Carl Phillips: FDA reveals its views on ecigs in new publication

[Kent C]

I don't see tobacco Control making any distinction between nic and 0-nic products in their prohibition attempts (even tho nicotine is their great satan). After all, even vaping 0-nic "looks like smoking," which is one of the few arguments left to them after their "science" is debunked.

(However, it *is* an important legal distinction, and it'll be interesting to see how it gets sorted out in the legislatures and the courts.)

I would change "which will make vaping pretty much cost prohibitive" to "which will create and promote a burgeoning and profitable black market in vaping supplies." It's happening w/ cigarettes; ecigs will be no different.

... but leaves VG, PG and flavorings and any remnants from the hardware as a target. It's the 'looks like smoking' that is considered by some to be a 'vice'.

Black market is the solution and has been for other consenting "vices," where rights are not violated, and the only possible direct 'harm' is to oneself - smoking, gambling, prostitution, alcohol (at one point), and a few others....

Just as their science is junk, so is their political science:


Vices Are Not Crimes by Lysander Spooner


Vices are those acts by which a man harms himself or his property.

Crimes are those acts by which one man harms the person or property of another.

Vices are simply the errors which a man makes in his search after his own happiness. Unlike crimes, they imply no malice toward others, and no interference with their persons or property.

In vices, the very essence of crime --- that is, the design to injure the person or property of another --- is wanting.

It is a maxim of the law that there can be no crime without a criminal intent; that is, without the intent to invade the person or property of another. But no one ever practises a vice with any such criminal intent. He practises his vice for his own happiness solely, and not from any malice toward others.

Unless this clear distinction between vices and crimes be made and recognized by the laws, there can be on earth no such thing as individual right, liberty, or property; no such things as the right of one man to the control of his own person and property, and the corresponding and coequal rights of another man to the control of his own person and property.

For a government to declare a vice to be a crime, and to punish it as such, is an attempt to falsify the very nature of things. It is as absurd as it would be to declare truth to be falsehood, or falsehood truth.

VicesAreNotCrimes

 

[swampergene]

It's going to be interesting how it pans out to say the least. Since they already lost using their drug regulation arm, they are really in a bit of a bind right now. The need to bring ecigs into the act given the current definitions, and that might be an issue legally. Here's the definitions in the act:

TITLE I—AUTHORITY OF THE FOOD
AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
‘‘(rr)(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.

This gets tricky. The ONLY thing that can tie ecigs to the act is nicotine. BUT....read paragraph (2):

(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).

subsection (g)(1) of the Federal Food, Drug, and Cosmetic Act state:

(g)(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). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Two points. The FDA has already recognized nicotine as a DRUG. So, if they classify it as a TOBACCO PRODUCT, the effects could possibly create a problem for ANY industry that uses nicotine for whatever reason. The other point is that it's considered a drug if it is used in the "prevention of disease" per the clause above, which it is if addiction in any form is classified as a disease. If either of these can apply, then nicotine by itself would NOT fit the legal definition of tobacco PER THE ACT. And again, nicotine is the ONLY way they will legally be able to define ecigs as a tobacco product that can be regulated by them per the powers given by congress.

Again, I tend to be very pessimistic when it comes to what the govt CAN do and what they WILL do. But the truth is, they have a very weak legal case to call ecigs or ejuice a "tobacco product". Seeing their final recommendations will be very interesting, and they are likely withholding them til the last minute because I'm sure they know that a competent lawyer may be able to build a case against them and their recommendations are going to be what gets the ball rolling AGAINST them. The FDA and their legal framework are SO big, it will be easy for them to miss something that someone dedicated to a single issue might otherwise see.

 

[KODIAK (TM)]

But philosophically, and getting back to sound bite thinking for just a moment, if these things are unknown and a report is now public saying "we need more information," then one can essentially conclude that this industry/product will be around for awhile,...

Respectfully, you do not understand how these "unknowns" bolster the FDA's reasoning for banning something.

I don't know how many times I've heard the, "We must err on the side of caution!" mantra (peppered with generous doses of the words, "children" and "smoking" of course.) Remember, e-cigs are guilty of all crimes until proven otherwise. All these unknowns merely reinforce their intentions.

 

[AgentAnia]

Respectfully, you do not understand how these "unknowns" bolster the FDA's reasoning for banning something.

I don't know how many times I've heard the, "We must err on the side of caution!" mantra (peppered with generous doses of the words, "children" and "smoking" of course.) Remember, e-cigs are guilty of all crimes until proven otherwise. All these unknowns merely reinforce their intentions.

