Given the date of the action and the 15 working day deadline for response, This only gets them publicity before the trial. These actions can't be used in that case bucause they are not related. As far as testing, every batch should be tested to ensure purity and insure that there has been no cross contamination. I think that's where the Johnson's creek issue was.
When a user comment is included in marketing material it is no longer a user comment it is an advertisement. Comments on message boards and forums would not qualify as ads because they are in a public forum.
Correction: What is coming up on September 23 is NOT A TRIAL.
The case has not yet begun. Smoking Everywhere (and NJOY) petitioned the court to issue an injunction against FDA seizing their products. They said that if everyone waited until the trial came up that they would be put out of business (irreparable harm). Judge Leon issued the injunction.
FDA appealed. It is the usual practice whenever any lower court decision of any type (trial verdict, issuing an injunction, etc.) the appeals court automatically issues a "stay of execution." So that's what happened. The appeals court automatically issued a stay, which temporarily excused FDA from complying with the injunction pending the outcome of the appeal.
The next thing that happens in the appeals process is that both sides submit legal briefs to the court pointing out portions of the law and making the argument why the court should find in their favor. That has been done. There have also been some "Amicus" briefs filed. These are "Friend of the Court" briefs offered for either the plaintiff or the defendent. Again, these must argue points of law.
Next is the hearing of oral arguments. That is what is scheduled for September 23. The attorneys for each side will make a speech in front of a 3-judge panel. The judges may ask the attorneys questions, but there will be no evidence presented, no witnesses called, and no jury. The job of the 3-judge panel is not to decide the merits of the case itself, but to confine itself to ruling on whether the lower court made a correct decision under the law. In other words, was Judge Leon operating properly under the law when he issued the injunction against the FDA seizing products?
After the oral arguments, the 3-judge panel goes off to ponder and discuss the appeal. After several months, they will issue a ruling. We don't expect that to happen until January.
Meanwhile, the entire trial process is put on hold. If the losing party for the appeal decides to pursue this to the Supreme Court, it could take years and years before the actual trial is begun.
So given that legal background, I'd have to say that this whole thing was a PR stunt on the part of the FDA to gain public approval for their action in "protecting the public" from these dangerous products.
BTW: Judge Leon disagreed with the concept that user comments convey the intent of the seller. Here is what he said:
Here, the overwhelming sum of Smoking Everywhere's promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use.
[SNIP]
FDA references only three claims made in Smoking Everywhere's literature: (l) electronic cigarettes offer "smokers a chance of smoking in a much healthier way," (2) electronic cigarettes are "a great alternative to help ... stop smoking real cigarettes," and (3) "I've been smoking real cigarettes for over 20 years and really wanted to stop ... I've been using it for 3 weeks now and feel great." (ARDET 49,21; FDA Opposition [#14] at 21). The latter two claims are customer testimonials posted on the Smoking Everywhere website. None of these claims, on their face, suggests an objective intent to treat nicotine addiction and withdrawal. At best, these claims demonstrate that Smoking Everywhere markets its electronic cigarettes as an alternative-albeit a healthier alternative-to traditional cigarettes. IS FDA does not point to any representation by Smoking Everywhere that its product is intended to help wean smokers off of nicotine. Nor does FDA identify any product labeling that includes instructions about how to overcome nicotine addiction using electronic cigarettes. The clear import of Smoking Everywhere's advertising is that it wants consumers to use its electronic cigarettes for the same recreational purposes and with the same frequency as traditional cigarettes. Thus, FDA's finding that the electronic cigarettes marketed by Smoking Everywhere appear to 15 To the extent that smoking cessation is a therapeutic claim distinct from the treatment of nicotine addiction and withdrawal, the Court is aware that the two customer testimonials referenced above suggest that electronic cigarettes are intended for smoking cessation, ifnot for treating nicotine dependence (as suggested by FDA). Given Smoking Everywhere's express disclaimer that its electronic cigarettes are not intended as a smoking cessation device, (AR DET 1), and given the overwhelming evidence in the record that its electronic cigarettes are intended merely as a recreational alternative to traditional cigarettes (and not necessarily as a therapeutic replacement for traditional cigarettes), the Court concludes that the two testimonials cited by FDA are not alone sufficient to support a finding that the product appears to be intended to help customers quit smoking. In this respect, Smoking Everywhere's electronic cigarettes are different from other nicotine products regulated by FDA that bear no similarity to traditional tobacco products and make express therapeutic claims.
I would recommend that every vendor with a web site (not just those who received letters) read this document. It contains the blue print for what you can and cannot say about your products and remain outside the jurisdiction of the FDCA.
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
