Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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I'd stick up for either Sun or Kristen.
There are many things to be sorted out, and the more discussion the better.
I thought "reduced harm" was referring to the activity of smoking/vaping.
If you substitute meat in your diet with tofu, the tofu is not considered a "meat product".
It is still my opinion that if e-cigs become classified as "tobacco products" it will effectively ban e-cigs for the vast majority of the public since it will be illegal to mail these tobacco products.
Shipments of any tobacco-related products will still be seized at the docks. However, this time it will be the ATF doing it, and there will be NO way to fight back. Instead, you could be facing charges and needing to look for a good defense lawyer.
Once e-cigs become tobacco products it will take years of fighting to have it considered for reduced harm status. And during that time, tobacco bans, taxes, and city/state/federal restrictions will make them too expensive, reduce the allowed types of flavors, and turn them into an unsavory alternative to smoking when compared to ineffective NRTs.
Also, the only people that have the resources to push the continued existence of this product (and only if they choose to) would now be the vaper's number one nemisis. Big Tobacco.
Classifying them as a tobacco product will effectively hand e-cigs right into the open arms of BT.
For a little while we would also still have the kiosk centers. But we all know how aweful those products are.
It is my opinion that getting it classified as a tobacco product will kill all of the aspects that make e-cigs so attractive as an alternative smoking device to new users (and kill it far faster than any of the anti's could have ever dreamed possible).
Whereas pushing to have it classified as a drug or reduced-harm product will (at the worst) only restrict the nicotine aspects. Hardware and 0-nic liquids would be under no such restrictions since battery holders and the non-nicotine ingredients contained in liquid can be legally sold in America. Only the nicotine would be subject to the possibility of restrictive measures.
I have to defend Sun also. IMO he has done a great job in keeping us informed as to what is happening in the legal battle. If there is something going on that he doesn't want to tell us about, I am sure there is a good reason.
You don't send a copy of your battle plans to the enemy.
You don't send a copy of your battle plans to the enemy.
Sun, are you referring to the "wolf pack" that I read about a couple months ago?
That's an interesting analogy but it falls apart because tofu is not made with an ingredient from meat. It would be more like substituting the coffee you drink with a caffeinated (or caffeine free) coffee flavored hot beverage--you know, something that was designed to look and taste just like coffee and provide the same physical effect (if caffeinated) without the toxins and carcinogens found in "the real thing"
YouTube - Denis Leary - Coffee
Well you know what they say about opinions... Everybody has one, but some are just wrong. The PACT act applies only to the specified products and e-cigarettes aren't specified--it doesn't matter if they are classified as tobacco or not.
Probably, but in the meantime, the FDA won't be able to have them banned or require the nicotine level to be reduced to zero. If they are not classified as a tobacco product, the FDA could completely ban their sale until they are proven to be "safe" in absolute terms rather than just safeR than cigarettes in relative terms AND proven to be effective as a smoking cessation device.
Tobacco bans? There is no such thing and congress has specifically told the FDA they can't ban tobacco--but the FDA can ban products containing nicotine that aren't tobacco products. Taxes? When a product is um, legal, it is subject to being taxed. I'm afraid you'll have to live with that because that's how things work in the real world. However, as Bill Godshall pointed out, most (if not all) states do not have a standing tax on tobacco products in general but rather tax specific tobacco products (which is some stores in some states sell "mini-cigars" that are cheaper than cigarettes because they aren't taxed the same).
Turn them into an unsavory alternative when compared to NRT's? Dude, NRT's make analogs seem savory. 8-o Ain't nothing they can do to e-cigs to make them unsavory compared to NRTs.
When did Big Tobacco become the nemesis? Tobacco companies aren't calling for the bans of e-cigarettes--tobacco companies want to sell them, actually.
In case you hadn't noticed, it is the pharmaceutical companies like GlaxoSmithKline and Pfizer (makers of Nicotrol/Nicoderm/Nicorette and Chantix) who line the pockets of the FDA and anti-smoking prohibitionist nazis like John Banzhaf. (ASH Introduction)
It is my opinion that getting it classified as a tobacco product will kill all of the bans that make e-cigs so much more difficult to purchase than other smoke-free tobacco products as an alternative to smoking cigarettes that kill people.
That is just plain wrong. The FDA has expressed its full intention to regulate e-cigarettes as a drug which means they will not allow them to be SOLD at all unless and until they undergo years of research to prove that they are effective as a smoking cessation device and then only by prescription...and the FDA would be able to require the nicotine levels to be reduced to zero if they want, whereas they are specifically not allowed by law to require zero nicotine in tobacco.
Please excuse and correct me if I'm wrong but isn't the "reduced harm" risk product a part of the HR1256 tobacco bill as it applies to a "safer" tobacco product? Thus to be a "reduced harm" tobacco product...the PV must first be classified as a tobacco product.
Or are we abandoning this avenue and for what...exactly?
