The current litigation between two electronic cigarette suppliers and the FDA has everyone in a tailspin. It certainly did not help that the FDA openly misled the public into believing that the electronic cigarette is as (or more) dangerous than tobacco cigarettes. Many medical health professionals have weighed in on this noting the following:

* Dr. Elizabeth Whelan, president of the American Council on Science and Health, called the FDA statement “distorted, incomplete, and misleading. She also noted that “products of combustion cause cancers, cardiovascular disease and lung disease, and more.”

* Dr. Joel Nitzkin, MD, MPH, DPA, FACPM, Chair, Tobacco Control Task Force, American Association of Public Health Physicians stated that “We have every reason to believe the hazard posed by electronic cigarettes would be much lower than 1% of that posed by (tobacco) cigarettes. The testing guidelines in the current tobacco act (circulating through Congress) would represent a ban on electronic cigarettes, (yet) if we get all tobacco smokers to switch from regular cigarettes (to electronic cigarettes), we would eventually reduce the US death toll from more than 400,000 a year to less than 4,000, maybe as low as 400.”

* Michael Siegel, a physician, researcher and professor at the Boston University School of Public Health noted that “What the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis. They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.”

Just for the record, all of the above public health officials are anti-smoking advocates.

The FDA and many anti-smoking groups are calling for the electronic cigarette to be pulled from the market on the basis that it is not a proven quit smoking device. The Electronic Cigarette Association (ECA) President Matt Salmon, former US Congressman from Arizona, noted in a letter to Congress that the ECA “acknowledges the health risks of cigarette smoking and advocates that smokers quit. But we also recognize the struggles that many have in quitting and who are looking for a more convenient and better alternative to tobacco cigarettes. While some of our customers have reported using our devices to help them quit smoking by slowing reducing the nicotine delivery in our products, it is important to note that our member companies do not market their e-cigarettes as smoking cessation products nor make any such claims.”

What is most important is the idea of claims. The FDA was formally named in 1930, and the “FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.” The original act had huge issues mainly that “False therapeutic claims for patent medicines were basically unregulated, as the manufacturer had only to show that he personally believed that his remedy worked to avoid prosecution, and standards for food purity and content were nonexistent.”

In 1938, after the 1937 Elixir Sulfanilamide Incident, where the SE Massengil Company created an elixir containing diethylene glycol as the base ingredient was given to children with strep which led to painful deaths, the Federal Food, Drug and Cosmetic Act was put into place. Following, came several examples of “incidents” and “near incidents” that lead for further revision of the Act.

But the question that lies at the heart of this debate is the electronic cigarette liquid really a “new drug” and is the electronic cigarette hardware really a “medical device”? According to the FDA’s definition of “new drug”, they state that the definition of a drug includes “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” To put this into comparison with other products on the market that do not require FDA approval, let us look at dietary supplements.

Currently, the FDA does not regulate dietary supplements. Those products do not have to be FDA approved for safety, however, they can be recalled by the FDA if there are enough complaints. The only responsibility the manufacturer holds is that “Manufacturers must make sure that product label information is truthful and not misleading.”

Keeping this idea in mind that products can be on the market without FDA regulation, lets look at nicotine. Currently, there is nothing contained within the FDA website referring to nicotine. However, there is a plant out there that has many of the same effects as nicotine and that is lobelia inflata which IS specifically mentioned on the FDA website. The FDA notes in Sec. 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent, that “Any OTC drug product that is labeled, represented, or promoted as a smoking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing.” But what happens if these claims are not to be made and the product clearly states that this product has not been evaluated by the FDA?

Now, let’s review what the FDA considers a “medical device”. The term “device”… means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

For comparison purposes, we need to look at tobacco vaporizers. Tobacco vaporizers are currently not FDA regulated. Many of the vaporizers currently sold on the market today, carry the warning that the vaporizer is not approved for medical-therapeutic purposes. If the electronic cigarette is simply a vaporizer, which is it as it uses no combustion, and there are currently hundreds of other products on the market that vaporize tobacco to deliver nicotine into the body, and those are not classified as “medical devices”, then these smaller, more compact versions should fall into the same category as the larger versions, like the Volcano.

If the electronic cigarette liquid uses ingredients that are found in traditional tobacco cigarettes, all ingredients are FDA approved as generally safe for consumption, and the supplier placing the product on the market is not making any claims, then based on the above arguments, the electronic cigarette liquid is not a “new drug” and therefor does not need to be approved by the FDA. This would also lead to the conclusion that if the liquid itself is not a “new drug”, then the hardware itself is not a “medical delivery device”.

