New FDA regulations and effect on DIY?
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I believe you're right in your conclusion and thanks for the remarks (def is drawn from FD&C Act). Nicotine cannot be used as a standalone end product for vaping (direct human consumption). Nor is FDA given authority to regulate it directly. FDA establishes no foundation for nicotine being the object of the regulations despite referencing it endlessly everywhere as tobacco. So two things here: The inferred general equivalency of nicotine and tobacco (irrespective of its form); and issuing from this unestablished proposition, the correlation of tobacco and "derived" products as equivalent. To what, in end effect? The control of nicotine.
I don't see FDA easily restricting nic sales without seriously compounding the burden of litigation already before it and to come. It's central though to a discussion of our opposition relying upon the unfettered legal use of this commodity.
Really hope there will be a congressional review and adoption of the deeming rule held at bay. Far more powerful and compels our further attention and engagement over the false security of any mitigating amendments. Meantime passive civil resistance and non-compliance alongside legal efforts are the two pronged approach that can make this unpalatable and not profitable to government. Conformance and compromise will only exacerbate our problems and those of industry moving forward.
Thx @dethnode. Good luck all.
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I believe you're right in your conclusion and thanks for the remarks (def is drawn from FD&C Act). Nicotine cannot be used as a standalone end product for vaping (direct human consumption). Nor is FDA given authority to regulate it directly. FDA establishes no foundation for nicotine being the object of the regulations despite referencing it endlessly everywhere as tobacco. So two things here: The inferred general equivalency of nicotine and tobacco (irrespective of its form); and issuing from this unestablished proposition, the correlation of tobacco and "derived" products as equivalent. To what, in end effect? The control of nicotine.
I don't see FDA easily restricting nic sales without seriously compounding the burden of litigation already before it and to come. It's central though to a discussion of our opposition relying upon the unfettered legal use of this commodity.
Really hope there will be a congressional review and adoption of the deeming rule held at bay. Far more powerful and compels our further attention and engagement over the false security of any mitigating amendments. Meantime passive civil resistance and non-compliance alongside legal efforts are the two pronged approach that can make this unpalatable and not profitable to government. Conformance and compromise will only exacerbate our problems and those of industry moving forward.
Thx @dethnode. Good luck all.
One Question:
Does the FDA have the Legal Authority to Regulate Products, meant for Human Consumption, if the Product in question has a Constituent Component that was Derived from Tobacco Plants?
My concern here is — do they have the authority to regulate nicotine?
I think your question is too broad in its implications. Context matters, i.e. history.
Allowing the FDA to dictate that anything having nicotine is tobacco is absurd and irresponsible. If that's the net effect in legal terms then those provisions of the FD&C are a failure. We all know the original intent was to control the cigco's unless you've been in a cave for decades. So I would think that "derived" was intended to be interpreted as how it would necessarily be construed in the context of working leaf tobacco for cigarettes. For purposes of that delivery device, a rolled cigarette. I don't see explicitly anything else.
Now literally, that is the question I see is before us. — Can the FDA compel an interpretation of derivative and derivative use. I don't think that was Congress' intention either. So FDA would have us dispense with the purpose of the statute which is always essential to the understanding of the language to one so broadly encompassing that anything can be considered tobacco. Remove the intent of legislation and yeah we can end up in a circular discussion.
Is that what you're driving at. It's intentional, that we get there chasing our tails.
Good luck.
My concern here is — do they have the authority to regulate nicotine?
I think your question is too broad in its implications. Context matters, i.e. history.
Allowing the FDA to dictate that anything having nicotine is tobacco is absurd and irresponsible. If that's the net effect in legal terms then those provisions of the FD&C are a failure. We all know the original intent was to control the cigco's unless you've been in a cave for decades. So I would think that "derived" was intended to be interpreted as how it would necessarily be construed in the context of working leaf tobacco for cigarettes. For purposes of that delivery device, a rolled cigarette. I don't see explicitly anything else.
Now literally, that is the question I see is before us. — Can the FDA compel an interpretation of derivative and derivative use. I don't think that was Congress' intention either. So FDA would have us dispense with the purpose of the statute which is always essential to the understanding of the language to one so broadly encompassing that anything can be considered tobacco. Remove the intent of legislation and yeah we can end up in a circular discussion.
Is that what you're driving at. It's intentional, that we get there chasing our tails.
Good luck.
I'll take your Answer to be a Definite Maybe.
And I'll give you a Specific Answer to the Question you Asked...
"do they have the authority to regulate nicotine?"
If the Nicotine is Derived from Tobacco, and if the Intended Use of the Nicotine is "Recreational", then Yes... I believe they Do.
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I'll take your Answer to be a Definite Maybe.
