So in everybody's most informed opinion(thus far) how long do we all think we have before we can no longer order nic base online?
New FDA regulations and effect on DIY?
- Thread starter rastapete69
- Start date
- th_trl_thread_readers 0
- Status
Just curious to those who know. I read most of the new reg's. Guess I must have missed it. But where is the specific language citing that nicotine itself is tobacco?
Good luck all.
Good luck all.
It is used in vaping therefore it is a tobacco product.Just curious to those who know. I read most of the new reg's. Guess I must have missed it. But where is the specific language citing that nicotine itself is tobacco?
Good luck all.
If I were an honest judge, I would indeed allow the FDA to classify anything that contained nicotine that's derived from tobacco as a tobacco product -- but not hardware or zero-nic liquids. I'm hoping there are some honest judges out there still.
Just curious to those who know. I read most of the new reg's. Guess I must have missed it. But where is the specific language citing that nicotine itself is tobacco?
Good luck all.
I don't think there is Any wordage in the FDA's Deeming that states that Nicotine is Tobacco.
That would seem to be a Conflicting Definition of Nicotine.
I fully agree with that. However it is not the way things are currently written up.
As it currently stands anything intended to be used in the process of vaping is a tobacco product.
My understanding of the SCOTUS ruling the FDA is proscribed from banning nicotine as far back as Brown & Williamson (1999). Why I'm asking if it is specifically deemed. Good luck.
Yes, I'm aware of this. But like I said, I'm really hoping that there are still some honest judges out there that won't let them get away with such double-speak.
Something I find particularly egregious is the FDA's demand that zero-nic liquids be labeled, "This product is made from tobacco." This requires manufacturers to make patently false claims! Last I looked, PG, VG, and most food flavorings were NOT made from tobacco! I do not see how any reasonably fair, honest court could let that stand.
The FDA was prohibited from banning nicotine as a DRUG. But not as a vaping ingredient....
And it is not officially banned it just must be approved.
And it is not officially banned it just must be approved.
I don't see how that Requirement can Possibly be Upheld by Any Court.
But hey, I Never thought I would be Able to Quit Smoking. So Stranger Things can Happen.
Rob you're right of course. But putting aside all the legal speculation as to whether such an interpretative assumption could or might be enforced…The question remains as to the language that specifically cites nicotine in and of itself as a deemed tobacco end product. Where is the bedrock foundational statement which equates nicotine to tobacco within these rules or authorizing legislation? Could anyone speak to this? Good luck.
Last edited:
This way they can get you both ways. They can force you to put "THIS PRODUCT IS MADE FROM TOBACCO" on a bottle of VG in order to make it legal to sell, and then they can bust you for false advertising. You've just got to learn to think like a politician (not something I'd wish on my worst enemy).
This way they can get you both ways. They can force you to put "THIS PRODUCT IS MADE FROM TOBACCO" on a bottle of VG in order to make it legal to sell, and then they can bust you for false advertising. You've just got to learn to think like a politician (not something I'd wish on my worst enemy).
I'd say that once you conform to their definition in any manner then you're bound by it. The minute you so label a product you subject yourself to the regulation…is somehow the way I'd see an attorney explain it. You're signing on to the FDA's characterization and are bound to it (as nonsensical and fraudulent as it might actually be). I'd prolly also expect them to say something like…the onus then is on you to disprove the violation…whereas, it might rest upon the FDA to prove that what you have is actually tobacco otherwise. It's a damned if you do and damned if you don't situation with these regulations. You're right there. Either way you need an attorney. I'm just a smart-$$$ whose read the UCC here and there.
Good luck.
Every regulatory agency is always going to do their very best to increase their power and influence. It's called politics. That, I believe, is the primary reason the FDA "deemed" everything they could think of as a tobacco product.
I'm not sure what their expectations are. They may think that lobbying from the pharmaceutical and tobacco interests will come through for them. Many people in the FDA probably truly believe that it's their holy crusade to protect the people from what they see as a health threat, whether the people want their "protection" or not.
The only way the FDA can regulate vaping products is if they're deemed to be tobacco products, placing them in the same category as cigarettes. The regulations for tobacco products are already in place, they're just looking to extend those regulations to as many products as possible. They can't really pick and choose which regulations apply to specific tobacco products.
