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.

The specifics have not been released yet, however it is on good authority that NJoy aka Sottera has officially intervened into the case of Smoking Everywhere vs the FDA over the rights of the FDA to block the importation of electronic cigarettes. This is an update to the “What is Going on with the Electronic Cigarette and the FDA” post. NJoy entering this case is of great benefit to the industry as a whole. NJoy doesn’t make health or cessation claims and making these claims appears to be the only legal basis for the FDA stopping the electronic cigarette from entering the United States. Time will tell if the thousands and thousands of individuals using the e-cigarette are told to stop by the FDA.

For full disclosure, Instead Electronic Cigarettes and NJoy are both part of the Electronic Cigarette Association.

Bill S.982 also known as the Family Smoking Prevention and Tobacco Control Act is now available online. This “Tobacco Bill” was under the name Waxman and now appears to be associated with Kennedy. The Bill is meant to give the FDA regulatory authority over tobacco products. It may or may not have the actual effect of limiting market access to potentially safer tobacco products and maintain the existing tobacco cigarette market. Philip Morris supports the Family Smoking Prevention and Tobacco Control Act.

I encourage you to read this bill and let me know your thoughts. All the implications of this bill are unclear, especially with regard to the electronic cigarette. I do hope Congress has the good sense to create a fair marketplace where smaller companies can compete with established Tobacco companies by offering alternatives to a known killer.

Finally a large media outlet has printed a story calling a duck a duck.

The Electronic Cigarette Association (ECA) is a 501(c)(6), which is a not-for-profit trade association. This allows us to collect donations (not tax deductible as a charitable contribution) but still lobby the government to recognize our agenda.

We have elected the board members and officers (Matt Salmon - President, Jack Leadbeater - Chair, James Watt - Vice Chair, Chad Green - Treasurer, Antoinette Lanza, Nick Bird, and Rob Winslow) and are just completing the official member application. The application will be circulated once complete.

The ECA has minimum membership dues for suppliers and manufacturers of a one time application fee of $500 USD and a monthly fee of $300 USD. Many companies are paying much more than the minimums. These funds, along with any donations received, will be used for these purposes:

1) Engaging Policy Impact Communications (www.policyimpact.com) to lobby Congress. Our lobbying efforts include proposing amendments to the Tobacco Bill (which continues to change names, but was first introduced by Waxman and now a new one is being introduced by Kennedy). The amendment proposed is designed to help protect the electronic cigarette from being pulled off the market.

2) Engaging Policy Impact Communications to perform the administrative duties necessary to keep the ECA in good standing with the IRS and other government agencies.

3) Engaging a media relations firm to battle misinformation being presented by e-cigarette opponents and to expand the reach of electronic cigarettes so all smokers have the freedom to choose an alternative.

4) Implement standards to ensure e-cigarette suppliers and distributors meet certain requirements.

5) Implement standards to ensure our products meet certain requirements. This process is time and resource intensive, but is necessary to ensure the future of our industry. Third party agencies will need to be hired to physically visit electronic cigarette and eliquid manufacturing plants worldwide to verify the standards the ECA has set out.

No board members are taking a salary from the ECA, although Matt Salmon is employed by Policy Impact Communications. No one ECA member will directly benefit more than any other member. This is about saving our industry, not one company.

What do companies get for becoming an ECA member? They will hopefully get to keep their business. What do consumers get for donating their money and time? They will hopefully get to keep legally buying and using electronic cigarettes. This is all hopeful, but possible if we band together.

Our goals are lofty. We have a product that is an alternative to tobacco (Big Tobacco) and an alternative to smoking cessation products (Big Pharm). These industries have almost limitless reach within Congress and in some cases within the Public Health community. However the electronic cigarette is a good product that provides an alternative to a known killer and is worth fighting for.

If you believe the e-cigarette should be pulled off the market, subjected to 2+ years of clinical trials at a cost in the millions, then eventually be sold in pharmacies as a quit smoking product for something well above current retail prices, then just go about your business.

If you believe the e-cigarette should be an accessible product to legal age smokers at a reasonable price and be held to specific standards, then I highly recommend you donate to the ECA. We will need it. Please visit www.ecassoc.org/donate/

Thank you for your support.

James Watt
ECA Vice Chair

Below is a letter that was sent to the FDA from Bill Godshall who is the Executive Director for Smokefree Pennsylvania.  We would like to thank Bill for taking an active role in the fight to allow smokers the freedom to choose an alternative to a known killer.

