Have you seen this? Link is inside thread to their article and it is interesting.
Devastating News for the Vaping
Devastating News for the Vaping
Deeming Regulations have been released!!!!
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When I read his quote, that statement really jumped out at me. I've never heard anything remotely like that from the FDA/Government/Gottlieb previously. I mean, it's no rock solid, solemn promise we can bank on, but it made me feel a little better for the time being about what might be coming. Far from the "epidemic, save the children at all cost" rhetoric we've gotten used to. Makes them actually sound reasonable.
Oops, meant to post this here, not in @rosesense link
Huh? That's a scare article picking out the worst and misrepresenting a whole lot of other stuff. I'd love to know who is claiming there will be no appeal. The FDA will not let this ruling stand in its current form as it creates a terrible precedent for the agency going forward on stuff they regulate totally unrelated to vaping.
Also, that claim about 98% of FDA rulings are unconstitutional because they're signed by "low level employees" is utter nonsense. If that were true not a single major pharma company would even bother with FDA regs, they'd claim they're unconstitutional and have their legal departments just kill anything the FDA comes up with, and we all know for sure that doesn't happen.
Huh? That's a scare article picking out the worst and misrepresenting a whole lot of other stuff. I'd love to know who is claiming there will be no appeal. The FDA will not let this ruling stand in its current form as it creates a terrible precedent for the agency going forward on stuff they regulate totally unrelated to vaping.
Also, that claim about 98% of FDA rulings are unconstitutional because they're signed by "low level employees" is utter nonsense. If that were true not a single major pharma company would even bother with FDA regs, they'd claim they're unconstitutional and have their legal departments just kill anything the FDA comes up with, and we all know for sure that doesn't happen.
And it's in a court brief, not a press release. A lot tougher to backtrack from.
I do not think any of us know whether they will appeal or not. The author(s) of that article seem to be convinced they won't, whereas you seem to be convinced they will. Does either of you actually have inside knowledge?
But even if the FDA does appeal, how we don't know whether that appeal will be successful. And even if an appeal happens and succeeds, 2021 (for "flavored" products) and 2022 (for all the rest) are no longer all that far away.
Hope for the best. Prepare for the worst.
Sorry, no insider tips from me. I'm going by my knowledge of FDA regulatory affairs and operations. This is bad legal precedent, and they don't like bad legal precedent messing with their decision making process. And remember, the appeal is a freebie, they already have all those government lawyers sitting around anyway collecting a salary. That in itself is a big cudgel as they don't need to worry about legal bills running up into the millions.
As to timing, sure, in 2016 it looked way off. It's now been 3 years with not much going on other than age restrictions and labeling. We knew this was coming and I think a good number of folks around here either already prepped, are still prepping, and will continue to prep right up until the end.
But in that time we've seen things like UL standards come out, more advanced protection circuits in decent regulated mods, and adoption of GMP and better record keeping by juice manufacturers. We've seen online sales restrictions to minors beefed up. Things haven't been standing still, but at least some of the progress made will be handy in addressing applications made to the FDA when the time comes. It also spread that capital expense out over several years rather than the shorter time frame when we started out.
If Judge Grimn excepts the FDA's Offer of Remedy, does the FDA even have a Legal Avenue to do an Appeal?
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So isn't the blog written by the vendor? I don't think Kai's would use a scare tactic with no basis. What would be the point in that?
Probably not. They're offering a settlement. If the judge accepts there's nothing left to appeal, and the decision would only apply in this specific case, and not bind the FDA beyond that. However, if the judge accepts and the other party doesn't, then an appeal becomes possible for the plaintiff who isn't satisfied with the terms.
IMO no point but it wouldn't be the first time a vendor has done that. Make it seem the end of days is here and maybe get people more involved in fighting regulation. It's all a matter of influencing public perception. That vendor really undermines credibility when trying to drag false information like how FDA regulations aren't constitutional for weird reasons like low level employees signing stuff. It reminds me of arguing federal income tax is unconstitutional and refusing to pay. That never turns out well.
That is/can be a Fundamental part of why a Defendant makes an Offer of Remedy. Because if excepted, and subsequently so Ordered, the Burden now shifts to the Plaintiff to get a Ruling Overruled on appeal.
Half a Pie can be Better than No Pie at all. Especially when the Half you get is Better than the Other Half.
