Hand Sanitizers, Methanol

FDA Puts Alcohol-Based Hand Sanitizers from Mexico on Import Alert

FDA Puts Alcohol-Based Hand Sanitizers from Mexico on Import Alert

In September, 2020, we published an article warning against the dangers of using hand sanitizers imported from Mexico, in particular Blumen Hand Sanitizer which is distributed by 4e North America and manufactured by 4E Global in Mexico.

In January, 2021, the FDA further reported that it had put all alcohol-based hand sanitizers imported from Mexico on import alert until the products can be safely evaluated.

The products in question have been labeled to contain ethanol (also referred to as ethyl alcohol, a primary, safe ingredient in SanitiSpray hand sanitizer). Instead, they tested positive for an alcohol base called methanol. Methanol, also referred to as wood alcohol, is said to be toxic if absorbed through the skin and life-threatening if ingested. To be clear, the FDA has never accepted methanol as a suitable ingredient in hand sanitizer nor as a replacement for ethyl alcohol.

A study of the hand sanitizers imported from Mexico indicated that 84% of samples analyzed between April-December, 2020 did not comply with FDA regulations. Further, over 50% of those samples contained dangerously high levels of methanol and/or 1-propanol, which, similar to methanol can be toxic and life-threatening if ingested.


What is an import alert and how does it affect you?

The FDA import alert, also referred to as an automatic detention list, is issued to a company or country (in this case, to Mexico) when there’s evidence of a shipment or shipments that have violated inspection and compliance regulations. The import alert is also given to the FDA’s own district offices, and inspection and compliance officers alerting them that, in this case, hand sanitizers from Mexico appear to be in violation of the FDCA (Food Drug and Cosmetic Act).

Under the FDA’s import alert guidelines, all hand sanitizers from Mexico will be subjected to heightened investigation which means they most likely will be detained at ports of entry under the DWPE (Detention Without Physical Examination). It is then incumbent upon the manufacturers and importers of the hand sanitizer to prove that they have corrected the violation.

Import alerts protect consumers because once just one shipment has been found to be in violation of FDA or FDCA guidelines, all subsequent shipments from the manufacturer OR Mexico can be detained.

By contrast, SanitiSpray hand sanitizer is produced in the US and its alcohol base in pure, 100% ethyl alcohol. SanitiSpray scented and unscented hand sanitizers are high-quality, sustainable, and FDA-approved with 80% ethyl alcohol as recommended by the CDC.


Check the FDA’s list of hand sanitizers to not use

The FDA regularly maintains a list of hand sanitizers it recommends that consumers should not purchase or use. This includes hand sanitizers containing methanol and 1-propanol. Keep in mind that the methanol, in most cases, does not appear as an ingredient on hand sanitizer products.


Need Help?

Per the FDA, if you or anyone is in danger or if you even think you’re in danger of having been in contact with a methanol- or 1-propanol-based hand sanitizer, immediately call 911. You can also call the Poison Helpline at 1 (800) 222-1222. You will be connected to a poison center near you. Learn more