Deeming Regulations have been released!!!!
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Exactly. We all know how sampling works in vape shops but the FDA and its lawyers either haven't bothered to find out or are lying about it. In any case, the brief misrepresents how most sampling takes place and is quite misleading.
I read quite a bit of the paper but not all, and the FDA comes across as the Big Dog with the Big Stick, like how dare Nicopure question their authority. In my opinion this sucks!
Yes they implied it in the document quite often.
They also misrepresent testing demonstrating harmful chemicals, and in an interesting turn, they note that BT makes most of the e cigs on the market, and so they evoke "would you trust BT to tell the truth about safety given their history?". Never mind Nicopure has nothing to do with BT e cigs, but they cast the aspersion anyway.
Besides, they still know better, so there.
Most of their discussion doesn't even discuss sampling in vapeshops. They are more likely talking about free handouts at vape shows, conventions and festivals, as this analogy makes clear :
Moreover, it is common sense that in crowded public spaces like stadiums and concert halls, where employees distributing samples (often young adults themselves) face “a dozen or more outstretched arms waiting (or grabbing) for samples,” minors can easily access the products by taking a sample themselves, “recruit[ing] an adult to obtain the sample on their behalf,” or by picking up a sample someone else has discarded. Inst. Med. Rpt. (1994) at 217 (AR 18,580). Thus, the free sample ban furthers the government’s interests by eliminating a
tried-and-true means by which minors have accessed harmful and addictive products.
The better analogy for sampling in vapeshops, is what the FDA themselves hinted at ( and which they say the R2B/Nicopure brief did not even respond to ):
Finally, Plaintiffs have no response to the FDA’s justified conclusion that the careful limitations on the amount of smokeless tobacco permitted for free samples at qualified adult-only facilities could not feasibly be applied to e-cigarettes. See 81 Fed. Reg. at 29,003. Thus, as the Sixth Circuit held, banning free samples “embodies a narrow fit between the harm articulated and the restriction employed.” Discount Tobacco, 674 F.3d at 541.
Why the " careful limitations ... could not feasibly be applied to e-cigarettes " is not made clear. I can't see any reason myself.
I don't have time to go back and check, but i am certain they made the point at least once, that the ecig market, just like the cigarette market, is dominated by BT. They didn't cite any sale numbers or studies to show this, they just threw it out there. Now, it's clear that the cigalike market is dominated by BT ( it didn't take them long to push non-BT brands to the periphery ), but that's only a portion of the industry. I have no clue what percentage of the market BT has if we were to include all types of vaping in the formula. Unfortunately there aren't any reliable numbers for the size of the open-system market.
They also tried to portray the PMTA process as not burdensome as manufacturers could use published data to support their products, as well as establishing a master file for ingredients. The implication is that if you use those ingredients, the FDA will allow their use, which is quite the opposite from their position to date. It almost makes you feel like the FDA insinuates doesn't understand why everyone is upset as they're making it so easy to market products.
It's true BT does hold a commanding share of the market, but as it's not BT filing this lawsuit, it's again a tad misleading to suggest the plaintiffs shouldn't be trusted because BT fooled them before. Why should Nicopure be painted the same as unsavory BT, and the judge shouldn't trust their arguments?
This makes it sound like just one drop of nic juice coming in touch with a minor will turn them into hard core addicts???
I see your point, but the regs were not written for Halo specifically. It's true that Halo is one of the plaintiffs in this case, but to be fair, they can't write one set of regs for BT, and another set for non-BT vendors in the market. Besides, the BT history of lying, is just a side point, one to make them look like the good guys, and the ecig industry as the bad guys. Their main point is, and always has been, that congress has put the burden on the industry to prove these products are safe, not on the FDA to prove they aren't.
That's what all the public service messages have said. Look at all those government paid billboards on the dark and secrecy danger of vaping claim that we've seen photos posted of here over the last months.
It is a side point, but a very nasty aspersion across an industry because of what BT did with cigarettes. These are not cigarettes, so past behavior should not be used to impeach an effectively new industry.
The more i think about it, the real hurdle we need to clear is the TCA, not the FDA deemings. The minute we were "deemed", we were " doomed ".
Unfortunately i am less optimistic now, after reading the FDA cross-motion twice, than i was before
If we are successfully deemed, we are truly doomed...it might take a hundred years to right this terrible injustice.The more i think about it, the real hurdle we need to clear is the TCA, not the FDA deemings. The minute we were "deemed", we were " doomed ".
Unfortunately i am less optimistic now, after reading the FDA cross-motion twice, than i was before
The only weak point in your argument I can find is we are now using tobacco products.Not exactly but close.
Your question is very appropo. I have no idea why the vaping industry seems to want to be an island unto itself. Read my foxhole theory below. Purists are always at a disadvantage but never seem to learn.
