Calwise Spirits owner Aaron Berg speaks after receiving a large amount of money from the FDA for the production of an emergency hand cleanser at the start of the pandemic.
PASO ROBLES – No good deed goes unpunished, said Calwise Spirits owner Aaron Berg after a meeting on Monday 28. In December, it was announced that all monographs from drug factories – including distilleries – must pay $14,060 to the FDA within 45 days.
In March, when the COVID-19 pandemic hit the United States, there was an extreme shortage of basic medical supplies such as face masks, hospital dresses and hand cleansers. In response, the U.S. Food and Drug Administration (FDA) issued an emergency declaration allowing distillers to manufacture a hand sanitizer.
The FDA has made it clear that the distilleries are no longer useful, and it is now in their interest to milk us for all we are worth, even though we are already struggling during the ongoing shutdown during the pandemic, according to Berg, who is known for the artisanal production of whisky, gin and rum at the Paso Robles distillery.
Like hundreds of other distilleries across the country, Berg has converted his still lifes into a nightly decontamination shop. It produced 5,000 gallons of hand disinfectant in six weeks and distributed it mainly to health workers, first responders and government employees in the front line of the pandemic. Orders for disinfectant pallets came from agencies and companies hundreds of miles away from its downtime – including the FBI, the State Department and the California Department of Emergency Management.
In six weeks time, Calwise Spirits owner Aaron Berg produced 5,000 liters of priority hand sanitizer.
Pictures courtesy of Calvis.
Some of my hand disinfectant was donated. The rest was sold at a fraction of the market price. My goal was to do as much work as possible for as little cost as possible and at the same time put redundant workers back to work. The hand cleaning company saved me from bankruptcy – but I didn’t make a huge profit.
It doesn’t matter if the distillery produces 5 gallons or 5 million gallons – they all owe the FDA at the eleventh hour. February 2021 $14,060. Although the distillery has donated every drop of hand sanitizer, it will have to pay $14,060. If the distillers do not submit their registrations to the FDA for the 31st time. In December, just three days after the announcement of the FDA, they will have to pay an additional $14,060 to continue working in 2021.
Although Berg saw the announcement on Monday, he didn’t realize it was affecting his business until Tuesday night, when he received an email explaining it from the American Distilled Spirits Council, a leading public interest group for the spirits industry.
The FDA’s Monograph User Overhead Fees Program (OMUFA) website extends these fees to companies that manufacture or process hand sanitizers in accordance with the Interim Policy for the Preparation of Certain Alcohol-Based Hand Sanitizers for Public Health Emergencies (COVID-19), wrote General Counsel and Corporate Secretary Courtney Armour.
A month ago, Berg was contacted by an FDA inspector who reviewed the production records for hand sanitizers. Berg has learned that many other distilleries in his state are also subject to sampling. I respect and appreciate the FDA’s efforts to protect the public by ensuring that defective products are not sold. I would understand if they followed up on the complaints, but it is unreasonable, during the revival of the worst wave of pandemics and company closures, to select arbitrary distilleries that abide by the law.
Berg said that when an FDA inspector asked specific questions about the value of the hand cleanser being manufactured. I found it strange that he wanted to know how much I earn, how much I sell and how much hand cleanser I still have. I think they were trying to estimate the size of the cake to determine how big a piece could be.
For Berg and other Californian distillers, the most lucrative time of the year, the Christmas period, was strongly marked by Governor Gavin Newsom’s recent decree. FDA fee of $14,060. A $500,000 pandemic could wipe out the holiday profits that businesses are counting on for the rest of the pandemic.
Now that the distillers have had their final blow since 2020, the consequences have only just begun.
On Monday, I thought I’d take the week off. I’ll call at the beginning of the new year. It looks like 2020 won’t hit me anymore, and how wrong I was, Berg said.
There are still many questions to be answered about the possible amount of $28,000. The government also imposed a $500,000 levy on distillers who produced a disinfectant at a time when the country was short of water and needed more.
Written in complicated legal language, many distillers didn’t even know the email was sent to them on Monday, December 28.
I didn’t understand what he was talking about. I didn’t think it was one of my concerns – I ignored it because I keep getting emails from the FDA when I write to five distilleries in our area. I knew I was making hand sanitizer, but one of them knew – and by telling them, I saved them $28,000.
The distillers will owe $14,060 for the production of the disinfectant by 2020, and if they do not register the plant with the FDA by the 31st. In December 2020, they still owe $14,060 for 2021.
That’s what many of these agencies like to do – they just announce it between Christmas and New Year because it gets lost in the crowd – they try to sneak in when they think no one’s paying attention, but fortunately people are paying attention now.
How can the community help our local distilleries?
Right now I think it is important that people know and understand what is going on and that they are willing to contact their local MP, because eventually Congress will put pressure on the FDA – the President or Congress will change that. This is the only action that can be taken, Berg said.
At this stage we can only be vigilant and do our research, which may seem simple and modest at the moment, but could mean much more in the near future.
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About Calwise Spirits Co… Aaron Berg, one of the world’s youngest master distillers, has created a line of premium spirits that embodies the essence of the Golden State. They are infused with natural ingredients that provide the pure taste of the Californian liquid represented by their flagship, Big Sur Gin. Visit CalwiseSpirits.com
Whether a distillery produces 5 gallons or 5 million gallons, it doesn’t matter – they all owe the FDA at the eleventh hour. February 2021 $14,060.
Aaron Berg, owner of Calwise Spirts.
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