E Juice not a tobacco product????

[kristin]

At the very least that no existing classification fits, so the FDA must create a new one.

And if the FDA is unsuccessful at convincing the judge that e-liquid, like nicotine water, is a product intended for human consumption that contains the unapproved additive nicotine and the judge rules that the FDA must create a new classification for non-tobacco nicotine products, how would that benefit e-cigarette users?

 

[BigBen2k]

I think I can see Kristin's point here.

While there are several ways to tackle this issue, getting to reclassify nicotine is the least likely to happen, because of prior failed attempts, and let's face it, the FDA will (rightfully) cling to its classification system, and may lack the authority to create new definitions of new products.

Congress has give the FDA a framework to work within, and the FDA acts within that framework.

It's kind of sad that we have to abandon the "reduced risk" category, as it was intended for just this, but hey, we have to start somewhere.

 

[DC2]

By all rights, nicotine should be a dietary supplement, as it fits any and all criterion to be one.
But since that is apparently not possible, the modified risk category is where this product really belongs.

The fact that the FDA appears to be wanting to make it incredibly hard to become a modified risk products speaks volumes.

 

[BigBen2k]

...
The fact that the FDA appears to be wanting to make it incredibly hard to become a modified risk products speaks volumes.

Well if we're going to speculate, then I'd guess that the FDA is being finicky to prevent abuses to the classification system, because lots of companies dance around the FDA.

 

[mezzio]

So how about this (slightly more illegal side of things depending on where you live).

........ contains ..., people can extract ... from plant matter rather cheap at home and have a super ... concentrate, sometimes upwards of 85-90% pure . Once this is done, its no longer considered ........ in the eyes of the law, its a ... extract, and carries a whole new set of problems if one is caught with it. I know people who have been caught with extracts and tried arguing that it is in fact nothing more than a different form of ........, and those arguments have been thrown out 100% of the time.

Marinol is a synthetic ... legal to produce, since ... is only derived from the ........ plant, even in synthetic form, its not considered .........

So there's 2 examples of a chemical compound found within a plant, and neither one is considered the plant after its extracted, so why is nicotine considered tobacco even after its extracted?

You can't have it both ways, you can't say a chemical compound extracted from one plant is still considered that plant (tobacco) while saying a chemical compound extracted from another plant is no longer considered that plant (........).

*Edit*
Hmm, owned by the filter, I guess you can try and figure out what I was saying by the content throughout... can't believe pot is filtered though.


Sent from my Google powered personal data extraction device

 

[Coastal Cowboy]

I can be as obtuse as anyone on this forum. Especially when I think I'm right.

dr g is on to something. I agree that what he advocates is a long shot, but it's a shot worth taking.

I refer you to the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act transferred responsibility from the manufacturer/vendor of a particular product or supplement, in that in OTC and prescription pharmaceuticals, the maker had to demonstrate safety. With DSHEA, the FDA must demonstrate that the supplement or product is unsafe before the agency can regulate it.

Divorcing nicotine from tobacco and revisiting the nicotine water issue of 2005 makes sense.

The nicotine water case is almost identical to the Favor Smokeless Cigarette issue in 1987. In both cases, FDA declared the products to be unapproved drugs. Neither the makers of the nic water nor the FSC maker decided to litigate.

In the Soterra case, FDA again tried to regulate a nicotine product as a drug delivery device. This time, the makers fought back and won in court and won again on appeal. Because of that decision, both the nicotine water and FSC matters are now open again to litigation.

The idea with this strategy is to position nic liquid as a dietary supplement that FDA, under DSHEA, must prove to be harmful or unsafe in order to regulate it.

Use Soterra as a shield against FDA regulating it as a drug, and, use the Court's language in how the products are marketed as to whether they are regulable at all under FSPTCA.

 

[BigBen2k]

I don't think there's enough evidence to support that strategy though, yet. I don't think anyone is going to put any money on that long shot, but hey, you never know. Not holding my breath on it though.

 

[dr g]

And if the FDA is unsuccessful at convincing the judge that e-liquid, like nicotine water, is a product intended for human consumption that contains the unapproved additive nicotine and the judge rules that the FDA must create a new classification for non-tobacco nicotine products, how would that benefit e-cigarette users?

As previously stated, the divorcement from tobacco alone would be a positive development. Without the tobacco boogeyman, a regulatory framework would need to focus on the nicotine itself, which you yourself have stipulated is scientifically known to be low-risk.

 

[DC2]

Trying to classify a nicotine product as a dietary supplement was attempted in 2005 and failed.

The FDA deemed that nicotine "does not meet the definition of a dietary supplement" and the "mere presence of nicotine in foods such as cauliflower, eggplant, potatoes, and tomatoes, without any evidence that these foods were promoted for their nicotine content, does not constitute 'marketing' nicotine as a food or dietary supplement" under the Dietary Supplement Health and Education Act.

According to the FDA, nicotine is "an article authorized for investigation as a new drug" and "21 U.S.C. 321 (ff)(3)(B) states that the term 'dietary supplement' does not include 'an article authorized for investigation as a new drug...for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food...."

"Nicotine was authorized for investigation as a new drug on December 2, 1987. To the best of FDA's knowledge, nicotine was not marketed as a food or dietary supplement before the date nicotine was authorized for investigation as a new drug."

http://www.ahpa.org/Portals/0/pdfs/06_0629_FDA_NicLite_ltr.pdf

The more I think about this, the more I think that this is something that could be challenged in court.

The above decision does not appear to have been decided in a court of law, it appears the FDA "just said so" and that was that.
We already know how that turned out for the FDA when they tried to treat electronic cigarettes as a drug.

Anyway, just thinking out loud here...


