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The FDA’s High Hand Sanitizer Hurdles Hurt Public Health

April 2, 2020

April 2, 2020
By Christina Sandefur

The coronavirus crisis has brought a lot of changes to our lives, but there’s one old-fashioned idea that’s as timely now as ever: practicing proper hygiene. Although the U.S. Centers for Disease Control and Prevention (CDC) says washing with soap and water is the best way to promote hand hygiene, those products are sometimes not readily available—that’s especially the case for essential service providers like delivery people and grocery store workers, or those visiting gas stations or recreational parks. For them, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60% alcohol.

Unfortunately, hand sanitizer is difficult to come by these days in some communities. That shouldn’t be a big problem, since manufactures could simply ramp up production to meet demand. But that can be challenging, thanks to the fact that it can take months to get the government permits to open up a new alcohol production facility.

That’s the bad news. But the American spirit finds a way.

Over the past few weeks, more than 575 distillers across the country have converted their supplies of alcohol meant for drinking into hand sanitizer instead. To ease the burden on distilleries as they repurpose to meet this growing need, Congress even waived the federal excise tax on distilled spirits ($13.50 per proof gallon excise – which is a lot even in normal times).

But no good deed goes unpunished by the U.S. Food and Drug Administration (FDA). While the Agency recently announced that it won’t “take action against alcohol production firms” engaging in such goodwill, it has also warned that those producing hand sanitizer must follow a rigid set of rules.

One is that distillers manufacturing hand sanitizer must add “bitterants” to the sanitizer, so as to prevent children or others from drinking it. But those additives are difficult to acquire. Some are not even available in the U.S. And it’s tough for distillers to remove bitterants from their equipment, which makes the eventual transition back to producing consumable alcohol challenging.

Worse yet, the FDA says the distillers’ hand sanitizers must be 94.9% ethanol by volume. Many distillers can’t meet that high requirement. And it isn’t necessary. The World Health Organization guidance says products with only 60% ethanol by volume are effective. In other words, the FDA letting the perfect be the enemy of the good—a bad idea when the health and lives of countless Americans are at stake?

Of course, following scientific standards that keep people safe is important. But the FDA is going far beyond what is necessary. By making it difficult or impossible for Americans to help each other out in this time of crisis, the Agency is threatening public health. This is another unfortunate example of how FDA overregulation is undermining our ability to fight this pandemic. During this all-hands-on-deck healthcare emergency, it is imperative that the FDA let those who are willing and able to help do their jobs.

Christina Sandefur is the Executive Vice President at the Goldwater Institute.




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