FDA Any other News on Today's Court Arguments?

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y cherry y

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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?

Yes, Congress mandated the 2007 predicate date as part of the 2009 tobacco Control Act. Which is why we need Congress to amend the TCA to change the date.

Please don't try to contact the judge. It would in no way make her more friendly to the plaintiffs in the case.
 

DC2

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What kind of parent does it take to raise a Matt Jackson?
Matt Jackson (Jeopardy! contestant) - Wikipedia

Sorry, but I majored in Psychology, and minored in Philosophy.
So questions like this interest me.

I also minored in Physics, but I don't see how that applies in this circumstance.
:laugh:
 

zoiDman

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What kind of parent does it take to raise a Matt Jackson?
Matt Jackson (Jeopardy! contestant) - Wikipedia

Sorry, but I majored in Psychology, and minored in Philosophy.
So questions like this interest me.

I also minored in Physics, but I don't see how that applies in this circumstance.
:laugh:


I’ll take Governmental Overreach for $300 Alex.

“Use of the FSTPA in subverting an industry to maintain tax revenues under the guise of Saving Children.”

What is the FDA Deeming Regulation?

“Correct.”
 

Lessifer

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What kind of parent does it take to raise a Matt Jackson?
Matt Jackson (Jeopardy! contestant) - Wikipedia

Sorry, but I majored in Psychology, and minored in Philosophy.
So questions like this interest me.

I also minored in Physics, but I don't see how that applies in this circumstance.
:laugh:
I knew I liked you, my BA is in Psych with a minor in Philosophy. No physics though, I was leaning towards statistical analysis for awhile.

As to the previous post, I would assume the FDA's argument would be, we are simply applying the tobacco Control framework, established by congress, to newly deemed tobacco products, as detailed in the FSPTCA.

As far as I can tell, they're not wrong, and if this judge isn't sympathetic to the idea that 0nic liquid, or the equipment used to vape 0nic liquid are NOT tobacco products, I'm not hopeful.
 

seminolewind

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So, we're fighting the FDA over the Tobacco deeming so that a few "Yahoo's" from the Wild West can vape nicotine free liquid? That's blatantly biased in itself. And shows us a great disrespect, as in making fun of us as if we were uneducated and not worthy of questioning the rulings of the FDA.
 
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seminolewind

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I get real tired of the people like .Gov, Judges, and regular people out there that think that vaping is supported by uneducated foolish smokers who will believe anything they hear. It is disrespectful for anyone to treat any of us like we are automatically wrong and naïve if we have a different opinion than they do-even if proven that we carry facts and they have been educated by the Internet for dummies team USA, heretics, and people who never gave a thought to fighting cigarette smoking as hard as they fight vaping-those who crawl out of the woodwork to voice their "educated" opinions.
 

seminolewind

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Re: Hearing Pennsylvania is placing a 40% tax on vaping as a sin tax? And in possession of a vaping product or even buying one outside of state lines will be fined?

I'm not sure you can fine people for purchasing over state lines. That may be illegal. But I know one thing. I am here to help any cause that will get our fellow Pennsylvanians get their products and not mark them up 40%. I wonder how a state can fine or tax someone for having glycerin, pg, food flavoring in their possession. It's also not hard to make a mech mod out of an altoids box. If you look around on this site, there a soooo many talented curious people that have built unreal vaping parts. So beautiful. They don't seem to be ones to up and quit their art. There are also many other people who love to make "how to do" videos. I made my first battery box mod watching a member video.

All in all we may not win this battle, but the war is still won by us one way or another. Any immorally or nonlegal action, decisions made for profit, or anyone who thinks that vaping is dangerous, unhealthy, evil, sinful, as bad as cigarettes, toxic, or not a cessation device for the majority of former smokers is wrong! They have also got their information from non research , here say, spite, or profit. I can't say that for any of us.
 
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r055co

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Way to soon to call it or even speculate on how it's going to pan out. But I really am thanking my lucky stars that I stockpiled. I still believe we're going to get screwed and screwed hard.

