E Juice not a tobacco product????

[Coastal Cowboy]

BTW, dr g, I agree that a potential course of action is to divorce nicotine from tobacco. I'm not sure that would ever work, but boy would it break the doors down on this regulatory conundrum.

Even with the low probability of success, if it gives the bureaucrats a way out of this mess they're in, it's worth an attempt. Drawing to an inside straight when the pot odds are there, well... You just never know.

Bureaucrats absolutely hate having their asses hanging in the wind, and giving them the opportunity to cover their asses never turns out wrong.

 

[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

Well, I guess that settles that then.

 

[JulesXsmokr]

wow - 19 pages so far!!!
my take - it's all about "who" and how many get the MONEY involved in taxing and regulating "something" that is now not taxed and regulated.
The free market place did this.
How dare us to think that we found renewed health, can save money (lot's of it), and can start new businesses as true entrepreneurs, and small business owners.
They want to nip it the .... before it gets bigger and bigger..
Nicotine, the compound found in a lot of different naturally occurring plant life, is to be spoken for, not by it's farmers, but the rulers who must tax..
End of Story..at least this little part of it.

 

[dr g]

It's not statutory law governing the definition, now. It's case law.

Mash here.

As Kristin has said over and over and over again, it's not about the origin of the product. It's about the product's intended use and how it's marketed. The DC District Court said so, and the three-member panel of the DC Circuit Court of Appeals agreed.

FDA tried to appeal to the full Court, but had that appeal denied. When the full Court of the DC Circuit denies your appeal, there is no chance of a writ of certiorari being granted by the US Supreme Court, so FDA gave up.

They've been in this six month, "we're gonna issue deeming regulations" mode almost since the Soterra decision was handed down by the DC Circuit panel.

I still think they punt again next month.

I asked earlier if there was any case law on this and was told no. Can you specify where it is in that decision?

All I see here addresses the FDA's justification to regulate, and that's not in dispute. What I am disputing is their justification to regulate as a tobacco product. Everything in that decision I can find explicitly acknowledges that the nicotine is derived from tobacco. Everything in the Tobacco Act and FD&C act is hinged on derivation from tobacco.

 

[jstaubin]

This link refers one to all the relevant court decisions The FDA & Deeming Regulations of E-cigarettes

 

[Robino1]

................

 

[kristin]

There HAS to be a written rule somewhere. So far I have seen none that say what you say regarding non-tobacco nicotine. What it looks like is there are two separate issues, one of nicotine being a tobacco product and one of tobacco products being intended for human consumption. This leaves open the question of nicotine from non-tobacco sources.

As far as I can tell, most nicotine coming from tobacco is what makes it a tobacco product, and non-tobacco natural nicotine would not be. The MN law linked to earlier more or less acknowledges to this.

I've already said:

There is no regulation that currently covers recreational use of nicotine extracted from plants other than tobacco, because it is neither a food, medical drug, cosmetic, dietary supplement, tobacco product or MRTP.

Except I was wrong. Upon further investigation, it seems pretty clear that even nicotine extracted from non-tobacco sources would be considered an unapproved "food" additive, because the FDA defines "food" as "a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption."

So, the FDA would consider even non-tobacco nicotine in any product intended for human consumption (which e-cigarette liquid is) to be an unapproved "food" additive - just like the nicotine water mentioned in my earlier post - unless it is a tobacco product or an approved drug. The FDA did not ban nicotine water because it was making medical claims or because it was a tobacco product. It banned it because it was intended for human consumption and contained an unapproved additive - nicotine - without specifying the nicotine added was unapproved because of a specific source. In that case, nicotine is nicotine. It didn't matter whether it was derived from tobacco or not.

The FDA could use the same rules it used with the nicotine water when dealing with non-tobacco nicotine in any product intended for human consumption - including e-liquid. Nicotine is clearly not approved by the FDA as an additive in products intended for human consumption unless it is in an approved drug or tobacco product and the FDA will clearly go after companies that try to sell such products that contain nicotine.

 

[dr g]

I've already said:


Except I was wrong. Upon further investigation, it seems pretty clear that even nicotine extracted from non-tobacco sources would be considered an unapproved "food" additive, because the FDA defines "food" as "a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption."

So, the FDA would consider even non-tobacco nicotine in any product intended for human consumption (which e-cigarette liquid is) to be an unapproved "food" additive - just like the nicotine water mentioned in my earlier post - unless it is a tobacco product or an approved drug. The FDA did not ban nicotine water because it was making medical claims or because it was a tobacco product. It banned it because it was intended for human consumption and contained an unapproved additive - nicotine - without specifying the nicotine added was unapproved because of a specific source. In that case, nicotine is nicotine. It didn't matter whether it was derived from tobacco or not.