EDIT: Apparently others thought out loud before I did
EDIT:

 

[Coastal Cowboy]

The only problem I see with advancing the divorcement strategy is the language in FSPTCA, which specifically mentions products that are "derived from tobacco." Currently, all available nicotine liquids are derived from tobacco.

However, perhaps a case could be made that since there is no tobacco remaining, the extracted nicotine is no more of a tobacco product than aspirin is a willow product, or that caffeine is a cocoa or coffee product. The refinement process that produces the USP grade nicotine liquid is so advanced that, while tobacco happens to be the most economical source for the substance, the two substances are no longer linked.

And, I'm just thinking out loud, too.

 

[dr g]

The only problem I see with advancing the divorcement strategy is the language in FSPTCA, which specifically mentions products that are "derived from tobacco." Currently, all available nicotine liquids are derived from tobacco.

However, perhaps a case could be made that since there is no tobacco remaining, the extracted nicotine is no more of a tobacco product than aspirin is a willow product, or that caffeine is a cocoa or coffee product. The refinement process that produces the USP grade nicotine liquid is so advanced that, while tobacco happens to be the most economical source for the substance, the two substances are no longer linked.

And, I'm just thinking out loud, too.

Yes, that's the next step. If we can get divorcement, then it opens up the possibility of tobacco-sourced nicotine to be proven chemically equivalent to non-tobacco nicotine.

 

[Coastal Cowboy]

Yes, that's the next step. If we can get divorcement, then it opens up the possibility of tobacco-sourced nicotine to be proven chemically equivalent to non-tobacco nicotine.

And we use the Soterra Court's language against FDA by calling the stuff a dietary supplement or herbal product, with an intended use that is recreational, rather than therapeutic. The "intended use" and "marketing" language is all over the Soterra decision.

Yes, you're on to something.

 

[BigBen2k]

... but then you have to provide the FDA with solid scientific evidence, and extended tests, demonstrating that it should be categorized the same as caffeine.

Not impossible, just not practical, at this point in time, IMO.

It may also conflict with existing tobacco products, in terms of the regulatory framework that the FDA has been given by Congress.

What's the current strategy, that Kristin was pointing to?

 

[Coastal Cowboy]

... but then you have to provide the FDA with solid scientific evidence, and extended tests, demonstrating that it should be categorized the same as caffeine.

Not impossible, just not practical, at this point in time, IMO.

It may also conflict with existing tobacco products, in terms of the regulatory framework that the FDA has been given by Congress.

What's the current strategy, that Kristin was pointing to?

Not under DSHEA, the dietary supplement act from 1994. That puts the responsibility squarely on FDA's shoulders to demonstrate that the product is unsafe.

Declare it to be a dietary supplement, and make FDA prove that it's unsafe.

Remember the Star Trek episode where the ship's computer got taken over by an alien life form?

Spock said, "Computer, compute to the last digit the value of Pi." Just to keep the bastidges busy while the crew figured out how to disinfect the thing.

By the time FDA figures out what the next step is, we'll all be dead.

 

[DC2]

And we use the Soterra Court's language against FDA by calling the stuff a dietary supplement or herbal product, with an intended use that is recreational, rather than therapeutic. The "intended use" and "marketing" language is all over the Soterra decision.

I'm no expert on dietary supplements, so I don't know if intended use is part of that equation...

But nicotine is a dietary product in that it is present in many vegetables.
It is also a closely related to niacin, which is a vitamin.

And it provides various enhancements to the body, such as increased memory, attention, and focus.
It could even be fairly shown to assist in weight loss.

These are all things that many dietary supplements are supposed to do...

 

[BigBen2k]

Not under DSHEA, the dietary supplement act from 1994. That puts the responsibility squarely on FDA's shoulders to demonstrate that the product is unsafe.

Declare it to be a dietary supplement, and make FDA prove that it's unsafe.

Remember the Star Trek episode where the ship's computer got taken over by an alien life form?...

By the time FDA figures out what the next step is, we'll all be dead.

That's too easy; pure nic is lethal, just to handle; known fact.

The same applies to caffeine though; how's caffeine currently classified?

 

[BigBen2k]

Hm, I think I see how this would work:

Extract nicotine from eggplant/cauliflower/tomatoes/potatoes, package it with VG and/or PG, and market it as "vegetable nicotine, a dietary supplement, intended to be vaporized for inhalation, recreationally". That, might bypass the tobacco regulation.

But where would it go from there? Force the FDA to prove that vegetable nicotine is no more harmful than caffeine, in order to allow the product to be sold?

(technicalities; the product would still have to meet FDA regulations for sanitary production, and quality control)

 

[Coastal Cowboy]

Hm, I think I see how this would work:

Extract nicotine from eggplant/cauliflower/tomatoes/potatoes, package it with VG and/or PG, and market it as "vegetable nicotine, a dietary supplement". That, might bypass the tobacco regulation.

But where would it go from there? Force the FDA to prove that vegetable nicotine is no more harmful than caffeine, in order to allow the product to be sold?

(technicalities; the product would still have to meet FDA regulations for sanitary production, and quality control)

Yes. Using the language from DSHEA and the Soterra decision.

The next step is how to deal with the fact that the nicotine is inhaled, rather than ingested, like other dietary supplements. That goes to intended use.

We're still drawing to an inside straight, and still thinking out loud.

 

[kristin]

The above decision does not appear to have been decided in a court of law, it appears the FDA "just said so" and that was that.

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.

Without the tobacco boogeyman, a regulatory framework would need to focus on the nicotine itself, which you yourself have stipulated is scientifically known to be low-risk.

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?

 

[BigBen2k]

I think it's pretty cool that we can hash these things out, even though we're probably advancing at a snail's pace, compared to a million dollar, roomful of lawyers.