ProActiv, Clinique, Other Acne Treatments Found to Contain Cancer-Causing Benzene Chemicals: Report

The independent laboratory Valisure has again issued a report finding that benzene, a cancer-causing chemical, is present in popular consumer items; this time raising concerns about the safety of popular acne products, including ProActiv and Clinique.

The testing lab published a report on March 6, warning that a common ingredient in acne treatments, benzoyl peroxide, is unstable and can form benzene at levels hundreds of times higher than federally allowed limits. As a result, the company filed a citizen’s petition (PDF) with the U.S. Food and Drug Administration (FDA) on March 5, calling for an acne treatment recall for all products that contain the chemical.

Valisure is based in New Haven, Connecticut, and used to operate an on-line pharmacy along with its independent laboratory, which routinely conducted chemical analysis of drugs and products sold their inventory. The company sold its ValisureRx division in April 2021, and now services as a widely respected consumer watchdog that has identified serious health risks linked to a number of widely used consumer products in recent years.

Since 2018, Valisure testing has resulted in massive Zantac recalls, metformin recalls, sunscreen recalls, spray deodorant recalls and dry shampoo recalls, after products were found to contain unsafe levels of carcinogenic chemicals, which were not discovered by the manufacturers or the FDA. These investigations have led to a number of product liability lawsuits and class action lawsuits against manufacturers of the contaminated products.

Benzene is an industrial chemical that has been associated with the development of several fatal forms of cancer, leukemia and other conditions, such as acute myeloid leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hairy Cell Leukemia (HCL), Non-Hodgkin’s Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome (MDL), Myelofibrosis and Myeloid Metaplasia, Aplastic Anemia and Thrombocytopenic Purpura.

Long-term side effects of benzene exposure have been proven to cause anemia, which is a condition that develops when your blood lacks enough healthy red blood cells or hemoglobin. Essentially, the chemical causes bone marrow not to produce enough red blood cells, which can damage an individual’s immune system.

Federal regulators have determined long-term exposure to benzene can significantly impact blood cells, to the extent it causes cancer such as leukemia, which affects the blood-forming organs.

Acne Treatment Benzene Risks

According to this latest report, Valisure tested dozens of prescription and over-the-counter acne products which contain benzoyl peroxide (BPO), including ProActiv, Clinique, CeraVe and other brands, including generic products sold under retailer labels like Walmart, Walgreens and CVS.

Researchers found that the products can produce amounts of benzene that are 800 times higher than the 2 parts per million (ppm) limit set by the FDA, raising concerns about the potential long-term side effects of the acne treatments.

“High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk,” the report states. “Incubation of a Proactiv product at the temperature of a hot car resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the Environmental Protection Agency’s calculated threshold for increased cancer by long-term inhalation exposure to benzene.”

The laboratory indicates BPO has been linked to benzene formation for years, with studies dating back as far as 1994, which found that benzene formed due to hardeners containing BPO and phthalates. In fact, the chemical industry has actively attempted to address BPO’s instability to prevent benzene formation over the years.

“The results show that simply the addition of an antioxidant can substantially reduce the formation of benzene by over 98%,” the report states. “These and other techniques that Valisure has investigated could help address the BPO degradation problem and fix it for future drug formulations.

Valisure Calls for BPO Acne Treatment Recall

In its March 5 petition to the FDA, the laboratory called for the agency to issued regulations, revise industry guidance, and issue an acne treatment recall and suspend sales for all BPO-based products.

The petition also calls for the FDA to conduct investigations into the manufacturing processes for these products and provide that information to the public. In addition, Valisure urges the FDA to develop new guidance for the analysis of benzene in BPO products, among other potential fixes.

Despite the profound impact Valisure has had in raising red flags about widely used drugs and consumer products, both the FDA and drug manufacturers have tried to push back against the company. The FDA conducted an inspection of the lab, with inspectors reporting violations some say were not things a small lab would need to comply with if it is not making drugs, which Valisure does not.

In addition, manufacturers targeted by Valisure’s testing have floated conspiracy theories, claiming Valisure is secretly working with plaintiffs’ attorneys to fleece the companies by using faulty testing methods. However, plaintiffs’ lawyers have said they do not intend to use Valisure’s test results in trials in many of the cases, and advocates for Valisure credit the testing laboratory with helping save lives by uncovering dangers that the FDA and manufacturers either failed to discover, or failed to disclose.