The Electronic Cigarette Association has just released a letter on it’s website that it will be sending to each member of Congress as well as some other public officials. In it, along with some information about the very poor job the FDA did in testing the electronic cigarette, there is important information about the position of the ECA when it comes to selling to kids. He is a quote:

“We do agree with the FDA, however; that E-Cigarettes should not be purchased or consumed by those under the legal age of smoking. We support any legislation, be it state or federal, that makes it illegal to sell e-cigarettes to children and those under the legal smoking age. We only market our products to committed long term smokers and would never want this to entice anyone who is not already addicted to nicotine to use our product.”

We at Instead Electronic Cigarette fully support the ECA’s stance and agree that it is important to keep those under the legal smoking age from purchasing electronic cigarettes or any other product that may contain nicotine.

Read the full Electronic Cigarette Association Letter To Congress

A humorous evaluation of the FDA press release regarding electronic cigarettes:

Recent Studies Indicate That the FDA May Contain Trace Elements of Bos Taurus Egesta

Update:  Since “13 Guys Named Ed” use a one page type website and the referred story is now buried, here is the actual post:

Recent Studies Indicate That the FDA May Contain Trace Elements of Bos Taurus Egesta
By Jason Katzwinkel

An FDA News Release from July 22, 2009:

FDA and Public Health Experts Warn About Electronic Cigarettes
The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Do you happen to have a beverage at your side? What is it? … Wait, what? Are you serious? O’m'gawd, your drink contains an ingredient used in antifreeze! Yeah, that’s right. Water. The term “…is an ingredient used in antifreeze” is the comestible, fear-mongering equivalent of “…then the terrorists win.”

I must concede that diethylene glycol is indeed toxic. That much is true. But how toxic is it? It possesses one-tenth the toxicity of household aspirin, not to mention one-fortieth the toxicity of nicotine, the primary component of e-cigaratte vapor which is administered in much higher doses. So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts nicotine, you’d stare blankly, shrug your shoulders, and take another long satisfying drag off of your e-cigarette before blowing a bunch of vapor in their faces. But when somebody starts throwing around a term like ‘diethylene glycol,’ people pay attention. Nobody knows what the hell it means and it doesn’t sound like something you’d necessarily want a tall frosty mug of.

Or does it? Diethylene glycol is also an ingredient found in toothpaste, mouthwash, cough syrup, dog food, wine and cigars among plenty of other consumer products. Do you know what it is not an ingredient of? Antifreeze. Propylene glycol is used in antifreeze. Diethylene glycol is used in coolants. Let’s get our scare tactics straight, shall we?

I’m reminded of city officials in Aliso Veijo, California who nearly proposed a ban on polystyrene containers because they heard that Styrofoam cups may contain dihydrogen monoxide, a colorless odorless chemical that is the main ingredient of acid rain and is lethal when inhaled. What is dihydrogen monoxide? H₂O.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

I have yet to see any marketing for these devices out in the wild, let alone marketing geared toward young people. My own searches bring up loads of marketing, but nothing even remotely geared toward teenagers. Every bit of e-cig marketing that I can find consists of either poorly constructed web pages that don’t appeal to anybody, or lots of heraldry, parchment and black satin. Perhaps teens are more sophisticated than I recall.
And c’mon, FDA. It’s like you’re not even trying. Chocolate and mint may appeal to young people? I guarantee that chocolate and mint appeal to young people. Chocolate and mint appeal to all people. That’s like saying scuba divers are preying on children because scuba diving places a major emphasis on breathing, an activity that many young people are known to participate in. What exactly would adult-centric flavors be? Liver & onions? Butterscotch hard candies? Dentu-Creme? What’s the flavor that appeals to twenty-four-year-olds and not sixteen-year-olds? It doesn’t exist.

Marketing aside, these things cost fifty to one-hundred-and-fifty dollars each, not including accessories and recharges. A pack of smokes? Ten bucks. The Senate has approved a number of tax increases on cigarettes with the specific logic that the higher the cost on cigarettes, the fewer the teens that will smoke them. If the FDA has anything to fear, its that tobacco cigarettes will act as a gateway to e-cigarettes.

