Health Canada should review over-the-counter acne treatments that an independent lab reported could contain a cancer-causing chemical, experts said.
On Wednesday, U.S.-based Valisure lab announced it detected “high levels of benzene, a known human carcinogen,” in many products that contain benzoyl peroxide used to treat acne.
Benzoyl peroxide can break down into benzene.
Valisure said it detected the carcinogen in creams like ProActiv, Estée Lauder’s Clinique and Clearasil, at several hundred times the U.S. Food and Drug Administration’s (FDA) conditional limit. It called on the FDA to issue recalls.
Miriam Diamond, a University of Toronto earth sciences professor, told Global News she believes Health Canada should also be reviewing the lab’s findings.
“Benzene is well known to be harmful,” she said, saying it can interfere with the immune system, with someone’s blood system causing anemia and that prolonged exposure can cause leukemia, a blood cancer.
“We can do our own product testing here in Canada or we can rely on the testing already done,” she said.
Alberta Society of Dermatologists resident Dr. Andrei Metelitsa said the data warrants close attention while saying the findings aren’t final.
“Before we make any final conclusions, we need additional evidence, and that evidence would necessitate additional labs doing the studies and additional reputable organizations,” Metelitsa told Global News.
In this week’s release, Valisure found benzene in 94 of 99 products containing benzoyl peroxide without any elevated temperature and concluded several treatments “could produce substantial amounts of benzene when stored at above-ambient temperatures, specifically 37 degrees Celsius, 50 degrees Celsius and 70 degrees Celsius” and “substantial production of benzene emanating externally into the air surrounding an unopened benzoyl peroxide product.”
Metelitsa said benzoyl peroxide is “extremely, extremely common” in prescription and over-the-counter acne treatments while Diamond noted benzene naturally occurs in crude oil.
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Health Canada, the World Health Organization and the FDA all state benzene can cause cancer.
Valisure’s lab results claim ProActiv’s 2.5 per cent benzoyl peroxide cream had nearly 800 times the FDA’s conditional benzene limit after being stored at 50 degrees Celsius for 18 days, with Esteé Lauder’s 2.5 per cent benzoyl peroxide Clinique holding 200 times the limit and Clearasil’s 10 per cent cream had 150 times the limit.
Metelitsa questioned how applicable those findings are, comparing them with someone leaving acne products in their hot car for a couple of weeks or in a steam shower.
“(Regulators like Health Canada) cannot just make immediate changes based on a single study from a single lab, even if this lab has already participated in some product recalls in the past,” he said.
Valisure’s findings in 2022 that some dry shampoos contained benzene led the FDA and Health Canada to issue recalls.
Diamond said 37 degrees is the human body’s internal temperature, meaning “the transformation of the benzoyl peroxide into benzene can occur within the body,” when it is absorbed through the skin (like acne cream is).
She said the testing at other temperatures was likely designed to study what would happen in hotter conditions.
“Is (50 degrees) realistic? No. But does that degradation occur over time? Yes. Does it occur over time at ambient or temperatures to which we’re exposed? Yes, that will happen,” she said.
“I do find that the testing represents a reasonable approximation of what could happen.”
Metelitsa said he would like to see the FDA conduct its own rigorous study and believes Health Canada should review Valisure’s data and “determine if the nature of the study… (was) actually done in a reproducible and accurate manner.”
The FDA said it received Valisure’s petition but generally does not comment on pending petitions.
It said it is committed to ensuring drugs Americans use are safe, effective and of high-quality.
“The agency acts on information provided from a variety of sources, such as that provided by Valisure, but such data must be verified as accurate and reproducible before it can be utilized to make regulatory decisions,” the statement said.
Global News asked Health Canada for comment on Wednesday but did not receive a response by time of publication Friday.
Reckitt, the company that makes Clearasil, in a statement Wednesday said it is confident all those products are safe when used and stored as directed.
“The findings presented by an independent lab today reflect unrealistic scenarios rather than real-world conditions,” the statement said.
Estée Lauder told Reuters news agency Clinique uses benzoyl peroxide in one product, which “is safe for use as intended.”
Walmart and Target, which also make products Valisure says could contain benzene, did not respond to Reuters’ request for comment.
Diamond said she hoped the findings pushed the manufacturers to reformulate their products so that the consumer is not exposed to such high levels of benzene.
Diamond said benzene leaves the body “within days” of someone stopping use of products. She recommended people use products the lab report lists as having lower levels of benzene. The report lists Clean and Clear’s 10 per cent benzoyl peroxide, five per cent Glenmark Gels and five per cent Sandoz Gels as having less benzene than the FDA’s limit.
Metelitsa said anyone using the products who is concerned could stop using them and consult a dermatologist.
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