The FDA and Electronic Cigarettes Part 2

Welcome to the second installment of our timeline in the saga of the FDA vs. electronic cigarettes.  If you’ve missed part one, click here to check that out first, I’ll wait.  Now, for those of you still here, when we last left the scene, we were mid-lawsuit.  The legal action picked right back up in January 2010, so that’s where we will begin.

2010

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 this 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.

2011

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.

2012

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.

Today

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!