FDA Recall Petition by Valisure for Products Including Benzene for Acne

There was benzene in hand sanitizers. dry shampoos as well as sunscreens. These days, acne treatments are being discovered to have significant concentrations of the chemical related to cancer in commonly used consumer products.

FDA Recall Products for acne, such as Proactiv and Clearasil, include chemicals that have been linked to cancer.

A petition submitted with the US Food and Drug Administration late Tuesday claimed that acne products from Clinique, Proactiv, and Target Corp.’s Up & Up contained higher concentrations of the carcinogen. The testing facility was independent. Benzoyl peroxide is the active ingredient in all of the impacted treatments, which the lab requested the FDA to recall while regulatory authorities look into the matter.

FDA Recall Products for acne, such as Proactiv and Clearasil, include chemicals that have been linked to cancer.

Per the US Centres for Disease Control and Prevention, benzene is a naturally occurring component of gasoline and tobacco smoke, and at high concentrations, it can cause leukaemia. Consumers are now more aware of the possible risks hidden in their bathroom cabinets, and concerns regarding the FDA’s industry supervision have been raised by the discovery of it in a number of well-known goods during the last three years. Products have been recalled by firms such as Procter & Gamble Co., Unilever Plc, and Johnson & Johnson.
The testing facility, Valisure LLC, located in New Haven, Connecticut, has positioned itself as a gatekeeper for customers. It submitted the petition on Tuesday and discovered the prior hazards. Valisure became more popular.

carrying out product research and has partnerships with major healthcare organisations, such as Kaiser Permanente and the US Department of Defence, to test medications taken by its members and eliminate inadequate care.

carrying out product research and has partnerships with major healthcare organisations
66 benzoyl peroxide treatments, including creams, lotions, gels, and washes that are either prescribed or sold over-the-counter by big-box stores, were tested by Valisure for its acne research. Benzene levels in certain therapies were found to be up to 12 times higher than the FDA‘s recommended maximum of 2 parts per million. The goods’ levels dramatically increased when they were tested at higher temperatures that were intended to simulate how they could degrade over time, such as in a steamy bathroom medicine cabinet.

In a stability test conducted by Valisure, benzene levels in Proactiv’s 2.5% benzoyl peroxide cream—which is made by Taro Pharmaceutical Industries Ltd.—went as high as 1,761 parts per million. In comparison, a cream of a similar nature from Target came in at 1,598 parts per million, and a Clinique treatment from Estee Lauder Cos. found 401 parts per million. When exposed to high temperatures for longer than two weeks, a 10% benzoyl peroxide lotion from Reckitt Benckiser Group Plc’s Clearasil increased to 308 parts per million of benzene, testing just at the FDA limit at first.
Comment requests were not immediately answered by representatives of the FDA, Target, Taro Pharmaceuticals, Estee Lauder, or Reckitt.

Based on annual estimates from the American Academy of Dermatology, acne is the most common skin problem in the United States, affecting up to 50 million people. Between the ages of 12 and 24, around 85% of people have some kind of the illness; the numbers are significantly higher among teenagers and young adults.

Based on annual estimates from the American Academy of Dermatology
The US market research firm Circana, based in Chicago, said that sales of over-the-counter acne treatments reached $1 billion in 2018, nearly double the $593 million in sales that year. Among the best recommendations for topical acne treatment made by the AAD guidelines is benzoyl peroxide.

Benzene can be formed from the breakdown of benzoyl peroxide, according to David Light, President of Valisure. This is why contamination occurs.
“This has long been known,” he stated in an interview. A simple check-in was all that was required.
A way to stop benzoyl peroxide in medication items from decomposing into benzene was filed for patent last year, and Light is named as an inventor on that approach.

The FDA withdrawn Zantac and its generic equivalents from sale in 2020, following a lab’s discovery that the drug’s active ingredient, ranitidine, may combine to generate the potentially cancer-causing compound NDMA. This was the subject of Valisure’s most well-known inquiry.

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The lab said in a statement on Wednesday that the findings from its study into those ranitidine-containing products were most comparable to those from its research on acne treatments.

The FDA cautioned drugmakers in 2022 to evaluate the possibility of benzene developing in their own products in response to Valisure’s earlier benzene results.

Products under its supervision are not routinely tested by the agency.

Even an unopened Proactiv product released substantial levels of benzene when held at 104 degrees Fahrenheit—the temperature of a hot shower—for over 17 hours, according to Valisure’s tests on benzene in the air surrounding acne treatments.

Products under its supervision are not routinely tested by the agency.

Using the same risk assessment method as the FDA, the Environmental Protection Agency has stated that breathing in 0.4 parts per billion of benzene continuously during one’s lifetime may cause one extra case of cancer for every 100,000 individuals.

 

 

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