Cole-Bishop Failed. What now for vape?

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Rossum

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Didn't Soetera resolve that FDA auth only applied to nic as a drug if a therapeutic claim attached?
That's not the way I read it. The way I read it is that it only applies to tobacco products if a therapeutic claim was attached. See emphasis below:

"Though Brown & Williamson is not crystal clear, we think the better reading is that the FDA lacks FDCA drug/device authority to regulate all tobacco products marketed without claims of therapeutic effect, i.e., as customarily marketed."

"In the absence of an authoritative agency interpretation, I conclude that, unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act.

The whole argument is that synthetic nic is not derived from tobacco, and thus not a tobacco product, right? What does that make it?
 
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zoiDman

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The whole argument is that synthetic nic is not derived from tobacco, and thus not a tobacco product, right? What does that make it?

Something that would Not fall under the Protections of the Recreational Use of Tobacco?
 

MacTechVpr

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That's not the way I read it. The way I read it is that it only applies to tobacco products if a therapeutic claim was attached…
The whole argument is that synthetic nic is not derived from tobacco, and thus not a tobacco product, right? What does that make it?

Yes, we agree on synthetic nic potentially falling into a (therapeutic) drug classification.

The two references you mention being undifferentiated and interchangeable for purposes of this decision (as noted by the acknowledgement, my 2nd cite) would mean that we agree. Sottera sees tobacco and nicotine derived from tobacco as the same object. And tobacco may not be regulated as a drug.

Do recall reading an analysis of the footnotes suggesting that the FDA accordingly could move to itself interpret derived nic a drug or something to this effect since Sottera seems to suggest such a discretionary latitude exists.

Perhaps that is a bridge too far and so we are left with a consequent deeming regulation just as onerous as if tab nic had been classified (a drug). In some ways perhaps all the more as we remain stigmatized by the anti-social characteristics and accrued adverse implications of the association.

And I still don't know what derived means.

Good luck. :)
 
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go_player

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I think the FDA already has sweeping powers to regulate drugs, and I doubt anyone make a successful argument that nicotine isn't a drug. Remember that the only reason the FDA wasn't able to ban vaping back in 2009-2010 is that Judge Leon told 'em something to the effect of, "Since it's made from tobacco, the most you can do is regulate it as tobacco." But that ruling (which has protected vaping for the last 6 or so years) wouldn't apply to synthetic nicotine.

This is partially what I was getting at. Even if it has protected vaping this seems perverse to me. It's one thing to distinguish between a chemical naturally occurring in a plant, land a purer derivation of that chemical, like nicotine in tobacco or caffeine in coffee (a distinction the FDA does make, I believe, in the case of caffeine.) It's another to distinguish between two essentially identical chemicals (pedantry aside I'm not aware of any important distinctions between synthetic and naturally derived nicotine.) Doing so makes very little sense to me, though I suppose the law is not always required to make sense.

Beyond that I think Congress has delegated or allowed to be delegated too much authority to the Executive, and particularly to regulatory agencies. It's a difficult question- it's not as if Congress can decide every detail of our very, and IMHO excessively complicated regulatory regime. But on matters of importance I don't think Congress should be able to avoid accountability by simply delegating much of what should be their responsibility. I'd like checks on their authority as well, of course, but perhaps I'm one of those libertarian wing-nuts.

At any rate, public opinion does matter, and even if the association of nicotine with tobacco has been legally useful in some ways, I think it is likely to be harmful in the long run, because I can't see tobacco ever again being widely viewed favorably in the US.
 

go_player

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That's not the way I read it. The way I read it is that it only applies to tobacco products if a therapeutic claim was attached.

I just read through the decision (admittedly pretty quickly.) It is clear that the classification of nicotine as a tobacco product is central to the line of argument in _this decision_, since that was enough to allow the ruling. Also worth noting that this ruling just granted preliminary injunctive relief. It didn't definitively establish a limit on the FDA's authority. It just said that there was a good enough chance the plaintiffs would win in the end that the FDA was going to have to wait for the legal process to play out before impounding their stuff.
 

DaveP

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Well, Trump seems to be on a firing streak in DC, so who knows, it could turn out to be good on the end.

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At least Trump appointed Gottlieb to FDA chief and he's been approved. Gottlieb has history as a vaping supporter. He was a partner in a company that operated vaping lounges and sold vaping hardware and juice. He had to sell his shares before becoming FDA chief. Gottlieb is also a Libertarian.

That, and Trump is intent on knocking down unnecessary regulation across the country.
 

vvvv

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IMO, the government cares less about kids forming vaping habits or "long" term health issues because they already have these problems from tobacco use. Converting the habit from tobacco/analog to ecig doesn't solve that problem and creates a problem of decreasing tax revenue, as vaping is much cheaper and the government gets less direct dollars from vaping than analogs, especially in countries outside the US where tobacco products are highly highly taxed.

In Canada, at least in my province, a typical premium pack of cigarettes ranges from $CAD 12-14, which would be around $8-10 USD. That means they earn about $6-8 tax dollars per pack sold in Canada.

These regulatory hurdles imo, mainly is to buy time for the big tobacco industries to figure out ways to develop and market products in the e-cig field. We can see how many have failed with the gas station "ecigs" so they realized this isn't an effective method of sale.

Until Phillip Morris and the like, develop their own ecig products that can have the same market influence as analog cigarettes, the regulations won't be clear cut and stable. The government wants to maintain the tax revenue from this source and they won't be able to maintain it with 3rd party resellers of vaping equipment that is only charged the sales tax instead of a "tobacco" or rather a "health adverse" tax.

Instead of classifying ecigs as a tobacco product or not, they want enough evidence to slap a "health adverse" tax on it, blaming the ecig habit on higher health care expense to justify the tax. If they classify it as a tobacco product it just makes it easier to maintain their tax revenue. However, they have realized it is legally hard to classify it as a "tobacco" product, so they will figure out another label to slap on it to generate a tax rate similar to analogs.
 

jseah

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If it's something people want, tax it to death. If it's something they can't make money on, outlaw it.

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It has always been the way for government to attempt to alter behaviors. The previous mayor of NYC was well known for that. He banned the use of transfats, he tried to ban the sale of soda in quantities larger than 16 oz to combat obesity because of the sugar (it was thrown out by the court), and he also tried to pass a snack tax that would impose an extra "obesity" tax on snacks like candy, chips and soft drinks (that never got passed by the city council because it would hurt low income families more).
 

zoiDman

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The sky IS falling.
Everyone who hasn't stocked up, please look at the way this is going and do something about it - remove yourself from the equation by stocking up.

That is Great. And I would say that Most of the ECF Members who read that have already done so.

But for Me, this Fight is for the 95% of Vapers who don't use e-Cigarette Forums. Many of whom have No Clue what is Going on.

Either at the Federal Level. Or in their Own State.
 

Rossum

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The sky IS falling.
Everyone who hasn't stocked up, please look at the way this is going and do something about it - remove yourself from the equation by stocking up.
I'm fully stocked. !#Ω#!

I would encourage everyone else reading this to be in the same position.

However, I think the sky is not falling as hard or as fast as it once was. Even if nothing at all is done to change the regs, I do not think the current administration is likely to put much of a priority on enforcing them.
 
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