The Real Scoop on FDA & eCigarettes!

[Venuvious]

Hey There!
Here's the site that explains a lot about all this! It's the New Zealand Gov. Health Site.
Healthnz.co.nz/ecigarette.htm

Here's part of it:

United States As of March 2008, the Ruyan® E-Cigarette (REC) and its cartridges can be imported, distributed, marketed and sold in the US as a smoking substitute or cigarette alternative, but not as a smoking cessation device. RAI and its advisors cite compelling public health reasons to market the REC and its nicotine cartridges to smokers, to satisfy cravings and urges for nicotine, and without producing second hand smoke and without endangering the health or well-being of family members, associates and/or bystanders. Ruyan® America Inc says it will regularly evaluate the timing of and opportunities represented by seeking and securing FDA-approval as a smoking cessation product.

As a substitute or alternative, the products as of March 2008 are exempt from FDA regulations in that:

· The US FDA in 1996 assumed powers to regulate nicotine and tobacco. The US Supreme Court in 2000 reversed this assumption. Meantime, as long as Ruyan does not make therapeutic claims the drug is not regarded as a medicine and can be sold in the USA as a cigarette alternative.

The US Treasury’s TTB has determined that the products are exempt from tobacco-related controls, limitation and taxation in that neither the REC or its cartridges contain tobacco; and, US Customs and Border Security has also determined that the products are not tobacco related. As the products do not contain tobacco, it is not expected that the Ruyan® e-cigarette would not be prohibited from any advertising or marketing medium by regulation.

Hope this Helps!

 

[Elle]

Meantime, as long as Ruyan does not make therapeutic claims the drug is not regarded as a medicine and can be sold in the USA as a cigarette alternative.

HealthySmokeShop.com
"The Healthier Way to Smoke!"

....

warning, i'm about to state the obvious and point out the irony here: bottom line is don't market as nrt, and don't make health claims, off the FDA jurisdiction we stay.

i find it amusing this was posted by a supplier with a tagline advertising vaping as a "Healthier Way to Smoke!"

 

[SupplierX]

You rock man!! Exaclty what I was trying to get across in my earlier post. Hopefully people will read this.

 

[Venuvious]

HealthySmokeShop.com
"The Healthier Way to Smoke!"

....

warning, i'm about to state the obvious and point out the irony here: bottom line is don't market as nrt, and don't make health claims, off the FDA jurisdiction we stay.

i find it amusing this was posted by a supplier with a tagline advertising vaping as a "Healthier Way to Smoke!"

Yes, Elle, I love america!
However, I don't advertise it on my site to be used as a smoking cessation device, just that for people like me, who smoked for 25 years and stopped at 1 1/2 packs of Non-filtered cigarettes and starting using this instead, it is definately a "Healthier Way to Smoke!"
You see, I have no intention of stopping right now. Maybe later, but right now this is exactly what I need, a "Smoking Substitute or Cigarette Alternative!"

 

[Elle]

Venu- your company, totally your business how you want to market it.

my point was; wether or not you market it as nrt, saying its the "healthier way to smoke" is quite literally making a HEALTH CLAIM.

i'm totally with you- i have zero plans to quit nicotine, and i do personally like you believe it IS the healthier way to smoke.

but is it legal or ethical to market this way without the lab studies we all so desperately want to back it up? my opinion is no, and i'm betting that if (some) suppliers to continue to market this way eventually we will not have the luxury of having the FDA out of our hair regarding our choice of smoking alternative... due to unsubstantiated claims such as yours.

i see what you're saying- i feel the same way, i really do. but bottom line is thats what we "think"- at this point i have no medical proof and neither do you.

food for thought.

 

[LaceyUnderall]

Venuvious!

Welcome and Thank You for weighing in on this! As taleywhacker stated... we have been attempting to get this point across for a bit now...

 

[aasupplyny]

"Mechanism. Lip pressure on the mouthpiece activates the electric circuit, sparking vapourisation of nicotine in a mist of propylene glycol"

 

[SupplierX]

"Mechanism. Lip pressure on the mouthpiece activates the electric circuit, sparking vapourisation of nicotine in a mist of propylene glycol"

I tend to agree.....ummmm...what are you talking about?

 

[nicowolf]

Venuvious,
We have been through a number of discussions here very recently about why claims of being "healthy" or "healthier" or "an aid to quitting" are potentially harmful to the cause of widespread acceptance of our new habit.

It is a general consensus around here that we cringe when we read these words on suppliers' sites. We cringe because we can see a scenario in the not so distant future where a government agency or a court of law asks for proof to substantiate these claims. We have no proof. We have no scientific evidence that definitively says these are "safe", or "less harmful", or an "aid to stop nicotine addiction". We have common sense arguments -' no burning means no carbon monoxide means healthier', 'no known carcinogens means safe' type arguments, but these will not CYOA in a court of law and will not garner FDA approval if this is classified as a new drug instead of a tobacco product. It will not help when someone ODs on nicotine, or a child drinks nicotine liquid that smells good, or it is found that some nasty chemical reaction happens to the liquid when it reaches the temperature range our atomizers run at, or any other unforeseen event.

