Smoking Everywhere V. FDA--Case Synopsis

[Sun Vaporer]

This is an action sounding in equity. In April of 2009, Smoking Everywhere, Inc.(SE) filed suit against the Food and Drug Administration (FDA), to "stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes" to the extent that FDA declared such products to be a new drug and/or new drug device combination. SE further alleges that FDA exceeded its statutory authority by adding SE’s products to an FDA Import Alert list, thus allegedly preventing their admittance into the United States. In addition to the complaint, SE filed a temporary restraining order and preliminary injunction Motion. SE claims that its electronic cigarette allows people to inhale vaporized nicotine without the cancer causing agents found in cigarettes.

SE contends that FDA exceeded its authority by claiming that electronic cigarettes are combination drug/device products that require FDA approval. SE argues that Congress has clearly indicated that FDA does not have the authority to regulate tobacco products relying in part on the holding in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). SE also pleads that FDA lacks the authority to regulate electronic cigarettes because they are not drug delivery devices.

Soon to follow, NJOY, Inc. filed a Motion it Intervene in the case which was granted and advanced, for the most part, the same allegations as SE,

The FDA was quick to counter SE and NJOY and filed a brief in opposition to SE's Motion. contending that electronic cigarettes are indeed both a drug and a device, and that Brown does not exempt them from FDA’s jurisdiction. Additionally, FDA argues that SE’s marketing practices proport that electronic cigarettes are intended to "prevent, treat, or mitigate the withdrawal symptoms of nicotine addiction," thereby squarly placing them within the FDA's jurisdiction as this would consitute a "drug" subject to full regulation.

The FDA was also quick to dispute SE’s claim that the Brown Court forcloses FDA regulation of all nicotine products in general, stating that Brown only forclosed regulation of tradional tobacco products and the electronic cigarette simply can not enjoy the sanctity of the Brown holding as it is not a traditional tobacco product, but rather a nicotine deliver system.

In the interim of the filing of this action by SE, On June 22, 2009, the Family Smoking Prevention and Tobacco Control was signed into law. This historic legislation granted authority to regulate tobacco products to the U.S. Food and Drug Administration.

The Honorable Justice, Richard J. Leon, who is assigned this case in Federal District Court in Washington D.C. , requested a rehearing and further briefing from the parties after the enactment of this litigation. This delayed SE’s and NJOY’s request for injunctive relief right though the summer and into the fall.

In September, ASH filed an Amicus Curiae (Friend of the Court) Brief in Support of the FDA, followed by another Amicus Curiae Brief filed ad hoc by a group of E-cigarette users called the Alliance.

Last month, Justice Leon stated that he had made a ruling on the requested equitable relief sought by SE and NJOY but was not ready to release it for reasons unknown.

No matter how Judge Leon rules, the e-cigarette is going to be subject to regulations. If Judge Leon determines it to be a tobacco product, the FDA will not be able to ban it, but would be able to make reasonable regulations such as no flavorings and a reduction in nicotine levels. The FDA can also mandate tamper proof and "dose specific" cartridges thereby rendering bulk e-liquid banned.

Should Judge Leon find that the E-cigarette is in fact a medical device and drug combination, then the FDA can ban the E-cigarette until the requisite applications are made and studies are done in an effort to gain FDA approval.

This case will surely go up on appeal to the 4th Circuit Court of Appeals no matter which way Judge Leon rules and it is very likely that all parties will Appeal. This Appeal will not take years like an appeal after a final judgment, as it is an interlocutory appeal (in the pendency of the case). Interlocutory Appeals are ruled on much faster, but they still do take time.

So every business day that the Court is open, I will be checking the Docket Sheet and reporting here what, if anything happened with the case as this case will ultimately determine the future of our Electronic Cigarettes and how we use them.



The situation is indeed one of great concern to all who use the electronic cigarette as an alternative.
　


Sun
　

[Misty]

Sun, what a great summary !!- and thanks for all the hard work involved in keeping up with this complex case day after day so that we can be up todate

[Royal]

Attached you will find the Defendants (The FDA's) Supplemental Brief in opposition to the plantiffs (Smoking Everywhere and Njoy) and intervener's motion for a preliminary injunction.

I believe this Brief was introduced some time back., so of course this is old news, but felt it may help to bring people up to speed on the case.