Nicotine and the FDA

[riddle80]

I've been researching most of the day today to find out what the connection with nicotine and the FDA is. I wasn't quite sure why the FDA has to control NRTs. Then I find out that nicotine addiction is considered a disease and I assume the reason the FDA is stepping in is that NRTs claiming to "cure" such a disease would be considered a drug. Thus forcing any company claiming to assist in quitting smoking to file a NDA (New Drug Application)

I also looked up the sections cited in the letter people were receiving from customs when their shipments were held.

This is what was written:

Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.

Section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act reads:

g)(1) The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—
(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,
(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or
(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.

FD&C Act Chapter V, Sections 501-510

Section 21 321(p) of the US Code reads:

(p) The term ``new drug'' means--
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ``new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

WAIS Document Retrieval

I've also looked up the nicotine lollipop case and the FDA warning letters sent. Here's the links to that.

http://www.fda.gov/cder/warn/2002/nico2.pdf

CNN.com - FDA stops nicotine lollipop, lip balm sales - April 10, 2002

And this one is to NicoWorldwide.

http://www.fda.gov/OHRMS/DOCKETS/dai...00001-vol1.pdf

They are currently selling nicotine water. Note the marketing techniques:

http://www.nicoworldwide.com/index.html


From what I can tell, harm reduction approaches are not very common. It's all about quitting smoking. It's been said before, but it definitely looks as if smoking is slowly being phased out. I have found a few that are supporting the harm reduction approach as they realize that not everyone wishes to quit (or can quit even if they want to).

Harm reduction - a tobacco-free approach

Nicotine and addiction. (tobaccoharmreduction.org)

Tobacco Harm Reduction- International Harm Reduction Association

Sorry for being redundant as I know some of this has been discussed elsewhere. I believe that Quit Smoking claims and wording are the #1 enemy in the case of the FDA. It really does appear to all be linked to marketing. Don't write a check you're a$$ can't catch!

I do wonder if only the few companies making these claims will be effected by this or if it will result in a ban for all of them.

Do any of you know if there are any regulations on nicotine? If there were ever a ban across the board I'd think it would be for this substance and not the devices.

[Misty]

Riddle!..this is a really in-depth research on your part..
very interesting!

[TropicalBob]

Nice research, Riddle. From what I've read, another test of the "drug" aspect of this is whether the concoction (e-liquid) causes a psychological or physiological effect. Yep, both. Ergo, it's a drug. So what the e-liquid makers have done is mix a new brew, not previously approved by the FDA, and failed to submit a New Drug Approval (NDA) form.

You are right that nicotine addiction is a medical condition. Even if our devices contain zero nicotine, they are still designed to treat nicotine addiction -- the makers virtually all say so! They claim they can just step us right down from 36mg to zero. That's treating nicotine addiction with a drug and a drug delivery device. That makes e-liquid and its delivery devices subject to FDA regulations. And that's the problem.

One more note: When a shipment to me was held up by Customs, it had to have FDA clearance. They wrote, asking what it was. I wrote a long reply, telling them it was an alternative to smoking cigarettes. They wrote back: Smoking cessation device. I said "no." THEY WOULD NOT RELEASE MY ORDER UNTIL I SIGNED THEIR FORM SAYING THIS WAS FOR SMOKING CESSATION.

At the time, I had no idea what it was all about. Now I do. These are going to die because they are not approved Nicotine Replacement Therapy products for smoking cessation. That's clearly how the FDA sees them, no matter our protestations to the contrary.

Thanks for your work on this.

[DisMan]

THEY WOULD NOT RELEASE MY ORDER UNTIL I SIGNED THEIR FORM SAYING THIS WAS FOR SMOKING CESSATION.

And this is *why* you do not give permission to regulate such devices. They blackmailed you into signing a statement that was false. They didn't "accept" your answer, which is not what they are permitted to do. They are permitted to ask you a question, and you are permitted to answer. They are not permitted to force your answer. I am pretty sure this is a violation of constitutional law for both incrimination and illegal search and seizure.

[Cymri]

not a bit redundant - we need posts like this one that get all the info into one spot.

The giant blunder was how ecigs were marketed from the beginning. The user manuals make the exact claim of being cessation devices which makes them subject to FDA control.

The big argument is goiing to be whether eliquid is a tobacco product. To me it clearly is since the nicotine is derived from tobacco and contains trace amounts of compounds that identify it as being from tobacco.

The whole addiction as disease notion really pisses me off. I hope to see that debunked by the medical community some day.

The only way I can see this going is for vaporizers to be manufactured in the US and marketed as herbal vaporizers thus bypassing the customs issue and the claims the FDA have about them being NRT devices.

The liquid will never be an accepted OTC product I am pretty sure. It will have to come down to little extraction kits that we can use with tobacco to make our own liquid. Marlboro french press anyone?

