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FDA puts all Mexican hand sanitizers on import alert

Posted 27 January 2021 | By Kari Oakes 

FDA puts all Mexican hand sanitizers on import alert

The US Food and Drug Administration (FDA) has placed all hand sanitizers from Mexico on import alert over concerns of methanol contamination. “This marks the first time the FDA has issued a countrywide import alert for any category of drug product,” noted FDA a press release announcing the measures.
 
The alert will “help stop products that appear to be in violation from entering the US until the agency is able to review the products’ safety,” according to the press release. The sanitizers in question are labeled as containing ethanol, but may also contain dangerous levels of methanol, which is toxic when ingested, may be absorbed through the skin, and can cause serious illness or death.
 
Methanol-contaminated hand sanitizers, said FDA, are known to have cause a host of adverse events, “including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health.”
 
An FDA analysis of hand sanitizers from Mexico found that 84% of the alcohol-based sanitizers did not comply with FDA regulations; more than half contained dangerous levels of toxic ingredients including methanol and another toxic alcohol, 1-propanol.
 
In a 26 January warning letter sent to Ignacio Reyes Gonzalez, a Jalisco-based Mexican firm, FDA reported that its analysis found just 1.4% ethanol and 63% methanol by volume in the products it sampled, not the 70% ethanol indicated by the labeling. The agency’s analysis of two other Mexican firms warned on the same day found similar wild variations between labeling and actual ethanol content, and both firms’ hand sanitizers had significant methanol contamination as well.
 
In practice, the alert means that hand sanitizers coming to the US from Mexico may be detained and will be subject to extra scrutiny. FDA is working with Mexican governmental authorities and manufacturers on the issue.
 
FDA has also taken steps against US-based manufacturers of alcohol-based hand sanitizers whose products also had undeclared methanol at dangerous levels. A total of 14 manufacturers have been warned by FDA since July 2020 for a variety of violations, including methanol contamination, off-specification ethanol content, misleading claims and problems with manufacturing.
 
A guidance issued this month provides industry with FDA’s policy for testing both ethanol and isopropyl alcohol for methanol during the pandemic. The increased demand for hand sanitizers during the pandemic has increased supply pressure, noted FDA.
 
“In the past, increased stress on supply chains has made ingredients more vulnerable to economically motivated adulteration,” wrote FDA in the guidance, so the policy applies to all products that contain pharmaceutical alcohol, not just hand sanitizers.
 
As background, FDA gives some highlights of the problems with current good manufacturing practices, including lack of adequate testing of active pharmaceutical ingredients and finished products, as well as reliance solely on the supplier’s certificate of analysis for purity and quality.
 
The guidance document breaks out considerations for manufacturers of alcohol-containing drug products, compounded drug products in particular, and hand sanitizers manufactured under FDA’s pandemic-related temporary policies.
 
“Today’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers. We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind,” said Judy McMeekin, PharmD, FDA’s associate commissioner for regulatory affairs, in the press statement.
 
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Tags: coronavirus, FDA, US

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