The "precautionary principle" so beloved by WHO and the EU seems to be leaking over to this side of the pond. What it boils down to, as you say, is "guilty until proven innocent." When you hear anyone [FDA] say "we don't know what's in them," [because our heads are buried in the sand] you can be sure they're adhering to the precautionary principle [We'll ban them till we know what's in them, which will be never, because we don't want to know. [Translation: because our paymasters don't want us to know.]]

 

[Berylanna]

The precautionary principle is totally valid...for new substances, created in labs, that have never been on Earth while we were evolving.

NOTHING in e-cig vapor is non-GRAS. Done.

 

[Stubby]

It's going to be interesting how it pans out to say the least. Since they already lost using their drug regulation arm, they are really in a bit of a bind right now. The need to bring ecigs into the act given the current definitions, and that might be an issue legally. Here's the definitions in the act:



This gets tricky. The ONLY thing that can tie ecigs to the act is nicotine. BUT....read paragraph (2):



subsection (g)(1) of the Federal Food, Drug, and Cosmetic Act state:



Two points. The FDA has already recognized nicotine as a DRUG. So, if they classify it as a TOBACCO PRODUCT, the effects could possibly create a problem for ANY industry that uses nicotine for whatever reason. The other point is that it's considered a drug if it is used in the "prevention of disease" per the clause above, which it is if addiction in any form is classified as a disease. If either of these can apply, then nicotine by itself would NOT fit the legal definition of tobacco PER THE ACT. And again, nicotine is the ONLY way they will legally be able to define ecigs as a tobacco product that can be regulated by them per the powers given by congress.

Again, I tend to be very pessimistic when it comes to what the govt CAN do and what they WILL do. But the truth is, they have a very weak legal case to call ecigs or ejuice a "tobacco product". Seeing their final recommendations will be very interesting, and they are likely withholding them til the last minute because I'm sure they know that a competent lawyer may be able to build a case against them and their recommendations are going to be what gets the ball rolling AGAINST them. The FDA and their legal framework are SO big, it will be easy for them to miss something that someone dedicated to a single issue might otherwise see.

You are missing some important points. In the US nicotine is defined by the intended use. The reason nicotine gum and patches are defined as a drug is because they have gone through the clinical trials and where submitted to the FDA for approval as a smoking cessation product. The only way electronic cigarettes could be classified as a drug are if they went through the same clinical trials and where submitted to the FDA as a smoking cessation product, or it they made claims to be a smoking cessation product (if they did the latter The FDA would shut them down as an unauthorized drug as they tried to do in 2009). It is all about intended use.

The intended use of electronic cigarettes is recreational, the same as cigarettes and all other tobacco products. Since nicotine is derived from tobacco and the intended use is recreational they can be in fact legally defined as a tobacco product.

You may not like that reality but those are the facts. When the FDA lost its case when it tried to ban electronic cigarettes as a drug delivery device the Judge advised the FDA that it could regulate them as a tobacco product.

 

[Roger_Lafayette]

[...] The intended use of electronic cigarettes is recreational, the same as cigarettes and all other tobacco products. Since nicotine is derived from tobacco and the intended use is recreational they can be in fact legally defined as a tobacco product. [...]

Agreed. And 0% nic juice can't be regulated as a "tobacco product" because the constituents aren't derived from tobacco. (Well, maybe my TFA cubano flavoring is. *sigh* Guess I'll have to give that up.)

However I believe the "intended use" part covers devices, which disturbs me greatly since they can go after vaping equipment. Which BT would dearly love for them to do, since that forces all vapers into cigAlikes (which wouldn't happen to 0% vapers if they banned e-liquid or regulated it so stringently that it was effectively eliminated). Killing off the local vape shops and the US internet suppliers is undoubtedly a goal that BP, BT, and BV (big vapor) will embrace with enthusiasm. There are some big fat salaries waiting for complaint CTP honchos.

Of course 0% nic. e-liquid and the sale/use of associated equipment can be regulated under some other rubric.

Incidently I don't think the FDA could use either its drug jurisdiction or its tobacco products jurisdiction to regulate e-liquid containing nic. that was derived from some other source, so long as the intended use wasn't therapeutic.

Although that wouldn't stop the DEA from declaring it as a controlled substance. (I still adhere to my theory that the long-term goal is "medicalization," in which case all water-soluble nic. could end up as a Schedule II substance. After all, "medicalization" is what was originally proposed for the EU's TPD, and what the UK's MHRA says it wants).

 

[Jman8]

Respectfully, you do not understand how these "unknowns" bolster the FDA's reasoning for banning

Respectfully, here on 4/29/14, I feel like I did understand accurately what I previously stated in this thread.