But I'm still hoping that all my stash isn't needed and I will just have a lot of gear to sell/trade.

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r055co

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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.”
.

IMO the lawyers need to highlight this and point out the fact that Congress gave the FDA the power to regulate Tobacco, NOT nicotine. If that was the intent then Tomatoes, Potatoes, Eggplant, etc would be in the same regulations.


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seminolewind

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IMO the lawyers need to highlight this and point out the fact that Congress gave the FDA the power to regulate Tobacco, NOT nicotine. If that was the intent then Tomatoes, Potatoes, Eggplant, etc would be in the same regulations.


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That would be the honest way to do things. Vaping products are actually known to not have tobacco , that's the point of using them. To be deemed a tobacco derivative seems to be taking a step backwards . It's ridiculous to call an anti-tobacco product a tobacco product.
 

Endor

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It's ridiculous to call an anti-tobacco product a tobacco product.
The most ridiculous part is that the deeming regulations actually require that eliquid that contains NO nicotine be labeled differently:

"This product is made from tobacco."

This, even though PG, VG, and the flavorings used have no association with tobacco at all. This alone shows the craziness.

As far as what was posted earlier about the discussions at the hearing, I agree that it doesn't look good. But, in some ways it makes sense... it is extremely difficult to get regulations overturned, as the FDA is following statue.

This is why, as a country, we need to rail against legislatures who pass these overarching laws and then hand off the heavy-lifting to an unelected, regulatory body to implement. This happens all the time, and is done to both allow these legislators to keep their hands clean, and to make it much more difficult for the common folk to fight the onslaught of insane regulations that precipitate from the statues.
 

seminolewind

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I need to refresh on the wording on the regulations. Because maybe there's a loop hole in their description in what they've listed. And from any component of an egig. I just wonder how many parts that are not derived from tobacco can be regulated as well when their common use is not only directed at vaping . I also wonder if intent can be used, since
based on how many items have regulations based on intent.

In cigarettes, did the paper and filter have to undergo the same testing? How about the packaging? How about the carton?
 

Endor

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I need to refresh on the wording on the regulations. Because maybe there's a loop hole in their description in what they've listed. And from any component of an egig. I just wonder how many parts that are not derived from tobacco can be regulated as well when their common use is not only directed at vaping . I also wonder if intent can be used, since
based on how many items have regulations based on intent.
I believe this is part of the arguments being made, as the regs definitely include components and parts.
In cigarettes, did the paper and filter have to undergo the same testing? How about the packaging? How about the carton?
My understanding is the answer is yes, when a change to one of those components is made. Remember that cigarettes were grandfathered in, so no pre-market tobacco applications (PMTAs) were never filed for cigarettes (as they were being sold) back in 2009. If a cigarette manufacturer wants to make changes to the filter, or paper, and I believe even packaging, there is either a Substantial Equivalence pathway -or- a full-blown PMTA needs to be filed.
 

Lessifer

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I believe this is part of the arguments being made, as the regs definitely include components and parts.

My understanding is the answer is yes, when a change to one of those components is made. Remember that cigarettes were grandfathered in, so no pre-market tobacco applications (PMTAs) were never filed for cigarettes (as they were being sold) back in 2009. If a cigarette manufacturer wants to make changes to the filter, or paper, and I believe even packaging, there is either a Substantial Equivalence pathway -or- a full-blown PMTA needs to be filed.
Absolutely if a tobacco company makes a change to the paper or filter, it sparks a SE application. Even RYO tubes and filters are subject to the same regulations. The BIG difference is that they have access to the Substantial Equivalence pathway, whereas vapor products do not.
 

seminolewind

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Listening to all this court talk, and the judge referring to us as "yahoos", and that we are whining about a few that vape 0 nicotine, that bias is already there. Instead of talking about yahoo motivation, she should stick to the laws that were not used correctly.

