FDA RJ Reynolds (RAI) files FDA comment asking for its competition to be banned

[Oliver]

When I say "in a sense" - I mean in that the regulatory burdens on tobacco are closer to medicines than they are, say, vitamins.

 

[NorthOfAtlanta]

I mean, yes - this is true. But it's also a complete nonsense.

The "meta" to this is that the FDA has been trying to regulate all nicotine as a drug since the early 90s. The tobacco act allows this (in a sense) but only if the nicotine is tobacco derived. If it's not tobacco derived, it's outside of the purview, and non-tobacco nicotine is on its way, very, very soon.

I wonder whether the non-tobacco nicotine will be regulated as a supplement? Probably that's the only regulatory option available under current laws.

This is going to make any Mod a true personal vaporizer as the FDA has already stated that their only hook to regulate e-cigarettes is tobacco derived nicotine. If nothing else it will drive regulators crazy trying to figure out how to get congress to add a substance that has not provably killed anyone or even caused any serious injury outside of a few battery problems.

If nothing else it will allow a few more years for development of better equipment and make it extremely difficult to enforce any e-cigarette laws as they would have to prove the liquid in any PV contained tobacco derived nicotine.

It is what I have long thought was Tobacco Controls achilles heel, if the nicotine is not derived from tobacco they have no control.

 

[DC2]

The tobacco act allows this (in a sense) but only if the nicotine is tobacco derived. If it's not tobacco derived, it's outside of the purview, and non-tobacco nicotine is on its way, very, very soon.

Non-tobacco nicotine is on it's way very, very soon?
I would love to know more about that!

I wonder whether the non-tobacco nicotine will be regulated as a supplement? Probably that's the only regulatory option available under current laws.

My thinking has always been that if someone comes up with non-tobacco nicotine, they will just call it a drug as opposed to a tobacco product.
I'm not sure how they can legally pull that off, but my thinking is that they will certainly try.

I've always been of the opinion that Big Pharma has an end goal to take over the nicotine trade.
It is a very promising "drug" for various infirmities, to say the least.

 

[No ash More Cash]

So we need to be protected from ourselves????

The cell phones companies tried to do the same thing with un locking phones even though you paid for the phone in full and you wasn't even with that carrier anymore

 

[readeuler]

If nothing else it will drive regulators crazy trying to figure out how to get congress to add a substance that has not provably killed anyone or even caused any serious injury outside of a few battery problems.

I wish I shared your optimism here. I can think of a certain Schedule 1 controlled substance whose LD50 is 10 times my body weight, yet has been outlawed at the federal level for quite some time...

I believe the propaganda of the past relied heavily on protecting the innocence of women from a certain 'madness.' This time they went straight for the big guns: the children.

 

[Gandalf the White]

I'm not sure how this one will turn out but I have a feeling it won't be as favorable as some may think.

 

[DC2]

I'm not sure how this one will turn out but I have a feeling it won't be as favorable as some may think.

I assume you mean "as favorable" to RJ Reynolds?
Like as in terms of giving them what they are asking for?

 

[WharfRat1976]

Ma Bad.....

 

[WharfRat1976]

Regulations.gov (pp. 2-3 of the comment)

You forgot to put the Billion Dollars in legal fees and "campaign contributions" behind RJR.

What is CASSA's budget again...We have Dr. F running our interference though

RJR sells billions of dollars of DEATH every second of every day but now they are concerned for the Public Health....The juxtaposition is positively macabre...

 

[Kent C]

What could be more illegal , immoral, or disgusting , how did they make they re money? Now they just want to kill any free market threats oh my...

Asking gov't to help do something they couldn't do on their own.

 

[skoony]

This is going to make any Mod a true personal vaporizer as the FDA has already stated that their only hook to regulate e-cigarettes is tobacco derived nicotine. If nothing else it will drive regulators crazy trying to figure out how to get congress to add a substance that has not provably killed anyone or even caused any serious injury outside of a few battery problems.

If nothing else it will allow a few more years for development of better equipment and make it extremely difficult to enforce any e-cigarette laws as they would have to prove the liquid in any PV contained tobacco derived nicotine.

