E cigarettes do not need FDA Approval

[SupplierX]

Everyone on this forum needs to chill. The only reason that e-cigarettes would need approval from the FDA is to be able to legally market the product as healthier or as a cessation method. The FDA doe NOT have jurisdiction over nicotine. The FDA is concerned with how products are marketed. They will send polite letters to companies that make claims that aren't backed up by clinical trials and thus under the FDA's jurisdiction. This product is for recreational use and as long as it is not sold as anything else, the FDA has no issue. If people start dying or geting violently ill from using e-cigs that is when there will be an issue that you need to be concerned about. People need to do research outside of this forum.
An example of this is Rogaine. Rogaine marketed and sold their product long before they got FDA approval. It wasn't till they got approval that they were able to market the product as a hair replacement therapy. The same example is any erectile dysfunction therapy.

E-cigs are here to stay, and the FDA has no jurisdiction to do anything about it.

 

[Terraphon]

Everyone on this forum needs to chill. The only reason that e-cigarettes would need approval from the FDA is to be able to legally market the product as healthier or as a cessation method. The FDA doe NOT have jurisdiction over nicotine. The FDA is concerned with how products are marketed. They will send polite letters to companies that make claims that aren't backed up by clinical trials and thus under the FDA's jurisdiction. This product is for recreational use and as long as it is not sold as anything else, the FDA has no issue. If people start dying or geting violently ill from using e-cigs that is when there will be an issue that you need to be concerned about. People need to do research outside of this forum.
An example of this is Rogaine. Rogaine marketed and sold their product long before they got FDA approval. It wasn't till they got approval that they were able to market the product as a hair replacement therapy. The same example is any erectile dysfunction therapy.

E-cigs are here to stay, and the FDA has no jurisdiction to do anything about it.

Please provide a link to a viable information source.

Thanks.

 

[SupplierX]

There is no one link. I would suggest the FDA's sight or wikipedia FDA and learn about what their resposibilities are.

 

[robw]

The FDA has the power to regulate any chemical natural or manufactured if it is marketed as a drug.
The FDA classifies nicotine a drug if it is marketed as a NRT.
If it is marketed as a cigarette, which is not considered a drug then the FDA does not regulate it.

 

[SupplierX]

Exactly!! That's what I am talking about.

The FDA has the power to regulate any chemical natural or manufactured if it is marketed as a drug.
The FDA classifies nicotine a drug if it is marketed as a NRT.
If it is marketed as a cigarette, which is not considered a drug then the FDA does not regulate it.

 

[Venuvious]

Everyone on this forum needs to chill. The only reason that e-cigarettes would need approval from the FDA is to be able to legally market the product as healthier or as a cessation method. The FDA doe NOT have jurisdiction over nicotine. The FDA is concerned with how products are marketed. They will send polite letters to companies that make claims that aren't backed up by clinical trials and thus under the FDA's jurisdiction. This product is for recreational use and as long as it is not sold as anything else, the FDA has no issue. If people start dying or geting violently ill from using e-cigs that is when there will be an issue that you need to be concerned about. People need to do research outside of this forum.
An example of this is Rogaine. Rogaine marketed and sold their product long before they got FDA approval. It wasn't till they got approval that they were able to market the product as a hair replacement therapy. The same example is any erectile dysfunction therapy.

E-cigs are here to stay, and the FDA has no jurisdiction to do anything about it.

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!

 

[Kate]

Does this mean that the shipments that have been stopped are being marketed as health devices and that's why the FDA have jurisdiction?

 

[robw]

Does this mean that the shipments that have been stopped are being marketed as health devices and that's why the FDA have jurisdiction?

The answer is "maybe"
If it is labeled "cigarette" the FDA can notify the ATF, and then the ATF will release it when no tobacco is detected.

If it is labeled "health" then the FDA can look at it and determine if it is labeled wrong.

Suppliers in China need to figure out what label is and is not getting through. Some resellers are probably keeping the success they have because they keep that label a secret from other resellers.

My feeling is the FDA will probably get used to e-cigs and liquids and who they are coming from and eventually put them on an OK list. Newer suppliers and resellers are going to suffer until this becomes familiar to those who guard the borders and ports.

