Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Father Luke]

Or is this the wrong place for this?

- -
Okay,
Father Luke

[LoneRanger]

Lone--As it goes to the jurisdiction of the FDA--it is an all or nothing as you put it. For those that have not taken a look, the Electionic Cigarette is linked right on the front page of the FDA website now. This is a full out and out right assult.

See U S Food and Drug Administration Home Page

Sun

Thanks Sun,Found the topic But it is old news did I miss something?

[Sun Vaporer]

Thanks Sun,Found the topic But it is old news did I miss something?

Lone--what I was pointing out was the fact that they put the E-Cig link on their front page---front and center. That shows you their mindset and how much effort is not being devoted on this issue.


Sun

[yvilla]

Sun,Is it all or nothing-can fda rule in favor of one company and not the other?

Lone--As it goes to the jurisdiction of the FDA--it is an all or nothing as you put it.
Sun

Sun, it's not quite so clear as that. Theoretically, the Judge could rule in favor of one and not the other - as the question of whether a product is a "drug" is based on all the facts and circumstances, ie, the "intended use" determination, and that could actually come out differently as to each company's ecig product.

In fact, to quote the FDA itself on this, from their Supplemental Brief in opposition:

Thus, whether an article is a drug depends on its “intended use.” The “intended use” of a product refers, in turn, “to the objective intent of the persons legally responsible for the labeling of drugs,” which “is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. . . .” 21 C.F.R. § 201.128.

http://www.fda.gov/downloads/NewsEve.../UCM173193.pdf (page 8)

[Barkingmad]

I am very interested in the out come of this trial, should the e cig be banned in the USA, I wonder how many other countries will follow the same line.

Too many, including us I reckon.

[Sun Vaporer]

The "Indented Use" as fully set forth states:

The words intended uses or words of similar import in §§201.5, 201.115, 201.117, 201.119, 201.120, and 201.122 refer to the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.
[41 FR 6911, Feb. 13, 1976]

Unfortunalty, as underlined above, the indended use can be inputed and does not hinge on what the manufacture states or does not state.

It is very hard to have Judge Leon not find that the "intended use" of the e-cig is to mitigate the harm of the use of cigarettes. And mitigating use means FDA regulated use.

Sun

[yvilla]

Sun, nothing in your last post changes the fact that the case is not necessarily all or none. It invloves a mixed question of fact and law, as to each party independently, and could conceivably come out differently as to each. That was my only point.

[Sun Vaporer]

Again, this case is more about the FDA then the e-cig. Either the FDA has Juridsiction of it does not. If Judge Leon finds it does then the FDA's embargo powers will be sanctioned as well and the FDA's right to bar the sale or marketing of the e-cig until they go though the approval process.

I strongly hope that the parties are consider to settle this case based on a fast track approval process.

Sun

[Territoo]

Lone--As it goes to the jurisdiction of the FDA--it is an all or nothing as you put it. For those that have not taken a look, the Electionic Cigarette is linked right on the front page of the FDA website now. This is a full out and out right assult.

See U S Food and Drug Administration Home Page

Sun

I noticed there's no way we can post our opinions there!

[Vocalek]

I appreciate all the analysis and consideration of the legal arguments. Having made the argument to Judge Leon, I can explain that this is a question of what constitutes a tobacco product versus a drug. A tobacco product is designed to produce a result and that is the use of nicotine derived through some mechanical process from tobacco. Nicotine is a compound that has physiological effects but both the Brown Curt and the new tobacco law providing FDA with certain authority look at the use of nicotine as derived from tobacco in a context different than a drug approval context. What the FDA has and continues to do is harp on the product as a drug and try and shift the debate away from the concept that nicotine can be used freely in this country if it is used non-therapeutically in the form of tobacco. The issue of relative safety takes on a completely different context if the safety benchmark is a traditional tobacco product - it is easy to demonstrate reduced risk. Phrase the question this way - Is the e-cigarette at least as "safe" as a traditional tobacco product and at least as "effective" for the intended result of a traditional cigarette. Now phrase the question as is the e-cigarette as "safe as an approved nicotine replacement therapy and as "effective" in stopping smoking. The first question is the analysis required for a "tobacco product" - the second for a "drug."

Legal One: Thank you. This is helpful.

Do you think it might be important to pin down the FDA on what they specifically require a product that they classify as "nicotine replacement therapy" to be and do? The FDA requires an NRT product to purposely deliver levels of nicotine well below the levels that a user can attain through traditional cigarette smoking, with the ultimate goal of NICOTINE cessation, as differentiated from SMOKING cessation. I can dig up verification of this if needed, but I suspect FDA will admit it.

Those who have the power to set policy believe that the only way to get a person to permanently quit smoking is to get them to permanently give up nicotine. Thus, they vigorouly opposed allowing higher levels of nicotine in gum, but were forced to back down when research showed that the initial cesation rates were much better with 4 mg than with 2 mg. They fought allowing gum, lozenges and the patch to be made available OTC, and the Nicotrol inhaler STILL requires a prescription. They do not want high-nicotine products to be available.

A more accurate name for class of products that FDA calls "nicotine replacement" would be "nicotine weaning." That is NOT the purpose and never was, of the electronic cigarette.

What the abolitionists fail to see is that those of us who become permanently dysfunctional without nicotine are never going to become ex-smokers unless we can obtain levels of nicotine from another product that does as good a job for us as a tobacco cigarette. The product needs to be as effective as a cigarette.

If it lives down to the FDA's requirement for effectiveness, it does us no good.

Research shows that over 90% of smokers want to stop smoking. But many, if not most, of us do not want to stop using nicotine.

This consumer product allows us to stop ruining our lungs and endangering the health of those around us without forcing us to suffer the debilitating consequences of nicotine deprivation.

The DSM-IV defines Nicotine Withdrawal as follows:

The withdrawal syndrome includes four or more of the following: dysphoric or depressed mood; insomnia; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness or impatience; decreased heart rate; and increased appetite or weight gain.

Reseracher John Hughes told me, "If problems persist after 6 wks, very unlikely to be due to withdrawal." (email message 8/4/2009) Translation: many smokers have underlying conditions that are permanent, which is what keeps them using nicotine.

There is no FDA-approved treatment for "difficulty concentrating" outside of methamphetamines. These drugs have many contraindications and side effects, and the FDA recommends that they not be used long-term. They are a temporary (if that) solution to a permanent problem.

If the FDA gets power over the electronic cigarette, it will either disapper entirely forever, or be turned into the FDA defintion of an NRT, making it useless for our purposes. Millions will continue smoking tobacco and millions will die.