I really don't think we are asking the right questions. Is mankind good for this planet?
Sheeple don't revolt. they are, instead, lead to slaughter.
Sheeple don't revolt. they are, instead, lead to slaughter.
FDA Big news coming out of FDA
- Thread starter Oliver
- Start date
- th_trl_thread_readers 0
- Status
It's hard to revolt now. Back in the 70s before technology and social media, it was a lot easier. But you catch a record now and you're screwed if your revolt fails. Even your car ins is affected by your criminal record. It's a crappy time to start a rebellion. I'd leave the country before I revolted lol.. You guys can fix it and maybe I'll retire here. Depends on if social security still existsI really don't think we are asking the right questions. Is mankind good for this planet?
Sheeple don't revolt. they are, instead, lead to slaughter.
It's easier to shoot down something when you narrow down the definition of that something to only contain negatives and uncertainties.
First you change the definition to a negative. Then you wait till The People demand protection from it. Good ol' Hegelian Maneuver.
This is part of a strategy fought on many fronts. It's not the end game.
I think the proposal is more a reaction to companies like nutricigs...
If there is one thing this is not - it's a reaction. This is being proactive and pulling at every available string - and clawing at the fabrics (read: definitions) til new strings come loose. You have a lot to learn about politics.
Many of us have been touting vaping as a "stop smoking aid" or "nicotine replacement" which it seems according to the FDA places our stuff under the 'medical' arm of their regulations.
Do local, regional, state and feds tax drugs? (while possible, surely not at the same level as tobacco and booze products (IE: "sin taxes")
It would seem to me that any juice sold at retail for 'vaping' would have to have a FDA seal of approval as well as a bunch of labeling requirements.
Do local, regional, state and feds tax drugs? (while possible, surely not at the same level as tobacco and booze products (IE: "sin taxes")
It would seem to me that any juice sold at retail for 'vaping' would have to have a FDA seal of approval as well as a bunch of labeling requirements.
Here is some thing I came across recently.
http://tobaccoanalysis.blogspot.com/2015/08/us-district-court-decision-may-cast.html
How does this affect the FDA's proposal?
Regards
mike
It certain seems to me that the FDA is getting ready to clamp down on ELiquid manufacturers and sellers, by shoring up its semantic framework in an effort to draw in ELiquid under the umbrella of "Drug" regulations........and if this is true, i think it might be a good idea for some of our favorite juice companies to take a look at the Compounding Pharmacy industry and how it effectively handles the FDA and avoids being deemed as "Drug Manufacturing". The short version is this: FDA already regulates and oversees the manufacturing of all of the constituents (base drugs, carrier compounds, etc...), and a Compounding Pharmacy is simply "mixing" them -- or better: "creating a delivery system for them". Plus (and this is very important), Compounding Pharmacies are self-regulating. They have a national association whose membership requires strict adherence to laboratory and product testing standards. Moral: The FDA likes it when you do their job for them.
The FDA already regulates nicotine, PG, VG and flavorings and I know that many juice companies have indeed become quite proactive, using certain ISO laboratory standards for their mixing facilities. But I think as far as the FDA is concerned, this is not enough. You need an external regulatory body (governance) and an external testing lab.
The FDA already regulates nicotine, PG, VG and flavorings and I know that many juice companies have indeed become quite proactive, using certain ISO laboratory standards for their mixing facilities. But I think as far as the FDA is concerned, this is not enough. You need an external regulatory body (governance) and an external testing lab.
1. FDA does not regulates nicotine, PG, VG, PG. Granted, it sets standards for USP classification, but it is in our (vapers) benefit. It does regulate flavorings as food additives. At least some benefit for vapers.
2. It makes no sense to FDA to regulate eliquids as drugs. Not financial sense, nor political.
3. I am awaiting that vaping stuff will be equated to smoking stuff and taxed correspondingly.
There is hope. There is legal precedent in place to keep us out from under the thumb of the FDA.
The Supreme Court struck down the 1996 rule in Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), holding that FDA lacked jurisdiction over tobacco products “as customarily marketed.” The Court found that Congress intended to exclude tobacco products from FDA’s jurisdiction. In Brown & Williamson, the Court determined that tobacco products could not be made safe and effective for their intended uses, and therefore, FDA would have to remove them from the market, but that Congress had foreclosed such action (529 U.S. at 135-139). The Court also observed that Congress, in enacting statutes to regulate the labeling and advertising of conventional tobacco products, such as cigarettes and smokeless tobacco, had “effectively ratified FDA’s long-held position” that the Agency lacked jurisdiction to regulate tobacco products “absent claims of therapeutic benefit by the manufacturer” (529 U.S. at 144).