OK, but by that logic, how do you explain the fact that they chose not to appeal Judge Leon's decision in Sottera almost a decade ago? Tell me that didn't mess with their decision-making process?
I don't know. I got whacked by teachers, parents, and an older brother...daily...sometimes multiple times daily. I survived.
Adults loved whacking kids because it was easy, not because it works. It has been my experience (I got wacked enough and other stuff by my mom that it would have qualified as child abuse today) that wackings, if administered sparingly as part of a REASAONABLE discipline system is perfectly fine. The key is "sparingly" and reasonable discipline.
It has been my experience that many people wacking kids do so when angry and don't really explain or teach much to the child. I hit my kid ONE time. He was a toddler and was about to walk into a 5 line road. I did it because "talking to a 116 month old about the dangers of traffic" would have been not very effective at all. It stopped the behavior.
Usually, smart, useful and cunning punishments and setting up a really effective reward system (including planned ignoring of some behaviors) works a HECK of a lot better.
There are two times I congratulate parents. One, when they are an effective parent of an autistic child because they get such nasty looks wherever they go. Second, if the kid wants some candy item or whatever and pitches a fit and the parent just says no and peacefully continues shopping. That is what you are supposed to do, it is called "planned ignoring" and will extinguish the behavior. Most people look at that sort of parent as Satan but I don't.
You gots to find the middle way.
Also I have some form of ADHD. So did my kid. I support any parent's right to like not medicate their kid if they do not want to (brain scan or not, and the Vanderbilt scale has shown perfectly reasonable efficacy so to me a brain scan is a bit OTT but whatever. I have done OTT things with my healthcare plan.)
However, MY life is a lot better medicated. I have had so much therapy (and am one) that like, I do know that behavior mod is not going to fix my problems.
I have also read a TON of literature on ADHD because I did not really WANT to medicate my kiddo. Untreated ADHD kids are lower in self esteem, higher in school drop out rates. engage in more substance use, and have more criminal records.
I think it is atuallly about society's negative messages to the ADHD that cause that. I did not get medicated until after my Master's degree and I'm not hyperactive (many women aren't compared to men) so I sat in the back drawing horse pics.
I was smart enough to compensate but there are times I wonder if I would have like made it into an MD program rather than the MSW I HAVE. Math would have been a LOT easier, for one. Etc.
I'm sorry to threadjack. I always have many thoughts about this. If I were an MD I would study vaping though possibly. That would have been fun.
Also, I might not have self medicated with tobacco and coffee. I don't know it for sure. But I might not have.
Anna
OK, but by that logic, how do you explain the fact that they chose not to appeal Judge Leon's decision in Sottera almost a decade ago? Tell me that didn't mess with their decision-making process?
No idea what the thought process was at the time, but the ruling did give them a pathway for regulation under the TCA. It wasn't like they were told "sorry, you can't regulate these things ever". I imagine the tobacco institute threw a party after that decision gave them so much new business they could go after, and look for increases in funding to meet their newly granted responsibilities.
Just to be clear, you're saying the FDA will definitely appeal this order unless Judge Grimm accepts their offer?
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That's like saying can you guarantee I'll wake up tomorrow morning (OK being flippant). There's no guarantee. But given how the FDA functions they hate being bound by judicial decisions for their rule making process. It's the same basis as the "Chevron" Supreme Court decision involving the EPA, and is regularly invoked by regulatory agencies as the basis of referring to their expertise in regulations within their purvue, rather than the judicial branch (it was also relied upon successfully by the FDA in the lawsuit brought by Nicopure when the deeming regs were first released).
So guarantee, no. But likely in keeping with general regulatory procedures to assert their right to make rules and regulations, yes.
This is all depressing.
It's like watching a train wreck in slow motion.
Thankfully, I'm not on the train itself, but in a car on a road parallel to the train tracks.
I've shouldn't have used the word definitely. I should have said you think the FDA will appeal unless Judge Grimm accepts their offer. I agree with that, and part of me hopes he doesn't accept it. It sounds like if he does, the vapor industry as we know it will only have ten months left.
I'm not sure what you're referring to. In their response, the FDA argued "under no circumstances should it set that deadline sooner than 10 months from the date of its decision". The plaintiffs are asking for 120 days.
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