FDA Any other News on Today's Court Arguments?
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A few key excerpts:
Although Judge Jackson lobbed questions at both sides, most of them were directed at Nicopure’s arguments against the rule. She questioned why, if the agency and Nicopure both acknowledged that the majority of the market involved tobacco products subject to regulation, the agency should lose its regulatory power just because a subset of consumers may not use nicotine-containing liquids.
“Is there anything else in the universe that anyone would do with a vaping device than put a liquid in it and vape with it?” Judge Jackson asked.
....
Block argued that the statute did not give the agency the ability to look at the likely use of a product to determine whether it was a tobacco product, and that the agency violated a number of other provisions and constitutional protections in a way that would push hundreds of smaller manufacturers out of the market.
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However, Judge Jackson questioned whether the sheer number of producers in the current “wild west” of the industry who purportedly could not comply with rules like properly labeling their products did not weigh in favor of FDA regulation. Further she said that certain requirements, such as a grandfather date for premarketing approval by the FDA, are mandated by statute and not subject to the agency’s discretion. “I don’t see the authority for the FDA to change a congressionally mandated compliance date,” she said.
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“We’re dealing with a plaintiff whose name is Nicopure,” he said. “Clearly their very reason for existing is to deliver nicotine to consumers.”
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Further, Crane-Hirsch said the complaints were about premarket approval processes and the studies required by the statute. To the extent that they are not, such as agency oversight of advertising and bans on sample giveaways, the agency offered reasonable, narrowly tailored solutions to keep minors from obtaining products and to prevent deceptive claims in the market, he said.
Although Judge Jackson lobbed questions at both sides, most of them were directed at Nicopure’s arguments against the rule. She questioned why, if the agency and Nicopure both acknowledged that the majority of the market involved tobacco products subject to regulation, the agency should lose its regulatory power just because a subset of consumers may not use nicotine-containing liquids.
“Is there anything else in the universe that anyone would do with a vaping device than put a liquid in it and vape with it?” Judge Jackson asked.
....
Block argued that the statute did not give the agency the ability to look at the likely use of a product to determine whether it was a tobacco product, and that the agency violated a number of other provisions and constitutional protections in a way that would push hundreds of smaller manufacturers out of the market.
....
However, Judge Jackson questioned whether the sheer number of producers in the current “wild west” of the industry who purportedly could not comply with rules like properly labeling their products did not weigh in favor of FDA regulation. Further she said that certain requirements, such as a grandfather date for premarketing approval by the FDA, are mandated by statute and not subject to the agency’s discretion. “I don’t see the authority for the FDA to change a congressionally mandated compliance date,” she said.
....
“We’re dealing with a plaintiff whose name is Nicopure,” he said. “Clearly their very reason for existing is to deliver nicotine to consumers.”
....
Further, Crane-Hirsch said the complaints were about premarket approval processes and the studies required by the statute. To the extent that they are not, such as agency oversight of advertising and bans on sample giveaways, the agency offered reasonable, narrowly tailored solutions to keep minors from obtaining products and to prevent deceptive claims in the market, he said.
Friday13th
Vaping since Friday 13th of July 2012
So... Congress mandated the grandfather date? In 2009?
Then Speaker Boehner, Majority Leader McCarthy and Fred Upton sent a letter to DHHS Secretary Burwell in Nov 2014 asking the FDA to MOVE the grandfather date to April 2014 or time of final rule.
Here's the letter Boehner sent:
https://dl.dropboxusercontent.com/u/18613027/Boehner Letter 24Nov2014.pdf
Anyone know how to forward this letter to Judge Jackson? Or maybe to Nicopure's lawyers?
ZM, could you give the rest of us that don't have access a recap of what it says? TIA
Train2 might be a better person to Ask about specifics. Because I don't have access to that Law360 Document either.
And am going by what someone who has Better Access to information has told me about Judge Jackson's questions.
Do Not attempt to contact Judge Jackson. It would be viewed as just a Nuisance. And she wouldn't see it anyway.
I am Pretty Sure counsel for Nicopure has seen the Letter that you posted. But you could forward it to the e-Mail addresses listed for the Attorneys for the Plaintiff at the bottom of the original complaint.
http://www.fdalawblog.net/Nicopure Complaint.pdf
It is Truly a Shame that we even have to Stock Up. But I am with you. And am Glad that I did.
Because I don't see any of this Playing Out very well in the Near Future.
The judge seems to be of the opinion that the FDA is doing what they've been tasked to do.
Hopefully she starts paying attention to the parameters the FDA is supposed to follow.
Because although they MAY be "trying" to do what they've been tasked to do...
They are doing it in many ways that violate HOW they are supposed to be doing it...
And it's hard for me to imagine a judge not seeing that clearly.
Unless........
Hopefully she starts paying attention to the parameters the FDA is supposed to follow.
Because although they MAY be "trying" to do what they've been tasked to do...
They are doing it in many ways that violate HOW they are supposed to be doing it...
And it's hard for me to imagine a judge not seeing that clearly.
Unless........
Doing it wrong, and doing it in a manner that is not in line with the congressional statute, can be two very different things.
Yes, but that's my point.
What they are doing they are doing in many obvious and enormously destructive ways...
Ways that are not in line with HOW they are supposed to do things...
My main concerns are as follows...
- They will destroy an industry, when they have been mandated to not do that
- They will create a black market, when they have been mandated to not do that
- They ignore the mandate to work towards lower harm alternatives
The "economic impact" requirements alone SHOULD get the FDA sent packing.
Any other outcome smells like the fix is in as far as I'm concerned.
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