With hand sanitizer in short supply in American homes and, more critically, in hospitals and other healthcare facilities, producers of distilled alcoholic beverages seized an opportunity to help. As reported in the middle of last month, some distilleries began producing sanitizer using the ethanol they had in abundant supply. Soon after, federal regulators stepped in with guidance meant to facilitate this non-traditional production. Bureaucrats’ innate need to mandate manufacturing standards, though, has thus far hindered this welcome deregulatory move.
Hand sanitizer is regulated as an over-the-counter drug. In a March 27 Food and Drug Administration (FDA) guidance, the agency announced that entities not currently regulated as drug manufacturers can produce hand sanitizer if they follow an FDA-dictated approach. The Alcohol and Tobacco Tax and Trade Bureau (TTB) also issued a guidance that reduces regulatory requirements and some taxes.
The problem for distillers is that the production method FDA requires in the guidance calls for denatured alcohol. The TTB guidance suspended excise taxes for alcohol used for hand sanitizers, but only if the alcohol is denatured. The CARES Act Congress passed at the end of March codified TTB’s guidance on excise taxes into law.
Denaturants are chemicals meant to deter human consumption of liquids. They’re not something a distiller would want in their gin, whiskey, or rum. Newsweek related the concern of one distiller: “introducing the denaturants into his manufacturing process would have unpredictable consequences down the line, potentially affecting the taste or odor of his spirits when the facility returns to normal production.” Also, not surprisingly, the high demand for denaturants has increased their price exponentially. Distillers, both individually and through trade groups like the Distilled Spirits Council of the U.S., have urged FDA to waive the denaturant requirement, calls that some Members of Congress have echoed.
FDA’s apparent failure to appreciate denaturants’ impact on the distilling process recalls the agency’s misguided attempt to regulate how beer, wine, and spirits makers share their “spent” grains with farmers. A February 2014 FDA proposed rule categorized the process of heating crushed grains to obtain fermentable sugars—if alcohol makers donated or sold those used grains for cattle feed—as food manufacturing. That categorization would require brewers and others to alter their “mashing” processes and develop extensive (and expensive) hazard analysis and control plans. As we wrote at the time, the rule would force brewers to landfill their spent grains, an added cost for the business and for the environment.
It took five months, but FDA ended up doing the right thing and reversed course in its final rule.
FDA needs to do the same thing with its demand that distillers make hand sanitizer with denatured alcohol. But it must act with far greater urgency. Conornavirus particles need to be killed, and the denaturing chemicals have nothing to do with killing germs. Perhaps that’s why the World Health Organization deems hand sanitizer without denaturants to be safe. Isn’t that good enough for FDA? Certainly, one would hope that the hold-up in FDA revising its guidance is not its need to test the WHO recipe.
In the meantime, some distillers who can afford to do so will continue admirably producing non-denatured hand sanitizer and donating it to first responders and healthcare providers. But a non-profit approach isn’t a long-term solution with such a huge healthcare-worker demand for sanitizer and won’t help the general public stay out of hospitals.
In a health crisis of this magnitude, FDA cannot allow the perfect to be the enemy of the good. To its credit, FDA has compromised some of its regulatory authority and allowed manufacturers flexibility to meet unanticipated demands. It must do so again, taking one very small step further to expand hand-sanitizer production.
Also published by Forbes.com on WLF’s contributor page.