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FDA Targets Mexican-Made Hand Sanitizers

'Import alert' comes after toxic chemicals were found in over half of samples tested

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The U.S. Food and Drug Administration (FDA) has placed all alcohol-based hand sanitizers from Mexico on a countrywide “import alert” that will allow federal agents to detain shipments until the products are determined to be safe to bring into the U.S.

The first-of-its-kind countrywide action comes after the FDA found that between April and December 2020, the vast majority (84 percent) of the samples tested from Mexico were not in compliance with agency regulations. Worse, more than half of the Mexican-produced sanitizers contained toxic methanol or 1-propanol at dangerous levels. 

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"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,” Judy McMeekin, FDA associate commissioner for regulatory affairs, said in a statement.

The agency first issued a consumer alert in June 2020 for nine hand sanitizers manufactured in Mexico that contained methanol, also known as wood alcohol. A Centers for Disease Control and Prevention (CDC) report found that from May 1 to June 30, 15 adults (13 men and two women with a history of swallowing alcohol-based hand sanitizers) were hospitalized after ingesting methanol-tainted products. Four died, and three were discharged from the hospital with vision impairment.

The FDA has since expanded its warning list to more than 200 hand sanitizers from 50 Mexican manufacturers as well as others made in China, Turkey, Korea, Guatemala and six U.S. states that have been found to contain methanol or 1-propanol, a chemical that if ingested can cause central nervous system depression, which can result in death, the agency warns.

The FDA has also issued 14 warning letters to businesses since July 2020 for distributing hand sanitizer with undeclared methanol and inappropriate ethanol content, for making misleading claims (including incorrectly stating FDA approval) and for engaging in improper manufacturing practices.

The agency previously issued import alerts on specific products that were found to be tainted. Under the first-of-its-kind countrywide alert for an entire category of drug products, agents can “detain without physical examination (DWPE)” any “alcohol-based hand sanitizer drug products offered for entry from the country of Mexico,” with the exception of FDA-approved manufacturers on a “Green List."

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The FDA continues to urge consumers not to use any hand sanitizer from a manufacturer on the warning list, even if the product or particular lot number is not listed, as some companies are recalling only certain, not all, of their hand sanitizers.

If you have purchased any of the hand sanitizers listed in the warning, the agency recommends that you stop using it immediately and dispose of it in “appropriate hazardous waste containers.” Do not flush them down the toilet or pour them down the drain, the FDA advises.

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The dangers of methanol

Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning, according to the FDA.

Symptoms of Methanol Poisoning

Early adverse effects may include:

  • Headache
  • Blurred vision
  • Nausea
  • Vomiting
  • Abdominal pain
  • Drowsiness
  • Decreased level of consciousness
  • Ataxia (inability to coordinate muscle movement)

Severe adverse effects may include:

  • Blindness
  • Seizures
  • Metabolic acidosis (high acid levels in the blood)
  • Death

Source: CDC

The Centers for Disease Control and Prevention (CDC) says that it can take between one hour and three days for adverse health effects from methanol poisoning to become apparent. It also cautions that methanol toxicity worsens over time and adverse effects can become more severe if left untreated.

"Initial adverse health effects due to methanol poisoning include drowsiness, a reduced level of consciousness (central nervous system depression), confusion, headache, dizziness and the inability to coordinate muscle movement (ataxia). Other adverse health effects may include nausea, vomiting (emesis), and heart and respiratory (cardiopulmonary) failure,” according to the CDC.

To help prevent the spread of the coronavirus, the FDA reminds people to wash their hands with soap and water for at least 20 seconds (especially after going to the bathroom, before eating and after coughing, sneezing or blowing your nose). 

If soap and water are not available, the CDC suggests using a hand sanitizer that contains at least 60 percent ethanol, to kill most disease-causing germs. Anything less than that may not work as well “for many types of germs” and may “merely reduce the growth of germs, rather than kill them outright,” the agency explains. Ethanol is also known as ethyl alcohol.

To make sure your sanitizer is as effective as possible, apply enough of it to cover the entire surface of both hands. Rub the product into your hands (paying special attention to the fingertips) until your skin is completely dry; it should take about 20 seconds.

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