Hopefully they don't get away with it. Congress has already ordered them to provide better justification, there's the possibility that the grandfather date will get moved, and they're gonna have a hard time proving their case in the courts. Specifically, the argument that they're unconstitutionally limiting free speech is quite a strong case. As I said before, they may be expecting that lobbying and influence from pharma and tobacco will be enough to push things their way.
BOOM!
I'm not sure what their expectations are. They may think that lobbying from the pharmaceutical and tobacco interests will come through for them. Many people in the FDA probably truly believe that it's their holy crusade to protect the people from what they see as a health threat, whether the people want their "protection" or not.
The only way the FDA can regulate vaping products is if they're deemed to be tobacco products, placing them in the same category as cigarettes. The regulations for tobacco products are already in place, they're just looking to extend those regulations to as many products as possible. They can't really pick and choose which regulations apply to specific tobacco products.
Hopefully they don't get away with it. Congress has already ordered them to provide better justification, there's the possibility that the grandfather date will get moved, and they're gonna have a hard time proving their case in the courts. Specifically, the argument that they're unconstitutionally limiting free speech is quite a strong case. As I said before, they may be expecting that lobbying and influence from pharma and tobacco will be enough to push things their way.
BOOM!
Rob you're right of course. But putting aside all the legal speculation as to whether such an interpretative assumption could or might be enforced…The question remains as to the language that specifically cites nicotine in and of itself as a deemed tobacco end product. Where is the bedrock foundational statement which equates nicotine to tobacco within these rules or authorizing legislation? Could anyone speak to this? Good luck.
I'm Not Sure where you are Trying to go with this?
From the new deeming regulation...
Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “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)
I would question whether nicotine base meets this definition of "tobacco product"...
1. any product made or derived from tobacco that is intended for human consumption
- nicotine base is not intended for consumption, it is a raw material that must be altered before being consumed.
2. including 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)
- nicotine base is a raw material other than tobacco used in manufacturing a component part or accessory of a tobacco product. it is a raw material used in manufacturing E-liquid (a tobacco product) and therefore meets the exception part of the definition of tobacco product itself
I am sure that this will not matter and they will regulate nicotine base, but I am just saying, that this could provide legal relief for nicotine base producers.
Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “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)
I would question whether nicotine base meets this definition of "tobacco product"...
1. any product made or derived from tobacco that is intended for human consumption
- nicotine base is not intended for consumption, it is a raw material that must be altered before being consumed.
2. including 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)
- nicotine base is a raw material other than tobacco used in manufacturing a component part or accessory of a tobacco product. it is a raw material used in manufacturing E-liquid (a tobacco product) and therefore meets the exception part of the definition of tobacco product itself
I am sure that this will not matter and they will regulate nicotine base, but I am just saying, that this could provide legal relief for nicotine base producers.
Neither is flour intended for direct human consumption.
Try just eating a mouthful of dry flour.
Try just eating a mouthful of dry flour.
granted, but flour is regulated in an entirely seperate regulation, infact, that regulation has an entire section dedicated to flour, likely because of your point, it was not under the basic terms a food product intended for consumption, but a raw material, yet they regulate it. Well they regulate it under a different regulatory guidance. The definition of food is different than the definition given of a tobacco product.
This was taken from the FDA regulations that grants authority to FDA to regulate the food industry. There is also a different defintion for cosmetics, drugs, etc...
(f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients.
This was taken from the FDA regulations that grants authority to FDA to regulate the food industry. There is also a different defintion for cosmetics, drugs, etc...
(f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients.
Therefore, they can under the regulation for food, regulate any and all raw materials and/or ingredients.
However, under the definition in the regulation for tobacco products, raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product are excluded. Nicotine base meets this raw material definition, and should by any court, be excluded from the regulation.
Of course, one sentence could negate that if the FDA was denied the ability to regulate nic base, and they wished to, they could amend the regulation to read "tobacco products include .... and any concentration of nicotine derived from tobacco that is suspended in a base commonly used for ENDS"
However, under the definition in the regulation for tobacco products, raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product are excluded. Nicotine base meets this raw material definition, and should by any court, be excluded from the regulation.
Of course, one sentence could negate that if the FDA was denied the ability to regulate nic base, and they wished to, they could amend the regulation to read "tobacco products include .... and any concentration of nicotine derived from tobacco that is suspended in a base commonly used for ENDS"
- Status
Similar threads
