Smokers have become the constant target of advertising and pressure from public health advocates and companies selling quit smoking products. Smokers have been told that they are killing themselves and killing those around them and the only way to fix this is to stop smoking. And they have been told that the best way to quit smoking is to use an FDA approved Nicotine Replacement Therapy product or drug. Smokers have been told that they need to quit smoking or die.

No one, including and especially smokers, can deny the health implications of smoking tobacco. But even with this knowledge, many smokers still find it hard to give up their smoking habit. Many try the nicotine gum or patch or pill but inevitably go back to smoking tobacco. But why?

Many quit smoking products have nicotine and smokers have been told that nicotine is what they are addicted to. So why would anyone go back to smoking? It is quite possible that you are addicted to your habit. Smoking is more than just nicotine. It is the hand to mouth action. It is the inhaling and exhaling. It is “taking a break”.

If you have tried to quit smoking, but have failed, try changing your smoking habit. Instead of smoking a tobacco cigarette, puff on an electronic cigarette. It will allow you to continue the act of smoking without combustion. Instead of lighting up your cigarette, fill your e-cigarette cartridge. Instead of opening pack after pack of cigarettes, charge your battery.

If you want to live a healthy lifestyle, quit smoking completely. If you like the act of smoking, but not the smoke itself, try changing your habit with an electronic cigarette.

Many in the electronic cigarette industry believe that Judge Leon’s ruling against the FDA is the final word in the battle over the future of electronic cigarettes. That is not the case. It was, however, a legal opinion about the potential outcome of a trial regarding the classification of the electronic cigarette. Judge Leon gave opinions on the 3 arguments that the FDA was making to show electronic cigarettes are a drug delivery device and that they have a legal right to stop the importation.

Structure Or Function Claims

The FDA argues that electronic cigarettes contain nicotine, a drug, and it effects the way the body works so it is a new drug.

Judge Leon answered this argument by stating, “Because plaintiffs sell their electronic cigarette products for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.”

The argument that the FDA is making here is the same one they made when they tried to classify tobacco cigarettes as a new drug. That didn’t work either.

Therapeutic Claims

The FDA argued that the sellers were making therapeutic claims, thereby making the electronic cigarette a new drug.

By definition, a new drug must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

Judge Leon’s opinion was, “there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette.”

He also stated, “Nor does the fact that plaintiffs advertise their products as a healthier alternative to traditional smoking mean that electronic cigarettes quality as a drug-device combination under the FDCA.”

So, making health claims does not make a product a new drug. However, he did mention that making quit smoking claims or nicotine treatment claims DOES make the electronic cigarette a new drug. In this case, there was no evidence either company was making such claims.

Harm To Third Parties And The Public Interest

Lastly, the FDA argued that stopping the importation of electronic cigarettes was for public health. A sad argument at best considering that electronic cigarettes are the alternative to a product that kills over 400,000 Americans each year.

Judge Leon found that “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.”

Conclusion

Judge Leon found that this was “yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA”.

So what does this mean?

It means that the FDA can not legally stop the importation of electronic cigarettes by Smoking Everywhere or NJoy. It means Judge Leon believes that if this goes to trial, the e-cigarette suppliers will win. It means that Judge Leon believes the electronic cigarette is a reduced harm tobacco product, as outlined in the Tobacco Bill.

Our Conclusion

The FDA can continue to stop other companies shipments, but leave themselves open to future lawsuits. Without specific therapeutic claims (i.e. quit smoking and treating nicotine withdrawal claims), they have no basis to stop the products until such time as they do prove it is indeed a new drug or the electronic cigarette is legally classified as a tobacco product as Judge Leon suggests. What is interesting is that Judge Leon made no mention of the distinction between the zero nicotine e-liquid and that which contains nicotine. Without nicotine, the e-liquid contains no part of tobacco. And the batteries, chargers, atomizers, and cartridges contain no part of tobacco. So it appears that the only thing that could possibly be included in the definition of a “tobacco product” is e-liquid that contains nicotine. And this has not been settled either.

I was in our local Mall the other day and ran into an electronic cigarette kiosk. Curiosity killed the cat as the old saying goes, so I stopped in to hear what the salesperson had to say.

The first thing that caught my attention was the claim that one could quit smoking with the electronic cigarette. Throughout the two plus years we have been blogging about the e-cig, we have hashed this one out over and over. There is no scientific proof that the electronic cigarette helps the user quit smoking. Also, the action of smoking is still there and can you really quit an action if you are still participating in that action? While you might be eliminating the effects of combustion by switching to a vaporizer, you are still getting nicotine and according to the Center for Disease Control, nicotine addiction is the disease, not necessarily smoking. We understand why the pharmaceutical companies and the “public health” organizations (who get their money from the pharmaceutical companies), want to call it a quit smoking device….so they can be the only ones to sell it. What we don’t understand is why e-cigarette suppliers want to make the quit smoking claim just to try and sell a few more kits while misleading the public and putting our entire industry at risk. We believe it is a smoking alternative, pure and simple.

