SE, NJoy vs FDA -- Discussion

[JustJulie]

Julie, I listened to the internet radio program. You all did a great job, of informing us of what's happening. I must be getting old, I didn't recognize the little trick that the FDA was trying to pull on Johnson Creek, until it was mentioned on the program.

I'm glad you liked the program, Jerry. I'm so grateful that Yvilla and Cit-e Steamer took the time to answer questions . . . and very grateful that Kevin provided such a great service for our community.

Yeah, I'm still fuming about what the FDA did with Johnson Creek. With so many cruddy vendors out there ripping people off and making truly over-the-top health claims, it seems ridiculous and mean-spirited for the FDA to single out Johnson Creek, who is clearly one of the good guys.

 

[JerryRM]

I look at it this way, Julie. Johnson Creek is one of the leading e-juice suppliers in the U.S.
If they comply with the FDA requirements for pharmaceutical manufacturing, wouldn't that be a de-facto admission by Johnson Creek that the e-cig is a drug/device ???

I believe it was Yvilla who mentioned that the FDA letter to Johnson Creek was for an inspection held over a year ago. Why would they send the letter now and not a year ago ?? That's what awoke me to the possibility that the FDA was trying to pull a fast one.

 

[thephoenix]

We gotta issue a press release on this one:

ASH Joins E-Cigarette Companies Against FDA

Washington D.C., September 14, 2010. John F. Banzhaf, Executive Director of Action on Smoking and Health (ASH) has joined with Sottera, Inc., doing business as njoy, as a plaintiff against the U.S. Food and Drug Administration (FDA). Orginally, Banzhaff filed an Amicus Brief on the side of the FDA, but apparently has had second thoughts about supporting a defacto ban on electronic cigarettes.
--CASAA Press Office

I keep rubbing my eyes and rereading this as I can't believe it. I even opened Julie's document. How can this be? I mean it's tremendous - but seriously? He was out to hang eCig companies - he's on our side now...I'm going loopy...

If this is real - its an amazing turn of events!

 

[thephoenix]

p.s. nice job on the radio show Julie!

 

[JustJulie]

I look at it this way, Julie. Johnson Creek is one of the leading e-juice suppliers in the U.S.
If they comply with the FDA requirements for pharmaceutical manufacturing, wouldn't that be a de-facto admission by Johnson Creek that the e-cig is a drug/device ???

I believe it was Yvilla who mentioned that the FDA letter to Johnson Creek was for an inspection held over a year ago. Why would they send the letter now and not a year ago ?? That's what awoke me to the possibility that the FDA was trying to pull a fast one.

Of course, I can't speak for Johnson Creek, but I'd frankly be shocked if that was even a consideration. My hope and expectation is that they will address the marketing issues raised by the FDA (even though I think some of them are a total crock of you know what), and then let the FDA know that, without admitting they've done anything wrong, they've changed their website and marketing materials to remove any possibility of confusion . . . and since they're not making any health claims, they're clearly not a drug. The CGMP violations should then be a moot point since those are requirements specific to pharmaceuticals.

And, yes, the inspections were done a year ago. And the reason why Johnson Creek wasn't cited with any violations at that point is because there likely were no problems . . . not until the FDA decided to declare that Johnson Creek was selling a drug.

But regardless of how Johnson Creek decides to handle this, the determination of whether a company is manufacturing/selling a tobacco product or a drug is one that really must be made on a case-by-case basis. Thus, what Johnson Creek does shouldn't constitute a de facto admission that would bind the entire industry.

On the other hand, how the FDA responds to whatever it is that Johnson Creek decides to do will give the industry as a whole some guidance on how to steer these rather rough waters.

 

[JustJulie]

I keep rubbing my eyes and rereading this as I can't believe it. I even opened Julie's document. How can this be? I mean it's tremendous - but seriously? He was out to hang eCig companies - he's on our side now...I'm going loopy...

If this is real - its an amazing turn of events!

LOL. Elaine is having some fun. Banzhaf has not jumped on the e-cig band wagon . . . he's still on the ban wagon. (Yeah, I know--terrible pun.) The likely explanation is a clerical error in categorizing him as an appellee.

p.s. nice job on the radio show Julie!

Thank you. But I have to admit that I'm happier being in the audience than in the co-host seat.

 

[mpetva]

Why is the 2nd pdf also addressed to our favorite "friend" Banzhass in addition to NJoy? Weren't there others who filed briefs? Why does Ash get special privileges? Is he an Appellee? (Ash is addressed as such in this letter).