Regardless of price, however, teens don’t start smoking for the flavor. “Boy, I sure could go for a mouthful of stink right about now.” Kids start smoking to be popular. To fit in. To be cool. To be bad ass. If some punk shows up on a street corner with an e-cigarette, it’ll be shoved up his ass within sixty seconds if he’s not laughed into oblivion.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

Do you see what they did there? Two unrelated sentences jammed together in a flurry of words to create the illusion that these specific public health experts are saying something that they never said. What that paragraph breaks down into is, “Some people have denounced e-cigarettes. The topic will later be discussed by these four other public health experts.”

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

If the FDA has no way of knowing the amounts or kinds of other chemicals in e-cigarettes, how do they specifically mention diethylene glycol and other carcinogens? And, in the very next paragraph: “The FDA’S Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of of cartridges from two leading brands of electronic cigarettes.” So this whole letter boils down to, “We’ve determined that e-cigarettes contain a number of chemicals, but we have no way of determining if there are any chemicals in these e-cigarettes because nobody has submitted these e-cigarettes we’ve been analyzing for analysis.”

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

Nitrosamines! Another ten dollar word. Scary stuff. It’s true that some nitrosamines might be carcinogenic; half of them have shown trends that indicate that they might be carcinogenic in humans. The risk is certainly there, but it’s not like the FDA has cared about it before, because anybody can find nitrosamines in many food products including beer, bacon, fish, pickles, and a variety of other meats and cheeses, as well as in party ballons and condoms. And, of course, in cigarettes.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

None of this is to say that I am pro- or anti-electronic cigarettes. Or that I am pro- or anti-smoking. I, myself, am an ex-smoker who can understand the benefits and detriments of smoking or not smoking tobacco or e-cigarettes. I’m not here to convince you one way or the other except to say that not smoking at all is probably the healthiest way to go, should you find yourself concerned about such things. My primary goal is to open the question: “What’s in it for the FDA?”

Why would the FDA put out a letter that is so obviously spun to demonize electronic cigarettes with virtually no evidence that they cause any more harm than the tobacco cigarettes that are perfectly legal today? I don’t know the answer to that, but I am curious to find out.

Below is the summary of the Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”.

The review of the now infamous FDA report on electronic cigarettes was done by:

Janci Chunn Lindsay, Ph.D.
Exponent Health Sciences
Toxicology and Mechanistic Biology Division
10850 Richmond Ave. Suite 175
Houston, TX 77042
July 30, 2009

It was done on behalf of NJoy, who was one of the companies the FDA targeted with their testing. It is important to note that NJoy is also one of the companies currently in litigation with the FDA. The summary is below, but you can download the entire review of the FDA’s report on e-cigarettes in pdf here.

SUMMARY:

* The report failed to present standard protocols for proper study design with regards to
the testing of the referenced control device, documenting the number of samples tested
either within or across tests, or presenting statistical analyses when quantifiable results
were obtained.
* The chemical content of similar nicotine-containing FDA-approved products was not
completely described with respect to the presence of tobacco-specific nitrosamines
(TSNAs) and other tobacco-associated impurities that have also been found in nicotine
replacement therapy (NRT) devices at similar, if not higher, levels.
* In the lots that were tested by the FDA, none of the key chemicals of concern in this
study such as TSNAs and tobacco-associated impurities were able to be quantifiably
measured in the liquid of NJOY’s cartridges because they were all below the limits of
quantification (LOQ).
* All of the tobacco-associated impurities found in the NJOY products were “present
but at less than the level of the Nicotrol® inhaler [manufacturer] specification”
according to the FDA report.
* There is no indication in the published scientific literature that cotinine or β-nicotyrine
are carcinogenic or have toxicity ratings of concern. These were the only tobacco-
associated impurities found in trace levels in the vapor phase of (some of) NJOY’s
products.
* The report does not reflect the actual dose of nicotine delivered to the user from the
“control” Nicotrol® inhaler device when used as recommended by the manufacturer
(6–16 cartridges/day or 24–64 mg of nicotine, 50 mcg/100 mL puff). By comparison,
NJOY devices delivered 46 mcg/100 mL in the highest-strength cartridge tested,
according to the FDA report.
* Data presented in the report does not adequately support the opinion that users of
NJOY products would actually be exposed to TSNAs and tobacco-specific impurities
in the vapor phase during normal device use; and if exposed, that those levels would be
a health concern as compared to other FDA-approved products.

