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The US declares hand sanitizer gels imported from Mexico as "potentially dangerous"


The Food and Drug Administration stops imports and states that more than half of the analyzed products contain toxic substances

Antibacterial gel sold in the Tepito neighborhood of Mexico City.Monica Gonzalez / EL PAIS

The United States has stopped the importation of all hand sanitizing gels from Mexico as of this week.

US authorities have described Mexican alcohol-based sanitizers as "potentially dangerous" because they contain methanol, a substance "that can be toxic when absorbed through the skin and can be fatal when ingested," a statement read. .

More than half of the products tested by the Food and Drug Administration (FDA) contained methanol or propanol at “dangerous levels” and in most cases it was not specified that it was included on the label.

"The use of hand sanitizers by consumers 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," said Judy McMeekin, FDA's regulatory affairs officer.

The implications of the import alert is that the products will be detained when they reach the United States without the need for a physical inspection of their content.

In most cases, the authorities choose to destroy the product so as not to have to bear the cost of returning it, explains Georgina Hernández, head of the quality management system at the Institute of Biotechnology of the National Autonomous University of Mexico.

Between April and December, the US agency analyzed a sample of 112 products from 53 Mexican manufacturers and found that 84% did not meet the specifications to be marketed, in most cases due to the presence of methanol.

Other products were identified as unserviceable for having too low concentrations of alcohol.

The FDA states that exposure to methanol can cause nausea, vomiting, and headaches.

The most severe damages cited in the statement include blindness, heart complications, permanent damage to the central nervous system and death from poisoning.

The agency also notes that children and adolescents are at higher risk.

Regulatory authorities assure that they are aware of at least 20 deaths associated with this substance, although they do not specify in what period, and add that at least seven people who died had consumed a product from Mexico.

Propanol, for its part, is a less aggressive compound than methanol and is in a lower risk category from the FDA, Hernández explains.

The gels have it in low amounts, but the continued use of the product can cause skin irritation, as well as damage to the respiratory and digestive tract if inhaled or ingested.

Methanol, for its part, has already been in the sights of the Mexican authorities, but more associated with deaths due to adulteration of alcoholic beverages.

"It's serious," says Hernández, "the fact of having an alert in the United States should lead the Mexican authorities to review what is happening."

This is the first time that the FDA has issued a country-wide import restriction on a pharmaceutical product.

The list includes 226 sanctioned manufacturers, the vast majority from Mexico, although there are also companies from China, Guatemala, South Korea and the United States.

Since June, the US agency had issued alerts to consumers for the presence of methanol in some Mexican products and in October it extended its list of cautioned products.

In Mexico, the Federal Commission for the Protection against Sanitary Risks (Cofepris), the Mexican counterpart of the FDA, warned in September of disinfectant gels with high amounts of ethanol.

The measures will remain in place until the safety of the product is reassessed and only companies that demonstrate that they were included without justification in the list will be able to continue exporting their products.

It is a long production chain that concerns both exporters and importers of disinfectant gels.

"The economic impact will affect both sides of the border," predicts Hernández.

For consumers, the specialist recommends avoiding bulk gels and opting for well-known brands, which tend to be more careful to comply with the specifications of regulators and have a clearer labeling of the supplies that their products contain.

It also suggests following the recommendations of the Federal Consumer Protection Agency (Profeco) and Cofepris for the extensive use of gels during the pandemic.

"The virus has a layer of lipids that alcohol helps to disaggregate, although the ideal is to use soap and water, which are responsible for doing the same," concludes Hernández.

Source: elparis

All news articles on 2021-01-27

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