FDA Publishes List of More than 100 Hand Sanitizers to Avoid

Posted by Marianne C. LeBlanc

Meet Marianne

Marianne is a trial attorney with over two decades of experience in representing clients and a member of BBO and served on the Regulators Subcommittee of the SJC Committee on Lawyer Well-Being. With record-setting verdicts in MA, Marianne’s advocacy skills draw on her commitment to making a difference both for clients and the community at large. Meet Marianne

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At the beginning of the COVID-19 pandemic, hand sanitizer was flying off the shelves and quickly became nearly impossible to come by. The usual retailers were sold out and second-hand sellers were charging exorbitant prices to capitalize on the frenzy. To meet the drastic increase in demand, the U.S. Food and Drug Administration (“FDA”) relaxed its policies on how the sanitizer is produced in March of 2020, allowing entities across the country to begin mass producing and selling the gels without first receiving FDA approval. Today, the FDA has issued a list of more than 100 hand sanitizers to avoid due to toxic substances, sub-potent levels of ethyl alcohol, or unproven claims. 

As a result of the relaxed policies, more than 1,500 retailers, including a large number of distilleries, registered with the FDA to produce hand sanitizer during the course of the pandemic. Shortly thereafter, as non-approved entities began production, the FDA issued its first warnings to consumers related to the potential dangers of sanitizer ingestion. In a statement issued on April 27, 2020, the FDA asked retailers to add denaturants to the products, rendering them unpalatable to people, after a 13 year-old ingested a non-denatured sanitizer packaged in a liquor bottle by a distiller. Without denaturants, the sanitizer tastes like regular drinking alcohol and increases the chances of ingestion. At that time, the National Poison Data System reported the number of calls related to hand sanitizer ingestion increased by 79% compared to March 2019. 

In June, the FDA issued several warnings for sanitizers that contain methanol, a highly poisonous substance, instead of the usual ethyl alcohol base. Methanol is typically used to create fuel and antifreeze and is highly toxic if absorbed through the skin, and life threatening when ingested. The agency has reiterated its warning to consumers with reports of increasing adverse events occurring from people ingesting hand sanitizer products containing methanol, including blindness, cardiac effects, nervous system effects, hospitalizations and death. Usually, methanol will not be listed on the product label as it is in clear violation of FDA policies; however, the FDA has clarified that even when listed, any level of methanol is not acceptable in any drug.  Ongoing testing has found levels of methanol contamination in hand sanitizer products ranging from 1% to 80%. 

As the “do not use” list continues to be updated, the FDA has warned consumers that methanol exposure can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death and is encouraging anyone who has been exposed to the substance and experiencing symptoms to seek immediate medical treatment. Also on the list are certain hand sanitizer products that are subpotent, meaning they contain less than the required amount of ethyl alcohol for effectiveness. A list of the 101 sanitizer products to avoid can be found through the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-warning-about-dangerous-alcohol-based-hand-sanitizers.