The U.S. Food and Drug Administration has placed an import alert on hand sanitizers from Mexico, following concerns around toxicity and ineffectiveness for a number of Mexican brands.
“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 said in a CNN report on Jan. 27.
Methanol (wood alcohol) can be toxic when absorbed through the skin and can be life-threatening if ingested. It is not an acceptable ingredient in hand sanitizer in the United States, according to the FDA.
Last June, according to Ars Technica, the regulatory agency began issuing alerts and warnings for consumers about dangerous and counterfeit hand sanitizers, many of which were made in Mexico. Since then, the FDA has issued alerts on 226 products. An FDA survey conducted between April and December 2020 found that 84% of Mexican hand sanitizers were not in compliance with FDA regulations.
CNBC also noted, during this time period, that more than half contained toxic substances at levels dangerous for human consumption, with exposure symptoms including vomiting, seizures, blindness, and effects on the central nervous system potentially severe enough to result in hospitalizations and death. The FDA added that young children are most at risk for the symptoms.
In addition to hand sanitizer products with methanol, the FDA discovered products containing another toxic ingredient, 1-propanol. Other scrutinized products simply contained insufficient amounts of safe ingredients needed to be effective.
Safe alcohols for hand sanitizers include ethanol (ethyl alcohol) at concentrations above 60% or isopropyl alcohol at concentrations above 70%.
In its announcement, the FDA—which released a list of the products in question—noted it is the first time that it has issued an import alert for any category of drug product from an entire nation.
“Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic … and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated,” Judy McMeekin, the FDA’s associate commissioner for regulatory affairs, said in the announcement.
As a result of the action, alcohol-based hand sanitizers from Mexico will now be subject to heightened scrutiny, and FDA staff may detain those Mexican hand sanitizer shipments coming into the U.S.