This week, we got new proof that hand sanitizers, a product people are using to stay healthy throughout the COVID-19 pandemic, ironically could be harming them. As of Thursday, the U.S. Food and Drug Administration (FDA) now has designated more than 200 varieties of sanitizer as unsafe.
Since the COVID-19 pandemic started, medical experts have urged people to wash their hands thoroughly or use hand sanitizer to kill the virus. When that advice led to a nationwide shortage of sanitizer, many companies that had not produced the product before filled the gap. In June, the FDA began issuing public warnings about 19 sanitizers that contained methanol -- which is toxic if absorbed through the skin or ingested. Now, more than 10 times as many varieties of sanitizer are on the FDA’s list.
Although dozens of deaths and illnesses have been connected to some of these sanitizers, consumers still have been able to buy them online or in stores. Our consumer safety system is broken, and we need to fix it.
First, the FDA doesn’t have the authority to prohibit retailers from selling dangerous over-the-counter products such as toxic hand sanitizer, or even ibuprofen or cough syrup, when one of those products is contaminated. A bill was introduced in 2017, and reintroduced earlier this year, to change that.
Second, in this case, the FDA isn’t even requiring manufacturers to test sanitizers for toxics in an approved lab (it’s recommended but not required), so unless someone brings it to the FDA’s attention, or the FDA does a product test, the agency would not know about a problem.
The reasons that the FDA has flagged certain sanitizers in the last 3 ½ months vary. Most have tested positive for methanol, also known as wood alcohol, or contain 1-isopropanol or another suspected contaminant, or were manufactured at the same facility where a toxic substance was used. In other cases, the sanitizers didn’t contain enough active ingredients to kill the virus that causes COVID-19 or were packaged in containers similar to those used for children’s applesauce or other foods, so there was a greater risk of accidental poisoning by eating the sanitizer.
To be effective, sanitizers should contain high percentages of either of two forms of alcohol -- at least 60 percent ethanol or 70 percent isopropanol -- that are safe on human skin, according to the Centers for Disease Control and Prevention. Experts believe that a shortage of ethanol and isopropanol led some companies to use dangerous ingredients -- often those other forms of alcohol -- either intentionally or out of ignorance.
Before March, companies had to register with the FDA to produce sanitizer because it’s considered an over-the-counter drug. But with the virus sweeping the nation, the FDA relaxed those rules, allowing unregistered companies -- many from Mexico and China, as well as the United States -- to suddenly manufacture sanitizer, as long as they promised to follow safety guidelines. That clearly didn’t work.
Something needs to change. The FDA says it relies on businesses to be good corporate citizens, with manufacturers voluntarily recalling dangerous products and retailers voluntarily pulling the items off store shelves. But it’s not required, and it doesn’t always happen. In the days after the FDA flagged some of these items, our U.S. PIRG Education Fund Consumer Watchdog team was able to buy them in nationally known department stores, in dollar stores and from online retailers. This shouldn’t be possible.
Belying half of its name, the Food and Drug Administration has the authority to pull dangerous food products off store shelves, but not over-the-counter drugs such as sanitizer. This would require congressional action.
The FDA does not need Congress’ approval to require stricter testing. In early August, the FDA started requiring hand sanitizer companies to test each lot of its ethanol and isopropanol for methanol contamination if they obtained the alcohol products from an outside source. The FDA said it “strongly recommends the test for methanol be conducted in a laboratory that has been previously inspected by FDA and found in compliance with Current Good Manufacturing Practice.”
But testing in a compliant lab isn’t required. Requiring it, instead of recommending it, should be a no-brainer, considering that harmful sanitizer has already caused illnesses and deaths in the United States and continues to be sold to consumers.
Here are some tips on how you can protect yourself:
Continue to check for updates to the FDA’s list of dangerous products because its investigation is ongoing.
Scrutinize any hand sanitizer purchased since March, which is when the FDA relaxed its guidelines to allow unregistered companies to produce hand sanitizer.
Avoid any sanitizers from any of the companies named on the FDA’s list, even if the variety or lot numbers are different.
Pay close attention to products manufactured in Mexico, products with no source of origin and product names you’re not familiar with or that sound odd, like simply “Hand Sanitizer.”
Pay attention to symptoms such as headache, blurry or impaired vision, nausea, vomiting, abdominal pain, loss of coordination, confusion or slowed pulse and, if you believe it could be connected to hand sanitizer, contact Poison Control at 1-800-222-1222 or your doctor.
Consumers, manufacturers or distributors who have questions can email the FDA at COVID-19-Hand-Sanitizers@fda.hhs.gov or the CDC at DRUGINFO@fda.hhs.gov