Or are we abandoning this avenue and for what...exactly?
Let's not forget the FDA's intent to label PV's a drug-delivery device combo - which would effectively block importation of your gear, too, as an adulterated product.
I have a question about that statement. How can they force the e-cigarette to zero nic and still declare that it is an NRT device. They banned drug paraphernalia such as pipes and bongs years ago and you see today how well that worked out. You sell the hardware as a personal vaporizer with flavored PG and you have a novelty item in my humble opinion. Its not a food and not a drug so how does the FDA get involved? Just curious.
That was the only thing I was saying he was being cryptic about, for pete's sake.
Sun is an official advisor to CASAA and being on the CASAA board of directors myself, I would think that an upcoming event with suppliers, that may completely change the course of action and would have a huge impact on what CASAA advocates and supports, would be something that he would want to share with us, rather than having us undermine whatever they want to do. At the very least, confidentially and off the forum.
If you notice, I've been on these forums for over 7 months and been active in this thread and I am very active in fighting to keep vaping legal.
I've thanked Sun several times for keeping this thread updated.
No need to stick up for Sun, he can take care of himself.
Please get all of the facts before chastizing someone.
Your posts are "cryptic" because you aren't naming names and not saying exactly what they are doing. That would be what cryptic means.
It's stupid of these suppliers to not at least give CASAA a heads up as to their intended action. For all intents and purposes, CASAA is working AGAINST them right now, because we don't know they exist and we don't know their game plan. They could be using CASAA's resources to pave the way for them instead of fighting for what you (and obviously they) feel is a lost cause!
The Amicus Brief is a completely different situation and there was no CASAA, Vapers International or Vapers Coalition at that time. As a matter of fact, key players of that Amicus Brief are members of the Vapers Coalition.
I implore you to have the leaders of this supplier group contact us and let us know what is going on and how we can help.
Reduced harm would apply to tofu in your scenario if tofu was also considered harmful.
"Reduced harm" means that the product is similar to the dangerous product, may carry it's own risks, yet the risks are considerably less than the product it's intended to replace.
Your opinion is wrong about mailing ecigs. Sorry. Read the PACT Act. It only applies to specific tobacco products and ecigs are NOT on the list. It would take an act of congress to get them added.
Have you read ANYTHING about this topic?
The FDA WANTS it to be classified as a drug, effectively BANNING it immediately. Then it'll take years and millions of dollars to get it approved.
As a tobacco product, it will at least stay available for us to use, it'll take a couple of years for the FDA to get standards established and give us time to prove it's reduced harm value.
Taxes are NOTHING. I've made this point several times:
A cigarette is 35 cents. A nicotine inhaler cartridge is $1.05.
Even with the taxes, ecigs will be CHEAPER AS TOBACCO PRODUCTS than if they get in the hands of the drug companies!!
EDITED to add: Sorry, Thad, I missed your post before posting this. You already covered everything!
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I have a question about that statement. How can they force the e-cigarette to zero nic and still declare that it is an NRT device. They banned drug paraphernalia such as pipes and bongs years ago and you see today how well that worked out. You sell the hardware as a personal vaporizer with flavored PG and you have a novelty item in my humble opinion. Its not a food and not a drug so how does the FDA get involved? Just curious.
The FDA's argument is that e-cigs are "obviously" a smoking cessation device--which they would continue to be even if the nicotine is removed. As a device intended "to affect the structure or function of the body" the FDA insists it has medical value and must be regulated as such.
Read here for an example of what the FDA does with "devices": FDAReview.org, a project of The Independent Institute
Propylene glycol is also a substance under the FDA's regulation. There is no proof that constant, longer term inhalation of PG is 100% safe.I have a question about that statement. How can they force the e-cigarette to zero nic and still declare that it is an NRT device. They banned drug paraphernalia such as pipes and bongs years ago and you see today how well that worked out. You sell the hardware as a personal vaporizer with flavored PG and you have a novelty item in my humble opinion. Its not a food and not a drug so how does the FDA get involved? Just curious.
Chancse are they would not enforce 0 nic, but as a tobacco product, they are literally not allowed to force 0 nic.
They have not forced tobacco to reduce nicotine levels and therefore, would have a difficult time arguing for ecig nicotine levels that are less than tobacco, as it's commonly known that nicotine is one of the safest ingredients in tobacco!
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Kristin,
What sounds a little "cryptic" IMO is statments about what and when the FDA will do certain things.
You state as a fact that:
Have you talked to any officals from the FDA? Have you personally sat down and met with people that promulgate FDA rules and regulations? I have and that is not what I am hearing.
Another thing you might want to revisit, and I will repeat it again:
What makes you think that if the E-cig is ruled a "tobacco" product, that the FDA can still not mandate an Approval process that is tantamount to a de-facto ban. We are not talking about a ban, which they could not do, but rather having an Approval process for saftey and licensure which would take the e-cig off the market until complied with.
