Deeming Regulations have been released!!!!
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I don't believe so. I believe that the only things which can be used is that which was used originally.
Bea,
I'll try to simplify. You're coming in at the middle of the legal process. The FDA supposedly did their research to write the deemings, Nicopure sued, the FDA responded to the suit, Nicopure submitted a rebuttal and the FDA just responded to the rebuttal. Now the judge is to review the submissions. All the evidence is limited to what was in the FDA deeming which Nicopure challenged in the suit. Oral arguments in the case are in October I think.
WH
I'll try to simplify. You're coming in at the middle of the legal process. The FDA supposedly did their research to write the deemings, Nicopure sued, the FDA responded to the suit, Nicopure submitted a rebuttal and the FDA just responded to the rebuttal. Now the judge is to review the submissions. All the evidence is limited to what was in the FDA deeming which Nicopure challenged in the suit. Oral arguments in the case are in October I think.
WH
It's unclear, the FDA official says, if [Other Stuff] "vape pens" that look and function like e-cigarettes would be covered by the new regulations. "The FDA does not have regulatory authority over products to be used in conjunction with [Other Stuff]," he says."If it doesn't meet the ['made or derived from tobacco'] statutory definition of 'tobacco product' we would not have that authority. If it meets the definition of a tobacco product, we have authority to regulate it only as a tobacco product."
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Was amended to this:
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
[*101] Sec. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT
(a) Definition of Tobacco Products.--Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321) is amended by adding at the end the following:
"(rr) (1) The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
It's interesting how definitions get "amended" when they need to change the meanings to those that the FDA needs.
[removed]
Was amended to this:
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
[*101] Sec. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT
(a) Definition of Tobacco Products.--Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321) is amended by adding at the end the following:
"(rr) (1) The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
It's interesting how definitions get "amended" when they need to change the meanings to those that the FDA needs.
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i
Thanks for explaining but you didn't have to. I'm not "coming in at the middle of the legal process". I have followed it from the start. And if Nicopure didn't submit those convincing pieces of evidence, IMO they should have.
The FDA is determined to regulate everything it possibly can. It wants to regulate products which aren't made or derived from tobacco as "components" or "parts" of tobacco products. In order to do that, the FDA has stated that it will look at the "intended use" of the component or part.
Nicopure's brief argues that the Tobacco Control Act doesn't leave room for the FDA to determine whether or not something is subject to regulation based on its intended use. Rather (it argues), the statutory definition of a tobacco product is based entirely on the physical make up of the product.
The confusion lies in bad draftsmanship. It's a cardinal rule that the definition of a term should not include the term being defined. That creates a definition that circles back on itself. E.g.: "Human" means an animal with human parents, or "dialectical materialism" means materialism that involves dialectic. The FDA is trying to make the problem go away by injecting "intent" into the definition.
Nicopure's lawyers understand that they can't simply brush aside "component or part" as meaningless. Congress will not be presumed to have added meaningless words or surplus language to a statute and the courts will always assume that Congress meant something and try to figure it out. (Granted, that's sometimes a dubious assumption). So Nicopure argues that "component or part" means something which is physically attached to a tobacco product, like a filter, cigarette paper or a cigalike cartridge with e-juice in it. You and others here have now read the FDA's counter to that argument and I'm curious to know how persuasive you think it is.
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The judge would not have allowed it. Period. I've written a number of earlier posts on this subject here and in other threads. Evidence which isn't in the administrative record is not admissible. We saw that when CASAA asked permission to file an amicus brief based on a survey which wasn't in the administrative record. The judge refused to allow it.
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@bigdancehawk thank you so much for following this case so closely and sharing your thoughts and expertise with us. It's really helpful coming from a lawyer.
Edit: thank you. I've read every post in this thread. Sorry I didn't get it.
Edit: thank you. I've read every post in this thread. Sorry I didn't get it.
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I'm glad you find it's helpful, even though I seem to always be saying you can't do this and you can't do that. ETA: There are some twists in these kinds of cases that are hard to understand, much less accept. I should be a little more patient with non-lawyers, and not even most lawyers are familiar with this area of the law.
In terms of what evidence can be presented, I know it's terribly frustrating to hear that Nicopure's hands are tied behind its back by the applicable rules. The Court's hands are tied too, as this process is subject to the Federal Administrative Review Act, which precludes new evidence in cases of this kind and places narrow limits on the scope of the court's review. I share your frustration, I wish the judge could have seen the film, and I think it's time to make some statutory revisions, starting with the FSPTCA and then on to the Administrative Review Act.
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I've been trying to dig my way through the reply, I get more and more depressed with each page.
How many man hours do you think it will take to compare all of the cited cases and other references in this document?
I count 50 cited cases, 16 statutes, four regulations, and seven other references. Most of the cases will be fairly long and the Calif. Law Review article alone is 52 pages long.* I'm guessing a careful analysis of the cited authorities would take 18-25 hours for a fast reader. I'm talking about a lawyer with a solid background in regulatory law.
*The law review article LINK is interesting and IMO doesn't support the FDA's position. The FDA cites it to support what it claims is their "break-even" approach. But the break-even approach requires an accurate assessment of the costs. A break-even analysis is one where you ask how great would the benefits have to be in order to justify the costs. The FDA pays lip service to the concept but that's not what they actually did. I don't see where the FDA has done that sort of analysis. Take a look at the article beginning with p. 1387 where some hypothetical examples are given. Do any of those resemble what the FDA did?
The FDA hasn't been known for following the rules regardless of what they're trying to do. It was obvious in 2009 when they were spanked by the courts, and it's obvious now with some of the "we know best, just ignore the lawsuit" comments in their replies. It's apparent that they're far too big for their britches and they're in desperate need of being taken out back behind the wood shed.
