E-cigarettes 'should not be marketed as smoking cessation aids'

[Tyhanna]

78. see there you again, you dont understand how FDA works

FDA regulates tobacco products, nobody has to submit any studies or any thing of that kind to the FDA. That only is required when they are trying to get a drug devise approved. FDA has yet to deem e-cigarettes a tobacco product yet. So tell me what are these required studies you think the e-cigarette community needs to submit to the FDA?

FDA has already submitted their regulations on e-cigs, cigars and smokeless tobaccos in October to the OMB in Washingtion.

Now the e-cig community did have a few sit down learning hours with the FDA and with the OMB, they gave them information about studies and general information about e-cigarettes. But that was not required, was done to help FDA to understand what it is they are dealing with. Once the OBM approves the FDA regulations then they get posted for a pubic comment period, 60-90 days depending. Then the FDA has X amount of time to review all comments, change what ever it is that they feel needs to be changed, then it gets sent back threw OMB for final approval. That is how it works.

Again unlike a drug product where they have to have years of studies and approval from FDA before a product can go to market, Tobacco products do have all that. They will regulate e-cigarettes with their deeming regulations at some point. Regulations like labeling, bottling, manufacturing. A lot like they would with food. And im sure there will be other regulation visited like advertising and not selling to minors law.