I wished someone could /would answer my questions. I am still utterly confused that Ash is listed as and Appellee on this letter! If there is a court clerical error, why has it not been corrected? How can that still be on something filed with the court just now?

 

[Tom_E_Calm7]

First and foremost everyone needs to realize whats happening. This ASH guy is not to be trusted in my opinion and everyone should be HIGHLY SKEPTICAL as far as his intentions. I just saw a poll recently that stated that smoking among teens and youths is up about 15-20%. So obviously this guy realizes hes fighting a loosing battle and wants to jump on another bandwagon. (I bet hes a Saints fan now too!) I say leave him in the dust. Ive personally read the propaganda and outright boldface LIES this guy has tried to perpetrate. Dont take my word for it, look up his website and history. GOOGLE HIS NAME, WHAT YOU FIND WILL SPEAK FOR ITSELF.

 

[thorn]

On the ASH changing sides issue.....Is it in anybody's best interest for this? Could they be changing sides just to dilute the defense and add confusion to their testimony so the FDA wins?

 

[JustJulie]

To all those who are wondering if ASH has switched sides and is now supporting NJOY, let me assure you that is absolutely, positively, without a doubt NOT the case.

ASH has been receiving copies of filings along with the parties to the case, so ASH probably filed some sort of notice with the court early on . . . maybe that caused the clerk to enter it as a party for purposes of giving notices. Who knows. But even though I'm not sure why ASH is being listed as an appellee in that court document, ASH is most assuredly not our friend.

 

[mpetva]

To all those who are wondering if ASH has switched sides and is now supporting NJOY, let me assure you that is absolutely, positively, without a doubt NOT the case.

ASH has been receiving copies of filings along with the parties to the case, so ASH probably filed some sort of notice with the court early on . . . maybe that caused the clerk to enter it as a party for purposes of giving notices. Who knows. But even though I'm not sure why ASH is being listed as an appellee in that court document, ASH is most assuredly not our friend.

Thank you!

 

[thephoenix]

Thank you. But I have to admit that I'm happier being in the audience than in the co-host seat.

Too bad! Cuz you're a natural.

 

[JustJulie]

Too bad! Cuz you're a natural.

ROFL . . . well, that's nice of you to say. (Your check is in the mail. )

No movement on the docket. Oral arguments are coming up soon, and I'm hoping Elaine will be able to attend so she can share her first-hand observations of how it went.

And in case anyone is wondering, I'll answer the question in advance: I have absolutely no idea how long it will take the Court of Appeals to actually announce a decision. And remember . . . whatever the decision of the Court of Appeals is, we're still going right back to Judge Leon for him to try the case on its merits.

 

[Tom_E_Calm7]

E_Cigs need a CELEB endorsment!!!!!!!!!!!!!

 

[Vocalek]

ROFL . . . well, that's nice of you to say. (Your check is in the mail. )

No movement on the docket. Oral arguments are coming up soon, and I'm hoping Elaine will be able to attend so she can share her first-hand observations of how it went.

And in case anyone is wondering, I'll answer the question in advance: I have absolutely no idea how long it will take the Court of Appeals to actually announce a decision. And remember . . . whatever the decision of the Court of Appeals is, we're still going right back to Judge Leon for him to try the case on its merits.

That's the plan, Stan. I hear that AutumnMist is going as well. We live near each other so maybe we can make the trip together.

 

[thephoenix]

(Your check is in the mail. )

awesome! I can just keep doling out compliments for $$...so just let me know!

 

[Dawolf]

E_Cigs need a CELEB endorsment!!!!!!!!!!!!!

I watched this video before, actually this video is what brought me back to e-cigs after I was turned off by the nasty Njoy cartridges. Hey they are celebrity doctors!, while not an official endorsement, these celebrity doctors acknowledge the potential, and even vaped up on stage!

http://www.youtube.com/watch?v=8OTWKn4WLa4

Ray

 

[JustJulie]

awesome! I can just keep doling out compliments for $$...so just let me know!

I used to give my daughters a quarter for telling me I was thin and beautiful. Now they're old enough that they can't say it with a straight face, not even for $1.



No movement on the docket.

 

[lonercom]

I used to give my daughters a quarter for telling me I was thin and beautiful. Now they're old enough that they can't say it with a straight face, not even for $1.



No movement on the docket.

You ARE thin and beautiful!

 

[JustJulie]

You ARE thin and beautiful!

Your check is in the mail.