FDA has released several warnings lately concerning hand sanitizers that contain methanol, which can be toxic.
“The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested,” reads a statement from the FDA.
The FDA provided a list of over 100 hand sanitizers consumers should avoid. On the list is local business Leiper’s Fork Distillery, which began making hand sanitizer in March due to a shortage. The FDA included Leiper’s Fork Distillery’s hand sanitizer on the recall list due to the product being “mislabeled as potentially containing methanol.”
Via Facebook, Leiper’s Fork Distillery stated, “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; Chapter 1, Subchapter A, Part 21, Subpart E, Specifications for Denaturants Title 27,21.130.”
“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,” they continued.
“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 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. Now it seems, based on this experience, it would have been much easier to place all of our employees on unemployment and collect government assistance for utilities associated with our facility.”
The distillery ended the message by saying, “The FDA listed us as a recall due to the fact that our product was mislabeled as potentially containing methanol. Leiper’s Fork Distillery disinfectant is simply food grade alcohol that has been denatured with natural lavender oil to prevent consumption. The product is perfectly safe for its intended use.”