Instead stands firm that smokers should have the option to smoke something other than tobacco cigarettes. There should be regulations and those regulations should be put forth by a regulatory body who understands that tobacco harm reduction products have a place in the free market.

“The Doctors” is a tv show syndicated throughout North America on early to late afternoon tv.  On January 7, 2009, they will review their top ten list of health trends of 2008 and the electronic cigarette made the list!

We are so excited that “The Doctors” have given a real look into the electronic cigarette and cannot wait to hear what they all have to say!  We will have an update of the program later tomorrow and if you can set your DVR, set it now so you won’t miss it!

For more information on “The Doctors”, please feel free to visit their website.  If you would like to add comments to our post tomorrow, please feel free to do so!  The electronic cigarette is really a great invention that will hopefully move smoking into a new realm!  We can hardly wait to see what real doctors are willing to say out loud and on the air about this ingenious smoking alternative!

It was bound to happen!  An informative review by WPVI-TV Philadelphia, PA regarding the electronic cigarette, where Dr. Richard Wender, Jefferson University Hospital family doctor and previous national president of the American Cancer Society, stated that “Anything that gets you off real cigarettes is better for your health.”

This is big news for the electronic cigarette world.  With the spreading visibility of the electronic cigarette, more and more are beginning to notice and ask questions.  Smokers who don’t want to quit because they love the action, can use this as a smoking alternative.

There are ongoing conversations regarding whether the electronic cigarette is a quit smoking device and should be regulated by the FDA.  However, one fact still remains, that unlike the patch, pill, or nicotine gum where one is forced to cease the habitual action of smoking, one is not forced to do the same with the electronic cigarette.  The user is still able to participate in the hand-to-mouth action as well as the dragging and exhaling.

So if you have been wandering around the kitchen, dying for a cigarette out of your secret stash and don’t think you can bear it anymore, try the electronic cigarette.  Also available with no-nicotine.  So if your patch has gotten you out of the nicotine phase but you find the action is missing from your life, give an electronic cigarette a whirl.  Buy your electronic cigarette today!

Also, the electronic cigarette made the top 10 list for 2008 on “The Doctors”!

Just to be clear, electronic cigarettes are not a proven method of quitting smoking tobacco cigarettes.  They are, however an alternative to smoking traditional cigarettes.  Unlike nicotine gum or the patch, an electronic cigarette closely mimics the actual physical motion and feeling of smoking.  It does deliver nicotine to the body via the vapor like mist but doesn’t include the harmful toxins found in tobacco smoke.  Many experts note that nicotine is addictive, but not necessarily responsible for many of the adverse health effects associated with smoking.  The problem comes from the many other natural and added chemicals produced by burning tobacco.

Having a smoking alternative such as electronic cigarettes can provide many smokers an outlet for their addiction.  There is no guarantee that any given smoker will like using the ecigarette or that they will stop smoking tobacco, but for many, it may be just what they have been looking for.

An Electronic Cigarette is not a quit smoking product.  It is however, a replacement to smoking tobacco, which of course is known to be very harmful.  If you have tried products to quit smoking and are back to smoking tobacco cigarettes, you may want to try an electronic cigarette or e-cigarette as it is often known, as an alternative to your current habit. It looks and acts like a regular cigarette, but rather than burning tobacco, it vaporizes liquid nicotine. The vapor is similar to smoke, but doesn’t smell and doesn’t contain many of the toxins associated with tobacco smoke. The electronic cigarette may not be for everyone, but if you are looking for an alternative, it may just be for you.

It is first important to not that Nicorette Gum has been approved to be sold as a smoking cessation device, while the electronic cigarette has not. With that said, they both deliver nicotine so I thought a comparison might be useful. There are more differences between these two alternatives to smoking cigarettes than there are similarities. Both give the user a dose of nicotine, however e-cigarettes or “electronic cigarettes” also provide the user with an outlet for the hand and mouth movement, which can be a very real concern for many who have been smoking and performing this action for many years. e-Cigarettes also deliver the nicotine to the user in a very similar way as a regular burning cigarette; inhaled into the lungs, while nicorette is ingested and absorbed. The debate rages whether nicotine itself is a health concern, but most admit that removing the other additives and toxins found in cigarettes is a good thing.

As any smoker who has tried knows; quitting smoking is hard. In fact some smokers don’t want to quit at all, they just don’t want cancer. If you have tried to quit smoking with no success, you may want to take a different approach and not quit at all. Try an e-cigarette as a smoking alternative. Again, the electronic cigarette is not meant as a quit smoking product, but rather an alternative to smoking tobacco.  Also, this product is not yet FDA approved in the United States and it may or may not end up being regulated by either the FDA or ATF.