[Harry Crazington]

Originally Posted by Cymri

The only way I can see this going is for vaporizers to be manufactured in the US and marketed as herbal vaporizers thus bypassing the customs issue and the claims the FDA have about them being NRT devices.

Great information Riddle...
also there already is an American made personal vaporizer according to this... The Ubie Vaporizer -- The Free Your Lungs !

[Sun Vaporer]

Originally Posted by riddle80

Do any of you know if there are any regulations on nicotine? If there were ever a ban across the board I'd think it would be for this substance and not the devices.

As many of us are away, nicotine clearly falls within the scope of FDA's authority to ban as we saw in the plight if nicotine water. With that in hand and the fact that the FDA has already decided to speak to the issue of our devices by saying that they are illegal to sell or market in in the US and their investigation is ongoing--Now only leaves in question the scope of what the FDA will mandate----Sun

See timeline of FDA v. Nicoine Water Nicotine Water

[Lithium1330]

Originally Posted by Cymri

The only way I can see this going is for vaporizers to be manufactured in the US and marketed as herbal vaporizers thus bypassing the customs issue and the claims the FDA have about them being NRT devices.

The liquid will never be an accepted OTC product I am pretty sure. It will have to come down to little extraction kits that we can use with tobacco to make our own liquid. Marlboro french press anyone?

Originally Posted by Harry Crazington

Great information Riddle...
also there already is an American made personal vaporizer according to this... The Ubie Vaporizer -- The Free Your Lungs !

And it is not the only one:

VOLATIZER is pleased to introduce the Volatizer® VM3™. The VM3™ revolutionizes the delivery of the bioactive ingredients of herbs, tobacco and botanicals. Protected by U.S. and foreign patents, with additional patents pending, the Volatizer® VM3™ represents the cutting edge of vaporization.

You’ve never seen or used anything like it! Developed after years of research, with its concealable mouthpiece, state of the art Lithium Ion battery, temperature control unit, built-in safety features and ergonomic design, the VM3™ is the only handheld, pocket size, battery operated, rechargeable vaporizer on the market.

No more smoke. No more burning. No more flasks or water filled containers. No more hoses. No more balloons. No more attached power cords. Incredibly efficient. Requires only a fraction of the herb or tobacco normally used. The VM3™’s patented, rapid-onset and smokeless nature, and its compact and easy to use design, are revolutionizing the vaporization industry.

AMOUNT: For finely ground herbs and tobacco, enough to cover the bottom of the vapor chamber and no higher than the interior ridge the mesh lid seats against. Less is better. No need to pack the chamber. Be sure and twist and seat mesh lid. For essential oils one drop on a small ball of cotton inserted into the vapor chamber.

------VM3 WEBSITE-----

The manufacturers of this unit may be very interested on rebamp the design for suit our needs, besides this is a very good business oportunity for any entrepreneur willing to work with them to supply the actual e-cigarette market with a better design based on this unit.

[Harry Crazington]

Yep Lithium, that's a sweet looking PV, but very expensive, here's another inexpensive one from the UK .. VaporGenie.com

With the exhorbinate new tobacco tax hike due April 1st, and added to each year thereafter, even extracting your own nicotine from tobacco to make DIY e-juice will be a lot more expensive. There are however many other unregulated plants worldwide that contain nicotine. Granted our ecigs are a very desirable method of delivery for our drug of choice, if they ban ejuice, or the ecig I plan on getting it however possible, as inexpensively & safely as possible. I ordered the two devices that I linked to, and will see if they are compatible with ejuice & report back. If we eventually get stuck with only heavily taxed tobacco products and no ecigs or juice, at least these will work more safely with ' the leaf '. Or grow your own, until that's banned too. I think that the American Revolution was initiated partially by the outrageous 5% tax that England levied on tea, taxes worldwide are way beyond that, on most EVERYTHING.

[Lorddrek]

The whole addiction as disease notion really pisses me off. I hope to see that debunked by the medical community some day.

I so hate this too. I have been sober for 4 years. Used to drink like a fish. Still think about it quite often. I must be diseased.

Many years ago cocaine was a big problem for me. Never really liked it but I couldn't ever say no. It was all around me so I stopped by leaving many close, longtime childhood friends behind. Did we all suffer from a disease?

I used to play Everquest and World of Warcraft up to 18 hours a day. I had to stop to get my "real" life rolling again. I loved playing these games but know I can't sacrifice any more time to them. I guess I was diseased.

I get out of control on Ebay buying stuff that I really don't need. Sometimes putting myself in quite a financial hole that takes a bit of time to come out of. Is this a disease?

I would think sex addiction must be considered a disease. How about those who embezzle and steal? Could be they are just suffering from a disease. The list could just go on and on.

But it's really just life and the choices you make. Poor ones are not diseases. Just bad choices. Just because you get sick or hurt others from them does not make it a disease.

Lorddrek