This post is updated regularly.
THE LEGAL BATTLE WITH THE FDA
Since the beginning of 2009, the FDA has been stopping imported shipments of electronic cigarettes at the border. One supplier, Smoking Everywhere, decided to sue the FDA on April 28th, 2009. 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 claim the e-cigarette with nicotine e-liquid is a combination product. The case is being heard by Judge Leon.
UPDATE May 16th, 2009 – NJoy has officially entered the lawsuit of the FDA vs the Electronic Cigarette
UPDATE July 22nd, 2009 – 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 September 10th, 2009 – A group of electronic cigarette smokers has filed an Amicus Brief in the lawsuit against the FDA.
UPDATE January 14th, 2010 – A Federal Judge has given Smoking Everywhere and NJoy an injunction against the FDA to stop them from seizing anymore shipments.
UPDATE February 10th, 2010 – The FDA appealed Judge Leon’s injunction and the Court of Appeals granted a temporary stay of the injunction while they review the case. This means in the meantime, the FDA can stop imported shipments of e-cigarettes from Njoy and Smoking Everywhere. Arguments are to be heard by the Appeals Court (Circuit Judges Garland and Kavanaugh and Senior Circuit Judge Williams) September 23rd, 2010.
UPDATE April 28th, 2010 – The American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Legacy Foundation, the American Lung Association, the American Medical Association, the Campaign for Tobacco-Free Kids, and Public Citizen filed an Amicus Brief with the court in support of the FDA. Read the filing by these public health organizations, many of which, if not all, accept money from the pharmaceutical industry.
UPDATE June 23rd, 2010 – NJoy filed a brief to the court. Read NJoy’s filing here. They argue that the stay of the injunction will hurt their business and the FDA has not shown that electronic cigarettes are harmful. They also argue that if the FDA is concerned about safety, they can regulation the e-cigarette via the new Tobacco Bill.
UPDATE June 23rd, 2010 – In the NJoy brief, it is also noted that Smoking Everywhere has exited the court case. Although there has been no official announcement, the rumor is that Smoking Everywhere is out of business.
UPDATE July 8th, 2010 – A group of Public Health Advocates and the Washington Legal Foundation both filed Amicus Briefs to the Court in support of making the electronic cigarette a tobacco product, not a new drug. Read the Amicus Briefs here.
UPDATE September 9th, 2010 – The FDA sent letters to 5 e-cigarette companies stating that they [the FDA] believe the companies are in violation of the Food and Drug Act.
UPDATE September 23rd, 2010 – Arguments were heard by the U.S. Court of Appeals for the D.C. Circuit. The Appeals court will determine if the injunction issued by Judge Leon against the FDA will stand.
UPDATE December 7th, 2010 – The U.S. Court of Appeals tells the FDA that the electronic cigarette can not be regulated as a new drug / medical device absent any health claims. It goes on to state the product should be regulated as a tobacco product under the new Tobacco legislation.
UPDATE April 25th, 2011 – The FDA issued a press release announcing it would not seek further court appeals, but rather regulated the electronic cigarette as a tobacco product.
THE FDA TOBACCO BILL
At the time of this post, 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 May 15th, 2009 – The Waxman Bill has become The Kennedy Tobacco Bill
UPDATE June 23rd, 2009 – 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.
UPDATE January 14th, 2010 – Judge Leon, who is presiding over the Njoy vs FDA case has stated he believes the electronic cigarette should be regulated via the new Tobacco Bill.
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. Compare the ingredients. E-Liquid is made up of propylene glycol, glycerin, 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 testing done on the electronic cigarette with very positive results. People have been using the electronic cigarette since about 2004. 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.
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.