Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Mitty]

How do we get a hold of him, Sun ?

 

[Bones]

The Federal Food, Drug, and Cosmetic Act (FDC Act) defines "drug" as any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body." All drugs and devices must be labeled with adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Products not generally recognized as safe and effective by experts are considered "new." Improper labeling is called misbranding. Marketing a "new" or misbranded drug or device in interstate commerce is a federal crime. Marketing without adequate directions for use is also a federal crime.
When products are marketed improperly, the FDA may issue a warning letter specifying the violations and demanding to know how the problem will be corrected. If a warning is ignored, or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Some comply, but many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.

Sun

From the FDA letter -

We focus on the product's "intended uses." FDA considers ALL of the circumstances surrounding the marketing of a product in determining its "intended uses." See 21 C.F.R. 201.128. The key elements in evaluating these products is whether they are intended to affect the body's structures and functions and/or to treat, mitigate, or prevent disease (e.g., nicotine addiction). See section 201(g) of the Act (21 U.S.C. § 321(g)).


Why does this apply if there is no nicotine in the package? (e.g.Nic-Free juice)
Where is the drug then? In what way does PG or VG "affect the body's structures and functions"? I have seen hallucinogenic mushrooms being sold on-line legally by labeling them NOT FOR HUMAN CONSUMPTION - Can this not be done? I know some people reject the idea of calling their e-cig a novelty item - But can we really afford such idealism if the worst comes to pass? On that point the FDA really seem to be reaching - At that point does the "intended use" route not open up for a Nic-Free device that makes no claim connecting it to smoking in any way? - I know that will leave us with bath-tub e-juice or creative shipping options until approved e-juice is available again - But why can that route not keep the devices on the shelf? e.g. NOT FOR HUMAN CONSUMPTION or NOVELTY ITEM FOR STAGE PRODUCTIONS - DO NOT INHALE

 

[SSRob]

I think it could be done, but, what reseller has the money and legal resources to defend themselves against the FDA should legal action be brought against them?

You can be as innocent as a baby but I can still acuse you of murder and drag you through court.

Thanks
Rob

 

[LaceyUnderall]

I think it could be done, but, what reseller has the money and legal resources to defend themselves against the FDA should legal action be brought against them?

You can be as innocent as a baby but I can still acuse you of murder and drag you through court.

Thanks
Rob

That's why we all have to get together and fight this as one. The FDA is going to pick us off one by one if we don't.

They CLEARLY can't just stop the ecig or they would have in July of 2008 when they said they first found out about the product. Then they had a second chance in Sept of 2008 with the WHO's announcement against the ecig. Then surely, when "The Doctors" aired their top 10 segment and undoubtedly asked a question or two, they could have had a go at stopping it then.

If they were under the assumption that the ecig "would just go away" then public health advocates my a**.

 

[OutWest]

How do we get a hold of him, Sun ?

Good question and seconded. Considering the latest turn of events and considering what Sun posted about how the clerks do read the letters and such, I will gladly write myself, but dont have the address.

 

[Bones]

I think it could be done, but, what reseller has the money and legal resources to defend themselves against the FDA should legal action be brought against them?

You can be as innocent as a baby but I can still acuse you of murder and drag you through court.

Thanks
Rob

Well - To be fair - It is SE and NJOY that have brought the FDA into court - Not the other way around - The FDA will stop shipments - The FDA does not need to take legal action if they already have legal authority -The burden of proof in this case is on SE/Njoy - Not the FDA -

Here is an even better question - Why does posting a disclaimer of:
"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." - Work for Smilin' BOB and Enzyte and not the e-cig?

This is clearly a product that claims OUTRIGHT to be: "intended to affect the structure or function of the body."

 

[Bones]

Sun's previous post - Don't thank me

You may write Judge Leon at the following address


The Honorable Justice Richard J. Leon
Clerk's Office
United States District Court
for the District of Columbia
333 Constitution Avenue, N.W.
Washington, D.C. 20001

 

[Bones]

I think it could be done, but, what reseller has the money and legal resources to defend themselves against the FDA should legal action be brought against them?

You can be as innocent as a baby but I can still acuse you of murder and drag you through court.

Thanks
Rob

What I suggested does not require a court battle - Just a repackaging and changing of the advertising -

 

[LaceyUnderall]

The burden of proof in this case is on SE/Njoy - Not the FDA -

This statement has been used around here before and I am slightly confused. Since when does the defendant not have to do the proving? Isn't it actually better to be the Plaintiff in a case?

When you are the plaintiff, you accuse someone of doing something and they have to prove they are not guilty of what you accuse. Is this not correct?