Sometimes I just wish we were under the radar, and no BT or FDA could say anything, and we could do our thing, and not have unwanted uneducated input , and just see how BT's profits dry up and there's no one there to squash. Because we will be not seen and not heard. It would actually be to our advantage to be this "ghost" who is taking their business away and they have no control over it. I like that better. We can't win doing things the right way. I am to the point of saying &%&( it.

Did anyone hear of someone called "swamp fox" during the Revolutionary war? Instead of lining up on battlefields and pick eachother off, the swamp fox had a group of renegades that were taking care of things the good ole American way. Not seen not heard, and beating the English. Learned from the American Indians. Take 'em by surprise and disappear once again. Ambush. Like ghosts. Even like the slave underground railroad.

So no matter what this court decision is, I think it goes to the supreme court at some point, but not winning this battle is probably a favor to us. It would be fun to watch BT go down the tubes and not be able to see who's doing it. They will not win.

Protecting a corporation that kill thousands a year, and being allowed to call non tobacco derived items "tobacco derived" is insane. If the FDA can get away with calling a blue apple red and making it a regulation, and people look the other way, I would prefer to remove myself from the situation entirely.

Like Blackhawk said , I have spent too many smokes in the rain and cold, and directed to a particular area, taken a 10 minute break for a 3 minute cigarette, and threatened that smoking in my car is a crime, and basically treated like a second hand citizen when I've done what the whiners wanted me to do and stopped smoking, but there's a bigger war to stay a nonsmoker. Some pat on the back.

I'll support those of us who retail vaping products. But at some point it's just me and my vaping within a group of vapers. You can label vaping tobacco derived, which is a blatant lie, because we have spent years becoming tobacco free. I am insulted when I've worked too hard to be tobacco free. I use a nicotine delivery device to be tobacco free.
 
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r055co

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Listening to all this court talk, and the judge referring to us as "yahoos", and that we are whining about a few that vape 0 nicotine, that bias is already there. Instead of talking about yahoo motivation, she should stick to the laws that were not used correctly.

Sometimes I just wish we were under the radar, and no BT or FDA could say anything, and we could do our thing, and not have unwanted uneducated input , and just see how BT's profits dry up and there's no one there to squash. Because we will be not seen and not heard. It would actually be to our advantage to be this "ghost" who is taking their business away and they have no control over it. I like that better. We can't win doing things the right way. I am to the point of saying &%&( it.

Did anyone hear of someone called "swamp fox" during the Revolutionary war? Instead of lining up on battlefields and pick eachother off, the swamp fox had a group of renegades that were taking care of things the good ole American way. Not seen not heard, and beating the English. Learned from the American Indians. Take 'em by surprise and disappear once again. Ambush. Like ghosts. Even like the slave underground railroad.

So no matter what this court decision is, I think it goes to the supreme court at some point, but not winning this battle is probably a favor to us. It would be fun to watch BT go down the tubes and not be able to see who's doing it. They will not win.

Protecting a corporation that kill thousands a year, and being allowed to call non tobacco derived items "tobacco derived" is insane. If the FDA can get away with calling a blue apple red and making it a regulation, and people look the other way, I would prefer to remove myself from the situation entirely.

Like Blackhawk said , I have spent too many smokes in the rain and cold, and directed to a particular area, taken a 10 minute break for a 3 minute cigarette, and threatened that smoking in my car is a crime, and basically treated like a second hand citizen when I've done what the whiners wanted me to do and stopped smoking, but there's a bigger war to stay a nonsmoker. Some pat on the back.

I'll support those of us who retail vaping products. But at some point it's just me and my vaping within a group of vapers. You can label vaping tobacco derived, which is a blatant lie, because we have spent years becoming tobacco free. I am insulted when I've worked too hard to be tobacco free. I use a nicotine delivery device to be tobacco free.
Big Tobacco definitely has a dog in the race, but the big player pushing to kill Vaping is Big Pharma. They are the Puppet Master pulling the strings in the FDA.

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