NASHVILLE, Tenn. (WTVF) — The FDA continued on Monday to warn the public about using methanol-based hand sanitizers that the agency calls “dangerous" by publishing a “Do Not Use” list of products - one of which was a sanitzer from the Leiper’s Fork Distillery.
The FDA has published a “Do Not Use” list of products. As of Monday afternoon, 87 products are on the do not use list. Adding to the confusion for consumers, many of the products do not have methanol on the label.
Methanol can be toxic when absorbed through the skin as well as life-threatening when ingested, the FDA said. Retailers are being encouraged to recall these products.
Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death, the FDA warns.
"Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M. Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. 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 FDA’s warnings come following a hand sanitizer shortage in the consumer and commercial markets. Amid the shortage companies that do not ordinarily produce hand sanitizers began bottling products before obtaining FDA approval.
NewsChannel 5 reached out to the distillery, they responded with the following email:
Because of requests for production by federal agencies and due to the Public Health Emergency caused by Covid-19; in response to the national shortage of disinfectant alcohol, Leiper’s Fork Distillery began producing 70% Ethyl Alcohol for use as a disinfectant on March 20, 2020. This was done as an answer to frantic requests from businesses and various agencies who had no viable option whatsoever in sourcing effective germicide to combat the spread of Covid-19.
From the start, our production methods never deviated from our knowledge of producing consumable beverage grade alcohol. For the production of alcohol, our fermentations consisted naturally of 100% corn and yeast. After fermentation, our process included a triple distillation to a concentration of near 90% ethyl alcohol. At that point, the distillate we were producing was technically beverage alcohol and would have been considered an American Light Whiskey according to classification. Because of the tremendous demand and resulting shortage of denaturants we added Lavender Oil as a denaturant per Federal Code; Title 27, Chapter 1, Subchapter A, Part 21, Subpart E, Specifications for Denaturants 21.130. 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%” to our label as an added deterrent. This statement was used simply as an added deterrent against consumption. Absolutely no methanol was added and a gas chromatograph, dated 07/22/2020, performed by Ferm Solutions, Inc, Danville, KY, shows NO-DETECTABLE traces of methanol. (See Attachment A) These results were submitted to the FDA on 07/23/2020.
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.
At no time were our intentions anything other than to help our community at all levels and to keep our fledgling business, into which we have poured our capital, blood, sweat, and tears, from collapsing. This venture was undertaken as a response to a request, by federal and state agencies, in filling a void in the fight against a global pandemic, the likes of which we haven’t seen in one hundred years. Also in this endeavor we were also attempting to bouy a sinking independent small business in a time of unprecedented crisis; where all sales of our core product had become a distant memory, with no visible end on the horizon, even today. We were able to aid many businesses in their effort to source a required PPE component, which was necessary for them to operate as “essential” services to our community. As a result, we were able help a multitude of first responders protecting our communities.
