FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban

[TropicalBob]

suppliers have Your lawyers ready and prepare to fight back, TropicalBob is not a lawyer.

Excuse me. Sun was quoting the exact words of the FDA, as I do. Those are not our words. They're FDA quotes. Now, your mind can play fanciful tricks all day. But e-smokers better pay close attention to the real world words being used by the FDA. No one needs to be a lawyer to understand them.

 

[Effex]

I got an idea, how about the FDA, FTC and whatever other 3-letter organization, FBI. KGB, CIA, MTV go after Chantix before going after my precious e-cigs?

You know.. Chantix! That cool little pill that helps people quit smoking? That cool little pill where, when you pop it, makes all your problems go away, like 10, 15 or 20 years of smoking, which re-wires your brain into needing to have that nicotine, and needing to have that cigarette smoking motion for to be fully satisfied.

One little problem though, it doesn't work all that well. On their website, they say it has a 44% success rate. Well. That sounds like a pretty hefty number! 44%! That's almost half the users! What they fail to mention is the other half. You know.. The suicides, the deep depression, the complete change in attitude and character, kind of like... A Lobotomy?

How come they are not making press reports and interviews about that?

 

[yvilla]

Excuse me. Sun was quoting the exact words of the FDA, as I do. Those are not our words. They're FDA quotes. Now, your mind can play fanciful tricks all day. But e-smokers better pay close attention to the real world words being used by the FDA. No one needs to be a lawyer to understand them.

Bob, you and Sun have been selectively quoting the FDA, unfortunately. You seem to love to quote Rita Chappelle as quoted by reporters, but not Christopher Kelly, as also quoted by reporters. You also seem to love quoting the letter that refers to certain ecigs as "unapproved new drugs" and as "drug-device combinations", but not another letter that shows that the FDA stance on ecigs is not quite so cut and dry as that, but rather depends on the claims and the marketing of particular ecigs. Indeed Dr. Nitzkin has also told us that:

"FDA authority is based on the claims of the manufacturers, not the content of the product. Under current law, if a product claims health benefits but has no acceptably scientific studies to back them up FDA can either force the product off the market or force the manufacturer to amend its labeling and marketing."

(As quoted by KDMickey http://www.e-cigarette-forum.com/fo...g-fda-no-banter-here-please-2.html#post161557)

And here once again, is the FDA letter that lays out that they proceed on a case by case basis in determining whether a particular product is subject to their regulation:

Thank you for your comments to the Division of Drug Information in Center for Drug Evaluation and Research at the Food and Drug Administration.

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.

FDA has reviewed several "electronic cigarettes" and determined that those products were making "drug" claims. We have detained and refused several such products on the grounds that they were unapproved new drugs as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. Additionally, because they were drug-device combinations under 21 U.S.C. 353(g)(1), they were also adulterated devices.

We will continue to review these products on a case by case basis.

If, after reviewing this information, you have any unanswered questions, please contact the Division of Drug Information by phone (1-888-463-6332) or e-mail (druginfo@cder.fda.gov). Thank you again for your message.

Division of Drug Information
Center of Drug Evaluation and Research
Food and Drug Administration

As quoted by lordmage http://www.e-cigarette-forum.com/forum/law-e-cigarette/10001-fda-congress.html#post156106

Do you still not see that, for example, the NJOY line of products may well be viewed as falling completely outside of FDA regulation, in light of their intended use, labeling, promotion and advertising as simply a smoking alternative? And that another ecig brand may be viewed as being illegally marketed as a smoking cessation product (ie, an unapproved new drug-device combination), and therefore subject to FDA regulation and seizure?

 

[Relentless]

I've been e-mailing many suppliers and it would seem they all agree with Yvilla... The FDA will only get involved if the manufacturer or seller claim these things are for an intended purpose... This is precisely why I can right now go buy a .... or one hitter...
All these companies have to do is follow the letter of the law and none of us will have problems...