And then again we have those regulations. Not the regulations about flavoring, but nicotine content and "regulated consumer dosing". IMO, the FDA e-cig will not look like what we all use now. I will reiterate again, that most people need a high dose of nicotine to start with. Absent that, the e-cig will be reduced to nothing more then a "legal regulated failure".
So be careful for what you wish for I guess is the best way to put it.
Sun
What sounds a little "cryptic" IMO is statments about what and when the FDA will do certain things.
You state as a fact that:
Have you talked to any officals from the FDA? Have you personally sat down and met with people that promulgate FDA rules and regulations? I have and that is not what I am hearing.
Another thing you might want to revisit, and I will repeat it again:
What makes you think that if the E-cig is ruled a "tobacco" product, that the FDA can still not mandate an Approval process that is tantamount to a de-facto ban. We are not talking about a ban, which they could not do, but rather having an Approval process for saftey and licensure which would take the e-cig off the market until complied with.
And then again we have those regulations. Not the regulations about flavoring, but nicotine content and "regulated consumer dosing". IMO, the FDA e-cig will not look like what we all use now. I will reiterate again, that most people need a high dose of nicotine to start with. Absent that, the e-cig will be reduced to nothing more then a "legal regulated failure".
So be careful for what you wish for I guess is the best way to put it.
Sun
Thulium--good point, but remember that the FDA can "insist" all they want until a Court tells them otherwise.
The E-cigs intended use is to deliver nicotine for recreational purposes with no theraputic endpoint or claim. Hard sell to a Court that this constitutes and meets the legal definition of being a "drug" the FDA can regulate. Although you never know what a Court is going to do, at least you give it a go if you think you have a good faith argument that the FDA is acting outside of its scope and overreaching.
Sun
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The different standards for regulation of drugs/devices that the FDA has in place allow them to seize imports of unregulated drugs and they can be made illegal to sell without the FDA approval that will undoubtedly take years to accomplish. Tobacco products, on the other hand, have been specifically exempted from the FDA's import and sales restrictions.
Yes, the FDA can require tobacco companies to comply with various regulations and they could theoretically revoke the license from companies unwilling to comply (but no one would expect that to happen to Philip Morris, would we?)...but tobacco products will remain on the market in the intervening time between now and whenever the FDA actually makes tobacco regulations. On the other hand, the FDA can remove unapproved drugs from the market until they are approved.
There was not even any active ingredient in that thing! It was 2 pieces of plastic and some lubricant, yet the FDA was seizing the product from doctors 3 years after they were submitted for FDA approval.
I could see it being possible for e-cigs to survive without being legally defined as a tobacco product. In other countries like the UK, it seems possible that the e-cig might be okay in the hands of the medical regulators because they have adopted a harm reduction stance. In the United States, however, it is my considered opinion that the FDA is absolutely not suited to regulate the e-cig as a drug/device combo without first undergoing comprehensive reform, and the 450,000+ people who will die each year it takes for the FDA to figure out how to make e-cigs as ineffective as an NRT should not be made to wait.
I wish the companies you hint are submitting e-cigs to the FDA for approval all the best of luck and I honestly hope they are allowed to start selling their products soon. That doesn't make Judge Leon's ruling that e-cigs are NOT a drug device any less critical to the future of e-cigs. Therefore, I am not convinced that SE would have been better off trying to go through the FDA first, but I would be happy to be proven wrong.
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Thulium--Check around, make some calls, meet with some people that make the FDA work. Many of them are independent contractors or are advisors to the FDA.
You will find that the general consensus is that if the "tobacco" theory was going to work for e-cigs, then the FDA is going to make a laundry list of what can and can not be done, including limiting nic levels drastically and having a license and Approval process. Further they are going to seek safety standards of the nicotine liquid in the cartridges. Almost the same safety standards and licenses that Big Tobacco has to comply with. The device must be approved as well in both design and content.
So this is not going to play out, where the Court rules it is a "tobacco" product and everyone goes on their merry way. To the contrary, it is going to be a long drawn out regulatory process very difficult for the little Suppliers to comply with that will IMO cause a de-facto ban with an end result of an E-cig that is, for all intensive purposes useless.
That is not the e-cig that most of us are looking for IMO.
Sun
You will find that the general consensus is that if the "tobacco" theory was going to work for e-cigs, then the FDA is going to make a laundry list of what can and can not be done, including limiting nic levels drastically and having a license and Approval process. Further they are going to seek safety standards of the nicotine liquid in the cartridges. Almost the same safety standards and licenses that Big Tobacco has to comply with. The device must be approved as well in both design and content.
So this is not going to play out, where the Court rules it is a "tobacco" product and everyone goes on their merry way. To the contrary, it is going to be a long drawn out regulatory process very difficult for the little Suppliers to comply with that will IMO cause a de-facto ban with an end result of an E-cig that is, for all intensive purposes useless.
That is not the e-cig that most of us are looking for IMO.
Sun
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