FDA Fees - No Good Deed Goes Unpunished

[GURPS]

No Good Deed Goes Unpunished: Distilleries That Made Hand Sanitizer Hit With FDA Fees


Yet the story gets even more perverse. Not only did the CARES Act penalize distilleries’ good deeds, but it did so in order to fund the FDA’s regulation — regulation that hampered distilleries in their attempt to provide much-needed hand sanitizer.

As the distillers launched into their heroic actions, the FDA imposed additional requirements on top of World Health Organization (WHO) guidelines for emergency sanitizer production. The FDA mandated that all alcohol used in hand sanitizer must first be denatured — rendered undrinkable — raising costs for distillers and slowing production.

Now, distillers have to foot the bill for the very regulation that made it harder for them to do their good deeds. All this at a time of increased uncertainty amid new lockdowns.

“It’s apparent the FDA has decided they don’t need us anymore and it’s in their best interest to suck us dry when we’re already struggling during the pandemic’s business closures,” Bergh remarked.

In a statement on Wednesday, Bergh said his distillery produced 5,000 gallons of hand sanitizer, prioritizing distribution to medical workers and those on the frontlines of the pandemic. “Some of my hand sanitizer was donated,” he explained. “The rest was sold at a fraction of the market price. My goal was to get as much out as I could, at as low of a price as I could, while being able to bring my furloughed employees back to work. The hand sanitizer business saved me from bankruptcy—but I didn’t make an enormous profit.”

 

[Tech]

Just need to find the slugger who enter the wording in the bill and check their contribution list. Big alcohol attempt to crush these small distilleries.

 

[GURPS]

In a Last-Minute Reversal, HHS Voids FDA Fees on Distillers Who Produced Emergency Hand Sanitizer


It's been a whirlwind 24 hours for American craft distillers, but 2020 is ending with some good news: Thanks to media coverage, including here at Reason, of an unexpected and substantial fee imposed by the Food and Drug Administration (FDA) on distillers who pivoted to produce much-needed hand sanitizer, the federal government has reversed course on what would have been a devastating blow to small businesses.

In the early days of the COVID-19 pandemic, many distillers shifted their production from spirits to hand sanitizer, complying with emergency guidance from the FDA. Much of this sanitizer was donated or sold at a low margin, helping to alleviate a dire shortage. These same distilleries were surprised this week by a notice from the FDA informing them that they were required to pay a fee of more than $14,000 as over-the-counter drug production facilities to cover the costs of FDA regulation.

Late today, however, the Department of Health and Human Services (HHS) reversed the policy. In a statement posted to Twitter, HHS Chief of Staff Brian Harrison said, "Small businesses who stepped up to fight COVID-19 should be applauded by their government, not taxed for doing so. I'm pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!"

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In a longer statement, HHS leadership distanced itself from the initial policy: "This action was not cleared by HHS leadership, who only learned of it through media reports late yesterday. HHS leadership convened an emergency meeting late last night to discuss the matter and requested an immediate legal review. The HHS Office of the General Counsel (OGC) has reviewed the matter and determined that the manner in which the fees were announced and issued has the force and effect of a legislative rule. Only the HHS Secretary has the authority to issue legislative rules, and he would never have authorized such an action during a time in which the Department is maximizing its regulatory flexibility to empower Americans to confront and defeat COVID-19."