E Juice not a tobacco product????

[DC2]

I wish it was true, because I agree that nicotine alone should not be regulated like cigarettes. But the FDA was backed by the law in that case. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(ff)) specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act (21 U.S.C. § 355), unless the article in question was marketed as a dietary supplement or food before its approval as a drug. FDA first approved nicotine as prescription products between 1984 and 1992 (gums and patches), so no new nicotine product could claim to be a dietary supplement after 1992.

Is there a court case involved here?

So, Congress would have to amend the Act to allow nicotine to be used as a dietary supplement. Realistically, what legislator is going to propose that nicotine - a so-called "highly addictive drug" - is a reasonable "dietary supplement?" How would they argue that nicotine has any nutritional value like vitamin C or calcium?

Well, we have a long way to go in proving this, but I think most of us that have been vaping awhile know that nicotine is not all that addictive.
Quite like not much more addictive than caffeine, at least when used outside of combustion scenarios.

As far as arguing that nicotine has any "nutritional" value, there is the possibility that it helps prevent Alzheimers and Parkinsons.
This MAY be quite similar to the idea that Vitamin C helps prevent Scurvy.

And then there is the whole thing about nicotine increasing memory, attention, and focus...
That spells dietary supplement all day long.

Yes, I know we are a LONG way from making this case, and that many things have to happen...
But I think all of those things are a reality, and that this is a move that SHOULD work in a world where real things happen for real reasons.

 

[Coastal Cowboy]

I have some real work to do (federal policy related, even), so my thinking out loud is gonna have to stop for a while.

At least on this subject.

I'll look at the USC sections Kristin mentioned that came from FDCA. But remember, federal agencies issue regulations that they think the stakeholders will let them get away with. If there's any risk of litigation, they typically stop dead in their tracks and rethink the concept.

 

[dr g]

And this is why we need our representative organizations to be open to these ideas rather than dead-set against them.

 

[kristin]

Is there a court case involved here?

No, it's the law as passed by Congress. The Act states that once a substance is FDA-approved as a drug, it cannot be sold as a "dietary supplement." Nicotine separate from tobacco has been sold as a drug for over 30 years.

Additionally, a dietary supplement is considered “new” if it contains an ingredient not recognized as a food substance, unless it was sold as a supplement before October 1994. The manufacturer must provide the FDA with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public. (So, the onus would be on the nicotine seller to prove safety in this case, because nicotine was not sold as a supplement before 1994 and it is not recognized as a food substance.)

The FDA has taken other "dietary supplements" off the market under this law for containing substances already approved as drugs and most recently banned some red yeast rice supplements containing lovastatin.

Well, we have a long way to go in proving this, but I think most of us that have been vaping awhile know that nicotine is not all that addictive.
Quite like not much more addictive than caffeine, at least when used outside of combustion scenarios.

As far as arguing that nicotine has any "nutritional" value, there is the possibility that it helps prevent Alzheimers and Parkinsons.
This MAY be quite similar to the idea that Vitamin C helps prevent Scurvy.

And then there is the whole thing about nicotine increasing memory, attention, and focus...
That spells dietary supplement all day long.

Yes, I know we are a LONG way from making this case, and that many things have to happen...
But I think all of those things are a reality, and that this is a move that SHOULD work in a world where real things happen for real reasons.

And in the 20 years it takes to prove all of that, we instead get the truth out that not all tobacco use is deadly or even hazardous, therefore, all tobacco should not be regulated the same. Then tobacco products such as sus, dissolvables and e-cigarettes are commonly accepted as low-risk products, lose the stigma associated with cigarettes and getting nicotine regulated under a separate framework is no longer even necessary.

 

[kristin]

And this is why we need our representative organizations to be open to these ideas rather than dead-set against them.

I'm not "dead set against" anything. But I'm not going to get all gung-ho over something without some reasonable expectation as to how it is going to make a difference - especially with limited resources, limited funds and limited time before the FDA actually deems regulations on e-cigarettes as tobacco products.

 

[dr g]

I'm not "dead set against" anything. But I'm not going to get all gung-ho over something without some reasonable expectation as to how it is going to make a difference.

Many of your arguments are based on assumptions and politics. The politics of ecigarettes is very much in question, establishing it as the best smoking cessation tool the world has ever seen will change a lot. It's going to happen.

As I've said before it's a terrible idea to in any way include tobacco in our fight. Our most powerful tool is divorcement from tobacco. It bothers me a lot that a board member of CASAA believes we are on the same footing as tobacco and fighting the same fight.

 

[BigBen2k]

Hum, I see (I think!)