IMHO vapers would do well to look around them and become knowledgeable about other spheres of influence, instead of being myopic.
1) Cig companies are not the same as cigar and pipe tobacco companies, they all have different wants and needs. i kinda considered them all "tobacco" but that was when I was a vaping purist. See below about that.
2) What cigarette companies have, and what cigar and pipe tobacco companies will NOW have, (and that the ecig industry won't have) is---- user fees. Altria wanted to reduce theirs, so they supported putting cigars under deeming regulation and submitted that in a docket to the FDA. (The FDA does have to have a budget that pays for the cost of tobacco regulation and research and has a set amount it needs to raise from tobacco companies......via user fees.)
That doesn't apply to ecigs since we are not in a category that the FDA can apply user fees to. (cigars, pipe tobacco, cigarettes, snuff, chewing tobacco and roll-your-own tobacco). This is the law and they already know this.
Cigars and pipe tobacco were previously unregulated so they didn't pay user fees. Now that they do, they will kick in $65 million of the $635 million the FDA needs, thus reducing the amount ALTRIA has to pay in user fees.
All these documents are out on the internet including the one Altria submitted to the FDA asking for cigars to be included in deeming.)
The only $$ the FDA gets directly is user fees. (Everything else associated with the cost of implementing regulations is not paid to the FDA.)
3) So of course the cigar and pipe tobacco industries WANT the exemption/grandfather/predicate dates changed. And so do we.
Obviously, Altria does not.
We can't help BT out with user fees so they really did not pick on us, they picked on the cigar and pipe tobacco sectors.
4) The lack of joining hands on some issues by the vaping community sometimes baffles me.
As Mazinny implied, if you think the cole bishop amendment got put into the appropriations bill by some vaping lobby, think again.
Yet, it seems that few vapers even know anything about the powerful industries that DID get it in there.
Just like back in 2011-2012, when the ecig industry wasn't making a centralized trade org and having their own lobby group so they could have some power, now they are not going to reach across to other sectors that are experiencing the same regulatory crisis....?
why? .....because well, you know, "we aren't tobacco!" .........which makes very little difference now, and a stupid point to stand on because that horse left the barn already......... because the FDA has and did regulate us as a "tobacco product". !!!!
Go ahead and keep standing on that.......the vaping industry seems always to want to become an island unto itself, but purists aren't winning anything here.......(they never do.......esp. if they don't have power behind them, big lobby groups, and a kick .... team who have cell phone numbers of legislators on auto dial)
4) If I were in a foxhole, I would not want the equivalent of a purist in the hole w/me. I would want somebody who wants the same things I want......in the immediate future........and who had the weapons and resources to make things happen.......so that we could BOTH SURVIVE. Survive to "live another day" ....
Getting things done is all about making the right "friends" who have similar goals, it doesn't mean you have to "be them" or "be like them." Some people here on this forum (and apparently many vendors as well) seem to live in a somewhat antiseptic purist world of agreement but one which lacks connection to other players.
You keep making everyone an enemy........all you end up with are a lot of enemies.
Not vapor products. Hence we are surly covered under the interpretation governing user
fee's. Even if I am totally wrong about this what interpretation do you think that the FDA
and, Gov. et al will use?
Regards
Mike
This has been one of my objections all along. We know it is not smoking by educating ourselves and by actual use of the product. The FDA hasn't bothered to look into the differences between vaping and smoking. It looks like smoking to them and that is all they see. But....isn't that what attracted us to vaping in the first place and why this invention is such genius? We all know that education is key to winning this battle.
I truly hope it doesn't take that long. I would love to see the egg on the faces of the FDA and all the haters.
What I'm talking about with the "other" pen is that the pen nor the ingredients come in contact with any tobacco or tobacco derived product. So it can't rule that as a "tobacco" product? If someone has an atomizer and a battery, and vapes 0 nicotine, there is no tobacco whatso ever, so the FDA has their rule include "intent".
In their brief, the FDA refers to vaping liquid as having toxins and carcinogens. Where is their documentation?
I read the whole brief quickly, and it appeared to me that while Nicopure's brief made specific statements and had documentation to back it up, the FDA acted like it meant nothing. However all their statements have not been backed up by studies. It appears to be backed up by heresay and opinion. If they had a valid study, they would have to admit that a million people have given up smoking for vaping. And those facts can also be gotten by BT if they'll share. The brief makes a lot of circles, and the FDA should not be making statements without some proof to back it up. It's unfair to state that vape liquid contains toxins and carcinogins. Their briefs are full of falling back on past rulings rather than addressing the facts, and throwing their weight around like "how dare you".
On one of my above posts, what I was trying to say was altered. Sooo, the FDA had actually amended the wording of the definition of a tobacco product to include all the components, etc, etc. I guess they can get away with that too.
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Which really is wrong, if more evidence is discovered after the original filing it should be considered. JMHO which is not how it goes.
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