Alright, folks. You may have seen that the FDA was in a fight with distilleries last week.
Let's unpack what happened, why it happened, and why it's now resulting in some extremely unusual behavior by HHS.
Thread below. Follow if you're interested.
If you're like most people, you might have stumbled across a few news items in this past week talking about how the big-bad-FDA was deciding to screw over distilleries with a $14,060 fee.
It should be noted that the only reason distilleries were being charged this fee was because they had been permitted by the FDA to make hand sanitizer.
It basically sounded like "no good deed goes unpunished by the government." Reddit's
The problem is that this is a wildly incomplete picture of what happened and why it happened.
So let's look at what did happen, and you can decide for yourself where the blame lies.
Let's start with some regulatory background here.
Hand sanitizer is regulated as an over-the-counter (OTC) product. Under that regulatory approach, entities which adhere to an FDA "monograph" may market an OTC drug without obtaining explicit FDA approval.