The second claim I heard was that the electronic cigarette is the healthier way to smoke. While we firmly believe vaporization is superior to combustion for a whole host of reasons, there are currently no clinical studies on the long term effects of electronic cigarette vapor. You may read from other dedicated e-Smokers that they see huge differences in their own health, but there is still no evidence of what the long term effects might actually be.

Another statement that jumped out was the ingredients that are claimed to be in this particular brands liquids; nicotine and water. This is not true…..or at least not completely true. Pure water needs a much higher temperature in order to vaporize so the base of all current e-liquids is either propylene glycol or glycerin or a combination of both. Propylene glycol is used widespread through many products currently on the market and the closest comparison would be for inhalation medicines like asthma inhalers. The idea that we are simply blowing out water vapor is untrue. What was interesting is that this company referenced Dr. Laugesen’s original study on the electronic cigarette vapor, yet missed the important fact that the vapor is not just water.

While wandering around the kiosk taking in all of the information, I ran across a handout compiled by the company to appear as a report from the FDA. According to the wording on this flyer, the FDA proved through recent testing that the e-Liquid was in fact 1400 times safer than tobacco cigarettes. This is not true. It is also not true that they determined e-cigarettes to be dangerous. In fact, the FDA testing was so poorly done it is hard to draw any relevant conclusions.

When it was all said and done, it was apparent the salesman was regurgitating what he had been told to say. For instance, he was completely unaware of the fact that ecigs have been in the US for almost three years now (he told me 4 months!). He also mentioned all other brands were knock-offs. Also not true. There may be many brands available, but very few have been on the market as long as the INSTEAD Electronic Cigarette (Established 2007).

I will give this kiosk one thing; Instead of putting kits, liquids and cartridges out on the kiosk counter, the only thing within reach were videos and flyers. All product was kept in locked drawers that consumers could not see into. The one sample was in a locked glass case directly in front of the cash register where the salesperson sat. If a supplier is going to go the kiosk route, this is the way to go. It makes it impossible for those young teen hands from grabbing stock and running.

We wrote this blog post not to discredit any particular company or method of sales, but rather to battle some of the misinformation being presented to the public. These falsities mislead consumers, misrepresent the industry, and give electronic cigarette opponents more ammo to recklessly shoot.

The intended use of a product is important not only from the perspective of categorization by the FDA but also to ensure the consumer is not misled by advertising. The FDA has been arguing that the intended use of the electronic cigarette is, or should be, to help people quit smoking. We do not believe this to be the case. We believe that this is another way to intake nicotine and participate in the action of smoking, without actually burning tobacco.

Many consumers who signed the electronic cigarette petition have stated that they have quit smoking with the electronic cigarette. However, these same consumers don’t state they have quit using nicotine, just that they have quit smoking. Smoking is not a disease according to the CDC, but nicotine addiction is, and there is no proof that electronic cigarettes help treat nicotine addiction. There is also no evidence that these consumers will not go back to smoking tobacco cigarettes.

It is a disservice to consumers to lead them to believe the electronic cigarette is a quit smoking product. There is no evidence as such. It continues the habit and the addiction to nicotine.

The intended use of the Instead Electronic Cigarette is to use it for the action of smoking. If you like to smoke, you may like the electronic cigarette. If you want to quit smoking, we recommend you go cold turkey or use a product that has been proven to help smokers quit.

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.

We wanted to address the report found on CBS News regarding the Electronic Cigarette as being an illegal product that cannot be sold.

As we noted in our recent post The Electronic Cigarette as a Homeopathic Drug, it is Instead’s belief that the device itself should not be held at customs because it is in fact a vaporizer and vaporizers appear to be legal.

The electronic cigarette has been sold in the United States for over two years now.  Up until this point, ATF has decided that they do not wish to regulate the e-liquid and the FDA has not wanted to get involved as well.  Now, all of the sudden they do?  It is interesting that millions are flocking to the e-cig and we can only come up with one reason as to why this nonfactual report would be aired:  The anti-smoking campaign is furious and the pharmaceutical companies have most likely noticed a drop in their profits when it comes to NRT’s.

Now, it does not help that some marketers are claiming this is a quit smoking product.  It is not a quit smoking product.  It is a smoking alternative.  It allows people to switch from a tobacco cigarette to something else.

Industry wide, Safe Cig has been warned to change their content on their website and to stop advertising them as a quit smoking method.  It sends the wrong message to the powers that be.  However, we would like to note that Jon from SafeCig has stated that Stephanie Stahl did not even show up for her interview with him and sent a stage hand to do her work.  There’s some good journalism integrity for you.

As far as the claims by the American Cancer Society and these not being tested, that is simply untrue and false statements should be ignored.  As we noted in our post Clinical Trials and Testing of the Electronic Cigarette, there have been tests done of a variety of different e-liquids and they have been found to be safe.  In fact, in one report, Dr. Laugessen even states that the electronic cigarette is a “safer alternative to tobacco cigarettes”.

