Nicotine and the FDA

[Frankie]

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

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.

[Harry Crazington]

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 '...at least according to the Wikipedia definition of the word disease.... Disease - Wikipedia, the free encyclopedia

[LaceyUnderall]

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!

[katink]

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?

[SmokeyJoe]

Lacy - Have a look at this website: AMORYN - Natural Supplement for Depression & Anxiety

Why wouldn't the FDA take action with this company?

[LaceyUnderall]

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".

[OutWest]

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.

[Lithium1330]

Maybe the wall of text in the disclaimer worth for something :S

AMORYN is not a drug and is not intended to diagnose, treat, cure or prevent major depressive disorder, bipolar disorder, dysthymic disorder, generalized anxiety disorder, panic disorder, or any other disease. AMORYN should not be considered equivalent to or a substitute for an FDA-approved drug. AMORYN and its logo are trademarks of BioNeurix Corp.
Placing an order indicates that you understand and agree to the Terms and Conditions of Sale.

The statements on the amoryn.com website have not been evaluated by the Food and Drug Administration. AMORYN is a dietary supplement, not a drug. AMORYN is not intended to diagnose, treat, cure or prevent any disease.

The terms "depression", "anxiety" and "panic" found on the amoryn.com website may refer to common emotions and should not be interpreted as referring to medically-recognized diseases. Statements about clinical research involving an ingredient in AMORYN for the treatment of a disease should be considered only as background information about that ingredient. These statements do not represent a claim about the effects or purposes of AMORYN itself and do not indicate that AMORYN is intended to treat any disease or as a substitute for any drug. Statements that an ingredient found in AMORYN has been proven in clinical trials to effectively treat a disease do not represent any claim regarding the effects of AMORYN and do not signify that AMORYN itself has been proven to effectively treat that disease.

[riddle80]

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.

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.

[TropicalBob]

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.