FDA Citizen Petition #4: Benzene in Hand Sanitizer Products
On March 24th, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention (CDC), the International Agency for Research on Cancer (IARC), the World Health Organization (WHO), and other regulatory agencies.
Valisure analyzed 260 unique batches from 168 different brands, and significant variability from batch to batch was observed even within a single brand. Twenty-one batches of hand sanitizer contained benzene above the 2.0 ppm FDA interim limit for the COVID-19 Public Health Emergency, with an additional 23 batches of hand sanitizer containing between 0.1 ppm – 2.0 ppm of benzene. Benzene was not detected in an additional 216 batches of hand sanitizer from 152 brands through initial analysis of at least one sample (see detailed tables in Valisure’s FDA Citizen Petition).
Media Highlights:
- Bloomberg: Carcinogen Found in Hand Sanitizers That Plugged Pandemic Gap
- Business Insider: Some hand sanitizers made during the COVID-19 pandemic found to have high levels of a carcinogen: study
- CBS This Morning: Study finds carcinogen above FDA limit in several hand sanitizer brands
- Chicago Tribune: Some hand sanitizers used to fight COVID-19 found to be tainted with cancer-causing chemical
- Fox News: Carcinogenic: Hand sanitizers used to combat COVID-19 found to have toxic, cancer-causing chemical
- Health: These Hand Sanitizers Were Found to Contain High Levels of Cancer-Causing Chemical Benzene—Here’s What to Know
- iHeartRadio: Cancer-Causing Chemical Found In At Least 44 Hand Sanitizers
- MedPage Today: Benzene Found in Multiple Hand Sanitizer Brands
- Newsweek: 21 Hand Sanitizers Found to Have High Levels of Cancer-Causing Chemicals
- The New York Post: Cancer-causing chemical in these hand sanitizers poses ‘serious risk’
- The People’s Pharmacy: Some Hand Sanitizers Are Contaminated with Benzene
- The Hill: Carcinogen found in hand sanitizers sold during pandemic
Related Documents:
- Press Release - Valisure Detects Benzene in Hand Sanitizer
- FDA Citizen Petition – Contains lists of products where benzene was detected at 0.1 ppm or above
- Attachment A – contains a list of products where benzene was not detected at 0.1 ppm or above
- Attachment B – Resolution from the American College of Cardiology regarding independent testing
- Attachment C – Contains images of all products tested by Valisure
- Summary Timeline of consumer product recalls due to benzene
