FDA Citizen Petition #8: Benzene in Benzoyl Peroxide Products

Valisure’s investigation into benzoyl peroxide (BPO) acne treatment products uncovered a new and deeply concerning mechanism of benzene exposure: the carcinogen is not merely a contaminant, but is formed through the degradation of the active drug itself.

Unlike previous findings of benzene in products like sunscreens or hand sanitizers—where contamination originated from raw materials—this study demonstrated that benzoyl peroxide can chemically degrade into benzene under normal conditions, affecting a broad swath of BPO products currently on the market.

Testing showed that:

  • Benzene levels reached over 800 times the FDA’s conditional 2.0 ppm limit
  • Elevated benzene was detected inside products and also leaking into surrounding air, posing an inhalation risk
  • A single Proactiv® product incubated at 70°C (158°F)—equivalent to a hot car—released benzene at concentrations ~1,270 times higher than the EPA’s threshold for increased cancer risk via long-term inhalation

Valisure’s testing included temperature-controlled stability studies at 37°C, 50°C, and 70°C—representing body heat, standard pharmaceutical stability conditions, and extreme environmental heat, respectively. These studies further confirmed the instability of BPO and the widespread potential for benzene formation under real-world storage conditions.

Valisure submitted a detailed FDA Citizen Petition, urging the agency to take action similar to its market withdrawal of ranitidine (Zantac) products in 2020. The petition included data on hundreds of tested products and called for immediate regulatory and industry response.

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Full Petition & Supporting Materials:

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Media Coverage Highlights:

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Valisure Detects Benzene in Benzoyl Peroxide

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FDA Citizen Petition #8: Benzene in Benzoyl Peroxide Products

March 6, 2024

Valisure’s investigation into benzoyl peroxide (BPO) acne treatment products uncovered a new and deeply concerning mechanism of benzene exposure: the carcinogen is not merely a contaminant, but is formed through the degradation of the active drug itself.

Unlike previous findings of benzene in products like sunscreens or hand sanitizers—where contamination originated from raw materials—this study demonstrated that benzoyl peroxide can chemically degrade into benzene under normal conditions, affecting a broad swath of BPO products currently on the market.

Testing showed that:

  • Benzene levels reached over 800 times the FDA’s conditional 2.0 ppm limit
  • Elevated benzene was detected inside products and also leaking into surrounding air, posing an inhalation risk
  • A single Proactiv® product incubated at 70°C (158°F)—equivalent to a hot car—released benzene at concentrations ~1,270 times higher than the EPA’s threshold for increased cancer risk via long-term inhalation

Valisure’s testing included temperature-controlled stability studies at 37°C, 50°C, and 70°C—representing body heat, standard pharmaceutical stability conditions, and extreme environmental heat, respectively. These studies further confirmed the instability of BPO and the widespread potential for benzene formation under real-world storage conditions.

Valisure submitted a detailed FDA Citizen Petition, urging the agency to take action similar to its market withdrawal of ranitidine (Zantac) products in 2020. The petition included data on hundreds of tested products and called for immediate regulatory and industry response.

‍

Full Petition & Supporting Materials:

‍

Media Coverage Highlights:

‍

Back to Newsroom

View Other Newsroom Posts

Valisure Detects Benzene in Benzoyl Peroxide

Vote & Participate in Nationwide Independent Pharmaceutical Quality Study

FDA Citizen Petition #8: Benzene in Benzoyl Peroxide Products

Valisure’s investigation into benzoyl peroxide (BPO) acne treatment products uncovered a new and deeply concerning mechanism of benzene exposure: the carcinogen is not merely a contaminant, but is formed through the degradation of the active drug itself.

Unlike previous findings of benzene in products like sunscreens or hand sanitizers—where contamination originated from raw materials—this study demonstrated that benzoyl peroxide can chemically degrade into benzene under normal conditions, affecting a broad swath of BPO products currently on the market.

Testing showed that:

  • Benzene levels reached over 800 times the FDA’s conditional 2.0 ppm limit
  • Elevated benzene was detected inside products and also leaking into surrounding air, posing an inhalation risk
  • A single Proactiv® product incubated at 70°C (158°F)—equivalent to a hot car—released benzene at concentrations ~1,270 times higher than the EPA’s threshold for increased cancer risk via long-term inhalation

Valisure’s testing included temperature-controlled stability studies at 37°C, 50°C, and 70°C—representing body heat, standard pharmaceutical stability conditions, and extreme environmental heat, respectively. These studies further confirmed the instability of BPO and the widespread potential for benzene formation under real-world storage conditions.

Valisure submitted a detailed FDA Citizen Petition, urging the agency to take action similar to its market withdrawal of ranitidine (Zantac) products in 2020. The petition included data on hundreds of tested products and called for immediate regulatory and industry response.

‍

Full Petition & Supporting Materials:

‍

Media Coverage Highlights:

‍

Valisure’s investigation into benzoyl peroxide (BPO) acne treatment products uncovered a new and deeply concerning mechanism of benzene exposure: the carcinogen is not merely a contaminant, but is formed through the degradation of the active drug itself.

Unlike previous findings of benzene in products like sunscreens or hand sanitizers—where contamination originated from raw materials—this study demonstrated that benzoyl peroxide can chemically degrade into benzene under normal conditions, affecting a broad swath of BPO products currently on the market.

Testing showed that:

  • Benzene levels reached over 800 times the FDA’s conditional 2.0 ppm limit
  • Elevated benzene was detected inside products and also leaking into surrounding air, posing an inhalation risk
  • A single Proactiv® product incubated at 70°C (158°F)—equivalent to a hot car—released benzene at concentrations ~1,270 times higher than the EPA’s threshold for increased cancer risk via long-term inhalation

Valisure’s testing included temperature-controlled stability studies at 37°C, 50°C, and 70°C—representing body heat, standard pharmaceutical stability conditions, and extreme environmental heat, respectively. These studies further confirmed the instability of BPO and the widespread potential for benzene formation under real-world storage conditions.

Valisure submitted a detailed FDA Citizen Petition, urging the agency to take action similar to its market withdrawal of ranitidine (Zantac) products in 2020. The petition included data on hundreds of tested products and called for immediate regulatory and industry response.

‍

Full Petition & Supporting Materials:

‍

Media Coverage Highlights:

‍

Back to Newsroom

View Other Newsroom Posts

Valisure Detects Benzene in Benzoyl Peroxide

Vote & Participate in Nationwide Independent Pharmaceutical Quality Study

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