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Timeline of Events: Benzene and Carbomer Regulation

News
Article

Following Valisure’s Citizen’s Petition to the US Food and Drug Administration, we are recapping recent years of regulatory action regarding benzene and carbomers.

Tada Images/Adobe Stock
Tada Images/Adobe Stock

Last week, New Haven, Connecticut-based independent laboratory Valisure LLC announced1 it had filed a Citizen's Petition2 to the US Food and Drug Administration (FDA) regarding its findings of high levels of benzene in benzoyl peroxide (BPO)- containing skin care products.

An initial stability study tested 5 products at temperatures of 37°C, 50°C and 70°C. Investigators conducted addition incubation testing with 66 BPO products, including creams, lotions, gels, and washes, commonly available over the counter or through prescription, at 50°C and 70°C for 18 days each per respective temperature.2

Including large name-brand consumer products, some of the testing products on the higher end of the spectrum contained more than 1000 parts per million of benzene. Presently, US FDA guidelines allow up to 2 parts per million of benzene.2

While clinicians and consumers alike await comment from the FDA regarding these findings, it should be noted that the FDA has a long history of involvement and regulation of benzene and carbomers that contain it. We recap recent involvement below.

This timeline will be updated as more benzene-related news comes forward. Please note: You may need to hover and scroll over the timeline to read the full summary of each event. You can also click here to view the timeline in a new window.

References

  1. Valisure detects benzene in benzoyl peroxide. News release. Valisure. March 6, 2024. Accessed March 14, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide
  2. Valisure citizen petition on benzene in benzoyl peroxide drug products. Valisure. March 5, 2024. Accessed March 14, 2024. https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf
  3. Valisure detects benzene in hand sanitizers. News release. Valisure. March 24, 2021 Accessed March 14, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-hand-sanitizers
  4. Scentsational Soaps & Candles, Inc. issues voluntary nationwide recall of scented hand sanitizers due to the presence of methanol (wood alcohol), benzene and acetaldehyde. News release. US Food and Drug Administration. April 28, 2021. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scentsational-soaps-candles-inc-issues-voluntary-nationwide-recall-scented-hand-sanitizers-due
  5. Valisure detects benzene in sunscreen. News release. Valisure. Published May 20, 2021. Accessed March 14, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-sunscreen
  6. Johnson & Johnson Consumer Inc. issues voluntary recall of specific NEUTROGENA and AVEENO aerosol sunscreen products due to the presence of benzene. News release. Johnson & Johnson. July 14, 2021. Accessed March 14, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-consumer-inc-issues-voluntary-recall-of-specific-neutrogena-and-aveeno-aerosol-sunscreen-products-due-to-the-presence-of-benzene
  7. Coppertone issues voluntary nationwide recall of specific lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone Sport Spray SPF 50 (1.6OZ) aerosols sunscreen sprays due to the presence of benzene. News release. US Food and Drug Administration. September 30, 2021. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/coppertoner-issues-voluntary-nationwide-recall-specific-lots-pure-simple-spf-50-spray-2021-launch
  8. Bayer issues voluntary recall of specific Lotrimin and Tinactin spray products due to the presence of benzene. News release. US Food and Drug Administration. October 1, 2021. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene
  9. P&G issues voluntary recall of specific old spice and secret aerosol spray antiperspirants and old spice below deck aerosol spray products due to detection of benzene. News release. US Food and Drug Administration. Published November 24, 2021. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pg-issues-voluntary-recall-specific-old-spice-and-secret-aerosol-spray-antiperspirants-and-old-spice
  10. Edgewell personal care issues voluntary nationwide recall of banana boat hair & scalp sunscreen due to the presence of benzene. News release. US Food and Drug Administration. Published July 29, 2022. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due
  11. Unilever issues voluntary U.S. recall of select dry shampoos due to potential presence of benzene. News release. US Food and Drug Administration. October 18, 2022. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unilever-issues-voluntary-us-recall-select-dry-shampoos-due-potential-presence-benzene
  12. Valisure detects high levels of benzene in several dry shampoo products and requests FDA actions. Valisure. Published November 1, 2022. Accessed March 14, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-dry-shampoo
  13. Edgewell personal care issues voluntary nationwide recall of Banana Boat Hair & Scalp Sunscreen due to the presence of benzene – updated. News release. US Food and Drug Administration. Published January 30, 2023. Accessed March 14, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due-0?utm_medium=email&utm_source=govdelivery
  14. Nithyanandan P. Risk factors for benzene contamination. US Food and Drug Administration. April 2023. Accessed March 14, 2024. https://www.fda.gov/media/168962/download
  15. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry. US Food and Drug Administration. December 27, 2023. Accessed March 14, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reformulating-drug-products-contain-carbomers-manufactured-benzene
  16. Moniuszko S. Benzene, a known carcinogen, found in some popular acne products, lab says. Here's what to know. March 6, 2024. Accessed March 14, 2024. https://www.cbsnews.com/news/benzene-carcinogen-found-acne-products-what-to-know/
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