Cancer-linked chemicals found in acne creams including Proactive, Clearasil

Acne products from brands including Proactiv, Target Corp.’s Up & Up and Clinique found 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 withdraw the affected treatments — all of which contain the active ingredient benzoyl peroxide — while regulators investigate.

According to the U.S. Centers for Disease Control and Prevention, benzene is a natural component of gasoline and tobacco smoke and can cause leukemia in high amounts. It has been found in several popular products over the past three years, increasing consumer awareness of potential dangers in their bathroom cabinets and raising questions about FDA oversight of the industry. Companies including Johnson & Johnson, Unilever PLC and Procter & Gamble Co. have recalled the products.

New Haven, Connecticut-based Valisure LLC, the testing lab that filed Tuesday’s lawsuit and exposed past risks, has positioned itself as a gatekeeper for consumers. Valisure gained prominence in conducting product research and has struck deals with large health care systems, including Kaiser Permanente and the U.S. Department of Defense, to test drugs used by its members and eliminate substandard treatments.

For its acne research, ValleySure tested 66 benzoyl peroxide products, including creams, lotions, gels, and washes that are available either over the counter at major retailers or through prescription. While FDA guidelines allow up to 2 parts per million of benzene, some treatments found Valisure had up to 12 times this amount. Those levels increased significantly when the products were tested at higher temperatures to determine how they might break down over time, for example if stored in a medicine cabinet in a steamy bathroom.

Proactiv’s 2.5% benzoyl peroxide cream, manufactured by Taro Pharmaceutical Industries Ltd., contained 1,761 parts per million of benzene during Valisure’s stability testing, while a similar cream from Target contained 1,598 parts per million and Estée Lauder Cos.’s 1,598 parts per million during treatment. Reached till. S Clinic touched the figure of 401 parts per million. Reckitt Benckiser Group PLC’s Clearasil 10% benzoyl peroxide cream was initially tested at the FDA limit, but it reached 308 parts per million of benzene after being exposed to high temperatures for more than two weeks.

Representatives for the FDA, Taro Pharmaceuticals, Target, Estée Lauder and Reckitt did not immediately respond to requests for comment. Reckitt fell as much as 3.4% in London and Unilever Plc fell 0.6%, while Estée Lauder fell 2.9% and Taro Pharmaceutical fell 4.7% in U.S. premarket trading.

According to the American Academy of Dermatology, acne is the most common skin condition in the US and affects about 50 million people each year. The number is even higher among teenagers and young adults: about 85% of people ages 12 to 24 have some form of this problem.

Data from Chicago-based market research firm Circana shows that over-the-counter U.S. sales of acne treatments totaled $1 billion last year, nearly double the $593 million in sales in 2019. The AAD guidelines name benzoyl peroxide as one of their top recommendations for treating acne topically.

David Light, president of Valizer, said the contamination occurs because benzoyl peroxide can break down and form benzene.

“This has been well known for a long time. It just needed someone to investigate this,” he said in an interview.

Light is listed as an inventor on a patent filed last year for a method of preventing benzoyl peroxide from breaking down into benzene in drug products.

Valisure’s most high-profile investigation was into the heartburn drug Zantac, which the FDA pulled from the market along with generic versions in 2020, months after the laboratory discovered the drug’s active ingredient – ​​ranitidine – may contain a potential carcinogen called NDMA. .

In a statement Wednesday, the lab said the results of its research on the acne treatment were similar to those examining ranitidine products.

“The benzene we found in sunscreens and other consumer products were impurities that came from contaminated materials; However, the benzene in benzoyl peroxide products is coming from benzoyl peroxide itself,” Light said in the statement.

In 2022, following Valisure’s previous benzene findings, the FDA warned drug manufacturers that they should assess the risk of the chemical forming in their products. The agency does not routinely test the products it oversees.

Valisure’s testing also examined benzene in the air around acne treatments and found that an unopened Proactive product also leaked high levels when exposed to 104 degrees Fahrenheit, the temperature of a hot bath, for about 17 hours. The Environmental Protection Agency has said that lifetime inhalation of benzene at a level of 0.4 parts per billion could cause one additional cancer per 100,000 people, a measure of risk the FDA also uses.

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Published: 06 March 2024, 07:16 PM IST