Below is a quote from an article in the Washington Times named FDA Smoke Screen On E-Cigarettes written by Dr. Elizabeth Whelan, president of the American Council on Science and Health.

“In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.”

Long live the freedom to choose.

BOSTON, July 27 — The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential.

A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA’s disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers.

In a July 22 news release, the FDA cited the detectable presence of carcinogens and “toxic chemicals” in a “small sample” of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.

Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story.

“The FDA’s laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes,” says Dr. Michael Siegel. “The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: ‘Are electronic cigarettes safe?’ That is not the right question. The right question is: ‘Are electronic cigarettes much safer than traditional ones?’”

Dr. Rodu states, “The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes.”

Dr. Joel Nitzkin speaking as individual states, “The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new “reduced exposure” cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill — FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

###

For more information and interviews, contact:

Michael Siegel, MD, MPH
Professor
Department of Community Health Sciences
Boston University School of Public Health
617-638-5167
Email: mbsiegel@bu.edu

Joel L. Nitzkin, MD, MPH, DPA
Chair AAPHP Tobacco Control Task Force
Phone: 504 899 7893 or 800 598 2561
Fax: 504 899 7557
jln-md@mindspring.com
www.aaphp.org

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville
Phone: 502-561-7273
Email: brad.rodu@louisville.edu
http://rodutobaccotruth.blogspot.com

ON BEHALF OF NJOY, CEO Jack Leadbeater
July 23, 2009
NJOY RESPONSE TO FDA CONFERENCE CALL

NJOY’s products have been on the market since at least April 2007 with no reports of significant
adverse health consequences. We do not market our products to children, and indeed take
affirmative steps to ensure that our products are not sold to minors by requiring retailers to agree to where the product is placed and request verification of appropriate age as it pertains to each state law.

NJOY has been tested by an independent third-party laboratory, Exponent. This testing, as well
as our consultation with medical experts, gives us confidence that our products are appropriate
alternatives for traditional cigarettes for the committed smoker. We are therefore surprised the
FDA’s testing has resulted in the Agency suggesting that our products represent a health risk on
par with conventional cigarettes. We will provide more information on NJOY’s testing and the
results in the next few days.

The FDA’s report admits its conclusions don’t apply to all products.

* Broad statements were made on the call that Diethylene glycol (DEG) was detected in
the test samples, but the specific report shows that DEG was not found in NJOY’s
products.

* The results touted by FDA related to antifreeze are inapplicable to NJOY’s products (per
the FDA report) .

* FDA’s report simply shows that the products contain certain tobacco-specific impurities
(at much lower levels than conventional cigarettes, and this is something we are having
our experts compare in the reports conduct by NJOY and the FDA).

We find it interesting the FDA’s report is dated May fourth and is only now being released. The
FDA has not asked us to relabel our product, or to remove it from product shelves, at any point in the two years we have been in the market.

We remain willing to work with FDA to address the Agency’s concerns.

———————–

For more information, read How The FDA Misled The Public About Electronic Cigarettes which also includes a link to the actual FDA study.

At 3pm, 7/22/09, the FDA made an announcement to media regarding the status of the electronic cigarette. The call was headed by Judy Leon of the FDA Office of Public Affairs.

Due to the recent litigation between two electronic cigarette companies, Smoking Everywhere and nJoy, and the FDA, the FDA tested 18 cartridges from the two companies. From the testing done by the FDA on the electronic cigarette, it was noted that they found inconsistencies in the manufacturing process and that in some of the cartridges there were small amount traces of known carcinogens (Tobacco-Specific Nitrosamines) and Diethylene Glycol found in one cartridge from Smoking Everywhere, which is harmful to humans. What they also withheld from the announcement is that diethylene glycol is used for drying tobacco products and is found in tobacco products. They also failed to mention that Tobacco Specific Nitrosamines (TSNAs) are also found in the currently FDA approved NRT’s.

From the conclusions of these lab tests performed by one FDA lab, it was noted that the electronic cigarette cartridges differ from one manufacturer to another and therefore, quality control is of great concern to the FDA. We can’t disagree. The whole industry is already moving towards implementing better manufacturing processes.

