Fda approval!

[cucurucho]

As far as I can tell the nicotine in e-liquid is taken from plants, there are other "essences" from tobacco.
That is not drug form nicotine, it is a form of tobacco. The FDA cannot regulate tobacco without getting the law changed.

Tobacco Law & Legal Definition

I don't see any mention of e-liquid there. Maybe someone should dish out $15 and 'ask a lawyer'.

 

[Lithium1330]

...Prohibit health claims about so-called “reduced risk” products that are not scientifically proven or that would discourage current tobacco users from quitting or encourage new users to start...

oops here they come...

 

[Myk]

Tobacco Law & Legal Definition

I don't see any mention of e-liquid there. Maybe someone should dish out $15 and 'ask a lawyer'.

Here you go,
http://www.farseegroup.com/UploadFiles/ingredients list for electronic cigaretter flavor.pdf

Tobacco essencial oil, natural from tobacco
Tobacco absolute, natural from tobacco
Nicotine (from tobacco leaf), natural from tobacco

That makes this a tobacco product. The form of nicotine is why it is not NRT which has to use an approved drug for or apply for new drug approval.

This is the exact thing Nicotine Water when through in reverse.
I don't see any mention of Nicotine water there either and that's marketed as a tobacco product now that they've changed their nicotine away from a drug form.

LOL, $15 to talk to a lawyer, that's funny.
My lawyer nephew would probably send me a bill higher than that if I asked him legal advice
He's tobacco friendly so I'll ask him if I see him before the FDA or Congress makes a move.

 

[palermo45]

I am not an attorney, but from what I gather in this message is that he is stating that a new drug application must be submitted and approved prior to selling this product. Then towards the end, he states that "None of these so-called "electronic cigarettes" is covered by an approved NDA."

So I interpret this as basically no one can legally sell these items. I even mentioned to him that mine did not contain any nicotine and only contained PG. Of coarse I never claimed this as being any type of smoking cessation device either. So basically he is saying that all the big companies selling these products in the US are breaking the law.

Any attorneys out there who can shed some light on this outrageous response received by the FDA??

Please note that url's were submitted to me, however I can not post them here until I have posted 15 messages. I can forward the complete e-mail to anyone who wishes. So I just wrote "?" in those spaces for now. I would also be glad to forward the FDA agents direct e-mail to anyone who wants it.

Your recent inquiry directed to the Division of Drug Information in FDA's Center for Drug Evaluation and Research, regarding the regulatory status of so-called "electronic cigarettes," was forwarded to me for reply. Please note that in order to make a definitive determination of the regulatory status of any product it is necessary that we review a complete description of the product's design, function, its formulation, labeling and promotion (including statements and representations on the Internet), and any other information (e.g., patents) that describe the product's intended uses. In addition, as a matter of policy, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions. Nonetheless, we can make the following general comments:

The "electronic cigarettes" that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action. In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body. The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA.

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.


A detailed discussion of the new drug application (NDA) process is available on FDA’s Internet Web site at: http://www.fda.gov/cder/regulatory/applications/default.htm. The sections of the Act referenced above are also available on FDA's Internet web site at www.fda.gov.


I hope this is helpful.



Kevin M. Budich
Compliance Officer
Food and Drug Administration
CDER/Office of Compliance
Division of New Drugs & Labeling Compliance
OTC Drugs Team
10903 New Hampshire Ave.
WO51-5174
Silver Spring, MD 20993

301-796-3304
kevin.budich@fda.hhs.gov

 

[CaSHMeRe]

forward the links to me ... i will edit your post to include them.

steve@puresmoker.com

 

[dc2k08]

break it up a little into paragraphs too, can you cash for legibility?

 

[CaSHMeRe]

break it up a little into paragraphs too, can you cash for legibility?

That's how the email came bud. Wasn't broken up

 

[Myk]

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.

Pipe tobacco has neither of those.
I have some with a California warning but none with a federal warning.

 

[nqhqhz]

I am not an attorney, but from what I gather in this message is that he is stating that a new drug application must be submitted and approved prior to selling this product. Then towards the end, he states that "None of these so-called "electronic cigarettes" is covered by an approved NDA."
.

Are you your agent is not talking about all of this in the NRT context? It doesn't matter if these "new drugs" don't "qualify" if people let go of the idea that they will somehow be accepted as medicine...

 

[palermo45]

The main problem I have with this entire scenario is the FDA picks and chooses who they allow to sell. I have some close friends who are physicians and who love the device and say it would help dramatically but are also aware that the FDA simply will never approve any device that simulates smoking. They told me that even if there is only PG in the cartridges it falls under the new drug category. What is up with that??

I never mentioned anything even remote to smoking cessation. I simply read up and saw how many unanswered questions there were especially hearing about some people getting their products detained and destroyed while others bring in product by container loads.

If the FDA is going to regulate this product, so be it, however they have no right to allow some people to sell while prohibiting others, especially if the product is identical in nature and there are no false claims.

Basically if I wanted to brand my own, and bring in cartridges only with PG, I can't? Sorry, but the law is intended to have the same guidelines for all parties. If a big company and say myself have identical product and neither of us have submitted any paperwork, is it fair that I am not allowed to brand my own product? Even if it is thoroughly responsible in every aspect? In my eyes, that is discrimination but good luck in sueing the FDA.

That is my view on this isssue!!