 

[franklyspeaking]

I've been e-mailing many suppliers and it would seem they all agree with Yvilla... The FDA will only get involved if the manufacturer or seller claim these things are for an intended purpose... This is precisely why I can right now go buy a .... or one hitter...
All these companies have to do is follow the letter of the law and none of us will have problems...

If you don't mind me asking... who have you emailed? Can you post the responses? I don't doubt you or Yvilla as I don't doubt Sun and Bob's stance either.

From what I can tell the waters are muddy, just the way they want them.

 

[Relentless]

I'm not posting responses without their permission and I'm not asking them for it.
Do you have an e-mail account?
Sending then reading e-mails is a remarkably easy process.

 

[franklyspeaking]

I'm not posting responses without their permission and I'm not asking them for it.
Do you have an e-mail account?
Sending then reading e-mails is a remarkably easy process.

I do have an email account.

I have sent emails to several companies and have gotten no response back.

If I did get a response I would share it with the board.

Maybe it's just me but I would take the high road rather than try and goad someone into a flame war.

 

[Relentless]

No flame war goading here I assure you. I received responses from four seller/manufacturers...
Realistically none of us can expect that a .... can be sold but a vaporizer cannot...
It is all about advertised intent of use:

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.


I'd say that's pretty clean cut...

 

[franklyspeaking]

No flame war goading here I assure you. I received responses from four seller/manufacturers...
Realistically none of us can expect that a .... can be sold but a vaporizer cannot...
It is all about advertised intent of use:

Whether a particular product is a drug (or a device) under the Federal Food, Drug, and Cosmetic Act depends on its “intended use.” In making that determination, the agency considers the product's label and labeling, its advertising or promotional materials, and other relevant sources. In order to make a definitive determination of the regulatory status of any product we have to evaluate the relevant information on a case by case basis.


I'd say that's pretty clean cut...

I disagree that the rules for products and devices marketed to burn tobacco apply to e-cigs. I also see a disparity between the written statements by the FDA and the verbal statements given to the press. While written statements might state how far they are willing to go when the stance is put in print. The verbal statements relay the sentiment and intent of where they would like to see it go.

 

[Relentless]

Where they would like to go?.. Yeah I understand that being a staunchly anti-government guy. I'm sure in fifty years we'll all be securely wrapped in bubble wrap and held down with government issue red tape, only ever allowed to utter the words "I'm Happy".
But those days are not yet here...

 

[Mike1218]

I think myself it isn't just the FDA it is cause they are trying to figure out how to TAX us my though only and im no one lol Mike

 

[yvilla]

I also see a disparity between the written statements by the FDA and the verbal statements given to the press.

No disparity between the FDA's written and verbal statements to the press. Here is FDA spokesperson Christopher Kelly, as quoted by the press, saying basically the same things as said in the letter to lordmage that I quoted above:

"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

http://www.news24.com/News24/Technol...477587,00.html

 

[franklyspeaking]

"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

http://www.news24.com/News24/Technol...477587,00.html

is different than:

A seemingly safer smoking option, the "e-cigarette," is illegal to market and sell in the U.S., according to Rita Chappelle, USFDA spokesperson.

Neither that device nor the vapor it produces has been approved by the Federal Drug Administration, Chappelle said.

Such products must meet approval through the Federal Cigarette Labeling and Advertising Act, Comprehensive Smokeless Tobacco Health Education Act or the FDA. Because the product uses strictly nicotine rather than a form of tobacco, approval rests on the FDA, Chappelle said.
Electric cigarette not quite ready for retail | cigarette, nicotine, tobacco - Local News - Gaston Gazette

or it sounds like it to me anyway...

 

[yvilla]

is different than:



or it sounds like it to me anyway...

Right. That's two different FDA spokespersons, both being quoted by the press.

Chappelle's statement's have none of the important qualifiers seen in Kelly's spoken statments and in the FDA letter I quoted.

