Policy Guidance Document Regarding E-Cigarettes

[tazzmann]

@PhiHalcyon - Are you autistic? The reason I ask is that I have a dear friend of mine who is and he talks almost identically the way you talk.

Personally, I agree with Kristin and others who have pointed out that it is "Intended use" and Active vs In-active ingredients that is the tell-tale sign of what a product is.

Of course, this is just my opinion.

tazz

 

[PhiHalcyon]

@PhiHalcyon - Are you autistic? The reason I ask is that I have a dear friend of mine who is and he talks almost identically the way you talk.

Personally, I agree with Kristin and others who have pointed out that it is "Intended use" and Active vs In-active ingredients that is the tell-tale sign of what a product is.

Of course, this is just my opinion.

tazz

No. I am not autistic. I am, however, somewhat altruistic. So, when a cursory review of your recent post history led me to your brief but moving story involving your daughter, I was inspired to want to share my understanding with you as clearly as I am presently able to do.

*******************

Here is the definition of tobacco products introduced in the Tobacco Act:

Section 201(rr) of the FDCA:
(1) The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
(2) The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).
(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).

Here is the definition of drugs:

Section 201(g) of the FDCA:
(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).


Ten years ago, the Supreme Court ruled that the FDA could not regulate tobacco products as drugs on the basis of being intended to affect the structure or any function of the body.

This decision was based on the fact that Congress (via various tobacco product regulations) had long demonstrated an intent that tobacco products continue to be sold; but, if they were to be regulated as drugs, then, in being too dangerous to serve any therapeutic purpose, they would need to banned.

However, this decision did not prevent the FDA from regulating tobacco products as drugs on the basis of therapeutic claims; only from regulating them as drugs on the basis of being intended to affect the structure or any function of the body.

Nicotine drug products that deliver nicotine via a non-tobacco excipient or device were NOT protected by this decision (the Brown decision) because nicotine drug products do not fit the definition of tobacco products that Congress intended (via regulation) to continue to be sold.

Thus, in not being protected by the Brown decision, nicotine drug products were regulable as drugs on the basis of being intended to affect the structure or any function of the body - even if no therapeutic claims were made.

Paragraph 1 of the definition of tobacco products (as introduced in the Tobacco Act) is so broadly interpretable as to be able to include all nicotine drug products in addition to the Brown-protected tobacco products Congress was giving the FDA the authority to regulate.

This is not a problem in the case of nicotine drug products that are sold for therapeutic use (Nicorette Gum, Nicotrol Inhaler, etc.). For, in being sold for therapeutic use, these nicotine drug products are clearly drugs, and are NOT tobacco products according to paragraph 2.

This leaves nicotine drug products (such as nicotine water) that are not sold for therapeutic use to now appear to be protected by the Supreme Court decision in Brown (from being regulable as drugs on the basis of being intended to affect the structure or any function of the body); even though, before the Tobacco Act, they would have NOT had this protection.

Hence, the reason for paragraph 4. For, by prohibiting the marketing of a tobacco product in combination with any other article or product regulated under the FDCA, Congress has ensured that any nicotine drug product NOT sold for therapeutic use would be prohibited; and, in being prohibited in the definition of tobacco products, NOT protected by Brown.

Therefore, just as before the Tobacco Act, nicotine drug products that are NOT sold for therapeutic use (but are now prohibited under paragraph 4) ARE regulable as drugs on the basis of being intended to affect the structure or any function of the body; and, in being regulable as drugs on that basis, are NOT tobacco products according to paragraph 2.

Paragraph (4): "A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement)."

To understand the meaning of paragraph 4, the first thing you should note is that when considering physically-combined articles or products (such as nicotine water), the term 'tobacco product' must be limited to its root meaning of "made or derived from tobacco".

Thus, when considering physically-combined articles or products like e-liquid and nicotine water, paragraph 4 must be understood to prohibit marketing nicotine in combination with any other article or product regulated under the FDCA.

The second thing you should note is the use of the words 'any other' rather than 'another'. The word 'another' would have been limited to referring to a singular article or product; whereas, the words 'any other' can also be referring to a plurality of articles or products.

