What the Future Holds for Electronic Cigarettes – Embargos, Bans, Controversy – Oh My!

If you’re new to the world of electronic cigarettes, you’ve entered at a time of tremendous excitement, controversy and confusion. If you’re not new, no explanation is needed other than to say that it would have been almost a full time job to keep up with the activity of the past of the past few weeks. Let’s start with just a brief recap of just what an e-cigarette is for anyone just tuning in and then i’ll try to summarize as best I can what’s going on and the possibilities for the future of the electronic cigarette, particulary in the U.S.

Electronic cigarettes have actually been in existence for about 5 years, having been invented by the Runyan corp. in China in 2004. They were designed to replace smoking tobacco cigarettes and cigars because, despite globally spreading smoking bans, many smokers are just not able to quit altogether. The basic concept is very simple. Electronic cigarettes for the most part look like a cigarette, deliver nicotine like a cigarette, and even function, ie- "puffs", like a cigarette. The genius, however, is in the details. Electronic cigarettes do NOT have tobacco or any of the other harmful chemical additives of regular cigarettes, there is no smoke or flame, and therefore no second hand smoke. They simply contain battery charged cartridges and emit a water propylene glycol based vapor that is both harmless and odorless. Because these are "smokeless" cigarettes, users are not subject to the widespread smoking bans and are able to smoke e-cigarettes in places like restaurants, bars, airports, workplaces, etc. Add to this the huge cost savings over tobacco cigarettes and it appears that we have a real winner here. Or do we?

Well, Big Tobacco sure doesn’t think so and they appear to be managing to "nudge" the FDA and Congress into their corner. There is widespread debate as to whether or not the FDA has jurisdiction over e-cigarettes and there is a bill currently in Congress that promises to further complicate the issue. The Family Smoking Prevention And Tobacco Control Act, passed by the House of Representatives on 04/02/09, and now in the Senate would allow the FDA "to review and consider the evidence for additional indications for nicotine replacement products." It wouldn’t take much to arrive at an interpretation of this that puts electronic cigarettes under the FDA’s control. Even in advance of any authorizing legislation, the FDA has already made moves to regulate e-cigarettes in the U.S. in the past week.

On April 28, 2009, a U.S. e-cigarette seller, "Smoking Everywhere", filed suit against the Food and Drug Administration, claiming the agency is illegally blocking imports of its products into the U.S. The suit, filed in the U.S. District Court for the District of Columbia, argues that "the FDA has overstepped its regulatory authority by banning shipments of the devices and insisting they need to go through the drug approval process." Several other U.S.. distributors have been forced to freeze sales because of this "embargo". An emergency relief hearing is expected to be held on this matter sometime in the next week.

On April 29, 2009, the FDA allegedly "leaked" an email, titled "FDA Takes Enforcement Action on Electronic Smoking Products". The email basically announced that a U.S. ban of electronic cigarettes would be announced on May 5, 2009 and would take effect immediately. William Godshaw of Smokefree Pensylvania, quickly and publicly responded on May 1, 2009 in an email to the FDA urging them to reconsider this action and "… consider the enormous public health disaster the agency would create by banning smokefree nicotine inhalers called e-cigarettes." Needless to say, May 5th came and went without an announcement from the FDA but both sales of electronic cigarettes and petition signatures were brisk throughout the day.

The topic of electronic cigarettes has gained a great deal of momentum with hundreds of thousands of global consumers, many in the United States, successfully using the products as an "alternative" to smoking tobacco cigarettes. The message that is being delivered by the FDA in it’s recent actions is telling those who can’t stop smoking, or those who don’t wish to stop smoking, that it is better for them to smoke tobacco, which is responsible for more than 400,000 deaths annually in the U.S. and is the leading cause of preventable deaths in this country. The Electronic Cigarette Association (ECA) has released an official statement on it’s website http://www.ecigaretteassociation.org in response to the FDA’s recent inquiry and actions with respect to electronic cigarettes.

So, what does the future hold for e-cigarettes? Well, currently the disctributors who either stock or manufacture the devices within the U.S. are still open for business. It will be interesting to watch how this plays out in the next 30-60 days but there is little argument that these devices have helped a great many people and are even being endorsed by many in the medical community as being a healthier "alternative" to tobacco cigarettes. These are not overly complicated devices so it is highly unlikely that you are going to see electronic cigarettes, or their "parts" disappear from the marketplace anytime soon. Regulations with respect to how they are sold and marketed seems very reasonable and probably necessary but to ban their existence entirely at this point is just absurd. I’ll finish with a great quote that I saw yesterday from The American Association of Public Health Physicians:

"Telling smokers they may not use e-cigarettes until they’re approved by the FDA is like telling a floundering swimmer not to climb aboard a raft because it might have a leak."

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