4 ms·

I took a quick look at the linked FDA rule PDF, but I cannot figure out what the penalty is for not registering. For instance it is not clear what would happen

by fernly 10y ago

I took a quick look at the linked FDA rule PDF, but I cannot figure out what the penalty is for not registering. For instance it is not clear what would happen to a small vape pen maker, selling into the legal marijuana states, who simply labels a product "This device NOT approved by the FDA for use with tobacco or substances containing nicotine; use with such substances may damage your health".

AlgorithmicTime 10y ago
"Oh, and BTW, please see our selection of nicotine tinctures down aisle 3."
paulajohnson 10y ago
Thats because a rule like this is "secondary" legislation that hangs off some piece of "primary" legislation. Primary is created by Congress, secondary is created by government agencies as specified by the primary legislation. Somewhere there is a piece of primary legislation saying that the FDA can make rules regarding the manufacture and sale of some defined class of items. The preamble to the FDA rule probably mentions it. That primary legislation will lay down the penalties for failing to comply. The problem is that the primary legislation doesn't relate the severity of the crime to the penalty, it just prescribes the maximum penalty. Since this has to cover anything up to selling baby milk adulterated with melamine, you are talking vast fines and years or decades in prison. In theory this could apply for failing to maintain proper paperwork on just one occasion. In practice the FDA gets to decide how serious your crime is, although it does have to be rubber-stamped by a judge, and if they wanted to do more than close you down then normal criminal evidence rules would apply.
- wtbob 10y ago
  So much for 'All legislative powers herein granted shall be vested in a Congress of the United States'! Y'know, the Constitution ain't perfect, but it's better than what we have now.

4 ms·

I took a quick look at the linked FDA rule PDF, but I cannot figure out what the penalty is for not registering. For instance it is not clear what would happen

by fernly 10y ago

AlgorithmicTime 10y ago
"Oh, and BTW, please see our selection of nicotine tinctures down aisle 3."
paulajohnson 10y ago
Thats because a rule like this is "secondary" legislation that hangs off some piece of "primary" legislation. Primary is created by Congress, secondary is created by government agencies as specified by the primary legislation. Somewhere there is a piece of primary legislation saying that the FDA can make rules regarding the manufacture and sale of some defined class of items. The preamble to the FDA rule probably mentions it. That primary legislation will lay down the penalties for failing to comply. The problem is that the primary legislation doesn't relate the severity of the crime to the penalty, it just prescribes the maximum penalty. Since this has to cover anything up to selling baby milk adulterated with melamine, you are talking vast fines and years or decades in prison. In theory this could apply for failing to maintain proper paperwork on just one occasion. In practice the FDA gets to decide how serious your crime is, although it does have to be rubber-stamped by a judge, and if they wanted to do more than close you down then normal criminal evidence rules would apply.
- wtbob 10y ago
  So much for 'All legislative powers herein granted shall be vested in a Congress of the United States'! Y'know, the Constitution ain't perfect, but it's better than what we have now.