February 25, 2020 

This week, the US Food & Drug Administration issued a warning letter to Absara Cosmetics S.A.P.I DE C.V., Zapata, Mexico after testing the company’s consumer hand sanitizer, “Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free.”

Since the coronavirus pandemic began, the increase of contaminated, toxic, poorly packaged, or falsely advertised hand sanitizers has plagued consumers and public officials alike.

The FDA detained “Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free,” formulated with 70% alcohol with aloe vera and glycerin, at the US-Mexico border earlier this month. The product was denied entry into the United States.

Following testing, the FDA determined the product was formulated with 58% ethanol, not the 70% ethanol advertised on the label.

“The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that its strength, purity, or quality falls below that which it purports or is represented to possess,” stated the FDA’s warning letter.

The FDA has requested a detailed follow-up investigation.

But, this is far from the only problematic hand sanitizer to infiltrate the marketplace since the onset of the pandemic.

Last month, the FDA issued an “import alert” on all alcohol-based hand sanitizers coming from Mexico. The import alert is an attempt to stem the recent market flood of hand sanitizers contaminated with the toxic ingredient methanol, or wood alcohol.

Methanol can be absorbed through the skin and is toxic. When ingested, methanol can be life-threatening. Methanol exposure can result in blurred vision, headaches, nausea, vomiting, seizures, coma, and nervous system damage.

“Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination,” the FDA stated.

This is the first time the FDA has ever issued a countrywide import alert for a drug product.

In addition to the tainted products, the FDA has also previously issued warnings about hand sanitizers packaged to look like toys, drinks, or food. Consumption of hand sanitizer can cause injury or death.

Product consumption has been a concern since the pandemic began in 2020, due to a surge in accidental poisonings.

“According to data from the National Poison Data System, there were 938 hand-sanitizer exposure cases reported to the 55 U.S. Poison Control Centers during a 10-day period, from January 1, 2021 to January 10, a 57% increase from a year ago,” explains Kelsie Sandoval in Insider.

Stay informed: the FDA recommends checking their do-not-use list of sanitizers at www.fda.gov/handsanitizerlist.

For more information or to report a problem visit: Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?

Take advantage of our new anti-aging guide, featuring the most innovative, highest-quality ingredients in the personal care industry.