Tainted Hand Sanitizers Reinforce Need for FDA Drug-Recall Authority

Soon after the first case of coronavirus disease 2019 (COVID-19) was diagnosed in the U.S., public health authorities began urging all Americans to frequently wash their hands with soap and water or, when hand-washing was not feasible, to use alcohol-based hand sanitizers containing at least 60% ethanol (ethyl alcohol) to prevent the spread of this potentially deadly infection. Panic buying and hoarding of hand sanitizers soon followed, resulting in months-long nationwide shortages of these products.

Predictably, unscrupulous companies exploited these shortages and the pandemic-induced consumer panic by marketing hand sanitizers that contained dangerous ingredients and thus violated regulatory standards established by the Food and Drug Administration (FDA). Notably, the FDA regulates hand sanitizers as over-the-counter (OTC) drugs.[1]

On June 19, the FDA first alerted consumers not to use any hand sanitizers manufactured by a company in Mexico after FDA testing of some of the company’s products revealed that they contained as much as 81% methanol instead of ethanol.[2] Methanol is highly toxic and can cause nausea, vomiting, headache, blurred vision, permanent blindness, acute kidney failure, seizures, coma, permanent brain damage and death.

Although anyone using methanol-tainted hand sanitizer as intended may be at risk because of methanol absorption through the skin, these products pose the greatest danger to young children who accidentally ingest them and to adolescents and adults who intentionally drink them as an alcohol substitute.

The FDA noted in its initial alert that the agency had contacted the manufacturer of the methanol-containing sanitizers on June 17 and “recommended” that the company remove its “potentially dangerous” products from the U.S. market but that the company had not yet agreed to do so.

From June to October, the FDA identified numerous other hand sanitizers containing methanol that were made by several other companies in Mexico.[3] The FDA again recommended the companies involved recall their products, but many apparently refused to do so. The FDA did issue import alerts to stop additional products from these companies from entering the U.S.

You are probably wondering why the FDA did not order recalls of these dangerous products. The shocking answer is that it lacks the legal authority to require recalls of prescription and OTC drugs.

When the FDA identifies tainted drugs that can cause serious harm to patients, the companies involved must take swift action to remove the dangerous products from the market. If drug companies balk at recalling drugs when asked to do so, the FDA must have legal authority to compel such action. Thus, for years, we have urged Congress to pass a law granting the agency that authority to better protect consumers, but our requests so far have fallen on deaf ears.
 

References

[1] Food and Drug Administration. FDA news release: FDA issues final rule on safety and effectiveness of consumer hand sanitizers. April 11, 2019. https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers. Accessed October 26, 2020.

[2] Food and Drug Administration. FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. June 19, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem. Accessed October 26, 2020.

[3] Food and Drug Administration. FDA updates on hand sanitizers consumers should not use. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use#products. Accessed October 26, 2020.