Login
Subscribe
In March, the Connecticut-based pharmacy Valisure[1] raised the alarm after its testing found that samples of many hand sanitizers marketed in the U.S. contained benzene, a known human carcinogen. Based on these findings, the company petitioned the Food and Drug Administration (FDA) to request a recall of the benzene-tainted hand sanitizers and to take other actions to protect consumers from these products.[2]
Benzene is a colorless, flammable liquid commonly used in the manufacture of...
In March, the Connecticut-based pharmacy Valisure[1] raised the alarm after its testing found that samples of many hand sanitizers marketed in the U.S. contained benzene, a known human carcinogen. Based on these findings, the company petitioned the Food and Drug Administration (FDA) to request a recall of the benzene-tainted hand sanitizers and to take other actions to protect consumers from these products.[2]
Benzene is a colorless, flammable liquid commonly used in the manufacture of other chemicals, including plastics, dyes, detergents and pesticides.[3] It has been linked to leukemia and other blood cell cancers.[4] FDA policy states that benzene should be avoided in the manufacture of drugs because of its unacceptable toxicity.[5] However, if benzene use is unavoidable in order to produce a drug, the benzene level should be no more than 2 parts per million (ppm).
Hand sanitizers are regulated by the FDA as over-the-counter drugs.[6] Soon after the first case of COVID-19 was diagnosed in the U.S., public health authorities began urging everyone to frequently wash their hands with soap and water or, when hand-washing was not feasible, to use alcohol-based hand sanitizers containing at least 60% ethanol (ethyl alcohol) to prevent the spread of the coronavirus. Panic buying of hand sanitizers soon ensued, resulting in nationwide shortages of these products.
In response to these shortages and the COVID-19 pandemic, the FDA issued temporary guidance allowing manufacturers to use fuel- and technical-grade ethanol in the production of hand sanitizer.[7] Normally, the FDA does not allow such ethanol grades to be used in the production of hand sanitizers because they sometimes contain harmful chemicals, such as gasoline and benzene. Under the agency’s temporary guidance, companies using fuel- or technical-grade ethanol to make hand sanitizer during the pandemic are required to test the ethanol for benzene (and other impurities) and may only use ethanol containing no gasoline and no more than 2 ppm benzene.
Valisure reported that it analyzed 260 unique batches from 168 different brands of hand sanitizers.[8] Twenty-one batches (8%) contained more than 2 ppm benzene, above the interim permissible limit set by the FDA. Another 23 batches (9%) contained 0.1 to 2 ppm benzene. The highest level of benzene detected was 16.1 ppm, eight times the interim permissible limit. Benzene was not detected in 216 batches of hand sanitizer from 152 brands. Benzene from these tainted products can be easily absorbed into the body through the skin.
There is no justification for continuing the FDA’s temporary policy allowing companies to make hand sanitizer with fuel- or technical-grade ethanol contaminated with benzene. To protect public health, the FDA should immediately rescind its temporary guidance and ask manufacturers of to recall any products tainted with benzene at a level of 0.1 ppm or more.
References
[1] Valisure. About us. https://www.valisure.com/about-us/. Accessed April 12, 2021.
[2] Valisure. Citizen petition on hand sanitizer products containing benzene contamination and other significant issues. March 24, 2021. https://www.regulations.gov/document/FDA-2021-P-0338-0001. Accessed April 12, 2021.
[3] American Cancer Society. Benzene and cancer risk. January 5, 2016. https://www.cancer.org/cancer/cancer-causes/benzene.html. Accessed April 12, 2021.
[4] Ibid.
[5] Food and Drug Administration. Q3C — Tables and list: Guidance for industry (revision 4). August 2018. https://www.fda.gov/media/133650/download. Accessed April 12, 2021.
[6] Food and Drug Administration. FDA news release: FDA issues final rule on safety and effectiveness of consumer hand sanitizers. April 11, 2019. https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers. Accessed April 12, 2021.
[7] Food and Drug Administration. Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19): Guidance for industry. March 2020 (updated February 10, 2021). https://www.fda.gov/media/136289/download. Accessed April 12, 2021.
[8] Valisure. Citizen petition on hand sanitizer products containing benzene contamination and other significant issues. March 24, 2021. https://www.regulations.gov/document/FDA-2021-P-0338-0001. Accessed April 12, 2021.
