currently have and use.

“Even with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low,” according to the FDA.

The six products found with elevated benzene levels are: La Roche-Posay Effaclar Duo Dual Action Acne Treatment, Walgreens Acne Control Cleanser, Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5%, Proactiv Skin Smoothing Exfoliator, SLMD Benzoyl Peroxide Acne Lotion, and Walgreens Tinted Acne Treatment Cream.

In addition, the manufacturer of Zapzyt Acne Treatment Gel, another acne product with BPO, found elevated benzene levels during its own testing and is voluntarily recalling the product, the statement said.

Specific lot numbers and expiration dates are available in the statement, and the FDA advises consumers to discard any products beyond the expiration dates. The FDA plans to publish its full testing results in at least one peer-reviewed journal in the next few months. The statement also notes that consumers may be confused by reports from third-party laboratories that may yield incorrectly high levels of contaminants such as benzene and stressed the need for validated testing methods to ensure reliable data.

Medscape Medical News recently reported the results of an independent study, which showed that production and ingredient composition were significant factors in the benzene levels in acne products. In the study, published in JAMA Dermatology, John S. Barbieri, MD, of Brigham and Women’s Hospital, Boston, and colleagues tested 111 products with previous benzene evaluations by an independent laboratory (Valisure).

The researchers found that leave-on products were associated with lower benzene concentrations than acne washes and that a weak association appeared between benzene concentration and time to product expiration date.

The American Academy of Dermatology weighed in on the issue in a press release on March 12 from outgoing president Seemal R. Desai, MD.

“The Academy recommends that patients follow best practices for storing and handling products containing benzoyl peroxide — such as storing products according to the manufacturer’s instructions at room temperature or cooler conditions and discarding those that are old or expired and those exposed to heat — and consult their dermatologist if they have any concerns,” Desai said in the statement. Those who are concerned about BPO products can choose other topical acne treatments including topical retinoids, salicylic acid, or azelaic acid products, or consult a dermatologist for additional options, he said.

Give Patients the Facts

Benzene is a known carcinogen that should never be in any consumer products, Adam Friedman, MD, professor and chair of Dermatology at George Washington University, Washington, DC, said in an interview.

“What is unique about benzoyl peroxide (BPO)–containing acne products is that this is a degradative byproduct of BPO, not just a contaminant,” said Friedman. “First and foremost, my colleagues and I need to be prepared to answer questions from our patients,” he said. “We need to allay fears and be mindful that our patients still need to manage their acne, for which we have non-BPO options,” he added.

“The reality is we don’t know the full story, so for those who just want to avoid BPO products, that is fine, and they have other options,” Friedman noted.

“That said, there are no data confirming a direct result of benzene contacting the skin and causing cancer,” Friedman told Medscape Medical News. Importantly, the majority of products with BPO did not have concerning concentrations of benzene, and those that did were specific batches (lot numbers), according to the studies, he said. Useful research might include the development of excipients that could prevent the observed degradation and further stabilize BPO, but such research would be challenging given the plethora of confounders, he noted.

Ultimately, Friedman said, “Remind patients to keep calm; we can still take care of their acne.”