This post is a continuation of our “What is Going on with the FDA and the Electronic Cigarette?” blog post from May 1st, 2009.
So what is going on now?
Well, as we noted, Judge Leon granted a preliminary injunction to the electronic cigarette suppliers until the case is resolved. This meant that the FDA couldn’t stop the importation of the products.
On Feb 2nd, 2010, the FDA filed an appeal of the injunction and was granted a stay of the injunction until the Appeal Board reviews the case. This means that the FDA can once again stop the importation of electronic cigarettes from these suppliers until the appeal board makes a ruling.
BEFORE: Ginsburg, Henderson, and Rogers, Circuit Judges
O R D E R
Upon consideration of the emergency motion for stay pending appeal and for immediate temporary stay pending this court’s consideration; and the motion to strike the emergency motion, it is
ORDERED that the motion to strike be denied. It is
FURTHER ORDERED that the district court’s order entered January 14, 2010, granting appellees’ motions for injunctive relief, be stayed pending further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay pending appeal and should not be construed in any way as a ruling on the merits of that motion
It is FURTHER ORDERED that appellees file and serve a joint response by 10:00 a.m., Thursday, February 4, 2010, and appellants file and serve any reply by 10:00 a.m., Monday, February 8, 2010. The parties are directed to hand-deliver the paper copies of their submissions to the court by the time and date due.
So, as ordered by the appeals court, Njoy and Smoking Everywhere filed a response on February 4th, 2010.
You can download and read the full Electronic Cigarette Suppliers Response To The Appeals Court here. Here are some highlights:
FDA also asserts that it has jurisdiction under the FDCA because ecigarettes are intended to “prevent or alleviate nicotine withdrawal symptoms,” and, thus, are intended for therapeutic use. The District Court rejected this claim as a matter of fact. The “intended use” of a product is determined by “the objective intent of the persons legally responsible” for labeling the product.
Although FDA acknowledges that it has not provided this Court with the “benefit of specific evidence of the dangers posed by [e-cigarettes],” it insists that “the threat to the public health is apparent” and cannot seriously be questioned. That argument is meritless. FDA cannot prevail with vague allegations of potential harm; rather, it must prove a likelihood of irreparable harm to warrant a stay.
Although e-cigarettes have been sold since 2007, FDA has not identified a
single instance, either in this Court or below, of an adverse health effect from ecigarettes.
The response from these electronic cigarette suppliers clearly outlines why they should be given an injunction:
1) Just because a product delivers nicotine, doesn’t mean it is a new drug…….if that was the case, tobacco cigarettes would be new drugs.
2) No therapeutic claims have been made by the suppliers.
3) Allowing the FDA to stop importation while the case is pending will do economic harm to the companies involved in the case.
4) The FDA has no evidence that electronic cigarettes pose any harm to the public.
On February 8th, 2010, the FDA filed it’s response to the Appeals Court. You can download and read the full FDA response here. Please note this is not the actual document.
Here are a few excerpts of the FDA argument for the stay of the injunction:
The Court in Brown & Williamson invalidated a rule that would have, for the first time, asserted FDA jurisdiction over cigarettes and smokeless tobacco as customarily marketed. As plaintiffs do not dispute, the selling point of their product is precisely that it is “NOT a real cigarette, there is NO real smoke, flame, tar or tobacco.”
The danger posed by the unrestricted distribution of unregulated products containing toxic chemicals cannot seriously be questioned. Even apart from the acute health risks that these products pose, there is no dispute that the nicotine is “a highly addictive pharmacological agent.”
The response from the FDA argues that the injunction should be stayed because:
1) Electronic cigarettes contain nicotine and are not tobacco cigarettes
2) It can interpret the new Tobacco Act as it sees fit, i.e. include or exclude the electronic cigarette from this Act.
3) Electronic cigarettes are marketed to kids and may pose danger
Here is my response:
1) Nicotine is not a substance only sold to treat nicotine addiction. Nicotine is regularly sold for recreational purposes in many forms, not just tobacco cigarettes.
2) The FDA is bound by law, just as every citizen and company in the United States.
3) There is no evidence that electronic cigarettes are marketed to minors or that they have, or will, harm anyone.
So where are we at?
THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA is reviewing the case, including the submitted responses and deciding if the FDA can continue to stop shipments of electronic cigarettes into the United States while the case is pending.
It will be an outrage if the Appeals Court allows the FDA to try to end the lawsuit via financial sabotage. Money should not interpret the law…..judges should.