In the category of “It’s about time,” the U.S. Food and Drug Administration (FDA) is now flagging all alcohol-based hand sanitizers imported from Mexico, saying the shipments are being scrutinized more closely and may be detained.
This is the first time the FDA has issued an import alert for any category of drug product from an entire country. It comes after 230 varieties of sanitizer, nearly all from Mexico, have been deemed unsafe.
In a stunning revelation, the FDA now says its analyses of alcohol-based hand sanitizers imported from Mexico from April through December found 84 percent of the samples were not in compliance with FDA regulations, most because they contained dangerous levels of toxic ingredients.
But the regulator is still slow-walking its efforts to protect consumers.
This move to review imports more closely comes more than seven months after the FDA first found that hand sanitizers imported from Mexico contained methanol, or wood alcohol, which can be harmful if absorbed through the skin, and life-threatening if ingested. Toxic hand sanitizers were connected to at least 20 deaths, plus numerous cases of blindness and other injuries and illnesses last year, the FDA said.
The crisis emerged last spring and summer COVID-19 gripped the nation and it was nearly impossible to buy hand sanitizer from recognized manufacturers, either in stores or online. Opportunists filled the void, selling hand sanitizer that they didn’t know or didn’t care was manufactured so carelessly that it contained toxic substances. Desperate consumers, meanwhile, jumped at the chance to buy something to help keep them safe. Most of us would have no reason to know that hand sanitizer is classified as an over-the-counter drug that these companies weren’t registered to sell. Never mind that we’d never heard of most of these brands before. My favorites were the ones without a brand: They just said, “Hand Sanitizer.”
By mid-August, the FDA had designated about 160 varieties of sanitizer as unsafe because they contained toxic alcohols or didn’t contain enough germ-killers to be effective. Only in August did the FDA start tip-toeing toward protecting consumers. It began requiring companies to test each lot of its ethanol and isopropanol (the accepted active ingredients) for methanol contamination if they were obtained from an outside source. But testing in a compliant lab isn’t required.
In September, the FDA strengthened testing standards, requiring producers to conduct an “impurity” test to find whether any methanol exists in any lot of alcohol used in production, and disclose the level.
Now we get the Mexico-wide import alert.
The actions to protect consumers still fall short. While the flood of toxic products slowed after known brands such as Purell and Germ-X started reappearing on store shelves in September, the FDA still flagged about three dozen potentially dangerous hand sanitizers in the last four months.
Here are steps that would protect consumers:
Stop allowing companies to produce over-the-counter drugs if they aren’t properly registered. The FDA in March 2020 relaxed its registration rules for hand sanitizer manufacturers, as long as they promised to follow safety guidelines. Oops.
Change federal law to give the FDA the authority to prohibit merchants from selling dangerous over-the-counter products such as toxic hand sanitizer, or even ibuprofen or cough syrup, if it is contaminated. The FDA can recall harmful food, medical devices and biological products, but not over-the-counter drugs. It was stunning to the U.S. PIRG Education Fund Consumer Watchdog team that we were able to buy hand sanitizers last year at multiple retailers even after they’d been flagged by the FDA. A bill was introduced in Congress in 2017, and reintroduced in early 2020, to change that.
Require manufacturers to test sanitizers for toxics in an approved lab (it’s recommended but not required). No more good faith gestures.
Require stricter product testing and stop bending the rules, even during a national health emergency. The number of deaths and illnesses was thankfully low, but even one is too many. This time it was hand sanitizer. Next time it could be baby aspirin or allergy pills. What over-the-counter product will be the next one to threaten your family’s health?
Consumer Watchdog, U.S. PIRG Education Fund
Teresa directs the Consumer Watchdog office, which looks out for consumers' health, safety and financial security. Prior to her current role, she worked as a journalist and columnist covering consumer issues and personal finance for two decades for Ohio's largest daily newspaper. She is the recipient of dozens of state and national journalism awards, including Best Columnist in Ohio, Best Business Writer in Ohio, and National Headliner Award for coverage of the 2008-09 financial crisis. Among the accomplishments she’s most proud of is receiving a journalism public service award for exposing improper billing practices by Verizon that affected at least 15 million customers nationwide. Her work caused Verizon to reach an $80 million settlement with the FCC, the largest ever imposed at that time. Teresa and her husband live in Greater Cleveland and have two sons and a dog. She enjoys biking, house projects and music, and serves on her church missions team and stewardship board.