The Food and Drug Administration and electronic cigarettes have a pretty long and storied history. I’ve commented about the FDA and its attempts to ban and demonize ecigs pretty extensively. I’ve realized perhaps not everyone is intimate with the rocky road we’ve been down. I thought perhaps a little perspective on how things have progressed so far might shed some light and provide a little context for many of the things discussed in the community.
To that end, I’ve put together a little timeline of how things have progressed with the FDA up to this point.
This is part 1 of 2. Click here for part 2
Electronic cigarettes begin to make their way to the United States after experiencing some popularity in Europe.
August 2008 GreenCig, a Chinese manufacturer registers their product with the FDA. According to this post on the ECF, the company classified their device as a nasal inhaler. There was a great deal of debate on the forum as what that meant, and even what types of nicotine was FDA Approved.
September 2008 The World Health Organization issues a press release for e-cigarette companies to stop making health claims about e-cigarettes being an effective smoking cessation therapy. The WHO states that “WHO has no scientific evidence to confirm the product’s safety and efficacy.” The release also notes that some marketers claimed the devices had the approval of the organization.
November 2008 GreenCig’s application for approval of its electronic cigarette is rejected by the FDA. The FDA cited the application as a new drug submitted without study data.
Early 2009 FDA begins seizing electronic cigarette shipments as they enter the country via China. The agency cites the Food Drug and Cosmetics Act as grounds for seizing the devices as incorrectly labeled medication and delivery devices.
March 2009 A group of Senators headed by Senator Lautenberg of New Jersey urge the FDA to crack down on electronic cigarettes (despite the fact that the FDA was already seizing shipments by this point). Several bloggers pointed out that the senator received significant funding from the pharmaceutical industry.
April 2009 e-Cigarette Company Smoking Everywhere files a lawsuit in federal court to stop the FDA seizure of electronic cigarettes. The company’s primary argument is that electronic cigarettes are a cigarette product and not medical devices.
April 2009 The FDA releases its lab report on electronic cigarettes. This report will be the basis for the future FDA press release attacking electronic cigarettes.
May 2009 nJoy joins Smoking Everywhere’s suit against the FDA. nJoy made no health claims in its marketing material, which appeared to be the FDA’s basis for seizing shipments.
June 2009 President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The law gives the FDA jurisdiction over tobacco products. See the FDA’s Infographic for more detail on what the act entails.
July 2009 The FDA releases their infamous press release making a number of negative claims about electronic cigarettes based on limited testing of cartridges from Smoking Everywhere and nJoy (the two companies suing the agency). The claims included:
- e-Cigarettes were marketed directly to young people
- diethylene glycol (used in antifreeze) found in one cartridge
- Samples contained carcinogens
- Samples contained toxic chemicals
- The original press release didn’t mention varying nicotine levels, that appears to have come later
July 2009 NJoy publishes an analysis of the FDA’s lab report (edit: original link is dead, here is a copy of a cached version) citing a number of deficiencies in the report. Among the findings:
- Lack of standard protocols
- No comparison to nitrosamines in nicotine replacement products
- Many substances mentioned were below normally detectable quantities
- Many impurities were present but less than found in the Nicotrol inhaler
- Nicotine levels in the control device (inhaler) were not published
- No study of the vapor was conducted.
August 2009 Tobacco Control advocacy group Action on Smoking and Health (ASH) files an Amicus brief in the Smoking Everywhere lawsuit in support of the FDA.
September 2009 An ad-hoc group of e-cigarette proponents, the Alliance of Electronic Smokers filed an Amicus brief in favor of the e-cigarette companies and disputing the ASH brief.
tkc(09/26/12 - 1:25 pm)
Interesting stuff. Thanks for putting it all together in this format.
I wish we could hook all politicians (and government workers that actually affect our lives) up to continuous stream IV's of truth serum. :D
Looking forward to part 2!
David Fleck(09/27/12 - 4:28 pm)
Great job, I am really looking forward to part two. I get so tired of the lies that big Pharma and these Governments come up with to try to stop the sale of e cigarettes. I switched from analog cigarettes to electric a little over a year ago and my Dr. can not believe the change in my breathing. He even told me that Nicotine is as bad as coffee for us and that it is all the carcinogens that hurt the body.
This is such a great article I would like to link it up to my Blog for my readers to view. We need to get the truth out there.
Steve K(09/27/12 - 4:32 pm)
Thank you! While doing this article I found some interesting correlation of the timing of things, like nJoy and Smoking Everywhere sue the FDA, and then shortly thereafter, the FDA comes out with this study that looked at… whaddaya know, Smoking Everywhere and nJoy cartridges.
I'm just sorry I decided to make everyone wait til Monday for the second half. But, it'll all be good after then since I can just link part 2 in this article.
Feel free to link anything you want to!
Gabriel Ecigs(09/29/12 - 10:43 pm)
The FDA can really burn my hide. They seem to use their power to make decisions for everyone else… as long as it lines their pockets. It's been a long battle between electronic cigarettes and the FDA, but I think that time should prove valuable on the behalf of the e cigarette fans… at least I hope ;) Thanks for putting all this together, it's a great post!
ed west(10/01/12 - 4:07 pm)
Thanks! Is there a part 2 or am I missing something?
Steve K(10/01/12 - 4:11 pm)
Right here: http://www.stevevape.com/the-fda-and-electronic-c…
absolutevapors(12/25/12 - 11:59 am)
This is someone's opinion that has neither knowledge nor insight to how bad cigarettes are for you and can say things like the FDA is on our side. They are in the big tobacco companies pocket and are trying to stop the electronic cigarette, but the only reason they have not made this a banned product is because the public knows better.