The FDA and Electronic Cigarettes, a Timeline Part 1
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.