FDA Citizen Petition #4: Benzene in Hand Sanitizer Products
As hand sanitizers became a critical tool during the COVID-19 pandemic, Valisure uncovered a dangerous public health risk: high levels of benzene, a known human carcinogen, were present in multiple over-the-counter hand sanitizer products, which are regulated by the FDA as drug products.
Valisure analyzed 260 batches from 168 different brands and found 21 batches exceeded the FDA’s interim limit of 2.0 ppm for benzene set during the Public Health Emergency. An additional 23 batches contained between 0.1–2.0 ppm, while 216 batches had no detectable benzene. The results revealed significant variability even within the same brands, indicating major quality control issues in manufacturing and supply chains.
Benzene is recognized as a Group 1 human carcinogen by the CDC, WHO, and IARC, and its presence in products designed for repeated, topical use presented a serious exposure concern. Valisure filed a detailed Citizen Petition urging the FDA to take action, which contributed to multiple product recalls and renewed calls for independent quality testing in consumer health products.
Full Petition & Supporting 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
- GOJO & Valisure – Promoting Public Health through Collaboration
- 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
Media Coverage 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