Thus, if glycerin, propylene glycol, and flavorings are articles or products regulated under the FDCA (and they are), then nicotinated glycerin; nicotinated propylene glycol; a nicotinated solution of glycerin and propylene glycol; a nicotinated solution of glycerin and flavoring; a nicotinated solution of propylene glycol and flavoring; and a nicotinated solution of glycerin, propylene glycol, and flavoring; are all equally prohibited under paragraph 4.

Therefore, in being prohibited under paragraph 4, none of these common versions of e-liquid are protected by Brown; and are all regulable as drugs on the basis of being intended to affect the structure or any function of the body - whether sold for therapeutic use or not.

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[Bill Godshall]

PhiHalcyon wrote:

This leaves nicotine drug products (such as nicotine water) that are not sold for therapeutic use to now appear to be protected by the Supreme Court decision in Brown (from being regulable as drugs on the basis of being intended to affect the structure or any function of the body); even though, before the Tobacco Act, they would have NOT had this protection.

Except that in 2002 (two years after the SCOTUS struck down the FDA's authority to regulate tobacco products in the Brown v FDA case), the FDA banned a nicotine water product (in response to a petition by CTFK, ACS, AHA, ALA, etc).

During the past two years, several nicotine water products have gone back on the market, however, after their manufacturers claimed that the products are homeopathic remedies that are exempt from the Food Drug and Cosmetic Act.

 

[DC2]

That sound you here is the crumbling of the logical framework for your arguments, PhiHalcyon.

 

[PhiHalcyon]

The fact that nicotine water is now sold and regulated as an OTC homeopathic remedy does not affect my conclusion one iota. Some may take comfort in the fact that an OTC homeopathic e-liquid is a possibility, but you will need 11.25 cases of 24 500ml bottles of 4mg strength to equal the nicotine content in a single 30ml bottle of 36mg/ml e-liquid.

Maximum nicotine strength in an OTC homeopathic product is: 0.01mg/ml.

Nicotine strength of a 500ml bottle of 4mg nicotine water: 0.008mg/ml.

36mg/ml e-liquid has 4,500 times this amount.

 

[DC2]

The fact that nicotine water is now sold and regulated as an OTC homeopathic remedy does not affect my conclusion one iota. Some may take comfort in the fact that an OTC homeopathic e-liquid is a possibility, but you will need 11.25 cases of 24 500ml bottles of 4mg strength to equal the nicotine content in a single 30ml bottle of 36mg/ml e-liquid.

Maximum nicotine strength in an OTC homeopathic product is: 0.01mg/ml.

Nicotine strength of a 500ml bottle of 4mg nicotine water: 0.008mg/ml.

36mg/ml e-liquid has 4,500 times this amount.

What happened to your 50% argument?

 

[PhiHalcyon]

Besides being misunderstood, nothing happened to my greater than 50% argument. But your question is irrelevant. For, nicotine water is not regulated as a tobacco product.

 

[DC2]

Besides being misunderstood, nothing happened to my greater than 50% argument. But your question is irrelevant. For, nicotine water is not regulated as a tobacco product.

Good point, so you're still arguing 50% or greater for a tobacco product then?

 

[PhiHalcyon]

I was arguing that greater than 50% made or derived from tobacco would need to be the minimum required to argue that e-liquid was a tobacco product that did not violate paragraph 4. I stand by that position too. But I never suggested that the part that was made or derived from tobacco should consist solely of nicotine. Nonetheless, it was merely an attempt to find a way to save the e-cig that has been proven impractical in its current form.

 

[DC2]

Nonetheless, it was merely an attempt to find a way to save the e-cig that has been proven impractical in its current form.

Not only is it clearly practical, but it does not yet need to be saved.
And putting a tobacco leaf in it isn't going to save it, if it can't stand the way it is now.

 

[PhiHalcyon]

Not only is it clearly practical, but it does not yet need to be saved.

Your vacuous assertion that it is practical for the e-cig to be saved in its current form is based on nothing but an irresponsible pretense of knowledge. Giving people false hope without a sound and coherent argument prevents those you fool from exploring other recourses than e-cig dependence. This is not the time for fairy tales, nor those who tell them. This is the time to prepare for what is inevitable.

 

[BCB]

So rather than using tons of big words, and realizing that many of us do not have your impressive intelligence, why don't you state more clearly the steps you recommend in the preparation "for what is inevitable." Help us out here. What specifically do you think should be done?

