Deeming Regulations have been released!!!!
- Thread starter Oliver
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At least it was finally released. The question now is what position will the FDA take when this is appealed. That will be one test of how Gottleib intends on handling the matter. Assuming the plaintiffs file an appeal.
I can't say I'm surprised at all, and I don't know if there are grounds for appeal.
The rules for how tobacco products are regulated were in the FSPTCA. All the deeming regulations did were to deem vapor products as tobacco products and to state that the FDA would apply the same regulations to vapor products as it applies to other tobacco products.
It's going be a Huge Challenge to do an Appeal. Given that Judge Jackson invoked the Chevron Doctrine on the Critical Points of the suite.
It also kinda Kicks the Legs Out from under any possible Legislative remedy.
The FDA now has a Green Light. And the Warning and Non-Compliance Letters for things like Post August 2016 Products are probably being printed by the 1,000's.
BTW - If anyone doesn't understand what the Chevron Doctrine is, or what concept of Judicial Deference implies, here is a Nice and Concise explanation...
"The origins of the [Cheveron] Doctrine aren’t especially political. The original opinion was written by Justice John Paul Stevens, then still a moderate Republican in the mode of Gerald Ford, who appointed him. (Stevens later became a liberal, one of the most outspoken on the Rehnquist court.
Stevens’s basic reasoning was that when Congress passed a law that did not have a clear meaning, the agency charged with applying the law should have the first crack at interpreting it. This made sense against the background of the now somewhat-old-fashioned idea that agencies are politically neutral experts whom Congress trusts to make wise decisions.
Given the agency’s expertise in the subject matter, Stevens reasoned, the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.
The court’s job was then twofold. First, in what came to be called step one of the Chevron doctrine, the court must determine if the law was in fact ambiguous. If it was, then at step two, the court was supposed to decide if the agency interpretation was reasonable."
Supreme Court Fans, Brush Up on the Chevron Doctrine
"The origins of the [Cheveron] Doctrine aren’t especially political. The original opinion was written by Justice John Paul Stevens, then still a moderate Republican in the mode of Gerald Ford, who appointed him. (Stevens later became a liberal, one of the most outspoken on the Rehnquist court.
Stevens’s basic reasoning was that when Congress passed a law that did not have a clear meaning, the agency charged with applying the law should have the first crack at interpreting it. This made sense against the background of the now somewhat-old-fashioned idea that agencies are politically neutral experts whom Congress trusts to make wise decisions.
Given the agency’s expertise in the subject matter, Stevens reasoned, the agency should have the authority to choose among potentially conflicting policy choices. Provided the agency’s interpretation was reasonable, the court should defer to it.
The court’s job was then twofold. First, in what came to be called step one of the Chevron doctrine, the court must determine if the law was in fact ambiguous. If it was, then at step two, the court was supposed to decide if the agency interpretation was reasonable."
Supreme Court Fans, Brush Up on the Chevron Doctrine
Because it is Easier for those who Don't Like to put Ripples in the Water to do Nothing when a Federal Court has basically given the FDA their blessing.
If Judge Jackson had ruled, in part, in Our favor, it would be a Much Easier sell that something Needs to be Done to change the Law.
FDA could now (in theory) send warning letters to all E-cigarette companies to verify that every product the are currently selling was being sold prior to August 2016.
While they vast majority of companies will be able to prove that they are in compliance. The few that can't could be in trouble
While they vast majority of companies will be able to prove that they are in compliance. The few that can't could be in trouble
My favorite part so far, page 5
"However, the FDA has plainly stated that the rule does not cover e- liquids that do not contain, or are not derived from, nicotine or tobacco, unless those liquids are reasonably intended to be used with nicotine-containing liquids."
But then the next paragraph:
"The Court concludes that the agency acted within the scope of its statutory authority: it was legally permitted to regulate that category of liquids, and to consider a refillable electronic nicotine delivery system to be a “component” of a tobacco product and therefore subject to regulation."
"However, the FDA has plainly stated that the rule does not cover e- liquids that do not contain, or are not derived from, nicotine or tobacco, unless those liquids are reasonably intended to be used with nicotine-containing liquids."
But then the next paragraph:
"The Court concludes that the agency acted within the scope of its statutory authority: it was legally permitted to regulate that category of liquids, and to consider a refillable electronic nicotine delivery system to be a “component” of a tobacco product and therefore subject to regulation."
Well then, why aren't all the parts of a cigarette and its contents listed on a pack of smokes? Seems if they are forcing the issue with eliquids that should be a no brainer. I would liked to have known the 'ingredients used in producing the product' that is harmful to my health. What is good for the goose doesn't appear to be good for the gander.
Not to get too political, but why did we ever allow our elected representatives to hand over so much power and responsibility to non-elected persons? Not just these agencies but also appointed judges? Sorry, I'll stop now. I just get so disgusted.
Because no one wants to actually do the work they were elected to do. I think it has something to do with Murphy's Law.......when elevated to their own incompetence, they will pass the buck.
Maybe because there was a time when such Power wasn't Abused and Over-Extended?
Last I heard, September 30, 2017. That's following a 6 month extension, and another 90 day extension.
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