E cigarettes do not need FDA Approval

[taleywhacker]

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]

Originally Posted by taleywhacker

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.

[taleywhacker]

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.

[taleywhacker]

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

Originally Posted by 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.

[Venuvious]

Originally Posted by taleywhacker

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]

Originally Posted by 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?

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.