FDA FDA response to lawsuits.
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Thanks for posting this. It helps to send mail to the right address-so to speak. A congressman may be easier to reach as well.
Isn't it always that the one who knows the least gets to make the decisions? The FDA could have easily made a new category for an item that is not tobacco related, and not exactly marketed as a purely smoking cessation device. It's sortof an alternative to smoking/cessation device. Especially that the majority of BT commercials about "their" new product were done as alternative to smoking.
With the way that the #'s of vapers has skyrocketed, it's going to become harder to prevent people from doing it.
I think the plaintiffs are going in the right direction. The argument that won't be solved easily is categorizing it correctly. The bottom line is that it is not a tobacco related device when there is no tobacco present and it's not used for tobacco as well. So the FDA is in error of mis-categorizing it leading to a bunch of guidelines/laws that do not address the device correctly. I hope somebody has common sense . I hope someone can take this as seriously as we do.
With the way that the #'s of vapers has skyrocketed, it's going to become harder to prevent people from doing it.
I think the plaintiffs are going in the right direction. The argument that won't be solved easily is categorizing it correctly. The bottom line is that it is not a tobacco related device when there is no tobacco present and it's not used for tobacco as well. So the FDA is in error of mis-categorizing it leading to a bunch of guidelines/laws that do not address the device correctly. I hope somebody has common sense . I hope someone can take this as seriously as we do.
In a summary judgment proceeding, a party can request oral argument, but the judge isn't required to grant it. Or the judge can request it. In summary judgment proceedings, expert opinions are typically submitted via affidavits. However, in an administrative review proceeding like this, all the expert opinions should already be in the record being reviewed--i.e., the judge isn't going to want to hear evidence that wasn't presented to the FDA.
I think some of you are missing the point that patches have been out for about 30 years.
And the FDA is still investigating ecigs which only recently came under their jurisdiction.
Please point me to where they have said that they believe nicotine in vapor products is more addictive than NRT.
As I've said several times in this thread, the case will almost certainly be decided on the pending motions for summary judgment. The next step will almost certainly be the district court of appeals for the District of Columbia.
I'm not sure if the, not a tobacco product argument will fly. Isn't it kind of like arguing that [Moderated] isn't a product of __________?
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Please point me to the evidence that the nicotine in vapor products is substantially different from the nicotine in NRT.
I don't know if it's Friday, but reply briefs/memoranda are typical and expected in summary judgment proceedings. After the reply memoranda are filed, there may or may not be oral argument. That's up to the judge. The judge will then take it under advisement for as long as she feels is necessary to decide the case and write her decision, and she will enter a written judgment. The judgment will almost certainly be explained in considerable detail ("findings of fact and conclusions of law"). And then there will be an appeal.
Even if you accept that nicotine is a tobacco product, should it then follow that anything related to the consumption of something that may, or more importantly may not, contain nicotine, should be regulated as a tobacco product?
bigdancehawk, what's your informed and educated guess as to how our side will fare in the district court of appeals?
Well, they couldn't actually do that. The FDA derives its authority from statutes enacted by congress. Congress has only given the FDA the power to regulate food, drug and tobacco products. Congress should enact a new statute that deals with vaping devices, because the current statute isn't a suitable framework for regulating them.
They Didn't mention NRT's in this statement...
Although they are often marketed as helping smokers quit, there is scant evidence to back
such claims, and some evidence that they in fact inhibit cessation. At the same time, there is
ample evidence that e-cigarettes present significant risks to the public health. To begin, they are
principally designed to deliver nicotine—one of the most addictive substances known to man—
and can do so as effectively as conventional cigarettes.
http://www.clivebates.com/documents/FDAresponse.pdf
But they do seem Convinced that Nicotine is "one of the most addictive substances known to man".
Right, ecigs shouldn't be in the same category as cigarettes, and the idea that 0 nic e-liquid is still a tobacco product is completely nonsensical
But wasn't that the FDA's problem?
If e-Cigarettes were not "Deemed" to be in the same Category as e-Cigarettes, then they would Fall Outside of their Authority when not Marketed/Advertised as a Drug Delivery Device.
I really need to read the reply briefs to see how effective the plaintiffs are at rebutting the FDA's points. I hate to admit it, but FDA's brief is a good piece of legal writing.
These kinds of cases are extremely difficult for the plaintiffs to win.* The odds are definitely not in our favor, but you never know until the fat lady sings. Fingers crossed.
*The standard of review gives administrative agencies every benefit of the doubt in these cases. The judge may be convinced that the agency had adopted boneheaded regulations and may vehemently disagree with them, but she may still have to bite the bullet and let them stand.
EDIT: Let me amend that just a little. She's a federal district judge appointed for life. She can do just about any damn thing she pleases. So I should have said "...but she may still reluctantly conclude that the law supports the FDA's position."
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