When the coronavirus pandemic hit Williamson County in March, Leiper’s Fork Distillery owner Lee Kennedy quickly pivoted to serve the community in a new way.
The distillery, known for its whiskey, live music events and tours, began producing and selling 70% ethyl alcohol disinfectant.
Between March 20 and May 20, Leiper’s Fork distillers made 2,100 gallons of disinfectant to help fill the void.
“We weren’t really doing it to make money,” Kennedy said. “We were doing it to keep the business afloat and help pay my employees.”
But when the FDA recently rolled out a list of sanitizers being recalled because they contain methanol, the distillery’s two disinfecting products, which Kennedy says were never listed as hand sanitizer, were on the list.
Kennedy claims that their product does not have methanol, but they do say that they added lavender oil and a label listing <1.5% methanol to discourage consumption of what would otherwise be a consumable beverage.
According to the CDC, methanol is an industrial solvent, pesticide and alternative fuel source that also occurs naturally in humans, animals and plants.
Exposure to methanol, however, can cause a host of symptoms, from blurred vision, nausea, seizures, blindness, and vomiting to gastrointestinal bleeding, coma, kidney failure and pancreatitis.
“It’s a complete nightmare,” Kennedy said about the consequences of mislabeling.
Kennedy first heard from FDA agents inquiring about his disinfectant’s ingredients on July 22. The next day, the FDA notified him of a full national recall and asked for a response within 24 hours. Kennedy wrote a four-page response and sent it in Friday.
On Monday morning, Kennedy awoke to a news report detailing new additions to the FDA’s list of recalled sanitizers. The next day, he again spoke with an FDA agent. This time, he had proof to back up his assertion: Results from an independent lab in Kentucky confirmed that his disinfectant did not contain methanol.
“Everything that we made there, we personally use, my family personally uses it,” Kennedy said. “It’s as natural a product as you’re going to get.”
Agents from the FDA visited the distillery last week, a meeting Kennedy called “refreshing.”
Since that meeting, “We’re fully working with them, and all communication since then has been good.”
In response to an inquiry from the Herald, FDA press officer Jeremy Kahn said the FDA doesn’t comment on compliance matters other than to the company involved.
Kennedy is hopeful the situation will soon be resolved, but he says he wishes he had known what to expect when he agreed to make the disinfectant.
“We were asked to join a space in producing disinfecting alcohol, which we are perfectly suited to do,” he said. We were not really aware of working within the intricacies of what they (the FDA) do.”