• Sympol

How to Choose a Safe Hand Sanitizer

Updated: 3 days ago

It’s no secret that the U.S. relies on imported goods. The cheaper manufacturing fees and labor in other countries are attractive to many businesses focused on their bottom line. Purchasing products manufactured by foreign companies is also a vital channel for the global economy. However, some things should be bought locally or at least within our country. We hear that supporting local businesses is essential, which is true, but this issue goes beyond that. Local businesses are supporting you! According to the FDA list of hand sanitizers that should not be used, imported hand sanitizer is over 95% more likely to be impotent or contaminated with methanol. Knowing this, we recommend purchasing hand sanitizer manufactured in the United States.

Update 12/29:

The FDA found 84% of samples taken from Mexico imports from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to have toxic ingredients.

Throughout the pandemic, there has been an alarming amount of hand sanitizer products imported from Mexico that the FDA has found to be contaminated or impotent. These products are labeled to contain ethanol (also known as ethyl alcohol), but tests show methanol (also known as wood alcohol) contamination. Methanol can be toxic and is not an acceptable ingredient in hand sanitizer or other drugs. The FDA has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert.

Under the import alert, any alcohol-based hand sanitizer from Mexico is subject to heightened FDA scrutiny. FDA staff has the authority to detain shipments. This is the first time the FDA has issued a countrywide import alert for any drug product.

Click here to read more about Import Alert 62-08.

About Testing Hand Sanitizer

On January 19, 2021, the FDA issued guidance detailing the agency’s policies for manufacturers and compounders of alcohol or isopropyl alcohol. The 13-page report “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)” was published by the U.S. Department of Health and Human Servies with the FDA, CDER, CBER, CVM, and CGMP. Read the full report here.

FDA stated, “methanol was detected in hand sanitizer drug products from multiple manufacturers through the screening and sampling of hand sanitizers imported into the United States.” The ongoing investigation into methanol contamination revealed that the leading cause of methanol contamination is inadequate product testing. Manufacturers of the hand sanitizer containing methanol did not perform any testing, or they performed insufficient testing. Each component of a drug product must be tested for conformity with all written specifications for purity, strength, and quality. These manufacturers failed to comply and test all components of their drug products.

Why is hand sanitizer from the U.S. the safest?

“Ethanol contaminated or substituted with methanol was seen in hand sanitizers imported into the United States from multiple countries. FDA is also aware of reports of methanol substitution in hand sanitizer distributed in several countries outside of U.S.” - release 1/19/2021

Methanol is not an acceptable ingredient in any drug product because it is toxic. Skin exposure to methanol can cause dermatitis, and the toxicity can be absorbed. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, blindness, seizures, coma, nervous system damage, or death. Everyone using hand sanitizer with methanol is at risk for methanol poisoning but especially those who consume it. No one should ever drink hand sanitizer. There are reports of young children accidentally ingesting and adults ingesting hand sanitizer contaminated with methanol.

Temporary policies due to COVID-19

The temporary policies outlined by the FDA states it "does not intend to take action against firms with respect to certain violations of the FD&C Act, including 501(a)(2)(B), provided that certain conditions be present” This means the FDA is allowing more leeway with hand sanitizer manufacturing as it does not require all hand sanitizer to go through FDA inspected laboratories. FDA strongly recommends testing for methanol in laboratories that have been inspected by the FDA and are found compliant with CGMP. This strong recommendation is just a recommendation and will not be a requirement, temporarily. As a consumer, you have the choice to buy your hand sanitizer from manufacturers who test their products at FDA inspected facilities and have their products registered with the FDA.

Impotent imports

A report released by the FDA on July 31, 2020, states continual issues with imported hand sanitizers are raising concern. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol. The agency continues to add these sanitizers to import alert to stop these products from illegally entering the U.S. market.

We went through the hand sanitizer on the FDA Do Not Use List, and the results are below.

This graph shows the origin of hand sanitizer on the FDA’s list of products you should not use. As you can see, Mexico has imported 89.4% of the hand sanitizers on the list. Note: the small sliver is Korea with 0.5%

Eight hand sanitizer manufacturers from America are listed. These manufacturers are from Tennessee, Utah, Georgia, two from North Carolina, and two from Ohio. No hand sanitizer manufacturers from California are currently on the list.

Main takeaways

Hand sanitizer created in the U.S. adheres to the FDA guidelines more regularly than those manufactured outside of the U.S. Hand sanitizer manufactured outside of the U.S. makes up 96.2% of the warning list provided by the FDA. Purchase hand sanitizer manufactured in the U.S. for more confidence, as our testing has proven to be more thorough. Sympol Products manufactures our sanitizer in an FDA inspected facility, and our sanitizer is FDA registered. This should help you trust our formula and process. We care deeply about credibility and producing products that are good for you. Going beyond the standard of sufficient hand sanitizer, we created a highly-effective hand sanitizer that nourishes your hands. You can trust that Sympol is more than safe - we’re protective.

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