Acne products from brands such as Proactiv, Up & Up and Clinique from Target Corp. have elevated levels of the carcinogen, an independent testing laboratory said in a petition filed with the U.S. Food and Drug Administration late Tuesday. The lab asked the FDA to recall the affected treatments — all of which contain the active ingredient benzoyl peroxide — while regulators investigate.
Benzene is a natural component of gasoline and tobacco smoke and can cause leukemia in large amounts, according to the U.S. Centers for Disease Control and Prevention. Over the past three years, it has been found in several popular products, increasing consumer awareness of the potential threats in their bathroom cabinets and raising questions about the FDA's oversight of the industry. Companies such as Johnson & Johnson, Unilever Plc and Procter & Gamble Co. have recalled products.
New Haven, Connecticut-based Valisure LLC, the testing lab that filed Tuesday's petition and exposed the previous risks, has positioned itself as a gatekeeper for consumers. Valisure rose to prominence through product research and has signed agreements with major health care systems, including Kaiser Permanente and the U.S. Department of Defense, to test drugs used by their members and root out substandard treatments.
For its acne research, Valisure tested 66 benzoyl peroxide products, including creams, lotions, gels and detergents that are available over-the-counter from major retailers or with a prescription. While FDA guidelines allow for a maximum of 2 parts per million of benzene, Valisure found up to 12 times that amount in some treatments. These levels rose significantly when the products were tested at higher temperatures, designed to mimic how they might break down over time, for example if kept in a medicine cabinet in a steamy bathroom.
Proactiv's 2.5% benzoyl peroxide cream, manufactured by Taro Pharmaceutical Industries Ltd., contained a whopping 1,761 parts per million of benzene during Valisure's stability testing, while a similar cream from Target reached 1,598 parts per million and a treatment from Estee Lauder Cos.' s Clinique reached 401 parts per million. A 10% benzoyl peroxide cream from Reckitt Benckiser Group Plc's Clearasil initially tested just at the FDA limit, but rose to 308 parts per million benzene after more than two weeks of exposure to high temperatures.
Representatives for the FDA, Taro Pharmaceuticals, Target, Estee Lauder and Reckitt did not immediately respond to requests for comment. Reckitt lost as much as 3.4% and Unilever Plc fell 0.6% in London, while Estee Lauder fell 2.9% and Taro Pharmaceutical tumbled 4.7% in US premarket trading.
Acne is the most common skin condition in the U.S., affecting as many as 50 million people annually, according to the American Academy of Dermatology. The numbers are even higher among teens and young adults, with about 85% of people between the ages of 12 and 24 having some form of the condition.
Sales of over-the-counter acne treatments in the U.S. totaled $1 billion last year, nearly double the $593 million in sales in 2019, according to data from Chicago-based market research firm Circana. The AAD guidelines list benzoyl peroxide as one of the top recommendations for the topical treatment of acne.
Valisure president David Light said the contamination occurs because benzoyl peroxide can break down and form benzene.
“This has been known for a long time,” he said in an interview. “All it needed was for someone to check.”
Light is credited as the inventor of a patent filed last year for a method to prevent benzoyl peroxide in pharmaceuticals from breaking down into benzene.
Valisure's most high-profile study involved the heartburn drug Zantac, which the FDA pulled from the market along with generic versions in 2020, months after the lab discovered that the drug's active ingredient — ranitidine — could form a likely carcinogen called NDMA.
In a statement Wednesday, the lab said the results of its study on acne treatments were most similar to its study on those ranitidine products.
“The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; But the benzene in benzoyl peroxide products comes from the benzoyl peroxide itself,” Light said in the statement.
In 2022, following Valisure's previous benzene findings, the FDA warned drugmakers to assess the risk of the chemical's formation in their own products. The agency does not regularly test the products it oversees.
Valisure's tests also examined benzene in the air around acne treatments and found that even an unopened Proactiv product leaked high levels when left at 104 degrees Fahrenheit, the temperature of a hot shower, for nearly 17 hours. The Environmental Protection Agency has said that chronically inhaling benzene at levels of 0.4 parts per billion over a lifetime could result in one additional cancer per 100,000 people, a risk measure also used by the FDA.
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Published: Mar 6, 2024 7:16 PM IST