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Regulation

Hand sanitizer firms dodge bill from the FDA

by Craig Bettenhausen
January 8, 2021 | A version of this story appeared in Volume 99, Issue 2

 

Two bottles of Dogfish Head hand sanitizer.
Credit: Dogfish Head Craft Brewery

Distillers across the US got a nasty surprise in the closing week of 2020: a bill from the US Food and Drug Administration for over $14,000. Early in the pandemic, hand sanitizer was in short supply around the world. Many distilleries, breweries, and winemakers pivoted to making sanitizer, often donating it or selling it at cost. On Dec. 29, the FDA said those firms counted as manufacturers of over-the-counter medicine and as such were required to pay user fees. After an outcry from small businesses and industry groups, Brian Harrison, chief of staff at the US Department of Health and Human Services, announced on Twitter on New Year’s Eve that his office had directed the FDA to void the fees, adding “Happy New Year, distilleries, and cheers to you for helping keep us safe!” The HHS added that the FDA does not have the authority to levy such fees without its approval. The American Craft Spirits Association, a trade group, applauded the reversal. It also reminded members that they must actively deregister with the FDA if they don’t plan to continue making sanitizer.

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