The FDA could use the same rules it used with the nicotine water when dealing with non-tobacco nicotine in any product intended for human consumption - including e-liquid. Nicotine is clearly not approved by the FDA as an additive in products intended for human consumption unless it is in an approved drug or tobacco product and the FDA will clearly go after companies that try to sell such products that contain nicotine.

There's a lot of assumption in this post. That's all I can say. I certainly hope you aren't speaking for the CASAA in this, I may have to reconsider my membership.

 

[kristin]

What does any of this have to do with CASAA? No, I'm not speaking for CASAA or representing CASAA policy. I'm just presenting facts as I find them.

 

[Robino1]

How to win friends and influence enemies.

Click!

 

[VV_James]

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

One does have to wonder how a substance that has been in constant use for hundreds of years before the 1st European set foot on this continent is now a "New Drug"?!?!?!?

 

[kristin]

There's a lot of assumption in this post. That's all I can say.

You stated that "Everything in the Tobacco Act and FD&C act is hinged on derivation from tobacco." The case of the nicotine water shows that FDA regulation of nicotine products doesn't hinge on nicotine's "derivation from tobacco." In some cases, nicotine is nicotine and that is not an "assumption." It's clearly documented in that nicotine water case.

 

[Robino1]

Kristin, it's like beating your head against a brick wall. Not worth the headache.

 

[jp_cfc09]

lol you guys still at this, too much for me I think

just let dr g win or when I come back itll be 100 pages and im not reading all that lol.

 

[dr g]

You stated that "Everything in the Tobacco Act and FD&C act is hinged on derivation from tobacco." The case of the nicotine water shows that FDA regulation of nicotine products doesn't hinge on nicotine's "derivation from tobacco." In some cases, nicotine is nicotine and that is not an "assumption." It's clearly documented in that nicotine water case.

This doesn't say that. http://www.medicinenet.com/script/main/art.asp?articlekey=20851
This product ran into trouble because it was marketed as a dietary supplement.

The point of a non-tobacco nicotine test case would be to be regulated as a tobacco product, which hinges on tobacco derivation.

 

[zoiDman]

Kristin, it's like beating your head against a brick wall. Not worth the headache.

I hear you.

My forehead is Still Sore from Yesterday.

LOL

 

[Robino1]

I hear you.

My forehead is Still Sore from Yesterday.

LOL

I can one up you, I have permanent marks on mine! Never mind, the one-up-manship is waaaay out of hand.

 

[Coastal Cowboy]

I asked earlier if there was any case law on this and was told no. Can you specify where it is in that decision?

All I see here addresses the FDA's justification to regulate, and that's not in dispute. What I am disputing is their justification to regulate as a tobacco product. Everything in that decision I can find explicitly acknowledges that the nicotine is derived from tobacco. Everything in the Tobacco Act and FD&C act is hinged on derivation from tobacco.

It's at Page 15, where the court affirms the lower court's ruling.

to wit:

As we have already noted, the FDA has authority to
regulate customarily marketed tobacco products—including ecigarettes—
under the Tobacco Act. It has authority to
regulate therapeutically marketed tobacco products under the
FDCA’s drug/device provisions. And, as this decision is
limited to tobacco products, it does not affect the FDA’s
ability to regulate other products under the “structure or any
function” prong defining drugs and devices in 21 U.S.C.§ 321
(g) and (h), as to the scope of which—tobacco products
aside—we express no opinion.

I do still think you're onto something. While I think it's a long shot, I think it's worth a try.

Divorcing nicotine from tobacco solves the problem, and if there's a reasoned way of arguing that it should be done, then someone needs to draft the language. You up for it?

 

[kristin]

This doesn't say that. http://www.medicinenet.com/script/main/art.asp?articlekey=20851
This product ran into trouble because it was marketed as a dietary supplement.

The point of a non-tobacco nicotine test case would be to be regulated as a tobacco product, which hinges on tobacco derivation.

And what would an attorney argue non-tobacco nicotine sold for human consumption should be regulated as that the FDA wouldn't have regulatory powers over?

 

[dr g]

It's at Page 15, where the court affirms the lower court's ruling.

to wit:

I do still think you're onto something. While I think it's a long shot, I think it's worth a try.

Looks to me like the term tobacco product was repeated, and the "structure or any function" prong was deliberately not commented on, for a reason. Did the ruling not bar the FDA from regulating ecigs as drugs?

Divorcing nicotine from tobacco solves the problem, and if there's a reasoned way of arguing that it should be done, then someone needs to draft the language. You up for it?

I wouldn't even dream of it unless I knew some very well-positioned (and well-heeled) forces were going to support it. And even then. I'd need a much larger monetary stake in this than I currently have -- this is something for someone who makes a good living serving the market, like a well-known juice maker.

Edit: hm, I thought you meant am I up to litigate!

And what would an attorney argue non-tobacco nicotine sold for human consumption should be regulated as that the FDA wouldn't have regulatory powers over?

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