I wonder if....

[gingersnaps]

I wonder if I just figured out what has got the fda panties in a bind. I was just reading in the forums and it hit me. The problem is that e cigs are an alternate for smoking but can be used as a quiting method if the user chose and in a much more controled way then any quit smoking product.

If the e cig stays it will not only reduce big tobacco profits but make all qiut smoking products obsolite. All that money that goes to research and programs will actually not be needed in the long run. so then they won't have an exuse for outragously high taxes that they lie about what it ges used for.

not to mention it will prove that the people do have control and lead to stronger movements on other issues. and because of how e cigs are spreading like wildfire I doubt they will win.

I would think that if the FDA was on our side they would say nothing about it bing a stop smoking product and just reg as tobacco. If it were to be reg as a drug sales and success would plumet. and aren't they supposed to be all about getting people off tobacco and/or making it safer.

one of the biggest reasons it works so well is because the people have control. If it were to get regulated as a drug you could probably kiss diy goodbye as well as anyhting that actually tastes good.

 

[Vocalek]

The more immediate effect is that all products could be removed from the market. That's way we are watching the case of SE v. FDA so closely.

The core issue is whether FDA can regulate them under the Food, Drug, and Costmerics Act as drug-delivery devices. Smoking Everywhere sued the FDA for seizing incoming shipments, and was joined by Sottera, Inc. (dba NJOY). The plaintiffs take the position that their products are not drugs, but rather an alternative to smoking. Shortly after the case was filed, the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") was passed by congress. The lower court granted an injunction against the FDA and ruled that since the plaintiffs were not claiming that their products are to be used to treat a disease, the FDCA does not apply; but the Tobacco Act provides FDA with all the authority it needs to protect public health and safety by regulating e-cigarettes as tobacco products. The FDA has appealed the injunction and continues to behave as if the products were drug-delivery devices.

If the FDA wins, no doubt they will step up their enforcement against the products under FDCA and order all sales to halt. The products will be gone until the day came that one company jumped through all the hoops of animal testing, clinicial trials, etc. and gains approval as a treatment for nicotine addiction. If it gets regulated as a drug you can bet your bipppy thast DIY will not be permitted, nicotine levels will be lowered to the same paltry level as the approved NRTs provide, and any product design flaws will remain for the duration. Getting one version of a product approved doesn't automatically grant approval for variations on the product. Each product must undergo expensive and time-consuming clinical trials.

If the plaintiff wins (Smoking Everywhere has dropped out of the case due to financial troubles, leaving NJOY as the sole plaintiff), FDA gets to regulate the products under the Tobacco Act. Things will still change, but there is a chance that we will be able to keep the products functioning as acceptable substitutes for smoking, once FDA grasps the concept of a nicotine product that isn't designed to wean the user off nicotine.