Two months after government regulators discovered toxic levels of methanol in some hand sanitizers in the United States, there’s reason for hope.
First, Purell hand sanitizer, the industry leader which commands about 25 percent of the market, should start appearing on store shelves again soon.
Second, the Food and Drug Administration (FDA) last week said it’s cracking down a bit on hand sanitizer producers starting Sept. 1.
The question is whether these developments will help drive bad actors out of the sanitizer business. More than 170 varieties under more than 100 brands of sanitizer have been labeled as potentially dangerous by the FDA because they may contain toxics or not enough active ingredients to kill germs including the virus that causes COVID-19.
As anyone who has tried to shop for treasured hand sanitizer the last six months knows, it’s been difficult to find any brand until the last month or so. Much of what you do find is fine, perfectly safe. But some of it’s not, or it’s labeled with brands you’ve never heard of. In some cases, the brand name is just “Hand Sanitizer” or “Alcohol Antiseptic.” For real.
It’s not surprising that it’s been nearly impossible to find Purell on store shelves in months, even though its two Northeast Ohio production plants have been operating 24/7 since early January. Purell is made by GOJO Industries. The Akron-based manufacturer says it has been focusing on supplying hospitals and other commercial customers.
GOJO resumed shipping to stores and online retailers a few weeks ago, according to Samantha Williams, GOJO’s corporate communications senior director.
A new manufacturing facility near Cleveland will produce Purell Surface Spray. The plant will open later this year and run at full capacity early next year, Williams said. GOJO also has a warehouse south of Akron and a manufacturing facility in France.
The privately owned company doesn’t disclose sales or volume of sanitizer produced, except to say it’s doubling capacity. “By this time next year, we will be capable of providing more than a billion uses per day, versus several hundred million a week, just last year,” Williams said.
That depends on GOJO’s ability to continue securing ethyl alcohol, the active ingredient it relies on to kill germs. Some manufacturers report difficulty getting ethyl or isopropyl alcohol. GOJO agrees.
“We have continually worked with our suppliers throughout the pandemic to dramatically increase raw materials and component supplies, yet this still remains a challenge for us,” Williams said.
If GOJO, which started in 1946 and began producing Purell in 1988, has had trouble getting ethanol, you can imagine how difficult it might be for others. This could explain why some new-to-the-market producers turned to methanol, even though it’s toxic to use on skin. Others produce sanitizer without enough active ingredients to kill germs. The FDA reports numerous illnesses and deaths from toxic sanitizer.
The FDA has flagged 160 varieties of sanitizer from 100-plus brands for methanol, 1-isopropanol or other suspected contamination. A couple dozen more don’t contain enough active ingredients.
On Aug. 17, the FDA is strengthening testing standards starting Sept. 1. Sanitizer producers will be required to not only conduct an “impurity” test to discover whether any methanol is present. They also must conduct a more sophisticated test to identify and disclose the quantity of any methanol present for each lot of alcohol received.
On Aug. 7, the FDA started requiring companies to test each lot of its ethanol and isopropanol for methanol contamination if the ethanol or isopropanol were obtained from an outside source.
The agency says 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, sounds like a good idea, considering that toxic sanitizer has already caused illnesses and deaths in the United States.