Please note that the letter below represents Mr. Godshall’s views and opinions.  In no way should this letter be taken as evidence that the electronic cigarette is safe or healthy or that the e-cigarette is a quit smoking product. Here is the letter:

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218

May 1, 2009

Ms. Heather Zawalick
US Food and Drug Administration

Per your recent e-mail (below), Smokefree Pennsylvania strongly urges the FDA to cancel its planned activities next Tuesday, and to consider the enormous public health disaster the agency would create by banning smokefree nicotine inhalers called e-cigarettes.

Denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users
reverting back to smoking cigarettes.  It is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products.

Cigarette smoking is 100 times deadlier than smokeless tobacco use, while smokefree nicotine products pose even fewer risks.  Switching from cigarettes to smokefree tobacco/nicotine alternatives reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use.  And millions of smokers have already sharply reduced their health risks by switching to smokefree tobacco/nicotine alternatives. Please review a report I coauthored: “Tobacco harm reduction: an alternative cessation strategy for inveterate smokers” at http://www.harmreductionjournal.com/content/3/1/37

In contrast to recent claims by e-cigarette prohibitionists, hundreds of thousands of smokers have quit smoking and/or reduced cigarette consumption by switching to e-cigarette products, and thousands have written testimonials at http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes- available and http://www.e-cigarette-forum.com/forum/ describing their experiences with these less hazardous nicotine alternatives.  Meanwhile, test results on the Ruyan e-cigarette http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf found no product hazards.

Also in contrast to claims by prohibitionists, there is no evidence that e-cigarette products have been marketed to youth, nor is there evidence of youth use of e-cigarette products (most of which cost more than $100). And most e-cigarette companies do not make claims that their products are smoking cessation aids.  As such, the FDA should not be classifying these products as drugs (in an thinly disguised effort to ban them).

The sensible policy solution is for US Congress to enact reasonable and responsible tobacco/nicotine regulatory policies to allow e-cigarettes and other smokefree nicotine products (that are marketed as alternatives to cigarettes) to remain on the market, and be regulated as a separate category of tobacco products.  Smokefree tobacco harm reduction provisions in legislation recently introduced by Rep. Buyer (H.R. 1261) and Senators Burr/Hagan (S. 579) would achieve this policy goal.  The US Senate also
can amend pending FDA tobacco legislation by Rep. Waxman (H.R. 1256) or soon-to-be-introduced legislation by Senator Kennedy with these or similar harm reduction provisions.

Most e-cigarette companies support reasonable and responsible regulations for their products.  If the FDA is truly interested in reducing the leading cause of preventable disease, death and disability, it would join us in urging the US Senate to enact these sound public health policies.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither Smokefree Pennsylvania nor I have received any funding from tobacco, drug or e-cigarette companies.

Thank you for your consideration, and feel free to contact me anytime.

Sincerely,

William T. Godshall, MPH
Executive Director

Here’s an update:

THE FDA
For the past few months, the FDA has been stopping a few smaller shipments of electronic cigarettes at the border. In the past couple weeks, they have begun stopping large shipments being brought in by some of the larger suppliers in the United States. One of those suppliers has decided to sue the FDA. The argument is that the electronic cigarette is functionally a cigarette and thereby falls outside the jurisdiction of the FDA. The FDA’s stance appears to be that the electronic cigarette is a medical device and the nicotine solution is a new drug. Together they are a combination product. The actual stance of the FDA will become clear very soon as they apparently plan a media blitz to publicize the FDA stance on the electronic cigarette.
UPDATE: The FDA media blitz was postponed indefinitely
UPDATE: NJoy has officially entered the lawsuit of the FDA vs the Electronic Cigarette

THE ELECTRONIC CIGARETTE ASSOCIATION
A few weeks ago, a bunch of electronic cigarette suppliers met in Chicago to begin the formation of the Electronic Cigarette Association. The Association’s goal will be to battle misinformation about the e-cigarette, to educate the public and policy makers about the product, to ensure electronic cigarette suppliers and manufacturers follow certain safety, labeling, and marketing guidelines, and to work with policy makers to ensure smokers have the right to choose an alternative to a known killer. Matt Salmon has been nominated as the President of the ECA. View Matt Salmon’s Video Message.

