Valisure recently published an article regarding their detection of benzene in commercial hand sanitizers. The article was covered by many national news outlets. Valisure acquired various hand sanitizer formulations (eg, gels, sprays),in an effort to have a sample representative of the general commercial supply. They analyzed 260 unique batches from 168 brands. Valisure found 44 batches (17% of tested samples) with benzene at 0.1 ppm (parts per million) or greater and 21 batches (8%) with benzene at 2 ppm or greater. The highest detected level was 16.1 ppm.
Benzene is considered carcinogenic to humans as defined by the CDC (Centers for Disease Control and Prevention), WHO (World Health Organization), and IARC (International Agency for Research on Cancer). Benzene is specifically associated with blood cancers (eg, leukemia). Exposure of benzene can be through inhalation, ingestion, skin absorption, and skin and/or eye contact. Benzene is listed as a Class 1 solvent by FDA and should not be used in the manufacturing of drug substances, excipients, and drug products due to its unacceptable toxicity. However, FDA issued guidance in March 2020 (updated February 10, 2021) that permits a limit of benzene not to exceed 2 ppm in hand sanitizer in an effort to fill the gap in supply of hand sanitizer resulting from the COVID-19 pandemic. The 0.1 ppm threshold that Valisure used comes from the NIOSH (National Institute for Occupational Safety and Health) recommendation that workers wear protective equipment if they may be exposed to benzene at concentrations exceeding 0.1 ppm or greater. To date, no hand sanitizers have been recalled due to the presence of benzene, but Valisure issued a Citizen Petition asking FDA to address their findings. FDA has recently recalled hand sanitizers containing methanol, microbial contamination, and 1‑propanol. FDA is maintaining a list of recalled products.
There are 2 potential sources of benzene contamination in hand sanitizer: purification method and carbomer content. Some chemical processes used in the purification of alcohols use benzene. One method used to give a gel its high viscosity is by adding “carbomer”. Carbomer is often manufactured using benzene and benzene impurity in carbomer products can measure in the thousands of ppm. It is not currently known whether the presence of benzene in any of the products tested by Valisure was due to the inclusion of carbomer or due to the purification method of the alcohol ingredient.
Additional information is available at the following links:
- Valisure article. March 24, 2021
**See link to FDA Citizen Petition within article to view specific products that contained benzene - FDA updates on hand sanitizers consumers should not use.