 

[Liberate_Yourself]

I do recall seeing some boxes did have "Health eCigarette" labeled on them..

 

[robw]

The retail box is not as important the customs declaration. These shipping forms are sometimes removed before the reseller or end user gets final delivery. It depends on if the shipper uses a single form or the address label it self also contains customs information.

The other part is customs typically lets small packages slip by, focusing attention to pallets and multiple boxes all going to a single location, as this is evidence of product going for re sale in the country.

 

[LaceyUnderall]

God taleywhacker I love you!

Yes, folks... Outwest (who isn't a supplier) even pointed this out. Many of the packages being stopped have the following jargin: "quit" "health" "cigarette" "lung apparatus".... the list goes on.

Suppliers are very aware of your concerns because we have them too! Most of us, if not all are users of the e-cig. We have done extensive research on how to import, transport, mark our packages etc. The form letter that is going around is open to many interpretations and I can definitely see why people would have concern. However, I am yet to receive a letter like this. Why? Because I am marking my package for what it is!

Again, we should all be thrilled that customs/FDA is stopping packages that are mis-marked. They are simply doing their job of ensuring that items coming through are what they say they are.

 

[TribbleTrouble]

Everyone on this forum needs to chill. The only reason that e-cigarettes would need approval from the FDA is to be able to legally market the product as healthier or as a cessation method. The FDA doe NOT have jurisdiction over nicotine. The FDA is concerned with how products are marketed. They will send polite letters to companies that make claims that aren't backed up by clinical trials and thus under the FDA's jurisdiction. This product is for recreational use and as long as it is not sold as anything else, the FDA has no issue. If people start dying or geting violently ill from using e-cigs that is when there will be an issue that you need to be concerned about. People need to do research outside of this forum.
An example of this is Rogaine. Rogaine marketed and sold their product long before they got FDA approval. It wasn't till they got approval that they were able to market the product as a hair replacement therapy. The same example is any erectile dysfunction therapy.

E-cigs are here to stay, and the FDA has no jurisdiction to do anything about it.

If you are talking about the devices alone, separate from the e-liquid, than you are right. It is when suppliers attach the wrong name to the devices (i.e. anything having to do with "Health" or "Quit Smoking"), that they have the FDA seizure issues. To avoid all of the problems, I believe the manufacturers & suppliers should go even farther by calling them "Personal Vaporizers" instead of "Electronic Cigarettes". Sell them without any e-liquid. Sell them with Blank Carts. If there is no liquid included, all they will be considered by the powers that be is "Personal Electronics", and nothing more. I want the liquid to be scrutinized by the FDA. I want all commercial e-liquid to get FDA approval before it is made available to the public. It will insure our safety. I just don't want to lose my gear while the FDA issues are being ironed out. I can make my own juice, but I can't make my own "Personal Vaporizer", like I have said many times before.

 

[LaceyUnderall]

If you are talking about the devices alone, separate from the e-liquid, than you are right. It is when suppliers attach the wrong name to the devices (i.e. anything having to do with "Health" or "Quit Smoking"), that they have the FDA seizure issues. To avoid all of the problems, I believe the manufacturers & suppliers should go even farther by calling them "Personal Vaporizers" instead of "Electronic Cigarettes". Sell them without any e-liquid. Sell them with Blank Carts. If there is no liquid included, all they will be considered by the powers that be is "Personal Electronics", and nothing more. I want the liquid to be scrutinized by the FDA. I want all commercial e-liquid to get FDA approval before it is made available to the public. It will insure our safety. I just don't want to lose my gear while the FDA issues are being ironed out. I can make my own juice, but I can't make my own "Personal Vaporizer", like I have said many times before.

TT - You are on the right track here. An electronic cigarette is a style of vaporizer so to change it's name to personal vaporizer... well you can't. It definitely IS a personal vaporizer... but it is a style of vaporizer.

And as far as FDA regulations... well... I too believe this is up for debate. Now, don't get me wrong. I believe that the e-liquid should be regulated. It promotes safety and consistency. However, I don't know if the FDA has to regulate it like it would the NRT's. This is where it becomes very grey.

