Right To Vape

I know this has been very controversial, but I think it will be helpful if we can interpretate this letter in the right way, because then we can take the right actions, here it is:

"Please be aware that 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. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

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."

The things that call my atention are:

"...are drug-device combinations..."

"...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...."

"...These cartridges may or may not include nicotine...."

"...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...."

So, what are the problems and what could be the solution?

Lith -

What a fabulous idea and what a great place to do this... at RTV!

Here is some case law that everyone should start reading... it isn't "light" reading so even though I am a tree-hugger and don't condone wasteful paper printing... print this out so you can vape/smoke and read on the loo....  This is mostly about tobacco but it does interpret the laws thoroughly and can be applied to the e-cig... which if we had to fight this all the way to the supreme court AHHHH.... then we would be citing previous rulings for our case.

http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=US&vol=000&invol=98-1152

I believe this case says a lot as to what the jurisdiction of the FDA according to the US Supreme Court.  Definitely a good place to start.

Also...  http://www.fda.gov/opacom/laws/fdcact/fdcact5a.htm  and http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm ... these are the sections mentioned in the letter.

Oooo... I love good discussions!

I want to be involved with this discussion because the subject interests me greatly. I will not try to put forward what I am saying is legal fact, I will just pose questions that the available facts will hopefully answer. Is the electronic cigarette lumped in with the liquid as a "Drug/Device Combination" only because the manufacturers & suppliers insist on keeping the two together for sale to the public? What would be the classification of the device if it was sold with no liquid? If you changed the name from "Electronic Cigarette" to "Electronic Vaporizer", would that not change it's attachment to the "Drug/Device Combination" tag? Marijuana is illegal to distribute or possess. Water Pipes (aka "Bongs") are associated in everyone's mind as being a part of a "Drug/Device Combination" with Marijuana, but yet "Water Pipes" are sold legally in head shops all across the country. Is it not because of the name change and the disassociation the suppliers of Water Pipes make between the substance and the device that enables them to still be legal and available for purchase? This is my main question about all of this. Do the facts have any answers for them?

Good reading indeed Lacey, need to print it for sure

@TribbleTrouble here is a document defining drug paraphernalia:

http://www4.law.cornell.edu/uscode/21/863.html

The term “drug paraphernalia” means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter. It includes items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing marijuana,[1] cocaine, hashish, hashish oil, PCP, methamphetamine, or amphetamines into the human body

I think (based on that document) that if you can use the device primarily for a legal purpose then it is not considered drug paraphernalia, remeber that shishas and bongs have been used from centuries to smoke tobacco, now a possible problem with our devices is that the FDA is considering them primary for drug use.

Also I want to point out that this thread IT IS NOT INTENDED TO CREATE HYSTERIA, it is just for a "sanity check" of the situation and for seek for solutions whatever their are, also take into account that it is not a MAYOR problem yet (and maybe never will be), because the FDA is not shutting down anybody, and suppliers can get their shipments without a problem, I just want to prevent instead of cure.

Please backup with documents your affirmations, lets try to not speculate and just present our founds.

Yes Kate, i was pointing out why bongs are legal in some circunstances, now what about if they say it is a new drug? is it still "nicotine"? has anybody founded something about this?

I agree fully with trying to interpret this FDA-document correctly. But shouldn't there be a step ahead of this, namely to interpret whether this document in itself is 'correct' - is given out correctly by the correct institution for the correct reasons and at the correct time?
(And in fact the above is allready leading to this pre-step a bit I think?)

One more question:

If we change the name of the device, can't the device escape this "Drug/Device" connection. If the industry hurries up and changes the name to "Electronic Vaporizer", than the "Drug/Device" connection with relation to "Nicotine" can be eliminated before the powers that be start to really pay attention to this. The fact that the word "Cigarette" is attached is the reason why this "Drug/Device" connection was made in the first place.

Good point, this letter was sended via e-mail to Smooth after a shipment of 500 units was held by customs, maybe we can ask him/her for more information, but s/he posted just one time on ECF, I saw another similar letter sended to another user of ECF, here is the link to the original post: http://www.e-cigarette-forum.com/forum/law-e-cigarette/5141-idea-avoiding-fda-approval-control-3.html#post89994

@TribbleTrouble there is not a "Product Code" for "Personal Vaporizer" in the FDA, but there is a "Product Code" for "Vaporizer" here is information about product codes:

General info about Product Codes:
https://www.access.fda.gov/pn/html/help/Product_Code.htm

Tutorial:
http://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/tutorial.cfm

Product Code Builder:
http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfm

In this last one try typing Vaporizer in "Option 3- Search Product Name" and then complete the process, at the end the builder gives you a product code.

As if the name will change the status of the device, well I don't know, this is something we need to investigate more, some hints written by suppliers let me know that changing the product code at least allow them to pass customs without the intervention of the FDA.

So... my thoughts are lost in the words "drug-device" combination.  Maybe the FDA would start with the juice first.  Is there any other device that this can be used in?  If not, is it possible they could label our e-cigs as nebulizers instead of vaporizers?

http://www.fda.gov/cdrh/ode/784.html

I don't quite know where I am going here... but comparison of vaporizer and nebulizer might be good?  I will read more... but here is what i am reading if you don't have enough already.

"Personal Vaporizer", "Personal Nebulizer", either one is better than "Electronic Cigarette". I think the "Cigarette" part is the thing that sets the antis & FDA off more than anything else. 

Also note the Intercenter Agreements define that an aerosol delivery device will be considered a drug product and regulated by the Center for Drug Evaluation and Research (CDER), when the primary purpose of the device is delivering or aiding in the delivery of a drug and the device is distributed with the drug. Therefore, if a device is intended to deliver a specific drug or if the labeling references a specific drug product, the device will be considered a drug product and regulated by CDER. It is important to note that Metered Dose Inhalers and Actuators are reviewed in the Center for Drug Evaluation and Research (CDER), where Nebulizers and Spacers as well as Metered Dose Inhalers intended for a ventilator circuit are reviewed in the Center for Devices and Radiological Health (CDRH). Since there are a variety of medical products in the category of nebulizers and MDIS, it is not possible to develop an exhaustive guidance document which will cover all modalities in most applications. However, the general principles regarding the information to be contained in a 510(k) should be valid for all cases.Dont think we can use the nebulizer angle at present because starter kits come with carts and devices are labeled for nicotene.[/cohttp://www.fda.gov/cdrh/devadvice/ide/index.shtmllor]IDE could provide op for needed test at FDA expense also shipping still allowed during investigation.

Yeah, along with the name change, suppliers have to stop selling the gear with liquid included. I know that sounds harsh and inconvenient, but until all of the FDA issues are ironed out, it is the only way to keep the devices with the new name to avoid getting lumped into another "Drug-Device Combination" issue. Stop selling the gear along with the liquid, and we might get to keep our gear after all.

The gear cán be used for other uses though, and is in fact being used as such (just flavor-no nicotine). While the liquid can also be used in different kinds of devices (i-inhale, vaporizers, wizz-stick to name a few). These alternatives both ways might not be recognized currently by FDA, but are valid because existing. So questions: are these in fact being recognized or not; what difference would a change in this perception make.

Pillbox just posted this on the Totally Wicked forum

i was informed yesterday that goods i sent in bulk to the USA were being held..FDA demanding my FDA number for the nicotine product..Which i cannot supply because there isnt one..These are now being returned to me..

Good points.  We don't want to be lumped in with the nebulizers.