The rest of the discussion was led by some heavy anti-smoking hitters in the public health industry. Jonathan Thomas of the Institute of Global Health, Dr. Jonathan Winickoff, Chair of the American Academy of Pediatrics and Dr. Matthew Mikenna of the CDC’s Office of Smoking and Health, all noted that their greatest concern is how the electronic cigarette is marketed and also how it has the ability to be a gateway to tobacco use.

The marketing concerns raised were that the ecig is marketed heavily to children through the enticing use of candy/fruit flavors and also that by putting “Adult Use Only” on a product such as the electronic cigarette, is a direct marketing tactic to children.

When asked if the electronic cigarette was a legal product to be sold in the US, Michael Levi, counsel for the FDA, noted that all of the products that have been held or seized have been new drug and drug delivery devices due to the marketing of them as smoking cessation devices. He also noted that in order to continue marketing them as NRT’s they would need the proper documentation and studies to sell them as such. He could not further comment due to the current litigation.

When further asked if anything has changed due to this call, if this announcement was actually to announce anything, Levi simply noted that the FDA wanted to make the public aware that the electronic cigarette is cause for concern based on the tests they had performed and that there was definitely a need for regulation to ensure that each and every product on the market is equal to what it says it is.

There is no doubt that the electronic cigarette needs to be regulated. But in what capacity and who is going to take on this huge task? It was very clear from the discussion that the FDA takes one stance: This is not a proven smoking cessation product and the only way they want to see this on the market is if it is.

It was clear from the lack of having any doctors/groups such as Dr. Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians or Dr. Michael Siegel of Tobacco Analysis, both prominent anti-smoking advocates but also FOR the electronic cigarette as a tobacco harm reduction strategy, that the FDA needs to be open to further discussions and also to acknowledge testing that has been done to date.

Hopefully, the FDA will not be blindsided by their defensive position due to their current litigation to see that even with the above testing on two of hundreds of different cartridges/liquids available on the market that there are a group of suppliers who do wish to be regulated, but regulated fairly.

It is interesting also that the doctors who were against the electronic cigarette and noting it as a “gateway to nicotine use”, did not voice any concerns regarding the recent overdose of nicotine by the 12 year old boy on a playground in the UK. A direct result of an anti-smoking group giving children nicotine without parental consent.

Or the fact that in another article today, Iayad Hasan, Director of the Cleveland Clinic Tobacco Treatment Center, declined the use of the ecig as a smoking cessation device because it does in fact leave the hand-to-mouth habit in tact and that does not aid in smoking cessation.

The facts are very clear. The electronic cigarette does need to be regulated. It does need quality control on the manufacturing side and it does need regulations for marketing. It is evidently clear that the electronic cigarette has helped thousands of tobacco cigarette users and it is equally clear that the Electronic Cigarette Association is needed now, more than ever. It is needed to implement standards. It is needed in order to keep the market free and open and not run by pharmaceutical and tobacco interests.

We have made a move that we believe brings even more value to our electronic cigarette kits. Each kit sold now comes with a USB charger and a USB to AC adapter. So now you have the option to charge your electronic cigarette batteries via a USB port on your computer or use the adapter to charger from a household wall outlet. This can also make traveling much easier as the USB charger is extremely compact. The total length of the USB charger is less than 2.5 inches. Here is a picture:

The USB to AC adapter is also quite compact with the longest side at just over 2 inches. To charge from a wall outlet, you simply plug the adapter into the socket and then plug the USB charger into the adapter. Here is a picture of the adapter:

So, now all Instead electronic cigarette sets come with this new USB/Adapter combination. If you wish to purchase the USB charger / USB to AC Adapter combination for your existing set, visit New Electronic Cigarette USB Chargers. We should note that these chargers will fit almost any model of e-cigarette.

As a side note, since we still have some of the older USB chargers left in stock, we have drastically reduced the price on these USB chargers for anyone wanting to charge their e-cigarettes via USB. Visit E-Cigarette USB Charger for this limited time deal.

