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Nicotine and the FDA

Discussion in 'Nicotine' started by riddle80, Mar 16, 2009.

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  1. riddle80

    riddle80 Super Member ECF Veteran

    Nov 25, 2008
    Nashville, TN
    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. - FDA stops nicotine lollipop, lip balm sales - April 10, 2002

    And this one is to NicoWorldwide.

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

    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. (

    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 ... 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.
  2. Misty

    Misty Forum Admin
    Suppliers Mgr
    Complaints Mgr
    Admin Verified Member ECF Veteran

    Supporting member
    Nov 16, 2008
    Riddle!..this is a really in-depth research on your part..:thumbs:
    very interesting!
  3. TropicalBob

    TropicalBob Vaping Master ECF Veteran

    Jan 13, 2008
    Port Charlotte, FL USA
    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.
  4. DisMan

    DisMan Super Member ECF Veteran

    Sep 2, 2008
    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.
  5. Cymri

    Cymri Senior Member ECF Veteran

    Feb 18, 2009
    Austin Texas
    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?
  6. Harry Crazington

    Harry Crazington Senior Member ECF Veteran

    Jan 13, 2009
    Las Vegas

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

    Sun Vaporer Moved On ECF Veteran

    Jan 2, 2009
    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
  8. Lithium1330

    Lithium1330 Super Member ECF Veteran

    Nov 22, 2008
    And it is not the only one:



    ------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.
  9. Harry Crazington

    Harry Crazington Senior Member ECF Veteran

    Jan 13, 2009
    Las Vegas
    Yep Lithium, that's a sweet looking PV, but very expensive, here's another inexpensive one from the UK ..

    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.
  10. Lorddrek

    Lorddrek Senior Member ECF Veteran

    Mar 6, 2009
    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 ....... 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.

  11. Frankie

    Frankie Super Member ECF Veteran

    Nov 13, 2008
    Having a drink is not a disease; it´s a choice. Having to have a drink is a disease. I do not think substance addiction will be crossed out from the disease list in my lifetime. For good reasons. When you are addicted, you are not making choices. You are forced to use by the disease.
  12. Harry Crazington

    Harry Crazington Senior Member ECF Veteran

    Jan 13, 2009
    Las Vegas
    It seems that the word ' disease ' is sometimes used as a very broad term. A disease is more of an effect caused by an outside action, such as (heart) coronary disease, (lungs) pulmonary disease, etc. caused by smoking tobacco. The necessity to continue using a substance (addiction) is more of a ' disorder ' least according to the Wikipedia definition of the word disease.... Disease - Wikipedia, the free encyclopedia
  13. LaceyUnderall

    LaceyUnderall Ultra Member ECF Veteran

    Dec 4, 2008
    USA and Canada
    Allrighty folks... in this mornings research on nicotine I am running across a big problem. I cannot, in fact, find anywhere on the entire Internet, where the FDA actually does have control over nicotine.

    Now, before I get an onslaught here, I want to make very clear that in the instance of NicoWater, and all of the other NRT's, they want to make very specific claims as to what the product does. In NicoWater's case, they wanted to make claims that it satisfies the nicotine craving. In the patch, gum, etc they all wish to make claims that it cures nicotine addiction.

    I have searched the FDA website high and low. I have searched the internet high and low. I have even searched the new drug applications, definitions, etc AND the HPCUS drug sheets and cannot find any mention of the FDA controlling Nicotine UNLESS it is in a product that wishes to make a specific health claim.

    Can someone please help me with a link? Seriously. I might actually go crazy trying to prove myself wrong!

    And just so everyone knows that I have put due diligence to all sides of this argument... I even think that Dr. David Kessler made an excellent point in his 1994 statement that all of the concocting the tobacco companies did to manufacturer stronger nicotine made them more of a pharmaceutical than tobacco. However, going from that point forward, and following the timeline where the FDA was given permission to control nicotine, then it was approved again and then finally overturned by the supreme court, I just can't find anything that actually states that yes, in fact, Nicotine is controlled by the FDA. Hell, I can't even find it listed as a drug on the FDA website.

    So anyone who can help turn my insanity into a link... it would be greatly appreciated!
  14. katink

    katink Ultra Member ECF Veteran

    Apr 24, 2008
    the Netherlands
    Well... didn't we wonder earlier, why the heck nicowater even went to the FDA in the first place? So I think nothing was to be found then either, that the FDA seriously does have nicotine under it's control... else we wouldn't have wondered (this must have been near to 2 months ago).

    Might it be an idea to ask someone in the know - how about an email to the harmreduction proff. for instance... Carl Phillips et al ? Or perhaps a PM to mr. Goodall if you can't get your answer over there? Or perhaps the AAPHP: Contact Us Page?
  15. Oliver

    Oliver ECF Founder, formerly SmokeyJoe Admin Verified Member ECF Veteran

  16. LaceyUnderall

    LaceyUnderall Ultra Member ECF Veteran

    Dec 4, 2008
    USA and Canada
    As far as claims... I don't know. They make some pretty straight forward claims. But so do those pills that guys can take to make their johnsons bigger and stronger. This doesn't have nicotine in it though and as I am getting ready to refer to it in my next blog post... it appears that the "peacock is taking over the zoo".
  17. OutWest

    OutWest Unregistered Supplier ECF Veteran

    Feb 8, 2009
    Oklahoma USA
    and I think that's just it - that it's all about the mistaken perception that ecigs are for quitting smoking, which goes back to the claims (manuals that say ecigs are healthy, that it satisfies cravings, that it helps for quitting smoking, websites that say the same, etc). I could be wrong, though.
  18. Lithium1330

    Lithium1330 Super Member ECF Veteran

    Nov 22, 2008
    Maybe the wall of text in the disclaimer worth for something :S

  19. riddle80

    riddle80 Super Member ECF Veteran

    Nov 25, 2008
    Nashville, TN
    This was the point in my post. I can't find any evidence they have an ounce of control over nicotine. The nicotine water was making the same types of claims many e-cig companies are (see link in original post), which is why the FDA banned them. All they had to do was come back with the homeopathic approach making no nrt/health claims and it's smooth sailing. When someone claims you can quit smoking with these it immediately puts it under the drug/device combination as nicotine addiction is a "disease" and claiming to cure this gives the FDA full authority.

    It's all in the marketing and claims. They may very well be planning to change the rules up, but at this point I'm almost certain they can do nothing over nicotine alone. A simple disclaimer could solve all the problems.
  20. TropicalBob

    TropicalBob Vaping Master ECF Veteran

    Jan 13, 2008
    Port Charlotte, FL USA
    I've previously suggested these be sold as "novelty" items, particularly with the new hookah coming to market soon.

    But, for the record, it is some stretch to think the FDA doesn't know what it does and does not have jurisdiction over. It has already stated very much on the record that it can control e-devices and liquids. Quibble all you want on the "real meaning". I don't share your imaginative stretch at all.

    We'll soon see if the FDA doesn't have control over nicotine ... which would mean that all those millions of dollars spent by Big Pharma to get FDA approval for NRT products were unnecessary. Big Pharma wasted its time and money 'cause the FDA can't control nicotine as a drug. That is some stretch! In fact, it's silly.

    I haven't posted on this simply because I thought it was a joke.
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