And I'll give you a Specific Answer to the Question you Asked...
"do they have the authority to regulate nicotine?"
If the Nicotine is Derived from Tobacco, and if the Intended Use of the Nicotine is "Recreational", then Yes... I believe they Do.
OT specifically of concern to DIY is where they draw the correlation of nic to tobacco. But my query is more detailed as to where might the authority be drawn to regulate nicotine specifically. Nic isn't derived at all from tobacco for human consumption generally speaking. And it's regulated now as incidental to tobacco production. It's an integral component. Separated from tobacco by process it's a distinctively different article as unequivocally understood, not by virtue of rhetoric or "rules" but by the marketplace. I would like to know upon what will they likely draw for authority if they attempt to ban it for vaping in isolation (which they haven't). They seek to control it by seizing the authority to regulate anything and everything that it might be put into. They characterize all these elements as tobacco to gain the authority to do so in the same manner as they do with tobacco. It's a convoluted, contorted and irrationally circular form of reasoning to avoid calling a spade a spade when it comes to vaping.
So I think we also agree, maybe. Yes they can adhere to a literal interpretation of intent. However, it would not be correct as is proving to be the case for their profound expansion upon the legislative purpose, in my opinion. So yeah, I think we both agree they're scum.
They can't call it a drug. Could call it a food and have some purview over the matter and it's handling. But they very well haven't become The Food, Drug and Vaping Administration by any act of Congress I've seen which distinguishes organic nicotine as a product under their exclusive control.
If my layman's legal reasoning here is out in left field, let me know where I'm goin' wrong. Most of the discussion on this subject I've seen is so closely focused on the commercial resale interest and its obligations to FDA that the fundamental individual right which is elemental to commerce (both buy and sell) isn't even in the frame.
Come Aug 8 I expect to be able to acquire nicotine that meets my spec from any technically qualified producer that sells to any or all alternative use markets without the FDA putting its hands in my business. And it's Congress' job to make sure if they do, have damned good reasons for doing it and the appropriate unambiguous authority. It's not their business to put a hand in my pocket.
The most important right at the end of the day that we have z in my estimation, in every way as important as election is the vote we make with our wallet. That's what's really being messed with here in no uncertain fashion.
Good luck z.
JMO, but I think it Kinda Is. LOL
Because I'm not sure what the Nicotine you are using was Derived from? But the Nicotine that I am using was Derived from Tobacco Plants.
The Hardware Issue and the Issue of 0mg and whether or Not a Coil can be Regulated, that all good Fodder for Lawyers to get Rich on Arguing it.
But I just don't think there are Any Legal issues with the FDA Regulating a e-Liquid that contain Nicotine that was Derived from Tobacco Plants. And every (affordable) Nicotine Base is an e-Liquid that contains Nicotine that was Derived from Tobacco Plants.
Nicotine was not "derived" from tobacco for purposes of any tobacco legislation I've read going back to the 90's. This expression and implication of it being a derived product being analogous to tobacco is seen to apply to a contemporary application. Not in play at the time the legislation was enacted. Yes again, you are right in a literal sense. But not in a contextual one. This matters in law I've often been reminded. Need to wrap up here.
If you're right and the literal interpretation applies everything made from or containing nicotine should be considered tobacco as they are analogous and indistinct commodities.
A “covered tobacco product” is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco. — A random FDA consumer response letter.
What's happened is the FDA has authored no definition whatsoever. Rather an amorphous regulatory shopping basket it can throw anything into by referencing nicotine.
How about some clarity, "…anything used to contain or deliver nicotine for human consumption." Why didn't they do that?
So yeah, again we agree so much fodder for the attorneys to argue over. And I don't see a delegation of authority to regulate nicotine from Congress. Does the rule rise to that level. That's my question. Not about the generic definition of derived. Obviously other's may agree and we'll see from their eventual filings.
Like I said the conundrum remains as we are not curtailed from purchasing it. It's our right.
Good luck.
p.s. Thx z for all your replies. Gotta go. Just sharing some thoughts on the contradictions here and my concern for the average user's access to this essential good.
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Our right?
Yeah the gummit can do pretty much what it wants. I can't even buy a six pack of beer on Sunday.
Yeah the gummit can do pretty much what it wants. I can't even buy a six pack of beer on Sunday.
Yeah, I guess we've been lucky they haven't ...... on our parade 'till now. Sad really. You get no argument from me. Minimalist gov I say. Good luck.
Nicotine was not "derived" from tobacco for purposes of any tobacco legislation I've read going back to the 90's. This expression and implication of it being a derived product being analogous to tobacco is seen to apply to a contemporary application. Not in play at the time the legislation was enacted. Yes again, you are right in a literal sense. But not in a contextual one. This matters in law I've often been reminded. Need to wrap up here.