The media attention about the electronic cigarette has been growing since it first emerged onto the market a few years ago. Although some has been very positive, or at least factual, other articles wander into the arena of attacking via misinformation. To help the public understand some of the false accusations about e-smoking technology, we issued a press release which contains some responses to the most common attacks against electronic cigarettes. Here is a quote from the press release:

And when asked about the safety and effectiveness of the electronic cigarette as a smoking cessation device, Mr. Watt responded by saying, “For those who want to claim it is a smoking cessation device, then they should do the testing. I believe smokers should have the right to choose an alternative to smoking that doesn’t contain the 4,000+ chemicals found in tobacco smoke. Quit or die is a flawed philosophy”

Read “The Battle Over Electronic Cigarettes“

The new Marlboro Brand Protection Act as some are calling it, was signed into law by president Obama on June 22nd, 2009. The actual bill is called H.R.1256, The Family Smoking Prevention and Tobacco Control Act and essentially gives the FDA regulatory control over tobacco products. Many argue that the Bill simply maintains the current market share by Philip Morris, who helped “kraft” the Bill H.R.1256 has the potential to put very tight restrictions on smoking alternatives that could have otherwise had a net positive effect on public health.

Whether or not it is a good bill or a bad bill, that seems to be in the hands of the FDA who will create the procedures and regulations to govern this age old industry. It is clear the FDA will have a lot of power in determining who makes money from selling tobacco and tobacco products. What is not so clear is how this “Big Tobacco meets FDA Bill” will effect the electronic cigarette. Below is the definition of a tobacco product according to the Bill:

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products- Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

`(rr)(1) The term `tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

`(2) The term `tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).

`(3) The products described in paragraph (2) shall be subject to chapter V of this Act.

`(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’.

The Electronic Cigarette as a Tobacco Product

I believe we can make a couple assumptions. First, the e-cigarette with zero nicotine would certainly NOT fall into the definition of a tobacco product. In this case, there is no nicotine, no tobacco, no drug…..just propylene glycol or vegetable glycerin, water, and flavoring. Second, the actual electronic cigarette device (battery, atomizer, mouthpiece/cartridge) could not be considered a tobacco product. So, the only thing that could be classified as a tobacco product would be the eliquid. But eliquid can be made with synthetic nicotine or with a compound similar to nicotine or with nicotine from another source other than tobacco. And if it is, then there would be no part of it derived from tobacco. The other argument is that nicotine extracted from a tobacco plant and purified is so far removed from the original plant that it ceases to be a tobacco product. This falls in line with the FDA’s current assertion that the electronic cigarette is a new drug and therefore needs approval.

The Electronic Cigarette as a New Drug

First off, it is a stretch to claim nicotine is a “new drug”, when in fact it is one of the oldest drugs used by man. Second, if the definition of a drug must include “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” then the electronic cigarette does not fall into this category. Using the e-cigarette is smoking, it doesn’t cure it (if smoking is even a disease to begin with). Some call it vaping, but it is still the habit of hand to mouth. Drug addiction is considered a disease by the CDC. So does the electronic cigarette diagnose, cure, mitigate, treat, or prevent drug addiction? Since e-smokers continue to get the nicotine, then NO. Users could use the zero nicotine eliquid, but there is no evidence that they will or even if they do, that they will stick with it and not go back to nicotine. If electronic cigarettes treat nicotine addiction then cola treats caffeine addiction.

So What is the Electronic Cigarette?

As many of us in this industry have stated from the beginning, the electronic cigarette is unique. It is a technology that will continue to create ripples well into the future. This doesn’t mean it should be given a free pass and it doesn’t mean it should be pulled off the market. It means we need to have rational and intelligent discussions with regulatory bodies to ensure the industry follows standards and consumers are protected. Instead of these discussions, the e-cigarette industry has been attacked by politicians with local agenda’s, by public health organizations with money ties to the pharmaceutical industry, and the FDA who seems to take orders from the pharmaceutical companies. Considering the size and scope of smoking cessation sales in the US and worldwide, it is not hard to contemplate the drive to protect the market.

The e-cigarette industry has begun the process of legitimizing the industry through the formation of the Electronic Cigarette Association. Although a very young organization with much yet needed to be done, the ECA strives to implement standards and bring trust to this new industry. The ideal situation would be for the FDA to work with the ECA to create standards while using industry money to regulate, rather than tax payer dollars. Prohibition didn’t work. The “quit or die” philosophy doesn’t work. And banning products that have the potential of the electronic cigarette can not possibly be in the best interest of public health.