Someone gets the gear and a lab, produces "vegetable nicotine", packages it and offers it as a dietary supplement, to which the FDA objects, triggering a lawsuit, which may or may not be successful, and if it is, then it falls on Congress to amend the FDA's mandate, which would require lobbying, for a product that, at $1'000+ per mg, really isn't popular, so there's just no commercial interest for Congress to do anything about it, but let's say they do (a rider on some other piece of legislation?), then you're now allowed to market "vegetable nicotine" and the FDA has enough evidence that the product is safe, whether it was provided to them, or they made it, many many years later.

Then, we'd have to demonstrate that tobacco nicotine, is the same as vegetable nicotine, so that Congress can pass another amendment to the FDA's current mandate, to treat nicotine separately from a tobacco product, and/or relaxing the reduced-risk category, while retaining the existing framework for the nastier tobacco products.

I got a headache

 

[kristin]

Many of your arguments are based on assumptions and politics. The politics of ecigarettes is very much in question, establishing it as the best smoking cessation tool the world has ever seen will change a lot. It's going to happen.

Your arguments are also based on assumptions and ignore the power of politics and past history in tobacco control.

It's a silly argument for us to be having anyhow, because nothing like what you suggest is going to happen before the FDA deems regulations on e-cigarettes as tobacco products. Our goal is minimal damage TODAY, not daydreaming about lawsuits in the future that may prove to be unnecessary if we succeed today.

We must get the truth out about tobacco vs. smoking, not perpetuate the myth that nicotine must be only used as a smoking cessation product outside of tobacco or that it is only "safe" outside of tobacco. If we don't "destigmatize" safer tobacco use, recreational inhalation of nicotine will remain stigmatized and opposed, as well. I am just not convinced by your argument that lighter regulations of nicotine will remove the stigma of nicotine use and solve any of our problems.

 

[kristin]

As I've said before it's a terrible idea to in any way include tobacco in our fight. Our most powerful tool is divorcement from tobacco. It bothers me a lot that a board member of CASAA believes we are on the same footing as tobacco and fighting the same fight.

CASAA is a tobacco harm reduction advocacy organization, not exclusive to e-cigarettes. We support ALL forms of tobacco harm reduction, including low-risk tobacco products. Our membership includes former smokers who depend upon products such as snus to remain smoke-free, because e-cigarettes alone don't work for them. We are about telling the truth about low-risk alternatives to smoking and exposing the ANTZ lies. Divorcing ourselves from tobacco was never the plan and it never will be. For us, it's about divorcing ourselves from SMOKING, because that is telling the truth.

 

[Coastal Cowboy]

I wish it was true, because I agree that nicotine alone should not be regulated like cigarettes. But the FDA was backed by the law in that case. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(ff)) specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505 of the Act (21 U.S.C. § 355), unless the article in question was marketed as a dietary supplement or food before its approval as a drug. FDA first approved nicotine as prescription products between 1984 and 1992 (gums and patches), so no new nicotine product could claim to be a dietary supplement after 1992.

So, Congress would have to amend the Act to allow nicotine to be used as a dietary supplement. Realistically, what legislator is going to propose that nicotine - a so-called "highly addictive drug" - is a reasonable "dietary supplement?" How would they argue that nicotine has any nutritional value like vitamin C or calcium?

I get it - I really do. I absolutely agree that nicotine outside of a deadly delivery system should have minimal regulations and pretty much be left alone unless proven a health hazard (similar to dietary supplement regulation.)

What I also know is the ANTZ mentality and history. Snus is proof that even long-term evidence of no health risks doesn't mean reasonable regulation, taxation and laws.



And then what? Nicotine addiction will be socially acceptable? The government won't try to sin tax it like alcohol, tobacco and gambling (and possibly fatty foods and sugary drinks in the future)? Local governments will stop trying to ban public use? The ANTZ will stop accusing e-cigarette sellers of enticing kids with flavors and be OK with the fact that "e-cigarettes model smoking behavior?" The FDA will be forced to allow the sale of flavored and bottled liquids?

I'm trying to understand exactly how this "new regulatory framework" for nicotine is going to address all of these e-cigarette specific issues?

Kristin:

Unless I'm missing it, I don't see where nicotine has been previously marketed as a drug, in your reference to USC 231 and 355.

When was nicotine marketed as a drug, and did it survive an FDA ban based on its unapproved status?

Not attacking. Just asking for future reference (I really DO need to get back to work).

 

[kristin]

Kristin:

Unless I'm missing it, I don't see where nicotine has been previously marketed as a drug, in your reference to USC 231 and 355.

When was nicotine marketed as a drug, and did it survive an FDA ban based on its unapproved status?

Not attacking. Just asking for future reference (I really DO need to get back to work).

It was approved for marketing as a drug by the FDA for smoking cessation and still is - gums, patches, inhalers and lozenges. If you recall, those products were originally by prescription-only. As soon as the FDA approved nicotine as a drug, it was no longer eligible to be considered a dietary supplement per the law.