I leave it to you to decide - is it possible the reporters quoting Chappelle are giving us words taken out of context, or simplified for purposes of their story? Is Chappelle discussing a particular brand of ecig in the stories where she is quoted?

Bottom line for me, Kelly's quoted statements, the FDA letter I quoted and Dr. Nitzkin's statements about it are all more in line with my understanding of what falls under the regulatory jurisdiction of the FDA.

 

[franklyspeaking]

Right. That's two different FDA spokespersons, both being quoted by the press.

Chappelle's statement's have none of the important qualifiers seen in Kelly's spoken statments and in the FDA letter I quoted.

I leave it to you to decide - is it possible the reporters quoting Chappelle are giving us words taken out of context, or simplified for purposes of their story? Is Chappelle discussing a particular brand of ecig in the stories where she is quoted?

Bottom line for me, the FDA letter I quoted and Dr. Nitzkin's statements about it are both more in line with my understanding of what falls under the regulatory jurisdiction of the FDA.

Good points and I hope your understanding is correct.

 

[strayling]

I leave it to you to decide - is it possible the reporters quoting Chappelle are giving us words taken out of context, or simplified for purposes of their story?

I think it's extremely likely. In the story from the Gaston Gazette notice how the bit about illegality is not a direct quote but the reporter's interpretation. That's a red flag right there.

 

[jukeboxsabotage]

Sun

Frankly I am getting really tired of you telling me what all of these companies are/are not doing.

Just because someone does not explicitly tell you every single one of their actions doesn't mean that they are not doing them.

If you wanted to know the procedures these companies had in the past to try and get ahold of the FDA and receive approval then, heres a thought, why didn't you ask then? Instead, now you harass people, like Ludo here.

Last time I checked it didn't say "Supplier" or "Manufacturer" under your name. So, until that changes I don't want to hear from you about what these companies are doing. I want to hear from the companies themselves.

And also, I am sorry Sun, I really have nothing against you and your posts have actually been quite helpful to me in the past. I know I am new here and don't really have the support that you do. I am just speaking my mind and I hope I don't make any enemies from it .



P.S. I'm sorry if someone has already said anything I have stated, but I am in a hurry now and didn't get a chance to read past page 9. And if something has happened in those 7 unread pages that makes my words completely invalid then I apologize for wasting time here.

 

[TimmyT]

Ladies and Gentlemen Please ! The only thing we know for certain is that none of us and I mean none of us know exactly what the FDA or FTC will or will not do. Remember E-cigs are still in their infancy and time IS on our side. I agree with many of you in that the greatest single determination of intent by the FDA will come in the form of how E-cig's are marketed and the claims being made. We must all be prepared for a fight and have the intestinal fortitude to see it thru. Nothing worthwhile ever comes easy and as a side note I would be willing to put my $$ where my mouth is. How bout you ? I end this post with a great quote by Roosevelt to the Rough Riders :

The credit belongs to the man who is in the arena
Who's face is marred with dust ,sweat and blood. Who knows the great enthusiasm's, the great devotions. Who spends himself in a worthy cause.
And if he fails he fails while daring greatly so his place shall never be with those cold and timid souls who know neither victory nor defeat.

TimmyT

 

[jukeboxsabotage]

I can agree to that

 

[TheBandit]

I'd like to throw in my take on the whole "what's the difference between something written and something verbal" thing. Something written can be a regulation, procedural requirement, a law, as well as many other firm legal kinds of...written, word thingys (sorry, my eloquence eludes me ). Something spoken cannot be one of these things, officially, unless quoting a written...law (for example). This Rita can say that these are illegal all day long, but that doesn't mean that they are unless there is something in place that is written to back her up. I mean come on, would it make it so if she said that elephants were pink? (I know, but please don't post it, you know what I mean)

The intent and claims and marketing thing has now been backed up at least twice, by this one FDA dude, and the new friendly Dr. guy. (Sorry, typing on my Wii, so I can't cite their names) Oh, ya, and a third time by the quote from the FDAs own actual guidelines. It seems pretty cut and dry to me.