(Although I'd prefer a good old fashioned "come to Jesus meeting" myself.)
(Although I'd prefer a good old fashioned "come to Jesus meeting" myself.)
This is what happens when Congress delegates broad legislative powers to administrative agencies and places severe limitations on judicial review. Congress should know by now that agencies are by nature inclined to extend their power to the max, try to control everything in sight, to justify their existence, to expand their staffs and increase their budgets. Rule making powers granted to these agencies should be quite limited and narrowly defined.
Deontological ethics , can this be questioned in the FDA's deeming?
There are a few points made by the FDA that don't make a lot of sense to me, and I'm not sure where they were covered in the admin. record. I get the feeling FDA did all of their research from the www and didn't actually go somewhere in person to see what really happens.
Free samples/sampling at a vape shop: FDA makes it sound like you go into the shop and get some free liquid to put in your pocket to take home with you. Tasting liquid is more like going to an alcohol store and getting to taste the different beverages on offer. If wine tasting isn't an issue in many locations, why is taste testing an issue at the local vape shop? Taking a couple of hits at the local store isn't really going to be enough to create an addict, and if you don't spend any money, the shop will likely 86 your hiney in short order. If you have to be old enough to walk in the door, you wouldn't have wee baby chilluns turning into addicts on taste samples. If they have checked my ID at the time I purchase something, why is it an issue to gift me a few ml of something to try?
The give-aways I'm aware of by the BT cigalike firms were done at events where it appeared they had set up a guest tent and were offering their wares to adults that attended the event and went to the tent. These events were rock concert/music festivals, motor sports, etc. They may have been attended by young adults, but I doubt that many children were unsupervised at these places. It wasn't Chuck E. Cheeze for sure. From the photos I've seen of the events, there appeared to be a gatekeeper from the business minding the door, and I assume checking ID's. I would expect that there were other tents offering other adult products as well. The open retail sections at the events usually have the souvenirs and other items that might appeal to kids, but they are not going to be set up in the same way as the adult products.
There will always be issues with juveniles attempting to get adults to go purchase restricted items for them. It is not unique to vaping, and is a local matter for local authorities to police the bad actors.
I also used to get to trade points for free swag with the product name on it. The items themselves were not something intended or appealing to children, and there were no cute little animals or disgusting dromedaries on the items.
I can't remember seeing everything in the original record, but was there ever any evidence of these things included in the record? If they are not able to show real examples of misbehavior by the vaping industry, how can they claim these things have happened? BT did that kind of stuff in the last century, but I haven't seen that kind of activity in the vaping community in general.
The other thing that really bothers me is that the FDA is mandating misleading/false information on the product labels. Any other commodity is required to have labels with accurate warning and content information or they are in violation of regulations for that product. Deliberately misrepresenting the product is a violation. Where does the FDA get off thinking that they are above the laws of other agencies?
Free samples/sampling at a vape shop: FDA makes it sound like you go into the shop and get some free liquid to put in your pocket to take home with you. Tasting liquid is more like going to an alcohol store and getting to taste the different beverages on offer. If wine tasting isn't an issue in many locations, why is taste testing an issue at the local vape shop? Taking a couple of hits at the local store isn't really going to be enough to create an addict, and if you don't spend any money, the shop will likely 86 your hiney in short order. If you have to be old enough to walk in the door, you wouldn't have wee baby chilluns turning into addicts on taste samples. If they have checked my ID at the time I purchase something, why is it an issue to gift me a few ml of something to try?
The give-aways I'm aware of by the BT cigalike firms were done at events where it appeared they had set up a guest tent and were offering their wares to adults that attended the event and went to the tent. These events were rock concert/music festivals, motor sports, etc. They may have been attended by young adults, but I doubt that many children were unsupervised at these places. It wasn't Chuck E. Cheeze for sure. From the photos I've seen of the events, there appeared to be a gatekeeper from the business minding the door, and I assume checking ID's. I would expect that there were other tents offering other adult products as well. The open retail sections at the events usually have the souvenirs and other items that might appeal to kids, but they are not going to be set up in the same way as the adult products.
There will always be issues with juveniles attempting to get adults to go purchase restricted items for them. It is not unique to vaping, and is a local matter for local authorities to police the bad actors.
I also used to get to trade points for free swag with the product name on it. The items themselves were not something intended or appealing to children, and there were no cute little animals or disgusting dromedaries on the items.
I can't remember seeing everything in the original record, but was there ever any evidence of these things included in the record? If they are not able to show real examples of misbehavior by the vaping industry, how can they claim these things have happened? BT did that kind of stuff in the last century, but I haven't seen that kind of activity in the vaping community in general.
The other thing that really bothers me is that the FDA is mandating misleading/false information on the product labels. Any other commodity is required to have labels with accurate warning and content information or they are in violation of regulations for that product. Deliberately misrepresenting the product is a violation. Where does the FDA get off thinking that they are above the laws of other agencies?
Nope, not at all. More than likely the FDA used older evaluations of BT and just threw some numbers out there.(maybe based on percentages or guessing). Probably hoping the razzle, dazzle double speak would make people back off. And possibly used as a segue way for setting a precedent for future taxation.
Yeah, well, thank God young boys out of high school, whose parents aren't rich enough to send them to college, aren't forced to go die for some other people on foreign soil against their will anymore. That's just plain bull.
I joined the military VOLUNTARILY for patriotic reasons but would've burned a draft card. No one forced anyone to fight in the 1st American Revolution. You're not fighting for freedom when you are forced to do it.
Thank you.
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.
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