Archive for August 27th, 2009

The Legal Argument About Why The Electronic Cigarette Is Not An NRT

As noted in a previous about how the new tobacco legislation effects the electronic cigarette, we noted that in order for a product to be a drug it must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”. And in order to be a new drug….it must be a drug.

So I contacted the Centers for Disease Control and Prevention (CDC) and asked if smoking was considered a disease. At first they just sent me all the statistics about how many people smoking kills. Then they got mad I kept asking. Then I eventually received this response:

“When reviewing responses related to tobacco use that were provided by CDC-INFO, we noticed your question asking if smoking is considered a disease. As noted by CDC-INFO, smoking is a primary risk factor for many diseases. Addiction to drugs, is viewed as a brain disease by the
National Institute on Drug Abuse (NIDA). For information about nicotine addiction, please visit NIDA’s Web site at
http://www.drugabuse.gov/ResearchReports/Nicotine/Nicotine.html and
http://www.drugabuse.gov/Infofacts/understand.html

So, according to the CDC, smoking is not a disease, but rather it may put the user at risk of getting an actual disease. Apparently they believe that NIDA is correct and being addicted to nicotine is a disease. Thus, the electronic cigarette [e-liquid] as a new drug is one that is intended to diagnosis, cure, mitigate, treat, or prevent the addiction to nicotine. Curing nicotine addiction would involve not using nicotine anymore.

UPDATE: I recently found where Norman Edelman, M.D., Chief Medical Officer for the American Lung Association stated, “Smoking is widely recognized as a disease of nicotine addiction,”

This is why Snus or dissolvables are not Nicotine Replacement Therapy (NRT) products. They are not marketed as a way to quit smoking (quit using nicotine). They are marketed to be used indefinitely, i.e. to continue using nicotine.

The nicotine patch or gum is meant to ween the user off of nicotine until they no longer use it….thus curing them. There IS a stop usage date on NRT products.

Selling a consumer an electronic cigarette as a quit smoking device would mean it necessary to instruct the consumer to eventually move to zero nicotine e-liquid and/or to ultimately quit vaping altogether.

For those who think that the mere fact that there is a zero nicotine e-liquid available means it treats nicotine addiction; please note that there is zero nicotine Snus and even a zero nicotine patch that is apparently not an NRT, but yet does claim to help users quit smoking (quit using nicotine). Of course no drug, means no “new drug”, which means it isn’t a NRT.

If there is no stop usage date, then how can an electronic cigarette cure nicotine addiction? And how can continuing the action that got the user addicted to nicotine in the first place help cure their addiction? If smoking / vaping / using an electronic cigarette with zero nicotine is the cure, then so is smoking a zero nicotine tobacco cigarette. Oddly enough, these nicotine free cigarettes do claim to help the user quit smoking, but still they are not an NRT.

So we have products that contain nicotine, have no stop usage date, and make no quit smoking claims that are not NRTs (dissolvables, Snus)
We have products that contain no nicotine or any drugs, that do make quit smoking claims and they are not NRTs (zero nicotine patch, nicotine free cigarettes)
We have products that contain nicotine (or other drugs), have a stop usage date, and claim to help users quit smoking. These are NRTs (gum, patch, pills)

Which of these is most suitable for the electronic cigarette? To be classified as a new drug under the classification of a NRT, the product must 1) contain a drug and 2) have a stop using nicotine date or imply one with the claim of quitting smoking. Also, the American Lung Association states, “To be most effective, nicotine replacement products should be used in conjunction with a behavior change program.” (Update: we now link to the Archive.org page of the American Lung Association as it appears they recently took down this page) It is pretty obvious that electronic smoking is a continuation of the action of smoking, thus making it a rather ineffective NRT at best.

Most reputable e-cigarette suppliers don’t claim it helps anyone quit smoking and there is no proof that it does. I have yet to see any manufacturer or supplier recommending a stop usage date. It can come with nicotine or not.

So an e-cigarette that contains no nicotine (or any other drug) and makes no quit smoking claims should be labeled (and regulated) as an NRT? If so it would be the only product of it’s kind.

And with nicotine e-liquid and no stop usage date, we have a product that perpetuates nicotine addiction, not cures it. The upside? Nicotine alone kills very, very, very few people (if any) but inhaling burning tobacco kills hundreds of thousands.

A Tale of Two Futures of The E-Cigarette

The e-cigarette or electronic cigarette mimics smoking using vapor. It can contain tobacco products, but doesn’t necessarily need to. Some believe it helps people quit smoking, while others (such as Instead) believes it is not a quit smoking product. So where does it fit in? A tobacco product needs to contain tobacco. A new drug needs to cure, treat, diagnose, or mitigate a disease or condition.

There is no clear answer. But, when we look past the question of regulation, taxation, and ultimate control here is what we find:

A product that a decent percentage of smokers find to be a reasonable alternative to burning tobacco. Inhaling burning tobacco is known to cause cancer and a multitude of other problems for the user and potential for those near the user. Inhaling vapor from an e-cigarette has not been shown to cause issues for the user or by-standers. There may be unforeseen issues of inhaling propylene glycol or glycerin vapor in the long term, but there is no way to tell without decades of testing. In the mean time, inhaling burning tobacco would continue to kill. It is hard to believe that inhaling propylene glycol for 20 years would be worse than inhaling all the dangerous chemicals found in tobacco smoke for 20 years. Even if the FDA was correct and the vapor contained traces of TSNAs (which it didn’t…..it found those in the liquid), tobacco smoke contains these TSNAs in much, much higher levels.

So who should regulate it? The FDA thinks they should as an NRT (Nicotine Replacement Therapy). The issue is this; as an NRT it would need to be pulled from the market and submitted by a pharmaceutical company as a quit smoking product. The cost is in the tens of millions and the testing can go on for years. Even after it is approved, it can then only be sold in pharmacies either with or without a prescription. This is all assuming a pharmacy even sees the potential and submits the application. In the meantime, people keep burning tobacco at their regular rate and dieing.

If we skip into the future and do find electronic cigarettes sold in pharmacies, we will find tobacco cigarettes being sold in gas stations. We will likely find electronic cigarettes have now become more expensive than tobacco cigarettes (the pharmaceutical company would need to make back their tens of millions). We find at least some smokers disappointed that they didn’t quit using the e-cigarette as the package so boldly claims.

Now lets look at an alternative future, one where regulation has come in a different form such as via the tobacco bill or via the industry itself or via a newly created category. The product is sold in gas stations beside tobacco cigarettes. Companies compete to reduce their prices while consumers continue to demand innovation, safety, and function. There is competition. It is marketed as another way to smoke. Smokers freely use the e-cigarette instead of their tobacco cigarettes, whether completely or sporadically.

Which scenario is in the best interest of the smoker and of by-standers?

Electronic cigarettes are not safe. They are not healthy. But inhaling burning tobacco is known to carry a high risk of cancer.