If you're right and the literal interpretation applies everything made from or containing nicotine should be considered tobacco as they are analogous and indistinct commodities.
A “covered tobacco product” is any newly deemed tobacco product, but excludes any component or part that is not made or derived from tobacco. — A random FDA consumer response letter.
What's happened is the FDA has authored no definition whatsoever. Rather an amorphous regulatory shopping basket it can throw anything into by referencing nicotine.
How about some clarity, "…anything used to contain or deliver nicotine for human consumption." Why didn't they do that?
So yeah, again we agree so much fodder for the attorneys to argue over. And I don't see a delegation of authority to regulate nicotine from Congress. Does the rule rise to that level. That's my question. Not about the generic definition of derived. Obviously other's may agree and we'll see from their eventual filings.
Like I said the conundrum remains as we are not curtailed from purchasing it. It's our right.
Good luck.
p.s. Thx z for all your replies. Gotta go. Just sharing some thoughts on the contradictions here and my concern for the average user's access to this essential good.
I dunno what to tell you Mac.
Seems like a Lot of Dancing is being done around the word "Derived".
Perhaps the Best thing for you to do is Read what Judge Richard J. Leon wrote in his ruling on SMOKING EVERYWHER Inc. vs. The Food and Drug Administration, January 14th, 2010.
https://www.gpo.gov/fdsys/pkg/USCOURTS-dcd-1_09-cv-00771/pdf/USCOURTS-dcd-1_09-cv-00771-0.pdf
Because it is the Foundation of what we are seeing Today with the FDA's actions.
But then my Friends figure it out and stop by on Saturday.Simple work-around: Buy two on Saturday.
Again no beer Sunday
The FDA deeming document specifically mentions "liquid nicotine" separately from finished e-liquid, so it's my understanding that nic base will be regulated as well.
The FDA cannot rule all products containing nicotine as tobacco products - otherwise, nicotine replacement products such as patches, gums and lozenges would then cease to be cessation aids and be regulated as tobacco products instead.
The deeming rule is contradictory in places, and intentionally vague in others, so that the FDA can interpret it as they see fit.
BOOM!
The FDA cannot rule all products containing nicotine as tobacco products - otherwise, nicotine replacement products such as patches, gums and lozenges would then cease to be cessation aids and be regulated as tobacco products instead.
The deeming rule is contradictory in places, and intentionally vague in others, so that the FDA can interpret it as they see fit.
BOOM!
I'll take your Answer to be a Definite Maybe.
And I'll give you a Specific Answer to the Question you Asked...
"do they have the authority to regulate nicotine?"
If the Nicotine is Derived from Tobacco, and if the Intended Use of the Nicotine is "Recreational", then Yes... I believe they Do.
Too specific, I think z. I pose the question at all because of the FDA's broad and unrestricted application of their legislated role as in Soettera. I'm asking what is the real limit.
If Congress granted the FDA the authority to regulate the canned meatball and spaghetti industry, does this then give them the power to regulate every alternative utilization of meat?
Is this the demonstrable intent of the legislature? I believe the question is relevant.
To my view just because the legislature did not qualify all potentialities the what is of a tobacco product this does not necessarily infer an unbounded authority of the FDA to do so. If it does, it may be legal but unlawful. Not my question though.
If nicotine is first extracted from tobacco and in context not being utilized for the purpose and specific industry of rolled paper tobacco products which intrinsically include nicotine, does this then give the FDA the power to broadly regulate nicotine in all its permutations and applications? Under which act?
To hold the premise that the FDA has been granted this broad reach and that the context does not pose a restriction, then to me it's a real problem for our law and courts. Never mind that NJoy held the same view as the FDA that nicotine only products are "tobacco products" in Soettera. That was a narrow issue before the court with FDA again applying authority it did not have. But it is their belief that I'm trying to validate as impartially as possible. Soeterra didn't solve our problems. It protected the commercial interests of importers. Nor does it explain much. It just limited the FDA's application of rules it applies elsewhere where they have a contextual jurisdiction (over a drug, health benefit claim).
Maybe the FDA is right. They can regulate meat.
The question is open for anyone that has a clear understanding. I think exceptions are there.
Good luck all.
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Yes, and if they did that would be clear. However, in doing so, defining tobacco as necessarily containing nicotine all else might be excluded, as you note. This would also affect other classifications such as drugs. Then too, the precise definition would have to be articulated. If nicotine then was absent in the form as defined the very classification might be inapplicable.
Which is the position I hold, we do not have a clear distinguishing definition. Yet the definition is ultimately what we are fighting about.