Could you just rephrase? Could you say "an alternative way to smoke", "we believe this is healthier than smoking cigarettes because....", "a cigarette replacement", "get nicotine in a less offensive way", "feel like you are smoking without actually burning anything", etc.?

Will you show us that you are willing to consider what we have to say? We have had others, recently, show us otherwise - that they were going to do what would bring in more newcomers, but not what would keep this legal and/or safe for ALL of us in the long run. Are you looking to be a supplier with loyal, longterm customers, or one with customers who buy once, learn from their mistakes, then inform others about those mistakes? These are choices for you to make. We make our choices based upon yours.

 

[Kate]

This is what the FDA say about your 'healthier way to smoke' Venuvious, you do fall under their jurisdiction according to them:

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. 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. Thus, the "electronic cigarettes" that we have reviewed are intended for "drug" use. 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 with FDA 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 is subject to enforcement action.
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."
http://www.e-cigarette-forum.com/fo...selling-e-cigs-usa-locations-2.html#post99928

 

[nicowolf]

Hey There!
Here's the site that explains a lot about all this! It's the New Zealand Gov. Health Site.
Healthnz.co.nz/ecigarette.htm

Here's part of it:

United States As of March 2008, the Ruyan® E-Cigarette (REC) and its cartridges can be imported, distributed, marketed and sold in the US as a smoking substitute or cigarette alternative, but not as a smoking cessation device. RAI and its advisors cite compelling public health reasons to market the REC and its nicotine cartridges to smokers, to satisfy cravings and urges for nicotine, and without producing second hand smoke and without endangering the health or well-being of family members, associates and/or bystanders. Ruyan® America Inc says it will regularly evaluate the timing of and opportunities represented by seeking and securing FDA-approval as a smoking cessation product.

As a substitute or alternative, the products as of March 2008 are exempt from FDA regulations in that:

· The US FDA in 1996 assumed powers to regulate nicotine and tobacco. The US Supreme Court in 2000 reversed this assumption. Meantime, as long as Ruyan does not make therapeutic claims the drug is not regarded as a medicine and can be sold in the USA as a cigarette alternative.

The US Treasury’s TTB has determined that the products are exempt from tobacco-related controls, limitation and taxation in that neither the REC or its cartridges contain tobacco; and, US Customs and Border Security has also determined that the products are not tobacco related. As the products do not contain tobacco, it is not expected that the Ruyan® e-cigarette would not be prohibited from any advertising or marketing medium by regulation.

Hope this Helps!

Thank you for posting this V. Your heart is in the right place and this is a small step in the right direction. It is very clear about Ruyan products, but not ALL e-cigarettes. Ruyan has produced some evidence for the powers that be, the others have not. Ruyan has sought permission, others have not. Ruyan has gone through proper channels and jumped through some hoops, others have not. I don't want to hurt your feelings or provoke you. I just want to provoke some thought within your mind - whether or not you share that thought with us is irrelevant - about how specific they were about Ruyan, and not including others, about how specific you want to be with your claims, about the impact that our opinions of you may have on your business venture (I truly want to trust and respect you, but need you to show that you care whether or not I trust and respect you).

 

[Liberate_Yourself]

Yes, Elle, I love america!
However, I don't advertise it on my site to be used as a smoking cessation device, just that for people like me, who smoked for 25 years and stopped at 1 1/2 packs of Non-filtered cigarettes and starting using this instead, it is definately a "Healthier Way to Smoke!"
You see, I have no intention of stopping right now. Maybe later, but right now this is exactly what I need, a "Smoking Substitute or Cigarette Alternative!"

I'm right there with you Venu.. I had a pretty bad habit myself, and these things definitely paved the road that I have been walking down ever since. I haven't looked back. I want to say a big Thank You for posting that information. It gives me a bit more confidence that imminent doom isn't so much a reality as some may think.

I also wanted to add that these nice people aren't really jumping down your throat, as much as being "passionately informative". You will get used to it. Just take what they say in, and don't be so argumentative.. These people are your clientele, and your brothers in arms when it comes to vaping. The best advice that I could ever give you is to just listen to what they have to say, and let them know that they have been heard. Most of em do more research than I could ever imagine, and are very well informed.

Good luck to you, thanks again for the info, and welcome to the forums!

 

[LaceyUnderall]

I also wanted to add that these nice people aren't really jumping down your throat, as much as being "passionately informative". You will get used to it. Just take what they say in, and don't be so argumentative.. These people are your clientele, and your brothers in arms when it comes to vaping. The best advice that I could ever give you is to just listen to what they have to say, and let them know that they have been heard. Most of em do more research than I could ever imagine, and are very well informed.

I 2nd that. You will learn a sh*tload here.

