Distillers making hand sanitizer threatened by FDA regulations

Scott Harris has been fielding calls from hospitals, police departments and emergency response stations asking for alcohol amid the coronavirus crisis.

Mr. Harris, co-founder of Catoctin Creek distillery in Purcellville, Virginia, has been eager to oblige, converting 55 gallons of disposal alcohol he already had into hand sanitizer and ordering another 1,000 gallons from his supplier. As one of those with easy access to alcohol, the key ingredient in sanitizer, he says he felt a “moral responsibility” to step up.

Hundreds of distillers from Hyattsville to Huntington Beach are doing the same thing, curtailing their brand-label production of whiskey, vodka and other spirits and joining in a nationwide sanitizer surge. It had been one of the country’s coronavirus success stories — an industry stepping up amid the crisis — and has drawn glowing press coverage from across the country.

Now it’s all threatened by Washington’s red tape.

The Food and Drug Administration has issued guidelines that distilleries say could shunt them to the sidelines, unable to use their stocks of alcohol any more to help out.

The problem, it turns out, is that sanitizer produced from alcohol made for drinking — known in the business as undenatured — just tastes too good, and FDA officials fear the consequences of children who get their hands on a bottle.

Agency guidelines say sanitizer must either be made from denatured alcohol, which is not drinkable, or if made from undenatured alcohol, it must have a “bitterant” added to make it unpalatable.

The distilling industry says there’s a shortage of bitterants that meet the FDA’s standards, and besides, they can be “very persistent.” Once added to the distilling process, it can be difficult to remove them when the distillers are able to get back to normal production.

The distillers are trying to negotiate a compromise.

“We appreciate the FDA’s concerns, but there’s got to be a way to do this,” said Chris Swonger, president of the Distilled Spirits Council of the U.S. (DISCUS). “We do have to find a path with the FDA to come up with a practical guideline for undenatured alcohol so distillers continue to fulfill the demand out there in the marketplace.”

The FDA, in a statement to The Washington Times, said it wants to work with the industry, but showed little indication it’s ready to change its rules.

“The FDA’s guidances explain that FDA does not intend to object to the manufacture of denatured or undenatured alcohol for use in hand sanitizers, so long as a denaturant (bitterant) is added prior to the final production of the hand sanitizer. Adding these denaturants to the alcohol renders the product less appealing to ingest,” the agency told The Times.

As is clear to anyone who’s stepped into a store over the last few weeks, sanitizer is in short supply. While health officials say washing hands with soap and water is the best defense against coronavirus, those who don’t have ready access, such as emergency workers and police, rely on alcohol-based hand sanitizer to kill the coronavirus.

That means a shortage threatens lives.

Enter distilleries, who have plenty of alcohol on hand, much of it already at the proof level needed to kill the virus.

DISCUS maintains a list of operations that have changed at least some of their production. More than 575 have stepped up.

Congress has done its part to help distilleries.

Part of the $2.2 trillion coronavirus stimulus legislation waives the federal excise tax on drinkable distilled spirits — a hefty $13.50 per proof gallon — clearing the way for producers to turn their product into sanitizer.

“The ingenuity on display by distillers and ethanol producers to step up and help meet the demand for hand sanitizer is truly inspiring. These businesses shouldn’t face an excise tax intended for consumable alcohol,” said Taylor Foy, a spokesman for Senate Finance Committee Chairman Charles E. Grassley, the Iowa Republican who oversaw the tax changes in the bill.

But there’s still a hiccup. The new law requires distillers to follow FDA rules to get the waiver.

“In the event that the FDA updates its guidelines to allow the sale of hand sanitizer made from distilled spirits, it can be treated and taxed the same as its industrially produced counterparts,” Mr. Foy said.

Dozens of House lawmakers over the weekend signed onto a letter begging the FDA to make the necessary changes.

“Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer from being produced and given to those on the front lines battling this pandemic,” they wrote. “We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities.”

Mr. Harris at Catoctin Creek said distilleries fill a unique role.

An establishment trying to start from scratch right now might take six or nine months to get the permits needed to handle the large amounts of alcohol needed. Distilleries have the permits in hand.

“We really had a moral responsibility to make hand sanitizer, because we can do this,” he said.

While some distilleries are shifting production lines, Mr. Harris said so far he’s been moving what he’s already got on hand in bulk. Catoctin Creek has already donated 55 gallons of disposal alcohol — the byproduct of production that they had kept around to use for cleaning.

That supplied six police stations, two emergency response stations, two hospitals and the Federal Aviation Administration’s air traffic control center in Leesburg.

Mr. Harris said his company is sitting on a newly arrived order of 1,000 pounds of bulk alcohol, which they’re working to turn into 140,000 ounces of sanitizer. But after that, he said, they could run into a problem. Kinks in the supply chain mean it’s tougher to get bulk supplies of alcohol.

The only option then is to make more alcohol through the usual process, beginning from scratch with grain.

For distillers who make vodka, that’s not as much of an issue. Their alcohol is already pure enough to meet FDA standards. But most craft distillers are making other liquor, such as whiskey or gin.

“That’s not strong enough for the FDA guidance, even though the [World Health Organization] guidance says anything 60% and higher can do,” Mr. Harris said. “We believe those FDA standards should be lowered to meet the WHO standards.”

“I don’t think the federal government has an understanding of the amount of need,” he added.

Sagamore Spirit in Baltimore said it’s made 54,000 liters of sanitizer, teaming up with the Johns Hopkins Health System to meet the rules.

But like Catoctin, Sagamore says its ability to ramp up production depends on the rules being changed.

“Sagamore Spirit has procured enough isopropyl alcohol to produce the initial 54,000-liter run, but since it is in short supply, the distiller’s ability to expand to the potential 100,000-liter monthly production level entirely depends on Congress’s willingness to waive the denaturing requirement,” the company said in a statement.

Another Maryland operation, Sangfroid Distilling in Hyattsville, says it’s the smallest distillery in the Washington region, with max production of about 20 to 30 gallons of sanitizer a week.

Congress’s tax relief helps, “but we’d be doing it anyway, even without the bill,” said Jeff Harner and Nate Groenendyk, Sangfroid’s co-owners.

Their first batches were made recycling “heads” and “tails,” the byproducts of their usual process, then blending them with hydrogen peroxide and glycerin.

Their next batches, made with help from a neighboring brewpub, Franklin’s Brewery, will use a high-sugar “beer” wash that they’ll ferment and distill.