 

[cliff]

Make our own juice..figure out how to make an atomizer.The rest should be easy.Maybe we'll be having vape easy's in our basement lol

 

[Thulium]

Maximum nicotine strength in an OTC homeopathic product is: 0.01mg/ml.

Nicotine strength of a 500ml bottle of 4mg nicotine water: 0.008mg/ml.

36mg/ml e-liquid has 4,500 times this amount.

That's the maximum amount for products intended to be orally ingested, e-liquid is intended to be turned into an inhalable vapor before ingestion. I understand you are worried about dosages, but the potency of e-liquid does not determine the dose. E-liquid that is 3.6% in concentrate (36mg/ml) is turned into a vapor before it is consumed, and I'm pretty sure that 2 drops of 3.6% e-liquid (3.6mg of nicotine) would produce enough vapor to fill SEVERAL 500ml bottles with vapor--it just doesn't travel well.

 

[DC2]

Your vacuous assertion that it is practical for the e-cig to be saved in its current form is based on nothing but an irresponsible pretense of knowledge. Giving people false hope without a sound and coherent argument prevents those you fool from exploring other recourses than e-cig dependence. This is not the time for fairy tales, nor those who tell them. This is the time to prepare for what is inevitable.

This is why it's hard to listen to you ramble on sometimes.
And that is coming from someone who has backed you up in the past.

 

[Windsage]

Based on all of this, the simple answer is to remove the nicotine. At that point you have a recreational device which can be used as a replacement for smoking.

 

[PhiHalcyon]

Help us out here. What specifically do you think should be done?

If we were truly a community of intelligent individuals with a due respect for the law, then the logical thing to do would be to form and finance a group of community members to develop a product that would enable us to preserve the benefits of the e-cig in a legal form.

I have understood this to be the logical course of action for quite some time, and have thus been working on a way to achieve this goal on my own, but it has been next to impossible to find anyone else who is willing to even fathom the fact that such a goal is actually necessary.

So, unless and/or until there is a marked transformation of attitudes and beliefs - along with a corresponding shift in thought, focus, and effort - many people will have nothing to truly pin their hopes on other than a timely commercial solution once the foreseeable disaster strikes.

Some have solutions of their own - but making, buying, importing, or possessing an illegal product after the higher court(s) have validated that illegality are not so much solutions as they are understandable acts of personal control and desperation. Stealth-vaping is a cool feature of the e-cig in some situations, but I wouldn't want to have to do so all of the time.

 

[PhiHalcyon]

That's the maximum amount for products intended to be orally ingested, e-liquid is intended to be turned into an inhalable vapor before ingestion. I understand you are worried about dosages, but the potency of e-liquid does not determine the dose. E-liquid that is 3.6% in concentrate (36mg/ml) is turned into a vapor before it is consumed, and I'm pretty sure that 2 drops of 3.6% e-liquid (3.6mg of nicotine) would produce enough vapor to fill SEVERAL 500ml bottles with vapor--it just doesn't travel well.

The dosage volume at issue is an accidental one, and the accidental dosage volume used in calculating the maximum nicotine potency was 30ml. This works out to a maximum of 0.3mg of nicotine per accidental dosage volume. Reduce the accidental dosage volume to a 1ml pre-filled cart, and we'll have worked up to 0.3mg/ml strength. So, assuming that a nicotinated solution of glycerin and/or pg could actually be sold as a homeopathic product, and assuming that the maximum nicotine potency is as flexible as we would need it to be, an accidental dosage volume of a single puff from a 1ml pre-filled and sealed cartomizer could - at 50 to 100 puffs per 1ml cartomizer - result in a nicotine strength of 15mg/ml to 30mg/ml. 2 puffs would cut the potency in half to 7.5mg/ml to 15mg/ml; and 5 puffs would cut the potency down to 3mg/ml to 6mg/ml. And the cartomizer/e-cig device would probably still need to be approved or otherwise deemed to be in compliance by the FDA.

Your point has potential value in theory, and I encourage you to try to solidify it with facts.

 

[Koman]

Based on all of this, the simple answer is to remove the nicotine. At that point you have a recreational device which can be used as a replacement for smoking.

Yeah, why wouldn't this work?