One reason I keep coming back to the homeopathic route is that while we seek HPUS approval, we can continue to use and sell our e-liquids. With the FDA approval, it is my understanding that we cannot. Also, with FDA approval, the liquid can be sold as a quit smoking method and NOT as a healthier way to smoke. If we go homeopathic, it can be sold as a healthier alternative to smoking but not as a smoking cessation device. I for one, would rather see this as a smoking alternative then as smoking cessation.

 

[TribbleTrouble]

TT - You are on the right track here. An electronic cigarette is a style of vaporizer so to change it's name to personal vaporizer... well you can't. It definitely IS a personal vaporizer... but it is a style of vaporizer.

And as far as FDA regulations... well... I too believe this is up for debate. Now, don't get me wrong. I believe that the e-liquid should be regulated. It promotes safety and consistency. However, I don't know if the FDA has to regulate it like it would the NRT's. This is where it becomes very grey.

One reason I keep coming back to the homeopathic route is that while we seek HPUS approval, we can continue to use and sell our e-liquids. With the FDA approval, it is my understanding that we cannot. Also, with FDA approval, the liquid can be sold as a quit smoking method and NOT as a healthier way to smoke. If we go homeopathic, it can be sold as a healthier alternative to smoking but not as a smoking cessation device. I for one, would rather see this as a smoking alternative then as smoking cessation.

If the homeopathic route for e-liquid would still insure the best purity & quality of e-liquid, then I would be OK with that. The key for me is purity & quality. I just feel that the only sure way to never lose our equipment is to keep it separate from the e-liquid when sold. I know that won't be considered very convenient for the first-time buyer, but it makes sure that they never go away. The first-time buyer can just come to this forum for their education on the world of "Personal Vaporizers", and they will get over the inconvenience.

 

[Terraphon]

OHAI GUISE!

What's goin' on in this thread?

Well, it seems that people are getting the hint, for now...I'll try to avoid getting into it with Lacey (very unnecessarily, I might add) again.

BTW, if you want to know what the law REALLY says, let me know...or go check the FDA thread in the legal section.

 

[LaceyUnderall]

If the homeopathic route for e-liquid would still insure the best purity & quality of e-liquid, then I would be OK with that. The key for me is purity & quality.

Absolutely. Purity and quality is of concern for me too... I don't eat organic to continue putting crap into my body from tobacco and I definitely wish to keep the eliquid as clean and pure as we can.

 

[TribbleTrouble]

OHAI GUISE!

What's goin' on in this thread?

Well, it seems that people are getting the hint, for now...I'll try to avoid getting into it with Lacey (very unnecessarily, I might add) again.

BTW, if you want to know what the law REALLY says, let me know...or go check the FDA thread in the legal section.

I don't know how much weight the New Zealand Health Dept. has on the laws of this country. When Tropical Bob has chimed in on threads like this, he always has said that the FDA has full jurisdiction in the matter of e-cigs, but I believe that is only because of the liquid in the device, not the device by itself.

 

[Terraphon]

I don't know how much weight the New Zealand Health Dept. has on the laws of this country. When Tropical Bob has chimed in on threads like this, he always has said that the FDA has full jurisdiction in the matter of e-cigs, but I believe that is only because of the liquid in the device, not the device by itself.

Bob is, for the most part, correct.

The FDA's main avenue of control, here, will be the liquid (the "drug") that we use in the e-cigs. They can, however, change their definition to include the delivery vehicle since one is technically useless without the other.

That's not to say that they WILL do this but they CAN if they want to start breaking out the loopholes.

Now, if we can get the LIQUID approved for use (this will literally have to be done on a manufacturer by manufacturer basis) that's a major part of the battle because they would have a hard time switching stances AFTER approval has gone through.

EDIT : Also, the NZHD doesn't have MUCH weight, in and of itself. Independent testing, though, holds a TON of water and that's a weapon we have.

 

[TropicalBob]

Thanks for a post of sanity, Terraphon. I've vowed to myself to stay out of these love-affair threads of dreams. Someone else is going to have to post reality checks. I'm becoming ... a reader.

 

[Terraphon]

Thanks for a post of sanity, Terraphon. I've vowed to myself to stay out of these love-affair threads of dreams. Someone else is going to have to post reality checks. I'm becoming ... a reader.

I learned, long ago, to not attempt rousing people from day-dreams.

It makes them cranky.