Thank you Vocalek for putting forth the effort and time to give us all this report.
SE, NJoy vs FDA -- Discussion
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Elaine
Thanks for going to the hearing and getting a report written so quickly, and in so much detail. It sounds hopeful. I really appreciate the time and effort you continue to put forth on everyone's behalf. Oh, and congrats on becoming Vice-President of CASAA.
Chris
Thanks for going to the hearing and getting a report written so quickly, and in so much detail. It sounds hopeful. I really appreciate the time and effort you continue to put forth on everyone's behalf. Oh, and congrats on becoming Vice-President of CASAA.
Chris
Thank you so much from me also! Great job Elaine!
Here is a small article about the proceedings:
FDA Continues Fight to Regulate Electronic Cigarettes - The BLT: The Blog of Legal Times
Here is a small article about the proceedings:
FDA Continues Fight to Regulate Electronic Cigarettes - The BLT: The Blog of Legal Times
Thank you so much for reporting on this. I have been reading through everything you've written and posted and have been on pins and needles for today to come. Can't wait for the decision. Thank you,Thank you, Thank you!
BTW, many (if not all) of Klein's arguments were circular. She continuously cited the FDA's position and FDA's previous actions to justify why the FDA is acting in accordance with the law in this case. "Bootstrapping run amuck" as Judge Leon so eloquently put it.
I checked into getting transcriipts. Yes, the court does sell a $45 CD, but that is not made available until the case is "over and done with." Not sure whether that applies only to the judge's decision on the appeal heard today or the entire case. As Julie said, this appeal is occurring in the middle of everything, before the case has even been tried in the lower courts.
I contacted the company that does the court reporting, and we can order printed transcripts of the oral arguments that cost $2.90 per page. The arguments went on for an entire hour, so that could be as much as 100 pages. This would have a 2-week turnaround.
I contacted the company that does the court reporting, and we can order printed transcripts of the oral arguments that cost $2.90 per page. The arguments went on for an entire hour, so that could be as much as 100 pages. This would have a 2-week turnaround.
I bet if you put up a button on the CASAA page to solicit some donations for this, you'd get the $300-$350 to pay for the written transcript if we can't get the CD. I know I would put $50 towards that project.
Considering Banzhaf's earlier quote about the appeals court "overturning a decision by a major federal regulatory agency...", I have a feeling that he does not understand the basic questions of this case. I wonder if he even knows which side he was paid to be on.
+1 and quoted for truth! 
Hubby and I would also be willing to donate towards the cost of the printed transcript.
So I want to make sure I read this right ~ How the products are marketed is whether the FDCA applies to electronic cigarettes. The FDCA (Food Drug and Cosmetic Act) holds ground against products containing nicotine if said products are marketed as nicotine replacement therapies. If products containing nicotine are not marketed as smoking cessation or any other form of nicotine replacement and are derived from tobacco then the products fall under the "Tobacco Act" where the FDA still has authority but limited.
I will gladly contribute towards getting the transcript and/or the CD. Let me know where to donate.
Great job Elaine!
The Chevron deference is where a statute is somewhat vague and a great difference is given to the regulatory agency that makes the interpretation. The FDA tried that in Williamson case and was shot down. But, like you, I am not a lawyer and I am sure that there are some lawyers on here that will interpret that for you in much clearer terms than a layman can. I too, would like to have a copy of that transcript to give to our lawyer for "future" reference. And I am sure that there will be a future need. Lol You have my email if you decide to take a collection.
The Chevron deference is where a statute is somewhat vague and a great difference is given to the regulatory agency that makes the interpretation. The FDA tried that in Williamson case and was shot down. But, like you, I am not a lawyer and I am sure that there are some lawyers on here that will interpret that for you in much clearer terms than a layman can. I too, would like to have a copy of that transcript to give to our lawyer for "future" reference. And I am sure that there will be a future need. Lol You have my email if you decide to take a collection.
No "movement" per se . . . just a little memorandum noting that the oral arguments occurred.
Thanks again, Elaine.
Thanks again, Elaine.
You have described the position of NJOY perfectly. The FDA lawyer is insisting that if a product contains nicotine, but no tobacco, it's automatically a drug. The agency apparently wants to ignore the "intended use" rule in this instance. I'm not sure that this is a wise position for them to take. That would open the door for General Mills to come back and say that oats are oats, and are not a drug. If General Mills wants to include information on the Cheerios box about lowering cholesterol, the FDA doesn't have a leg to stand on insisting that they file an NDA or remove the "health claim".
I would assume that CASAA would pay the cost of the transcript?
If so, let me know and I will go donate some more money to CASAA.
If the cost is coming out of your own pocket, let me know how to contribute please.
And thanks, from all of us!!
If so, let me know and I will go donate some more money to CASAA.
If the cost is coming out of your own pocket, let me know how to contribute please.
And thanks, from all of us!!
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