HHS Orders to Retract $14,060 FDA Fee on Emergency Hand Sanitizer Manufacturers •

PASO ROBLES – After a huge public outcry, the Department of Health and Human Services (HHS) has ordered the Food and Drug Administration to reverse its last-minute decision to impose a $14,060 tax on manufacturers of emergency hand sanitizers.

The FDA announcement earlier this week was designed to eradicate our holiday profits, said Aaron Berg, Paso Robles-based distiller and owner of Calwise Spirits Co. As people gathered around us and spoke out, we became the beneficiaries of a New Year’s miracle.

When the COVID-19 pandemic hit the United States in March, there was an extreme shortage of hand disinfectants. In response, the U.S. Food and Drug Administration (FDA) issued an emergency declaration allowing distillers to manufacture a hand sanitizer. The Mountain Distillery has produced more than 5,000 gallons of hand sanitizer that has been distributed to numerous federal and state agencies, including the FBI, the State Department, the California Fire Department and the California Department of Emergency Services. In December, it was announced that all monographs on drug production, including the distilleries, were due to the FDA $14,060 within 45 days.

Berg contacted several media channels last week, including the Paso Robles Press, and the story spread quickly and was picked up by all the major media channels. It has attracted the attention and anger of concerned citizens and even some members of Congress. About 24 hours later, HHS announced that it was taking steps to prevent the FDA from filing a complaint.

Although HHS has asked the FDA to waive this tax, the FDA has not yet explained how it will adhere to it. As far as distillers are concerned, there are still many questions to be answered.

Although the intention is to abolish the levy for the activities in 2020, it seems that distillers will still be taxed if they operate after 1 January. to continue the activities, including the sale of current stocks. Have distillers who have been written off to avoid payment lost their current stock, which is currently unsaleable? asks Berg.

A statement from HHS Director Brian Harrison states that management was unaware of the plan to charge exorbitant fees and would never have authorised such action.

Director Harrison may not have authorized it, but it is clear that someone in a senior management position within HHS or the FDA has authorized it, Berg said. A month ago, together with dozens of other distilleries in the country, they were subjected to a random audit.

An FDA inspector who contacted Berg said she was involved in an operation officially called Mission Critical, which looked at production records and sales of the hand sanitizer manufactured, sold and in stock. The inspector also told Berg that the FDA is considering imposing a tax on disinfectant.

concludes Berg: It is now clear to me that the critical mission was not just a matter of public security. Part of his job was estimating the size of the money cake so they could take a piece of it. He goes on to say: I respect and appreciate the FDA’s efforts to ensure public safety by preventing defective products from coming onto the market. I would understand if they followed up on a complaint, but carrying out random checks on compliance in the distilleries during a pandemic outbreak and closures would be an excessive burden.

For now, it seems that Burners can rest on their laurels knowing that they don’t have $14,060 billion and can focus on the most pressing issues of the new year.

I am grateful to the American Distilled Spirits Council and the American Craft Spirits Association for their tireless efforts in the federal government. I think the outcome of this story is proof that people at the base can make a difference. In the end, this would not have changed without public protest and support. Thank you to all those who have dedicated themselves to small businesses like us – your voices have been clearly heard. Mountain shared.

Original story: The FDA charges $14,060 to manufacturers of emergency hand sanitizers.

About Calwise Spirits Co.

One of the world’s youngest master distillers, owner Aaron Berg, has created a line of premium spirits that embodies the essence of the Golden State. Visit CalwiseSpirits.com


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