Remember Distilleries Who Aided in the Pandemic This Year? The Feds Are Hitting Them With Surprising Surcharges from the FDA

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After being called into action small businesses are becoming punished by the government.

After a yearOne of the under-reported stories from the year was how President Trump made numerous moves to take down the governmental blockages to businesses for the sake of getting help in dealing with the pandemic. When ventilators were said to be at a crisis-inducing low the President removed some of the federal restrictions that prevented different companies from partnering on the production of the needed equipment. He also made a similar move in regards to the nation’s brewers and distillers.

When the pandemic was initially breaking out across the country two realities were in play for these businesses. There was a steep drop in their commerce, and the country was in need of cleansing products in the name of safety. The producers of alcohol-based products were in a unique position to fill a void quickly, and the administration saw fit to remove the thresholds and blockages preventing them from otherwise producing hand sanitizer.

Distilleries were not licensed and permitted to make a product regarded as a healthcare item, but the executive orders cleared the way for these companies to begin using their alcohol production for sanitizing products. Now those same small businesses which rose to the occasion are being punished. The FDA this week has come out with the announcement – those alcohol producers who helped get sanitizer to healthcare workers and nursing homes are being hit with a sizable bill – a charge of $14,060.

 A charity group gives free hand sanitizer to people to protect against possible MERS, Middle East Respiratory Syndrome, virus on the street in Seoul, South Korea, Wednesday, June 10, 20

Here is where it gets to the typical bureaucratic infuriation. For these businesses to be cleared to make sanitizer they were classified as OTC monograph facilities. As they were creating what is deemed an over-the-counter non-prescription drug the CARES Act deems that they are to be regulated by the FDA. That new bill was for the regulatory activities enacted by the FDA. It was not a requirement for  this production

What the FDA did when it was announced these distillers would make hand cleaners was requiring that they add a step to their production to make the usable alcohol in the sanitizer denatured. This was done to ensure that the alcohol would not be consumed. So the FDA added a requirement that delayed the release and added cost to the production, and now they are issuing a bill for their effort at adding a problem. Typical governmental asininery.

Not only are struggling businesses being hit with this surprise expense over a product many of them donated or made the barest of revenue from, but they are told now they need to move quickly on the company designation – if they do not alter their status as a monograph by close of business today they will be on the books as one for 2021, meaning they will have a secondary bill coming due in another year.

This is the kind of stone-headed federal operations that is a daily nightmare. Companies compelled to help society are now charged by the same government, billed for federal activities that made the process longer and more costly. The owners will surely be turning to their normal products now to alleviate the anxiety of seeing their good deeds going punished.

 


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