Thursday Jan 14th 2010 Federal Judge Richard J. Leon granted electronic cigarette distributors Smoking Everywhere and NJOY preliminary injunction against the FDA’s detainment of their e cig imports calling the FDA’s arguments in the case quote:
… bootstrapping run amuck.
Judge Leon’s ruling included a court order instructing the FDA to release detained shipments of electronic cigarettes and to halt further detainments of the devices pending the completion of a full trial.
Judge Leon also submitted a 32 page memorandum opinion justifying his court order with a detailed analysis of the current law.
But, is the judge’s ruling really a win for the electronic cigarette and e cig smokers everywhere? What are the long term implications of the judge’s ruling in this case?
In order to fully understand a brief background is necessary.
Early in 2009 the FDA started detaining imports of electronic cigarettes on the basis that that the FDA believed them to be drug / device combinations unsafe for their intended purposes.
Smoking Everywhere Inc., one of the larger electronic cigarette distributors, quickly sued the FDA and requested a preliminary injunction claiming that the electronic cigarette, like a regular cigarette, is a tobacco product and that the FDA had no jurisdiction to ban or regulate them.
NJOY, another electronic cigarette distributor joined the law suit when the FDA started to detain their imports of the devices as well.
In an interesting twist late in 2009, President Obama signed the Family Smoking Prevention and Tobacco Control act into law which actually put FDA in charge of regulating tobacco products and probably electronic cigarettes as well. I wrote about the possible implications of this in an article I wrote last year.
Summary of the Ruling
So after this sordid history and all the waiting, what are the details of the judge’s ruling on the case? What are the potential good and bad implications moving forward?
I had to read all 32 pages of Judge Leon’s memorandum opinion twice in order to get even a basic understanding of the case, but I will try to simplify here.
I also must reiterate that this ruling is only the beginning granting preliminary injunction that allows the importation of electronic cigarettes for the remainder of the trial.
Potentially Good Implications
In Judge Leon’s opinion paper he argues that he granted Smoking Everywhere’s preliminary injuction because he believes electronic cigarettes should be classified as tobacco products. More specifically, he believes they fall into the category of “modified risk tobacco products” according to Smoking Everywhere Inc.’s claims that they reduce harm compared to traditional cigarettes.
Judge Leon rejected the FDA’s argument that electronic cigarettes are drug / device combinations unsafe for their intended purposes for several reasons. First, because quote:
… electronic cigarettes as marketed by plaintiffs, are the functional equivalent of traditional cigarettes.
The “intended use” of a product is determined by “the objective intent of the persons legally responsible” for labeling the product.
Since Smoking Everywhere and NJOY both state that their product is not for smoking cessation and encourages continued recreational nicotine use, then electronic cigarettes cannot be considered drug /device combinations according to the law.
At the end of the paper, Judge Leon only barely considers denying the injunction based on “harm to third parties and the public interest,” stating:
I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone.
If electronic cigarettes are considered tobacco products they will not require the “FDA approval” everybody seems to be clamoring for. So states with existing electronic cigarette bans such as Oregon, will probably seem to even a little more silly in their demands for FDA approval than they already do.
The Governator of California doesn’t have to worry about this though because he terminated the proposed ban on the sale of electronic cigarettes in his state at the 11th hour, largely due to this pending litigation of Smoking Everywhere v. FDA.
Potentially Bad Implications
If you read the article I wrote after the Family Smoking Prevention and Tobacco Control Act was signed into law giving the FDA power to regulate tobacco products you probably have an idea what some bad implications of this ruling could be.
Right now, all evidence suggests that at the conclusion of the Smoking Everywhere v. FDA trial electronic cigarettes will probably be classified as tobacco products and the FDA will regulate the heck out of them.
Judging by what the FDA has already done and is talking about doing this means that fruit, candy, and otherwise tasty electronic cigarette refill cartridge flavors could be banned and also nicotine levels could be reduced.
To enforce this bureaucracy surly will not be cheap which means that taxes may begin to plague electronic cigarette sales reducing their cost advantage over traditional cigarettes.
Its All Good Though
From reading Judge Leon’s opinion paper I learned that the current law doesn’t allow banning tobacco products completely or forcing the nicotine level to absolute zero.
Overall, I think the Judge Leon’s ruling in Smoking Everywhere v. FDA is a win for the electronic cigarette and the electronic cigarette community.
Even if they FDA bans flavored e cig cartridges and reduces the nicotine levels there will be “after-market” ways to flavor and amp up the nicotine level
Happy vaping for now.