FDA reverses course on charge for distilleries making hand sanitizer

Rogue’s “Helping Hand Hand Sanitizer” is displayed in three containers produced by the distillery last spring.

Move saves Rogue from being rewarded for good deed with a fee

NEWPORT — On Dec. 29, Rogue Ales & Spirits received a notification from the U.S. Food and Drug Administration that it, like many other distilleries throughout the country, owed just over $14,000 for its manufacture of hand sanitizer during the first month of the COVID pandemic, when such supplies were hard to find.

When Rogue converted some distillery operations to produce the “Helping Hand Sanitizer” in March of 2020, it donated the 80 percent ethanol solution to local first responders, county offices and others in the community. The company partnered with a distributor in April to produce another sanitizer batch using beer and again distributed to first responders. It also sold a limited release to the public on its website.

While the FDA had granted a special exemption to allow distilleries to produce hand-sanitizer, a provision of the CARES Act classified such operations as, “over-the-counter drug monograph facilities,” mandating the FDA collect a steep user fee. According to the agency, Rogue owed $14,060, and the least 800 distilleries nationwide and dozens in Oregon that joined Rogue in pivoting operations likely received the same bill. Last year was a revenue killer, especially for small craft breweries and distilleries, with restrictions on on-site services and a decline in tourism, so converting operations allowed many to put disused equipment to work for the community, as well as provided an opportunity for some to generate a bit more income.

Outcry after the fees were publicly reported led to an about face from the agency. The chief of staff for the Department of Health and Human Services, which includes the FDA, announced on Twitter New Year’s Eve that the department had ordered the cessation of “these arbitrary, surprise user fees.”

Dharma Tamm, Rogue president, told the News-Times via email, “The idea that the FDA would levy fees on those who stepped up in a time of need is absolutely ridiculous. With that being said, we are proud to have been able to help in our small way and would gladly do it again. We were relieved to see that the 2020 fees have been waived and will keep fighting so that there are no additional, unwarranted fees in 2021.”

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