THE WAXMAN TOBACCO BILL
As we speak, the Senate is getting ready to vote on the Waxman Tobacco Bill, officially known as the Family Smoking Prevention and Tobacco Control Act. This Bill gives the FDA the authority to regulate tobacco. Although this sounds like a great idea, the issue is this: Philip Morris (Altria) supports the Bill. Once read, it is easy to see why. The Bill allows the FDA to keep smoking alternatives off the market. Although they are limited in that they can’t keep all alternatives off the market, they can pick and choose. Philip Morris also gets a position on an advisory board dealing with the regulation of these products. Although it is a non voting seat, it still allows them to influence which competing products are allowed to be brought to the market.
UPDATE: The Waxman Bill has become The Kennedy Tobacco Bill
UPDATE: The FDA Tobacco Bill was signed into law by President Obama, but the language in it appears to exclude the electronic cigarette so long as it doesn’t contain a tobacco product.

ELECTRONIC CIGARETTES VS TOBACCO CIGARETTES
The stance that Instead Electronic Cigarettes takes is this: the electronic cigarette is an alternative to tobacco cigarettes. Tobacco cigarettes kill hundreds of thousands of Americans each year. Is the e-cigarette safer? Not sure yet….but compare the ingredients. ELiquid is made up of propylene glycol, water, flavoring, and nicotine. Tobacco smoke contains Ammonia, Acetone, Arsenic, Carbon Monoxide, Cyanide, Formaldehyde, Methane, Nicotine, Tar, Toluene to name some of the bad ones out of the almost 5000 chemicals found in tobacco smoke. There has been some testing done on the electronic cigarette in other countries with very positive results. At least 2 tests are currently being done on the actual vapor by reputable American labs. We expect the results in then next week or so. People have been using the electronic cigarette for about 7 years worldwide. There have been no reported cases of ill effects (unless you are allergic to propylene glycol, in which case the vapor will cause irritation). Why is the electronic cigarette being held to higher standards than tobacco cigarettes? And if it is higher standards you want, what are they? We as an industry are happy to comply with reasonable standards. With that said, if we push the e-cigarette through the pharmaceutical route, it may be years before we see it and it will likely get priced the same way that the nicotine gum is…..more expensive than smoking. Why does the FDA insist on making anything with nicotine in it jump through so many hoops? Is nicotine or smoking the problem? Are they trying to keep people smoking tobacco? Seriously.

PUBLIC HEALTH ORGANIZATIONS
So, why are many (not all) of the larger public health organizations against the e-cigarette? For one, misinformation. Many believe the e-cigarette is being marketed to kids. While this may be true of some unscrupulous suppliers, the vast majority of US suppliers do not market or sell to kids and don’t want kids to use this adult product. In fact, we at Instead don’t want non smokers to use it. We just want every smoker in the world to switch to e-cigarettes. That’s it.

Another argument is that companies are marketing the electronic cigarette as a quit smoking product. Again, this is true of some, but not of the vast majority of US suppliers. We at Instead don’t believe this is a quit smoking product. We believe it is an alternative….something else to do. It may or may not be better for you, but it should be the choice of the smoker to decide what is best for him or her. It is sad that public health organizations haven’t taken a more active role in determining the safety of the e-cigarettes and doing a scientific comparison of the vapor vs tobacco smoke. Instead, they have chosen to come out against it with no basis other than “it hasn’t been proven to be safe”. True, but it certainly hasn’t been proven to be unsafe either. We as an industry are moving to provide scientific data about the safety of the e-cigarette. We just need a little time. A little help might speed things up.

WHAT WILL HAPPEN
That is the 2+ Billion dollar question. There are undeniably large forces with a vested interest in this market. As an esmoker or as someone who cares enough we need help. We are a small industry. We are small American businesses. But with a little public support, we have a chance to balance the scales. They may have the money, but we can have the numbers.

WHAT CAN I DO?
1) Write your Senators and other elected officials. Tell them about your experience with the electronic cigarette. Send it certified mail. Find out who is your Senator . Find out who is your Congressman. Write President Obama.

2) Contact your local Tobacco Free Kids, American Lung Association, American Cancer Society and other public health organizations to inform them about your experience with the electronic cigarette. Give your money away wisely.

3) Contact The FDA to express your opinion about the electronic cigarette.

4) Tell those around you about the electronic cigarette and what is going on.

5) Create a video about your experience and email it to us. We are working with others to put together a compilation video of esmokers discussing their experience.

6) Sign the Electronic Cigarette Petition

7) Sign up for the newsletter and give money or time to the Electronic Cigarette Association.

CONCLUSION
The electronic cigarette represents a choice to a known killer. Choice is not only good, it is the fundamental basis of our society. Choice is freedom.