The FDA has added more products to its list of potentially harmful hand sanitizers that may include methanol. The list, which now totals 87 products, includes products from suppliers mostly based in Mexico, but one newcomer is based in Tennessee.
In a press release, the FDA said that it has been working with all listed manufacturers to recall products and encourage them to remove the products from store shelves and e-commerce platforms. It’s also sent an official warning letter to one company, Eskbiochem S.A. de C.V., over products that it says were manufactured at its facility with “undeclared methanol” and misleading claims of FDA approval.
“We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol,” FDA commissioner Stephen M. Hahn, M.D., said in the press release. “Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”
The sole U.S. supplier on the list was Leiper’s Fork Distillery, whose hand sanitizer was found to be labeled as containing methanol, and therefore recommended by the FDA for recall.
The company’s owner, Lee Kennedy, refutes those claims. Per the Nashville Post:
Despite the claim from the FDA, the distillery’s owner, Lee Kennedy, argues that his product contains zero methanol and that it “is absolutely safe.” Kennedy told Post sister publication Williamson Home Page that the hand sanitizer his distillery produces contains zero methanol and that the FDA had falsely claimed as such due to what was essentially a misunderstanding or miscommunication.
Kennedy asserted that due to the lack of information at the onset of the pandemic and hand sanitizer shortage, his company played it safe while manufacturing the product.
“Back when we were getting this together, there wasn’t a lot of direction coming from our regulatory agencies, so literally what’s in that disinfectant is simply beverage-grade alcohol with natural lavender oil that was introduced into it to keep people from consuming it,” Kennedy said.
Kennedy added that methanol was included on the product label as a “potential ingredient,” and the FDA’s recommended recall is unnecessary and a mixup.
“We actually had a gas chromatograph—a chemical composition analysis—of the product done by Ferm Solutions Inc., and the results of that test showed no detectable traces of methanol whatsoever,” Kennedy told the Nashville Post. “So if anything, it should have been recalled as mislabeled, but the product is absolutely safe.”
The distillery first started making the bulk hand sanitizer in the spring, and distributed it to local first responders, according to WKRN.
“Despite the addition of lavender oil and because of the concern that individuals still may have been tempted to consume the product, we made the additional decision to add ‘methanol 1.5 percent’ to our label as an added deterrent. This statement was used simply as an added deterrent against consumption,” Kennedy said in a statement. “… In hindsight, given the recent developments of unscrupulous international producers using large amounts of methanol to taint their products, this decision would not have been made. Along with the addition of unpalatable lavender oil, this was merely an attempt to be responsible and to further deter possible consumption. Regardless, the product has been proven perfectly safe for its labeled and intended use.”
There’s no word whether the distillery will formally contest the FDA’s claims. For the time being, it remains on the list.
