Distillers Fought Covid-19 by Making Hand Sanitizer. Now, the FDA Wants to Make Them Pay!

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As the Covid-19 pandemic swept across the U.S. during the spring of 2020, the country was hit with a massive shortage of hand sanitizer and other disinfecting products. An estimated 800 distilleries voluntarily switched their production from making whisky, vodka, gin, and other spirits to producing high-strength alcohol for use in hand sanitizers and disinfectants. Many of these distillers donated their time and equipment - as well as the sanitizers - to help health care workers and first responders protect themselves. Most of these distilleries are small, family-run local businesses who were already reeling from the impact of the pandemic.

On December 29, the FDA announced that these distilleries will be treated as "drug manufacturing facilities" and be charged $14,060 as a "user fee" unless they completely exit the sanitizer business and de-register with the FDA by December 31. That fee could rise by $9,060 for distilleries that exported all of their sanitizers outside of the U.S. These distilleries do not make any other type of FDA-regulated "over the counter" medication, and normally would not be subject to FDA regulation or fees. Distilleries are regulated by the Treasury Department's Alcohol and Tobacco Tax & Trade Bureau, which has already agreed to waive the federal excise tax on alcohol produced by these distilleries for use in hand sanitizers that met FDA requirements. 

According to the Distilled Spirits Council, distilleries were never told by the FDA until December 29 that they would be subject to these fees, for which payment is due on February 21, 2021. Many of the distillers involved have been hit with economic damage from the pandemic due to the closings of their distillery tours and tasting rooms, along with the collapse of the "on-trade" market due to the closings of bars and restaurants in many parts of the country. 

The FDA has the power to waive those fees, and this petition asks that the agency do so immediately. Distillers stepped up for us, and we ask that you stand up for them by signing this petition urging the FDA to specifically exempt distilleries that produced hand sanitizer during the pandemic from the "Over-the-Counter (OTC) Monograph Drug user fee program."