Also, with the statement that the “problem is the vapor you see has not been proven safe”.  This statement is correct.  HOWEVER, the second hand smoke from a tobacco cigarette HAS been proven UNSAFE and therefore, if it can be sold legally, then there is absolutely no reason a smoker cannot make the determination for themselves that the vapor is better than tobacco smoke.

We find it extremely interesting that such a hoolala is being made over a product that is actually moving millions of people world wide from tobacco and pharmaceutical products.  The only thing we can come up with is that the “big boys” aren’t getting their dimes and they are less than happy.

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”!

I’ve been getting a lot of questions about the electronic cigarette lately. Most are found in various places on the site, but for ease of use, I will try to give a few quick answers and the most frequently asked questions and the electronic cigarette.

Q. What is the difference between an e-cigarette and an electronic cigarette and an e smoke?

A. Nothing….just various names for the same product.

Q. What is the difference between the electronic cigarette and the mini electronic cigarette?

A. Size is the biggest difference. The white electronic cigarette we sell and the mini electronic cigarette work in the same manner. The regular electronic cigarette (also referred to as the white e-cigarette) is about the size of a pen, while the mini electronic cigarette is just slightly larger than a traditional tobacco cigarette. The nicotine cartridges for the normal sized electronic cigarette tend to last slightly longer than those for the mini.

Q. How does the electronic cigarette work?

A. The electronic cigarette is essentially three parts; the battery, which screws into the atomizer, where the mouth piece/nicotine cartridge fits into. When you inhale, the atomizer vaporizes a small amount of the liquid nicotine in the cartridge which is then delivered through the mouth piece. We also have a video about how the electronic cigarette works.

Q. Does the vapor smell?

A. The vapor is exhaled and appears like smoke, but does not smell. The liquid nicotine contained in the cartridge does have a slight odor of the flavor of the cartridge.

Q. What are the nicotine levels?

A. A nicotine cartridge (or ELiquid) can come in high, medium, low and no nicotine levels. This is the amount of nicotine in a cartridge. If you are a heavy smoker or smoke cigarettes with no filter, we recommend starting with high. Smokers of mild or light cigarettes should try the medium.

Q. What flavors are available?

A. We offer Tobacco and Mint (Menthol) flavored nicotine cartridges. We can get other more exotic flavors if you wish. We don’t stock these as they are very low demand. However, if you do want one of these flavors, feel free to contact us with your request and we will order it for you or at least consider carrying it in the future. There is no additional cost, only a longer waiting period to receive your order.

Q. How long does one refill cartridge last?

A. Testing has shown the average inhales of a tobacco cigarette is approximately 15 puffs. A filled cartridge, depending on the model of electronic cigarette, will last from 30 to 60 puffs or 2 to 4 cigarettes. Don’t fall for the “one cartridge is a pack of cigarettes” line….this is simply not the case. WIth that said, a prefilled cartomizer will last longer or about 15 cigarettes worth. These cartridge/atomizer combinations have a much larger wick than a refillable cartridge. In any case, we have switched to ELiquid Smoke Juice that is used to fill empty e-cigarette cartridges. We find this makes for a more satisfying esmoking experience.

Q. How will I know when a nicotine cartridge needs to be replaced?

A. When inhaled, no vapor will be present. This will let you know you need to replace or refill the cartridge.

Q. Do you need to turn on the electronic cigarette?

A. No, when inhaled the electronic cigarette will automatically activate. There is no on/off switch.

Q. How long does a battery last?

A. The battery life will vary greatly with use, but on average about 3 hours under heavy use. For some lighter smokers the battery will last all day. Both the electronic cigarette and mini electronic cigarette come with 2 batteries and a charger so you never need to go without your electronic cigarette.  When the battery needs to be recharged, the led light on the end will begin to blink.

Q. Will the electronic cigarette help me quit smoking?

A. The electronic cigarette has not been proven as a smoking cessation device and should not be considered a viable way to quit smoking.

Q. Is there a warranty?

A. Our components come with a 30 day replacement warranty.  We have found defective parts will generally be noticed within this period. We take care of our customers, so call or email us if you have problems, even after the warranty period and we will do what we can.

Q. Where do I buy and should I get a set?

A. We offer the INSTEAD Electronic Cigarette Set (2 batteries, 2 atomizer, 5 empty cartridges, 1 charger, carrying case and pouch) and we offer sets that comes with a bottle of Eliquid. Buy Electronic Cigarettes Here.

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.

Although the electronic cigarette is not a quit smoking product, it is an alternative to smoking. There is no one best way to stop smoking or to change habits. Some have had success with the cold turkey route, others with natural methods such as CigArrest ( CigArrest Official Site), and still others have quit smoking with medication, nicorette or the nicotine patch. There seems to be a new “best way to stop smoking” every week especially as technology changes. However, many of these methods do not address the physical habit of hand to mouth. The E Cig may not be the answer to stopping smoking, but it does allow the user to continue the smoking motion. The debate continues about if e-smoking is better for you, but we encourage users to compare the ingredients in tobacco smoke with those in eliquid and esmoke.