In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, plaintiffs sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those 10 products into the United States. 3 Between the filing of the lawsuit and a decision on the motion for a preliminary injunction, Congress passed the Tobacco Control Act and the President signed it into law. The District Court subsequently granted a preliminary injunction, relying on Brown & Williamson and the recently enacted Tobacco Control Act (Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010))
But from what I gleen, the FDA IS trying to label e-cigs as a medical device and regulate it as such. If that is the case, then, with a prescription from a doctor, all of our e-cig related purchases become a tax write-off as a "medical expense" and could be exempt from any "sin taxes" the government tries to impose on them.
The Supreme Court struck down the 1996 rule in Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), holding that FDA lacked jurisdiction over tobacco products “as customarily marketed.” The Court found that Congress intended to exclude tobacco products from FDA’s jurisdiction. In Brown & Williamson, the Court determined that tobacco products could not be made safe and effective for their intended uses, and therefore, FDA would have to remove them from the market, but that Congress had foreclosed such action (529 U.S. at 135-139). The Court also observed that Congress, in enacting statutes to regulate the labeling and advertising of conventional tobacco products, such as cigarettes and smokeless tobacco, had “effectively ratified FDA’s long-held position” that the Agency lacked jurisdiction to regulate tobacco products “absent claims of therapeutic benefit by the manufacturer” (529 U.S. at 144).
In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, plaintiffs sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those 10 products into the United States. 3 Between the filing of the lawsuit and a decision on the motion for a preliminary injunction, Congress passed the Tobacco Control Act and the President signed it into law. The District Court subsequently granted a preliminary injunction, relying on Brown & Williamson and the recently enacted Tobacco Control Act (Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010))
But from what I gleen, the FDA IS trying to label e-cigs as a medical device and regulate it as such. If that is the case, then, with a prescription from a doctor, all of our e-cig related purchases become a tax write-off as a "medical expense" and could be exempt from any "sin taxes" the government tries to impose on them.
uuhhmmm some how I don't think the health care system is going to let that one fly... lol and I am sure that uncle sam will make sure he gets his as well...
but hey... we can dream... lololol
For example, claims related to satisfaction, pleasure, enjoyment, and refreshment have been recognized as euphemisms for the delivery of a pharmacologically active dose of nicotine. While these claims relate to effects on the structure or function of the body, FDA does not consider these tobacco satisfaction and enjoyment claims to fall within its drug and device regulatory authority. Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product--such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”--to fall within its drug and device authority; however, we invite comment on this.
So... As long as e-cig makers and retailers don't market them as a "stop smoking" aid and instead say that they are an "alternative" with the same effects, they are not a medical device according to current law.
So... As long as e-cig makers and retailers don't market them as a "stop smoking" aid and instead say that they are an "alternative" with the same effects, they are not a medical device according to current law.
Maybe I am off point on this... But wouldn't the A.T.F. (alcohol tobacco and Firearms) be the ones to deal/govern/stick their nose in this matter? Not the FDA?
not that I know that much on this, but didn't the FDA try a few times to pull tobacco under their banner, and the courts slapped their hand and thus partly how/why ATF is the "guy"?
not that I know that much on this, but didn't the FDA try a few times to pull tobacco under their banner, and the courts slapped their hand and thus partly how/why ATF is the "guy"?
Last edited:
Why wouldn't you just go to underground market for product? That would also be reasonable way to revolt, in that no one would be physically harmed.
Kids for sure will be, if not already are, getting product from underground market. If DIY is at all a possibility, then underground market will be booming. But even if DIY is impossible (which I find highly unlikely), underground market will be viable.
IMO, FDA has the uphill battle to fight here. Cause once states and/or feds move to regulations, an underground market will emerge. It will be less popular as long as legal market is fairly priced, easily accessible. And immensely popular if/when legal market is unfairly priced and less accessible. Plus FDA (and states) will be fighting court battles by those that refuse to go to an underground market. And if states and feds overplay their hand, we stand very good chance of average non-vaping person suddenly supporting us, in similar way that 'other stuff' has popular support because everyone knows it is tamer than what feds have it designated as.
I wonder why we tout them this way. I quit smoking vaping, how about you?
It's all so very laughable, cigarettes kill you. This is a known variable. Vaping saves lives, this is a known variable yet let's regulate it out of existence because it 'may' not be deemed fully safe in some configurations some day.
We as users can say anything we want about our personal experiences with ecigarettes, I have always and will always say they can get you off cigarettes.
Claiming nicotine replacement is dubious, it's not nicotine that's very addictive in cigarettes. It's freebase nicotine created by chemically boosting with ammonia, a HIGHLY addictive chemical in its own right..more so than nicotine.
I posted my comments. Was pleased to see the P. Busardo also posted...apparently right before I did.
- Status
Similar threads
- Locked
- Locked