It is what I have long thought was Tobacco Controls achilles heel, if the nicotine is not derived from tobacco they have no control.

they don't need congress to approve anything.they have been given the authority to do so.
its already been determined it doesn't matter where the nicotine comes from.
thats why they mention addictive nicotine and electronic nicotine delivery devices(ENDS)
more and more as opposed to vapor that looks like smoking and second hand vaper.
by this time next year nicotine will be betrayed as the most addictive and harmful substance known to man.
by the ANTZ not us.
regards
mike

 

[NorthOfAtlanta]

Mike, I don't have time to find it at this time, but both in the 2009 court ruling and in the press conference about the deeming regulations it was stated that the only way the FDA had any control was if it was deemed a tobacco product and sourced from tobacco.

They lost in 2009 trying to control it as a drug which means it must be a tobacco product or congress must add it to the law.

eta: Their use of other names is nothing but propaganda to make the public believe they have control and apparently it's working.

 

[bigdancehawk]

they don't need congress to approve anything.they have been given the authority to do so.
its already been determined it doesn't matter where the nicotine comes from.
thats why they mention addictive nicotine and electronic nicotine delivery devices(ENDS)
more and more as opposed to vapor that looks like smoking and second hand vaper.
by this time next year nicotine will be betrayed as the most addictive and harmful substance known to man.
by the ANTZ not us.
regards
mike

To expand on NOA's reply: The FDA's authority to regulate e-cigarettes is derived from the Family Smoking Prevention and Tobacco Control Act, which defines a "tobacco product" as "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)." (emphasis added)

[EDIT: This is a badly botched definition because it includes the very term being defined (tobacco product) in the definition. It's like defining "acorn" as the fruit of a plant that produces acorns. It leaves unanswered the question, "Does a 'component' have to be made from or derived from tobacco in order to be a tobacco product?" Given the ambiguity, the answer should be "yes."]

[Further EDIT: What the **** does "family" have to do with it? Is that supposed to make everybody feel all warm and fuzzy about it?]

Under other statutes, the FDA has the power to regulate drug products. So the FDA tried to classify e-cigarettes as drug products. However, they were shot down in the courts. Therefore, unless an e-cigarette purveyor makes therapeutic claims, the FDA's sole authority to regulate e-cigs is derived from the FSPTC Act.

In short, unless the nicotine is derived from tobacco or unless the purveyor makes therapeutic claims, the FDA can't regulate it. However, at present this is a hypothetical discussion because it isn't economical feasible to synthesize nicotine or extract it from other plants.

 

[skoony]

To expand on NOA's reply: The FDA's authority to regulate e-cigarettes is derived from the Family Smoking Prevention and Tobacco Control Act, which defines a "tobacco product" as "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)." (emphasis added)

[EDIT: This is a badly botched definition because it includes the very term being defined (tobacco product) in the definition. It's like defining "acorn" as the fruit of a plant that produces acorns. It leaves unanswered the question, "Does a 'component' have to be made from or derived from tobacco in order to be a tobacco product?" Given the ambiguity, the answer should be "yes."]

[Further EDIT: What the **** does "family" have to do with it? Is that supposed to make everybody feel all warm and fuzzy about it?]

Under other statutes, the FDA has the power to regulate drug products. So the FDA tried to classify e-cigarettes as drug products. However, they were shot down in the courts. Therefore, unless an e-cigarette purveyor makes therapeutic claims, the FDA's sole authority to regulate e-cigs is derived from the FSPTC Act.

In short, unless the nicotine is derived from tobacco or unless the purveyor makes therapeutic claims, the FDA can't regulate it. However, at present this is a hypothetical discussion because it isn't economical feasible to synthesize nicotine or extract it from other plants.

thanks for the response.
as you pointed out one can interpret the meaning of that clause to anything.
most assured the term derived from a tobacco product will be used in its
most literal sense.
derived adjective

Definition of DERIVED

: being, possessing, or marked by a character (as the large brain in humans) not present in the ancestral form <derived features>
First Known Use of DERIVED
1969
Synonyms for derived
adj derivative
borrowed copied derivational imitative unoriginal

regards
mike

 

[Nate760]

as you pointed out one can interpret the meaning of that clause to anything.

That's why we have courts and judges. Judge Leon stated in Sottera that the FDA's authority to regulate vapor products rests with the "made or derived from tobacco" language contained in the FSPTCA. Until and unless Congress passes new legislation that either 1) amends the FSPTCA to change the language of the relevant passage; or 2) creates a new regulatory scheme specifically for the e-cig/vaporizer product class, this is a settled issue.