FDA rescinds fees charged to distilleries making hand sanitizer - NBC 4
Early in 2020, when the country was beset by the COVID-19 pandemic, craft distilleries all across the nation stepped up to fill the void in hand sanitizer, pivoting their businesses to produce WHO-formula sanitizer that was FDA approved. The ACSA worked closely with the FDA to ensure that all of these craft distillers could be quickly added as "drug producers" (their definition of someone making sanitizer), so that the public would be assured that the products being put out in this emergency period were safe and regulated.
Fast forward to just before New Year's Eve 2020, when these same craft distillers begin receiving emails from the FDA stating that they owe the FDA $14,060 due February 11th, 2021, for the privilege of working with the FDA last year. What's more, these fees never existed when the distilleries registered with the FDA. They were applied retroactively. Many of these distilleries donated or sold their sanitizer at cost, and a surprise $14,000 bill would put many of them out of business. Worse still, the fees doubled if the distilleries let their registration continue to January 1, 2021.
Truly, no good deed goes unpunished.
Becky Harris, Catoctin Creek's chief distiller and current president of the American Craft Spirits Association (ACSA), along with Margie Lehrman, CEO of the association, got on the phone with congress and officials at the Department of Health and Human Services. All day, during New Year's Eve, Becky and the organization are frantically speaking with HHS, explaining the unfairness of this surprise, retroactive fee.
In a story that doesn't often happen, the HHS agreed, and ordered the FDA to rescind the fees, bringing every craft distiller across the nation a very happy new year.
Drew Wilder reports from NBC 4 Washington: