Smoking Everywhere V. Fda

[Christopher]

Some of the newer members may not be aware of the ongoing FDA Vs. Smoke Everywhere & NJOY Case. So here is a summery that was put together by Sun from ECF.

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 claims that the Electronic Cigarette is a "tobacco product"

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 purport 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 forecloses FDA regulation of all nicotine products in general, stating that Brown only foreclosed 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.

On January 14, 2010, some 10 months after this litigation was first filed, the Honorable Judge Leon issued a ruling, granting SE and NJOY a Preliminary Injunction against the FDA to stop the FDA embargo against SE and NJOY’s products coming into the United States. See Attachment 7111.

The FDA quickly requested an Interlocutory Appeal and a Stay of Judge Leon’s ruling.

On February 2, 2010, the Appeals Court (DC Circuit), issued an Administrative Stay of Judge Leon’s ruling and on March 31, 2010, the Court granted the FDA’s Request for a Stay of Judge Leon’s ruling pending the Appeal. The Court also denied SE’s and NJOY’s Motion to Strike the Stay.

We pick up the Case at this juncture on Appeal.

CONSIDERATIONS:

No matter how the Appeals Court or Judge Leon rules, the e-cigarette is going to be subject to regulations. If the Court determines the E-cigarette 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 many other reasonable regulations such as possibly tamper proof and "dose specific" cartridges thereby rendering bulk e-liquid banned.

Should the Court 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 by Manufactures or Suppliers and studies are done in an effort to gain FDA approval which is a very time consuming and costly venture with no guarantees of approval.

　

　

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.

[kitsune]

Great post Chris--will be looking forward to any updates !!!

[Jeffb]

That was an excellent synopsis of what has transpired. Thanks for keeping us informed Chris.

[fusiontech357]

kinda sounds like we are doomed form and angle ..

[Phaseman66]

Two things the world needs:

1. less lawyers

2. more VAPING!

Thanks Chris for keeping us informed.

[NeRo9k]

Phaseman66

3. Less FDA involvement in matters that that hurt their wallet.