FDA Citizen Petition #8: Benzene in Benzoyl Peroxide Products

On March 6, 2024, Valisure announced the detection of benzene, a known human carcinogen, can form at high levels in Benzoyl Peroxide ("BPO") acne treatment products. Benzoyl Peroxide is considered a drug product regulated by the Food and Drug Administration (“FDA”). Results from Valisure’s tests show that on-market BPO products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) for benzene, and the current evidence suggests that this problem applies broadly to BPO products currently on the market. High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk. Incubation of a Proactiv® product at the temperature of a hot car (70°C) resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the Environmental Protection Agency’s (“EPA”) calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.

Unlike Valisure's previous findings of benzene in sunscreens, hand sanitizers and other consumer products where the benzene came from contaminated raw materials; the benzene in benzoyl peroxide products come from the drug itself degrading into benzene, meaning that the benzoyl peroxide market is broadly affected. Valisure is asking the FDA to consider a market withdrawal, similar to Valisure's 2019 FDA Citizen Petition on Zantac/ranitidine products, that were subsequently removed from the market globally.

Valisure's petition details results on hundreds of products tested, where benzene was detected at high levels, especially in stability studies looking at temperatures including 37°C (98.6°F - body temperature), 50°C (122°F - accepted pharmaceutical stability testing temperature) and 70°C (158°F - hot car temperature). High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potentially serious inhalation risk.

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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

On March 6, 2024, Valisure announced the detection of benzene, a known human carcinogen, can form at high levels in Benzoyl Peroxide ("BPO") acne treatment products. Benzoyl Peroxide is considered a drug product regulated by the Food and Drug Administration (“FDA”). Results from Valisure’s tests show that on-market BPO products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) for benzene, and the current evidence suggests that this problem applies broadly to BPO products currently on the market. High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk. Incubation of a Proactiv® product at the temperature of a hot car (70°C) resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the Environmental Protection Agency’s (“EPA”) calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.

Unlike Valisure's previous findings of benzene in sunscreens, hand sanitizers and other consumer products where the benzene came from contaminated raw materials; the benzene in benzoyl peroxide products come from the drug itself degrading into benzene, meaning that the benzoyl peroxide market is broadly affected. Valisure is asking the FDA to consider a market withdrawal, similar to Valisure's 2019 FDA Citizen Petition on Zantac/ranitidine products, that were subsequently removed from the market globally.

Valisure's petition details results on hundreds of products tested, where benzene was detected at high levels, especially in stability studies looking at temperatures including 37°C (98.6°F - body temperature), 50°C (122°F - accepted pharmaceutical stability testing temperature) and 70°C (158°F - hot car temperature). High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potentially serious inhalation risk.

‍

Media Highlights:

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Related Documents:

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Valisure Detects Benzene in Benzoyl Peroxide

Vote & Participate in Nationwide Independent Pharmaceutical Quality Study

FDA Citizen Petition #8: Benzene in Benzoyl Peroxide Products

On March 6, 2024, Valisure announced the detection of benzene, a known human carcinogen, can form at high levels in Benzoyl Peroxide ("BPO") acne treatment products. Benzoyl Peroxide is considered a drug product regulated by the Food and Drug Administration (“FDA”). Results from Valisure’s tests show that on-market BPO products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) for benzene, and the current evidence suggests that this problem applies broadly to BPO products currently on the market. High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk. Incubation of a Proactiv® product at the temperature of a hot car (70°C) resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the Environmental Protection Agency’s (“EPA”) calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.

Unlike Valisure's previous findings of benzene in sunscreens, hand sanitizers and other consumer products where the benzene came from contaminated raw materials; the benzene in benzoyl peroxide products come from the drug itself degrading into benzene, meaning that the benzoyl peroxide market is broadly affected. Valisure is asking the FDA to consider a market withdrawal, similar to Valisure's 2019 FDA Citizen Petition on Zantac/ranitidine products, that were subsequently removed from the market globally.

Valisure's petition details results on hundreds of products tested, where benzene was detected at high levels, especially in stability studies looking at temperatures including 37°C (98.6°F - body temperature), 50°C (122°F - accepted pharmaceutical stability testing temperature) and 70°C (158°F - hot car temperature). High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potentially serious inhalation risk.

‍

Media Highlights:

‍

Related Documents:

On March 6, 2024, Valisure announced the detection of benzene, a known human carcinogen, can form at high levels in Benzoyl Peroxide ("BPO") acne treatment products. Benzoyl Peroxide is considered a drug product regulated by the Food and Drug Administration (“FDA”). Results from Valisure’s tests show that on-market BPO products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) for benzene, and the current evidence suggests that this problem applies broadly to BPO products currently on the market. High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk. Incubation of a Proactiv® product at the temperature of a hot car (70°C) resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the Environmental Protection Agency’s (“EPA”) calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.

Unlike Valisure's previous findings of benzene in sunscreens, hand sanitizers and other consumer products where the benzene came from contaminated raw materials; the benzene in benzoyl peroxide products come from the drug itself degrading into benzene, meaning that the benzoyl peroxide market is broadly affected. Valisure is asking the FDA to consider a market withdrawal, similar to Valisure's 2019 FDA Citizen Petition on Zantac/ranitidine products, that were subsequently removed from the market globally.

Valisure's petition details results on hundreds of products tested, where benzene was detected at high levels, especially in stability studies looking at temperatures including 37°C (98.6°F - body temperature), 50°C (122°F - accepted pharmaceutical stability testing temperature) and 70°C (158°F - hot car temperature). High levels of benzene were not only detected inside BPO products, but also in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potentially serious inhalation risk.

‍

Media Highlights:

‍

Related Documents:

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Valisure Detects Benzene in Benzoyl Peroxide

Vote & Participate in Nationwide Independent Pharmaceutical Quality Study

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