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.
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.
January 2010 The FDA is ordered to stop blocking imports of electronic cigarettes by Federal District Judge Richard Leon. Judge Leon noted that the FDA could use its newly granted tobacco regulation powers to deal with electronic cigarettes according to an article in the New York Times.
February 2010 The FDA wins a temporary stay of the injunction issued in January pending a review by the appeals board. The FDA is free to continue blocking shipments.
April 2010 A group of of public health organizations including he 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 file an Amicus brief in support of the FDA’s actions.
June 2010 Smoking Everywhere drops out of the court case. At the time, there were questions surrounding the company’s ability to survive amidst the legal fees and impact to its business caused by the seizures.
June 2010 nJoy files a brief appealing the stay on the basis of adverse impact on its ability to conduct business in addition to the FDA’s inability to demonstrate harm from electronic cigarettes.
July 2010 Another Amicus brief is filed in support of the FDA by health advocacy groups.
September 2010 The FDA sends a warning letter to five e-cigarette companies: E-CigaretteDirect (not the UK vendor), Ruyan, Gamucci, E-Cig Technology and Johnson Creek. The letter states that the agency intended to regulate the products under the Federal Food, Drug and Cosmetic Act and their products were not in compliance.
September 2010 The Federal Appeals Court hears arguments concerning the stay of the injunction in the nJoy V FDA case.
September 2010 (Side Note) The New York Times publishes a piece that the FDA caved to political pressure from Senator Lautenberg and others to approve a knee replacement device that the agency had previously denied approval. Clearly not e-cigarette related, but I thought I would just leave that here.
December 2010 The Federal Appeals court rules in favor of nJoy and reinstates the injunction against electronic cigarette seizures. Judge Leon advises the agency to use the Tobacco Control act to regulate e-cigarettes. The FDA must decide if it wishes to take its case to the Supreme Court.
Janurary – March 2011 Various vendors report in online forums and blogs that the FDA is continuing to stop electronic cigarette shipments into the country in defiance of the court order from December, 2010.
February 2011 Totally Wicked sues the FDA over shipment seizures in the wake of the previous court ruling.
April 2011 The FDA announces it will not appeal the decision in the nJoy case. The FDA finally stops intercepting e-cigarette shipments. The agency announces it will pursue e-cigarette regulation under the Tobacco Control Act. In its letter, the FDA announces that intends to leverage the following steps to regulate the devices under the Act:
- The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
- The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
- Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
- “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
May 2011 Totally Wicked voluntarily drops its suit against the FDA in light of the announcement and the FDA’s stopping seizures.
July 2011 The FDA announces its intent to have draft regulations concerning other tobacco products (including e-cigarettes) by October.
October 2011 A group of Senators led again by Senator Lautenberg send a letter to the FDA urging the agency to “move swiftly” to begin regulation of electronic cigarettes.
December 2011 The FDA announces a comment period for regulation of non-face-to-face sales of electronic cigarettes, leading to speculation that the FDA may severely limit online and mailorder sales of electronic cigarettes.
May 2012 After several quiet months from the FDA, lets slip via a sources sought request that it intended to have draft regulations of e-cigarettes in place by Summer 2012. The request was for technology to identify online and offline advertising for tobacco products.
August 2012 The FDA releases a report on “adverse events” reported from e-cigarette use. The report showed some 100 adverse effects were reported. Analysis of the report on the ECF noted that there are millions of users of the system, and a number of individuals thinking they were being helpful submitted adverse impact reports for things like “being able to breathe easier” which likely artificially inflated the number of adverse impacts, which likely are just a handful of things.
Summer has passed, and no draft regulations have been put forth by the FDA. Speculation among the cigar industry is that the agency likely won’t propose anything until the election is over. There is further speculation that the exact steps the FDA takes will depend on the political landscape after November. This is perhaps true, but it seems to me that the train has already left the station and the FDA will roll something out in the future.
How oppressive it will be, nobody knows. Speculation ranges from simple quality control over e-liquid on the low-end to very strict regulation allowing only pre-filled cartridges with either tobacco or menthol flavoring (along with online sales and advertising bans) on the extreme end of the spectrum.
Thank you for sticking with me through this massive undertaking. I hope I gave you a little more perspective on how the FDA exists within our vaping culture. I’d love to hear what you think about the FDA and any potential regulations in the comments!
September 26, 2012 – Steve K. – http://stevevape.com/