Published 11:30 IST, January 28th 2021
'Potentially dangerous': US FDA regulators warn about 'toxic' Mexico hand sanitisers
US: The Food and Drug Administration has warned that more than half of all alcohol-based hand sanitisers imported from Mexico comprise ‘toxic’ ingredients.
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The Food and Drug Administration has warned that more than half of all alcohol-based hand sanitisers imported from Mexico comprise ‘toxic’ ingredients. With this, the FDA placed the product on a countrywide ‘import alert’. “Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment”, read the official press release.
Today, we placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert to help stop potentially dangerous or subpotent products from entering the US: https://t.co/rXNKhYfIrN pic.twitter.com/9h92GF2bi3
— FDA Drug Information (@FDA_Drug_Info) January 26, 2021
However, the FDA will still consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured as per the US current good manufacturing practice requirements. This is the first time that the FDA has issued a countrywide import alert for any category of drug product. As per the press release, Methanol, or wood alcohol, is the substance that makes the use of such sanitizers harmful. It can be toxic when absorbed through the skin and life-threatening when ingested.
Consumption increased significantly
Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs said, “Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated”. He further added that the actions are necessary to protect the safe supply of alcohol-based hand sanitizers. He added, “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”.
The press release says that 84 per cent of the samples analyzed by the agency from the month of April to December were not in compliance with the FDA’s regulations. More than half of the samples contained toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. To ensure safety, the agency reminds manufacturers, distributors, repackagers that they are responsible for the quality of their products. Also, it urges manufacturers to test their raw ingredients to ensure they meet labeling specifications.
(Image Credits: Unsplash)
11:32 IST, January 28th 2021