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AARS Responds to Valisure’s Data on Benzene in BPO Products

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The statement said the petition came as a surprise to many ahead of AAD, and delves into the data complexity and patient considerations.

The American Acne and Rosacea Society (AARS) has released a statement about the citizen petition filed by Valisure on benzene in benzoyl peroxide (BPO) drug products. “Public safety is the first priority of the AARS. While we await the FDA review of the information, testing data, and proposal reported in the petition, the AARS is evaluating and researching the details stated in the document in order assure its accuracy and provide guidance based on scientific fact,” said James Del Rosso, DO, president of the AARS in a press release.1

He went on to add, “This petition came as a surprise to all of us in dermatology as BPO is FDA-approved in many over the counter and prescription topical products, including a few recently approved prescription products for acne or rosacea.” AARS leadership said that right now,“there are many questions about this issue and we do not yet have all the answers.” The AARS believes patients and dermatologists should have transparent conversations to determine the best treatment course to take until there is further guidance from the FDA and verification of the safety and stability of BPO products.

Del Rosso emphasized the importance of encouraging patients to conscientiously follow storage procedures recommended for the BPO products being used, which may minimize the potential for benzene formation. “Some products also indicate specific instructions on how long to keep a BPO-containing product until it should be discarded. Other recommendations include discarding expired BPO products and those that have been exposed to temperatures above room temperature. For new BPO products, store at refrigerator temperature which at least theoretically can reduce degradation of BPO to benzene. Replace BPO products every 3 months or as recommended on the specific product,” he explained.

The statement from the AARS concluded that the potential presence of benzene in BPO and other personal use products is a serious issue requiring more data. "The AARS also hope that manufacturers and regulators2 will carry out appropriate due diligence and take this opportunity to do the right things and determine what is best for the good of all patients. The AARS is committed to doing its part now and along the way,” Del Rosso said.

Dermatology Times has previously spoken with Valisure's president and co-founder David Light, as well as Christopher Bunick, MD, PhD, to discuss methods and data. Numerous clinicians have also shared their perspectives on the findings.

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References

  1. Response statement from the AARS to the Valisure citizen petition on benzene in benzoyl peroxide drug products. News release. American Acne and Rosacea Society. March 20, 2024. Accessed March 20, 2024. https://www.einpresswire.com/article/697481595/response-statement-from-the-aars-to-the-valisure-citizen-petition-on-benzene-in-benzoyl-peroxide-drug-products
  2. Reformulating drug products that contain carbomers manufactured with benzene. News release. US Food and Drug Administration. December 27, 2023. Accessed March 20, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reformulating-drug-products-contain-carbomers-manufactured-benzene

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