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.