Furthermore, like so many other Government agencies, the FDA is an outdated worthless system!! All they do is pick and choose who they like and what they like and they all have God complexes. Even more of a joke is the bureau of the (I believe it is CPSC or something like that) they oversee new products and there are only like 3 employees for the entire Country. LOL,,,

I've lived in the US my entire life but after I make enough, I am out of here!! This Country is totally corrupt and does not give a rats ... about it's citizens. It is only about the dollars and finding new way of fining people. Sure, let's give 840 Billion to the poor banks that intentionally screw people over but what about the people being screwed over? Sorry!! Maybe next time?? It really churns my stomach!! Let's see if Obama can do anything to make this a better place and get it back on track. I rooted for him and hope he can actually do some good.

Sorry about the venting!! I'll keep to topic from now on!

 

[GabbyD]

Got news for ya'. Every country's government is all about the money. Good luck finding something that fits your idealistic view. It's one we all agree with, I'm sure, but it just doesn't exist.

I agree that the FDA is corrupt.

 

[Myk]

Are you your agent is not talking about all of this in the NRT context? It doesn't matter if these "new drugs" don't "qualify" if people let go of the idea that they will somehow be accepted as medicine...

I agree.
They are the wrong form to be a NRT drug delivery. Not going to happen. If that is the goal the juice needs to be reformulated to use a commonly used NRT drug. Even then the process could take years.
Or you keep the juice as it is - a tobacco product, and market it as a tobacco product and hope the BATFE doesn't decide to tax it.

I like option B better.

Of course the FDA is going to say it's not a tobacco product, they are dying to get their hands on tobacco but can't (at least for now). So any tobacco product they can get their hands on is a win in their book.

 

[TropicalBob]

Thanks for posting that FDA response. I found it very clear.

Our stuff is not legal. Ouch! Enforcement, however, is not being done and we can only hope that the economy is so screwed up that a small matter like e-cigs will escape action needed on larger matters, like food and drug safety!

Let's see, if we take some caffeine from coffee beans and add that caffeine to a cola drink, then the drink is afterwards called a coffee product, right? Or if we put caffeine in a pure tobacco snus product like Energy, it will no longer be regulated as a tobacco product, but as a coffee product? I think not.

E-cigs aren't a tobacco product and the FDA is not about to stretch the imagination to that limit.

 

[LaceyUnderall]

How about this, Johnson Creek have FDA approval - nicotine liquid is ok -


http://www.e-cigarette-forum.com/forum/general-discussion/5064-our-numbers-growing-3.html#post81426

True or false ... would Johnson Creek lie?

I did a follow up question for a point blank yes or no and the response was that JC has registered the facility and the product but has not achieved FDA approval for their juices. They do hope to have that in the next few months, definitely by the end of the year. So we shall see.

 

[Myk]

Thanks for posting that FDA response. I found it very clear.

Our stuff is not legal. Ouch! Enforcement, however, is not being done and we can only hope that the economy is so screwed up that a small matter like e-cigs will escape action needed on larger matters, like food and drug safety!

Let's see, if we take some caffeine from coffee beans and add that caffeine to a cola drink, then the drink is afterwards called a coffee product, right? Or if we put caffeine in a pure tobacco snus product like Energy, it will no longer be regulated as a tobacco product, but as a coffee product? I think not.

E-cigs aren't a tobacco product and the FDA is not about to stretch the imagination to that limit.

Similarly, is that cola or tobacco product now a drug because they added an extracted drug?
Seems you and the FDA would have us believe it is.

Put e-juice up for approval as NRT and see why it's not allowed. It's not allowed because it's not a drug form of nicotine. To keep pushing it as NRT means you are trying to get that non-drug form of nicotine to be OK'ed as a new drug.
You're not going to get tobacco extract accepted as a new drug.
You're not going to get vaping accepted as a delivery device for that new drug.

 

[TropicalBob]

Go all the way back to page one of this thread, Lacey, and you'll see what JC did. Same as the GreenCig action that started this thread. GreenCig registered its e-cig as a nasal inhaler. That almost certainly will be challenged at some point. It has no "certification" or "approval."

Read the first two pages of posts in this thread for a clearer idea of steps through the FDA. We were deceived by inaccurate wording.

 

[Kate]

That's more like it Lacey, they have registered - for something to do with prevention of terrorism. They want us to think that their product is approved and kosher by linking it with the FDA but that is deliberately misleading. The FDA will bite them on the bum if they get wind of what they've been claiming.

 

[LaceyUnderall]

Go all the way back to page one of this thread, Lacey, and you'll see what JC did. Same as the GreenCig action that started this thread. GreenCig registered its e-cig as a nasal inhaler. That almost certainly will be challenged at some point. It has no "certification" or "approval."

Read the first two pages of posts in this thread for a clearer idea of steps through the FDA. We were deceived by inaccurate wording.

Thanks for the suggestion. I am doing that now.

 

[palermo45]

You know, I believe this is the FDA standard form they send to people in reference to products they are not even familiar with. As I was trying to gain information, I even came accross 1 agent who was a sweatheart and also a smoker and said she would love to try a product like that. LOL!! Unfortunately I couldn't refer her to any Companies I know which sell as I don't think and sellers would appreciate me sending an FDA agent to their site so I just suggested she googles it and wished her luck. I am not taking their bs and bullying lightly and I will take this fight all the way!! I already have a few very high profile attorneys lined up and will discuss with them a strategy for suing for discrimination. Let's see what the pros say!!! I especially love attorneys who can't stand inept organizations like the FDA!! Like Obama said, change is coming!! Hopefully that will include shaking things up with the FDA and get them to change their out dated, lame and discriminitive approaches. They may be Gov't but that doesn't scare me in the slightest and I will always fight for my rights!!

 

[palermo45]

I have family in Venezuela. Although Chavez is a nutjob, just to spite the US he would go on the air and highly endorse the E-cig. That would be hillarious!! I would love to hear that guy openly give the FDA the finger. lmfao