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.

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.

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
UPDATE: The FDA made an announcement on electronic cigarettes and misled the public about electronic cigarettes in an apparent attempt to influence the lawsuit and/or turn the public against the product.
UPDATE: A group of electronic cigarette smokers has filed an Amicus Brief in the lawsuit against the FDA.
UPDATE: A Federal Judge has given Smoking Everywhere and NJoy an injunction against the FDA to stop them from seizing anymore shipments.
UPDATE: The FDA appealed Judge Leon’s injunction and the Court of Appeals granted a temporary stay of the injunction while they review the case.

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. Testing is underway in the US. 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 e-smoker or as someone who cares about the damage caused by tobacco smoke, we need your 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 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.

Choice can be controversial to say the least. It is however the basis of an enlightened society. The right to choose what you want to be when you grow up. The right to choose your partner. The right to choose your own clothes, what you eat, what you drink, and how you live. A choice made that effects others in a direct and negative way needs to be examined. This is the case with smoking in public. This is a choice that may have direct negative effects on those around you.

So let’s examine this from the perspective of esmoking. Smoking an electronic cigarette, or vaping or e-smoking as it is sometimes known, produces a vapor that is inhaled and exhaled. The ingredients in the actual liquid to be vaporized includes propylene glycol, water, flavoring, and sometimes nicotine. Some formulas also include lemon juice, vinegar, and citric acid. Studies are being done as we speak as to what the composition of the actual vapor is, but considering that no combustion is taking place, it is a distinct possibility that the vapor is made up of the same stuff as the ELiquid. Making this assumption, the question arises, who are you effecting when e-smoking? If you believe the second hand “e-smoke” is dangerous, it is likely you are also against fog machines at theme parks, concerts, and theatrical performances. If this is the case, please also consider fighting for a ban on perfume in public.

Here’s another argument: esmoking may be dangerous to the user. True, it may be. More testing will help determine the degree of danger. With that said, tobacco cigarettes are known to be dangerous and they are not banned. Sky Diving can be dangerous, so let’s ban it. Working in a coal mine or on a crab boat is dangerous…..let’s ban it. Is it really the government’s job to protect me from my own choices?

This is obviously a complicated issue on many levels, but when you break it down to the lowest common denominator, it is about choice, freedom, and personal liberty. God bless America and while He (or She) is at it, please also bless the righteous with common sense.

Write your Senators and other public officials to tell them about your experience with the electronic cigarette. It may help those voting on the Family Smoking Prevention and Tobacco Control Act aka The Waxman Tobacco Bill (NYTimes Article Here, TheHill.com Article Here) to be informed voters. It is still unclear whether or not the Waxman Bill will effect the electronic cigarette, but either way, a Bill that lumps other nicotine products in the same category as burning tobacco is of little help to smokers or those with who care about someone who smokes.