FDA Citizen Petition #4: Benzene in Hand Sanitizers

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).

These results of benzene body spray resulted in the recalls of ArtNaturals’ products, Scentsational Soaps & Candles products, and Best Brands Consumer Products, Inc.

Complete Valisure Citizen Petition Documents:

  • Complete 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. (File size: 75 MB)

Media highlights:

FDA Citizen Petition #4: Benzene in Hand Sanitizers

April 13, 2022

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).

These results of benzene body spray resulted in the recalls of ArtNaturals’ products, Scentsational Soaps & Candles products, and Best Brands Consumer Products, Inc.

Complete Valisure Citizen Petition Documents:

  • Complete 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. (File size: 75 MB)

Media highlights:

FDA Citizen Petition #4: Benzene in Hand Sanitizers

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).

These results of benzene body spray resulted in the recalls of ArtNaturals’ products, Scentsational Soaps & Candles products, and Best Brands Consumer Products, Inc.

Complete Valisure Citizen Petition Documents:

  • Complete 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. (File size: 75 MB)

Media highlights:

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).

These results of benzene body spray resulted in the recalls of ArtNaturals’ products, Scentsational Soaps & Candles products, and Best Brands Consumer Products, Inc.

Complete Valisure Citizen Petition Documents:

  • Complete 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. (File size: 75 MB)

Media highlights:

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