"Electronic cigarettes: Safety concerns and regulatory issues"

[Brodius Bacchus]

Irrelevant. Smoking cessation is NOT A MEDICAL CLAIM. Smoking is not a disease. Can you follow along and comprehend the point?

See the last quote under "Regulatory Argument" in my post above (page 2 in this thread).

 

[aditas]

When I pit my words against the FDA's I used an argument. e.g. smoking is not a disease. Do you see the correlation. Smoking is not a disease = TRUE therefore no medication is possible.
You have to break the correlation in my logic to prove that I am wrong. Something that you failed to do. I am still right.

 

[Pumaman]

When I pit my words against the FDA's I used an argument. e.g. smoking is not a disease. Do you see the correlation. Smoking is not a disease = TRUE therefore no medication is possible.
You have to break the correlation in my logic to prove that I am wrong. Something that you failed to do. I am still right.

Ok, I'll try...

If SE sold pet rocks or meditation crystals and called them a smoking cessation device, then you MIGHT have a small point, but they would still be subject to truth in advertising laws. But they don't, they sell nicotine delivery systems and make unsubstantiated and inaccurate claims (and yes SE HAS made both) about them. The FDA has jurisdiction over nicotine as a drug. This makes e-cigs a medical device and drug delivery system. The FDA has not only the right in law but a MANDATE to asses the safety of medical devices and drug delivery systems before they can be sold legally. Proof of safety is the responsibility of the entity selling and marketing the device, NOT the FDA. The only hope I see for continuing legal sales is that they will be classified as tobacco products in the end, as categorization as an NRT means the regulatory process must be followed. No one currently involved in the USA in the sales or marketing of e-cigs has anything like the resources needed for that. Eventually one of the major manufacturers may go through the process, but that is nowhere even close. Or maybe Pfizer or someone will step in after everyone else is forced out of the market (it is a 100 million dollar market supposedly) if it is classified an NRT.

I don't like it either if it helps.

 

[dragonpuff]

When I pit my words against the FDA's I used an argument. e.g. smoking is not a disease. Do you see the correlation. Smoking is not a disease = TRUE therefore no medication is possible.
You have to break the correlation in my logic to prove that I am wrong. Something that you failed to do. I am still right.

Inhalation of tobacco smoke provides nicotine to the user. Nicotine is addictive and people often smoke tobacco to alleviate withdrawal symptoms.

The DSM-IV-TR (Diagnostic and Statistical Manual, fourth edition, revised) is the current American standard for the diagnosis of all psychiatric disorders. One class of disorders in the DSM is "substance use disorders," and in this class are definitions for two smoking-induced diseases:

Nicotine Withdrawal

Nicotine withdrawal is defined by the DSM-IV-TR as a condition in which a person, after using nicotine daily for at least several weeks, exhibits at least four of the following symptoms within 24 hours after reduction or cessation of nicotine use:

1. Dysphoric or depressed mood
2. Insomnia
3. Irritability, frustration, or anger
4. Anxiety
5. Difficulty concentrating
6. Restlessness
7. Decreased heart rate

Nicotine Dependence

The following are DSM-IV-TR criteria for diagnosis of nicotine dependence:
The user must demonstrate at least three of the following criteria occurring at the same time during a 12-month period:

1. Tolerance—Signs of tolerance are a need for a markedly increased amount of nicotine to produce the desired effect or a diminished effect with continued use of the same amount of nicotine.
2. Withdrawal, as manifested by either the characteristic nicotine withdrawal syndrome, or nicotine (or a closely related substance) is taken to relieve or avoid withdrawal symptoms.
3. Nicotine is used in larger amounts or over a longer period than intended.
4. The user has a persistent desire or makes unsuccessful attempts to cut down on tobacco.
5. A great deal of time is spent in obtaining or using the substance (e.g., chain smoking).
6. Important social, occupational, or recreational activities are reduced because of tobacco use.
7. Use of the substance continues despite recurrent physical or psychological problems caused or exacerbated by tobacco—for example, continuing to smoke despite diagnoses such as hypertension, heart disease, cancer, bronchitis, and chronic obstructive lung disease.

Source: Nicotine Dependence

Due to the above criteria, any drug or device that makes any claims regarding the alleviation of nicotine cravings or nicotine cessation is subject to FDA regulation for the treatment of a disease.

 

[Brodius Bacchus]

This thread has left the initial purview of the OP. I have answered the question in the OP on page 2 of this thread, if anyone cares to see it. Out of fairness to Tom09, can the current debate please be carried over into a new thread on the topic.

Thanks.

 

[Tom09]

The authors offer arguments in two realms: the FDA's regulatory powers, and health.

Regulatory Argument
[...]
Health Argument
[...]
Conclusion
Based on FDA studies of two e-cigarette brands, and the health effects of nicotine cited above, the authors conclude that e-cigarettes are not a proven, safe alternative. Furthermore, the FDA has the power to regulate e-cigarettes as a new drug.
As I stated before, much of what has been written has already been discussed. Much of it is now at the forefront in the legal proceedings in Smoking Everywhere V. FDA (I recommend you follow Sun Vaporer's updates on the ordeal).
[...]

　　
Many thanks, Brodius Bacchus, for providing a clear and detailed summary of this article.

I certainly understand that it’s FDA’s position to classify e-cigs in terms of a new drug. Personally, I don’t think that’s the appropriate box. Unfortunately, however, the manufactures/mass suppliers have not exactly been pushing to establish a basis for harm reduction arguments.

 

[dragonpuff]

This thread has left the initial purview of the OP. I have answered the question in the OP on page 2 of this thread, if anyone cares to see it. Out of fairness to Tom09, can the current debate please be carried over into a new thread on the topic.

Thanks.

I apologize. I'm done arguing now.

 

[Brodius Bacchus]

My pleasure Tom.

Sun Vaporer, and any other person familiar with law, will have to weigh in on the FDA's chartered powers and the greyness associated with the status of the e-cigarette (tobacco product or drug [i.e. nicotine] delivery system).

Perhaps what needs to occur is a recognition of the division between the manufactured item (i.e. the e-cigarette) and the complimentary good (i.e. the liquid). From what I've seen, what's at issue, mainly, is the contents of the liquid (primarily, the nicotine) and not the engineering of the e-cigarette. Of course, the manufacturers are offering the liquid with the e-cigarette, which seems to be implicating the e-cigarette in it's entirety.

I don't know. For now, just stay up to date with Sun Vaporer's docket tracking.