 

[nicowolf]

I'm right there with you Venu.. I had a pretty bad habit myself, and these things definitely paved the road that I have been walking down ever since. I haven't looked back. I want to say a big Thank You for posting that information. It gives me a bit more confidence that imminent doom isn't so much a reality as some may think.

I also wanted to add that these nice people aren't really jumping down your throat, as much as being "passionately informative". You will get used to it. Just take what they say in, and don't be so argumentative.. These people are your clientele, and your brothers in arms when it comes to vaping. The best advice that I could ever give you is to just listen to what they have to say, and let them know that they have been heard. Most of em do more research than I could ever imagine, and are very well informed.

Good luck to you, thanks again for the info, and welcome to the forums!

You said it Liberate!
We really do have a more open relationship with our suppliers here than in any retail establishment. We, the consumers, are very open and honest with our feedback. We tell you exactly what we like, what we wish for, what we don't like, what scares us, what modifications we are making to your products and what effects we get from those modifications, etc. In other words, we tell you EXACTLY how to please us - sometimes you have to read through the emotions and see that we take the time to complain because we want to continue doing business with you, if we didn't want to buy from you we would simply go elsewhere and never offer any explanation. We don't, as a whole, hold grudges once something has been resolved - there is always someone who feels the need to blow off steam, but usually because it wasn't resolved for them. We our suppliers here, even the occasional cantankerous one. Please don't see our words to you as an assault, they are a plea really, to take another look at your wording.

The article you posted mentioned March of 2008 as the date that the power was taken away from the FDA. I wonder when the FDA sent that info that Kate linked to. I don't know which is more recent because the OP didn't give us a date for that transcript other than the date he/she posted it. It does sound to me that the FDA is preparing to engage in a power struggle/game of chess, and our bleoved electronic friends are the pawns

 

[Terraphon]

This is what the FDA say about your 'healthier way to smoke' Venuvious, you do fall under their jurisdiction according to them:

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. 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. Thus, the "electronic cigarettes" that we have reviewed are intended for "drug" use. 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 with FDA 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 is subject to enforcement action.
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."
http://www.e-cigarette-forum.com/fo...selling-e-cigs-usa-locations-2.html#post99928

I think EVERY U.S. supplier out there needs to take notice of this.

Find out the process of filing this application and getting it approved or the FDA can very easily come in and shut you down.

Get it done before all of our choices get taken away.

 

[Elle]

+1 nico and liberate- i second what the two of you wrote completely.

no hard feelings V, i believe we all want the same things here in terms of e-cigs. any criticisms written were not personal attacks, but an effort to help ensure you and others stay in business and that we the consumers have reliable suppliers who dot their i's and cross their t's.

1 "F-up" from a well meaning supplier (or even a non-well meaning one) could ruin it for us all... surely you understand.

best,

elle

 

[LaceyUnderall]

I think EVERY U.S. supplier out there needs to take notice of this.

Find out the process of filing this application and getting it approved or the FDA can very easily come in and shut you down.

Get it done before all of our choices get taken away.

There is no need to. This is from a form letter that is provided to those shipments that are stopped in customs because they are mis-marked. The FDA does not know what an "electronic cigarette" is. They know what a vaporizer is.

Plus, suppliers cannot apply for FDA approval unless they are the manufacturer.

Edit: The other issue might be because of what is written in the actual manufacturers manual. Many state that these units are "quit smoking" devices. This WILL stop your package dead in it's tracks.

 

[Kate]

The FDA have been having shipments stopped on the grounds mentioned in the last few months. That is a considered statement that is specific to 'electronic cigarettes'. Lithium posted a list of some Joyetech products that were stopped in either December or January recently. For sure they are interfering with certain shipments on the grounds that this is a health/drug delivery product and they have jurisdiction.

What you say about suppliers is spot on Nico, they are valuable members of the community and the good ones engage with the rest of us to make things better all round.

 

[Terraphon]

There is no need to. This is from a form letter that is provided to those shipments that are stopped in customs because they are mis-marked. The FDA does not know what an "electronic cigarette" is. They know what a vaporizer is.

Plus, suppliers cannot apply for FDA approval unless they are the manufacturer.

Edit: The other issue might be because of what is written in the actual manufacturers manual. Many state that these units are "quit smoking" devices. This WILL stop your package dead in it's tracks.

EDIT :

Apparently I'm an idiot and can't read so I COMPLETELY misunderstood what Lacey was saying and proceeded to jump in her ... over nothing.

As for the legalities of the situation, I'm more than happy to explain the various U.S. codes that cover this, if people would like.

 

[Kate]

I wonder if there might be a misunderstanding here.

Lacey might be saying that 'electronic cigarette', 'healthier' and 'quit smoking device' are mislabelling?

If any such label or claim is used for importing then the FDA can stop the shipment because they have jurisdiction.

If no claims are made and the devices are labelled something like 'personal vaporisers' (which is what they are) then the FDA do not have jurisdiction?

What about flavoured liquid nicotine intended to be inhaled, how can that be honestly labelled and imported?