Good luck.
Too specific, I think z. I pose the question at all because of the FDA's broad and unrestricted application of their legislated role as in Soettera. I'm asking what is the real limit.
If Congress granted the FDA the authority to regulate the canned meatball and spaghetti industry, does this then give them the power to regulate every alternative utilization of meat?
Is this the demonstrable intent of the legislature? I believe the question is relevant.
To my view just because the legislature did not qualify all potentialities the what is of a tobacco product this does not necessarily infer an unbounded authority of the FDA to do so. If it does, it may be legal but unlawful. Not my question though.
If nicotine is first extracted from tobacco and in context not being utilized for the purpose and specific industry of rolled paper tobacco products which intrinsically include nicotine, does this then give the FDA the power to broadly regulate nicotine in all its permutations and applications? Under which act?
To hold the premise that the FDA has been granted this broad reach and that the context does not pose a restriction, then to me it's a real problem for our law and courts. Never mind that NJoy held the same view as the FDA that nicotine only products are "tobacco products" in Soettera. That was a narrow issue before the court with FDA again applying authority it did not have. But it is their belief that I'm trying to validate as impartially as possible. Soeterra didn't solve our problems. It protected the commercial interests of importers. Nor does it explain much. It just limited the FDA's application of rules it applies elsewhere where they have a contextual jurisdiction (over a drug, health benefit claim).
Maybe the FDA is right. They can regulate meat.
The question is open for anyone that has a clear understanding. I think exceptions are there.
Good luck all.
Like I said, I just Don't know where you are going with All This?
Or even the Specific Question(s) you say you would like Answers/Input on?
If I understand it correctly, there may be a concern that we'll need to import our meat from China to avoid regulation
Senate Oversight Committee Chairman Ron Johnson is going to give an Interview Tonight to discuss the FDA and e-Cigarettes.
Senator Ron Johnson (@SenRonJohnson) | Twitter
Please pass it Along to people who might Not have heard about it.
Senator Ron Johnson (@SenRonJohnson) | Twitter
Please pass it Along to people who might Not have heard about it.
Think my last post gave a good example of why the FDA's over-reach is based upon blank license. I don't believe "derived from tobacco" gives the FDA the authority to write an open-ended definition of tobacco without spelling out what nicotine is. The latter is supposedly why it's so essential for them to regulate tobacco. What we're all objecting to even as the issue is not being framed that way. To question the legitimacy of the FDA's authority in the first place.
I have no problem with the FDA regulating if duly authorized. I do with Congress extending such extremes of flexibility to an appointed committee.
Things are unclear to people I feel because they have no idea what the underlying principle or mechanism is that's thwarting them. So no, I don't think the phrase was ever intended to mean the FDA's present construction. Yet it's remained the unchallenged prevalent usage in definition. And I find that rather odd given the FDA's such emphatic reliance upon it.
Nicotine absolutely is tobacco…in the context of combustion of tobacco leaf based products. Alone it also is what it is, an alkaloid molecule. But the latter is not tobacco. At least I don't think a reasonable person would so figure. They are as dissimilar as a vitamin C tablet and an apple receiving different treatment under the law and by definition.
A clear definition of both tobacco and nicotine which would serve to qualify the scope not established by Congress with respect to the FDA's role and reach could be a start to answering the question…does FDA have an unqualified power to regulate nicotine?
If they do and are intent on destroying an independent e-cig industry then not a single PMTA will be approved for nic makers in this market.
Our right to purchase will be gone, not considered.
That's my concern and why I frame the proposition this way. The present state of the code, case law, and regulation conflate the two commodities which are distinct in fact as in the marketplace.
Accordingly, why now that FDA's intractability is evident we're now starting to walk back on FDA deeming and thinking e-cigs are better viewed as a distinct market commodity if there's to be further legislation. But will that solve the problem of itself. No. Not as long as the perspective of any future laws fail to disentangle the associations between the plant and the molecule. Why? Because vaping is not the combustion of tobacco and could never have been foreseen to be the same.
They are controlling the convo z. And language is the primary weapon they use against us. So yeah, the uncontested "derived from" is the knife we have stuck in our back.
The FDA's role traditionally has been limited to an informative role for the consumer insofar as organics are concerned. Setting labeling and packaging requirements, for example. I don't have a problem with that as you likely don't either. But extensions of power like this are a hazard to the public's well being as we are seeing in favor of powerful commercial interests.
My question was not rhetorical. I do want to know if somewhere along the line the FDA wasn't actually granted direct control of nic in some obscure passage or ruling. I'd like to believe the FDA acts in some way ethically. And I'm no expert on this agency.
Thx for the comebacks and effort to appreciate my POV.
Good luck.
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