 

[OutWest]

Sun's previous post - Don't thank me

You may write Judge Leon at the following address


The Honorable Justice Richard J. Leon
Clerk's Office
United States District Court
for the District of Columbia
333 Constitution Avenue, N.W.
Washington, D.C. 20001

Well, I do thank you I knew it had been posted (and was thinking it was Sun that had posted it) but I ran some searches and couldnt locate it. So, thank you And, thank you too, Sun

 

[Bones]

This statement has been used around here before and I am slightly confused. Since when does the defendant not have to do the proving? Isn't it actually better to be the Plaintiff in a case?

When you are the plaintiff, you accuse someone of doing something and they have to prove they are not guilty of what you accuse. Is this not correct?

As I understand it - They are the ones who must prove the charge that the FDA overstepped authority in stopping their shipments - I agree with what you said - That seems to be the way it is from what I have read here - I'd love to be told it Lawyers have a way of making you think you are crazy real quick - Think about it too much and you will be crazy -

 

[LaceyUnderall]

As I understand it - They are the ones who must prove the charge that the FDA overstepped authority in stopping their shipments - I agree with what you said - That seems to be the way it is from what I have read here - I'd love to be told it Lawyers have a way of making you think you are crazy real quick - Think about it too much and you will be crazy -

well... we all know one thing for sure... we know nothing until the judge makes his statement LOL.

 

[Breakfree]

I mean, JEEZ LOUISE could we have a new thread titled FDA BREAKING NEWS? This update was just waaaaaaay too hard to find and it SHOULD be of utmost importance!

 

[eric]

As far as I'm concerned, the burden of proof should be placed on the FDA. They're the ones who claimed SE and NJoy were guilty of bringing drug devices into the USA. If SE and NJoy challenged this statement, the FDA should definitely bear the burden of proof.

Then again, I'm not a corrupt government entity. What we the consumers say is meaningless.

 

[Coco]

Here is a news release from the FDA that just was announced---but I'm not allowed to post URLs to because I don't have made 15 posts or more

pls visit the fda gov news events

it mention diethylene glycol and nitrosamines

 

[No More Ashes]

Just saw this hit:

FDA: Electronic cigarettes contain toxic chemicals

finance.yahoo.com/news/FDA-Electronic-cigarettes-apf-1543561070.html?x=0&.v=8

Why anyone would use Chinese juice is beyond me anyways.

 

[CoderGuy]

Here is a news release from the FDA that just was announced---but I'm not allowed to post URLs to because I don't have made 15 posts or more

pls visit the fda gov news events

it mention diethylene glycol and nitrosamines

Hi Coco, there is already a thread all about that: http://www.e-cigarette-forum.com/forum/e-cigarette-news/28130-fda-news-release.html

CoderGuy

 

[happily]

You guys can argue til your blue in the face..................smiling bob can get away with whatever he wants as long as he pays off the right people

there are a million way e-cig's could be marketed but you are stepping on the wrong people's toes

this is not about...........not intended for human consumption.........common sense and the fact that they are 1000 times safer than analog's will NEVER, EVER, EVER..............EVER be the deciding factor in this case. I am not bagging on anyone's opinion here because the best opinion's are based on common sense, but that's where we lose reality with this subject

COMMON SENSE HAS NO PLACE IN POLITICS

 

[LaceyUnderall]

Ohhhh--Lacey--No--when you are the Plaintiff in a civil lawsuit--it is you that bears the burden to make out a case and advance enough evidence to prove your case. The Defendant really has do to nothing. The Defendant can offer prove to refute the evidence, but the burden of prove is always on the Plaintiff. If at the end of the Plaintiff's case, they have not met the requisite burden, the defendant will alway move for a directed verdict and the case will be dismissed outright. There are so many types of cases where it is more advantageous to be the Defendant--such as the case here.

Sun

Thank you! I have been curious about this.

 

[Bones]

You guys can argue til your blue in the face..................smiling bob can get away with whatever he wants as long as he pays off the right people

there are a million way e-cig's could be marketed but you are stepping on the wrong people's toes

this is not about...........not intended for human consumption.........common sense and the fact that they are 1000 times safer than analog's will NEVER, EVER, EVER..............EVER be the deciding factor in this case. I am not bagging on anyone's opinion here because the best opinion's are based on common sense, but that's where we lose reality with this subject

COMMON SENSE HAS NO PLACE IN POLITICS

Yes - Well - I take no offense as my opinion was offered before I had seen the Press Release - Now - It is all too clear that this case is just a step in the dance and means nothing - All that is left now is to Fight!

They play the media - We play the media -

SHOUT THE TRUTH FROM THE MOUNTAIN TOPS