FDA Alert: Popular Acne Treatments Used by Millions of Teens Linked to Leukemia

By Sean Adl-Tabatabai

March 10, 2024

Dangerous levels of benzene, a chemical that causes cancer, have been detected in many popular acne treatments, according to a report issued last week.

Valisure tested dozens of prescription and over-the-counter products, including popular brands Proactiv, Clinique, Clearasil and Target Corp.’s Up & Up, and found they can contain “dangerously high” levels of the deadly chemical.

The Defender reports: Testing also revealed that benzene levels increase when the products are handled or stored at higher temperatures — such as left in a hot car or stored in a steamy bathroom.

The lab filed a Citizen Petition with the U.S. Food and Drug Administration (FDA), sharing the results of its analysis and asking the FDA to recall the products and suspend their sales while regulators investigate the issue further.

Acne is one of the most common skin conditions in the U.S., affecting up to 50 million people per year in the U.S. Approximately 85% of adolescents experience the condition at some point.

Bloomberg reported that sales of over-the-counter U.S. acne treatments totaled $1 billion last year.

Acne medications containing benzoyl peroxide, which breaks down into benzene, are commonly recommended by dermatologists and health websites as an easily accessible over-the-counter treatment.

The American Academy of Dermatology guidelines strongly recommend benzoyl peroxide for treating acne topically.

Benzene, long known to be carcinogenic, is a popular chemical solvent commonly used in chemical and pharmaceutical industries and found in trace amounts in substances ranging from cleaning products to cigarette smoke and gasoline. It evaporates quickly, so much human exposure can come from the air.

According to the World Health Organization, “there’s no safe level” of exposure to benzene in the air we breathe.

Breathing or otherwise absorbing benzene over time can lead to leukemia and other blood disorders, according to the FDA.

Over the last several years Valisure also identified high levels of benzene in sunscreen, hand sanitizers and other consumer products, leading the FDA to alert drug manufacturers and recommend against the use of benzene in pharmaceutical products.

Health Canada recalled some sunscreens. Companies including Johnson & Johnson, Unilever and Procter & Gamble Co. have also recalled aerosol sunscreens, antiperspirants and dry shampoos.

While those products contained high levels of benzene because of impurities from contaminated ingredients, Valisure President David Light said in a statement, “The benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself, sometimes at hundreds of times the conditional FDA limit.”

“This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action,” he added.

Valisure tested 66 benzoyl peroxide products, including creams, lotions, gels, washes, liquids and bars.

FDA guidelines allow up to two parts per million of benzene. Several of the products tested showed benzene levels well above two parts per million. Those levels jumped to tens or hundreds of times the allowable level when products were tested at higher temperatures designed to replicate the conditions in which they might be transported or stored.

Christopher Bunick, M.D., Ph.D., associate professor of dermatology at the Yale University School of Medicine and physician-scientist at Yale Dermatology, told The Defender that benzoyl peroxide is susceptible to free radicals or oxidants, which cause it to break down into different chemicals, including benzene when exposed to heat.

Among products with the highest benzene levels was Proactiv’s 2.5% benzoyl peroxide cream, manufactured by Taro Pharmaceuticals, which contained 1,761 parts per million of benzene.

Target’s Up & Up 2.5% benzoyl cream had 1,598 parts per million; Estee Lauder’s Clinique 2.5% benzoyl peroxide cream had 401 parts per million; Reckitt Benckiser Group’s Clearasil 10% benzoyl peroxide cream had 308 parts per million, and Walgreens 10% benzoyl peroxide cream had 114 parts per million.

The lab also found high levels of benzene in La Roche-Posay’s benzoyl peroxide cream, Sandra Lee’s benzoyl peroxide lotion, Neutrogena’s benzoyl peroxide gel, CeraVe’s benzoyl peroxide cream and many others.

The researchers also tested for benzene in the air surrounding the products and found that even an unopened Proactiv product leaked high levels of benzene when kept at 104 degrees Fahrenheit for just under 17 hours.

This shows that benzene “can leak out of some product packages and pose a potential inhalation risk,” the company wrote.

“Valisure’s findings are significant for the skincare industry,” Bunick said, citing several reasons:

“First, manufacturers must maintain certain quality and safety standards as mandated by the FDA. Current benzoyl peroxide products do not meet that standard, especially with regards to stability over time and temperature.

“Second, … benzene is a well-established carcinogen in the same highest danger category as asbestos, lead and formaldehyde.

“Third, it is less clear to fully comprehend the health implications of benzene exposure, because the cancer-causing effect may take decades to manifest. It is a similar scenario to sun exposure, where sunburns in one’s youth potentially lead to skin cancers in adulthood, sometimes 20-40 years after exposure.

“Lastly, a new report out of the U.K. showed that low-level benzene exposure (at levels below 1 part per million, which is less than what is seen in many benzoyl peroxide products) increased risk of all-cause mortality, cardiovascular disease and multiple cancers, including hematologic and lung.”

Valisure also tested products containing other ingredients, such as salicylic acid or adapalene. Those products had benzene levels that were either undetectable or below the FDA’s current limit of 2 parts per million, the lab reported in its Citizen Petition. Only the products containing benzoyl peroxide contained high levels of benzene.

The FDA, Estée Lauder and Reckitt did not immediately respond to The Defender’s request for comment.

An FDA spokesperson confirmed in a statement Wednesday and reported by CNN that the agency had received the petition and would respond.

“Such data must be verified as accurate and reproducible before it can be utilized to make regulatory decisions such as recommending product sale suspensions and recalls,” the statement said.

Valisure’s Light has a patent application pending on formulations and techniques to reduce the rate of benzyne formation from benzoyl peroxide breakdown, Bloomberg reported, although the patents have not yet been granted.

The lab is also known for its investigation into Zantac, which the FDA pulled from the market in 2020 after the lab notified the agency that the drug’s key ingredient, ranitidine, could expose people to a carcinogenic substance called N-Nitrosodimethylamine. Another lab, Emery Pharma, confirmed the findings. Both labs submitted Citizen Petitions demanding recall.