According to the FDA's National Drug Code Directory, Nicotrol nasal spray was approved for marketing as a prescription nicotine drug in 1996.

 

[dr g]

CASAA is a tobacco harm reduction advocacy organization, not exclusive to e-cigarettes. We support ALL forms of tobacco harm reduction, including low-risk tobacco products. Our membership includes former smokers who depend upon products such as snus to remain smoke-free, because e-cigarettes alone don't work for them. We are about telling the truth about low-risk alternatives to smoking and exposing the ANTZ lies. Divorcing ourselves from tobacco was never the plan and it never will be. For us, it's about divorcing ourselves from SMOKING, because that is telling the truth.

I was actually referring to smoking advocacy/smoking "trutherism", which appears to be one of your causes.

Personally I also have a problem with trying to fight tobacco regulation with tobacco, I don't see ecigs as harm reduction as much as harm elimination. They are so much stronger of a case than whole tobacco products.

 

[VV_James]

WOW! This movie now has a longer run time than the entire Lord Of The Rings Trilogy complete with the Directors commentary version, and all the behind the scenes featurettes, and gag reels!

​

 

[Robino1]

WOW! This movie now has a longer run time than the entire Lord Of The Rings Trilogy complete with the Directors commentary version, and all the behind the scenes featurettes, and gag reels!

​

Pass the popcorn please.

 

[DC2]

It was approved for marketing as a drug by the FDA for smoking cessation and still is - gums, patches, inhalers and lozenges. If you recall, those products were originally by prescription-only. As soon as the FDA approved nicotine as a drug, it was no longer eligible to be considered a dietary supplement per the law.

What bothers me about this is that it doesn't seem like nicotine is a real "drug" in that it is not intended to diagnose, treat, cure or prevent any disease.
It is being used in the pharmaceutical industry to help people quit smoking, and if I am not mistaken smoking is not considered a disease.

My gut still tells me that the idea that nicotine is a drug can be challenged in court.
At least until Kristin straightens me out again.

 

[CaliforniaGirl]

What bothers me about this is that it doesn't seem like nicotine is a real "drug" in that it is not intended to diagnose, treat, cure or prevent any disease.
It is being used in the pharmaceutical industry to help people quit smoking, and if I am not mistaken smoking is not considered a disease.

My gut still tells me that the idea that nicotine is a drug can be challenged in court.
At least until Kristin straightens me out again.

Has nicotine really never been used by the medical profession?

It seems to me like it would have a variety of medical applications. Tightening capilaries in the case of excess blood flow, for example, or as a stimulant, which are used quite regularly in the medical profession.

 

[CaliforniaGirl]

You know what...I just remembered something as I was typing the above.

My brother-in-law had colitis. For a while, his doctor had him on the nic patch. I can't remember exactly what it was intended to do for his colitis. It could have been an off-label prescription. But yes, in that case a doctor did prescribe nicotine...for something, anyway.

 

[zoiDman]

It was approved for marketing as a drug by the FDA for smoking cessation and still is - gums, patches, inhalers and lozenges. If you recall, those products were originally by prescription-only. As soon as the FDA approved nicotine as a drug, it was no longer eligible to be considered a dietary supplement per the law.

...

But didn't each of those Delivery Methods (Gums, Patch, Inhalers, Lozenges) have to go thru a Long and Costly Study/Clinical Trial Phase?

Would that be the Same for a "Drug" e-Liquid?

 

[damthisisfun]

Why are we arguing among ourselves - we all either quit, reduced or dont smoke anymore. I am concerned abt all the lady in Ohio I believe making headlines when her fake Ego bat supposedly exploded with a "KABOOM" - while she was vaping "OIL" and a study I read today about kids and ecigs...

 

[ennagizer]

But didn't each of those Delivery Methods (Gums, Patch, Inhalers, Lozenges) have to go thru a Long and Costly Study/Clinical Trial Phase?

Interesting question. I did some quick searching to find out - didn't come up with the answer, but found this:

FDA first approved nicotine gum and patches as prescription products between 1984 and 1992. These products were shown to be safe and effective for use when someone first stops using cigarettes, and then uses the NRT to help manage the symptoms of withdrawal, usually for 8-12 weeks depending on the product.

The NRT gum and patch products were switched to OTC marketing between 1996 and 2002, based on scientific research showing that these products were safe for use without a prescription. The nicotine lozenge and mini-lozenge were approved directly for OTC use in 2002 and 2009, respectively.

The quote comes from this source:
Nicotine Replacement Therapy Labels May Change
This is the first time I've seen the article and find it very interesting. Especially this:

The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.

The changes being recommended by FDA include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT.

To me this is saying that it's ok to smoke while using an OTC NRT product, and it's ok to use more than one NRT product at the same time. So, why all the hub-bub about vaping?