Things To Remember When Writing Fda

[owutaqt]

These are the things we need to cite when we write the FDA, we cannot continue to support the e cig as a way to quit smoking, it is not a smoking cessation device. It is an alternative to smoking. We all deserve alternatives to anything we do. We can choose our cable companies, we can choose our favorite colors, we can choose where we live, we have to fight for the right to CHOOSE how we smoke. We choose to smoke on a personal vaporizer, it is not a cigarette, it is not an electronic cigarette, it is a personal vaporizer that we CHOOSE to use as an alternative to smoking. The FDA cannot according to this judge take away our right to choose an alternative. That is where we need to fight. JMHO

But Judge Leon rejected that reasoning, agreeing with manufactures that electronic cigarettes are "the functional equivalent of traditional cigarettes."

"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," states Leon's ruling. "Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable."

Leon was appointed to the U.S. District Court by President Bush in 2002.

The FDA recently gained the power to regulate tobacco-based cigarettes, but since electronic cigarettes don't contain tobacco they don't fall under that regulation.

The Campaign for Tobacco Free Kids said Leon's ruling, if upheld, "opens a gaping hole in the protection FDA has provided against the sale and distribution of non-tobacco products."

A federal judge says the Food and Drug Administration overstepped its authority in recent efforts to regulate electronic cigarettes.

A ruling by U.S. District Court Judge Richard Leon handed down Thursday sides with two electronic cigarette suppliers, Smoking Everywhere and NJOY, in their lawsuit against the FDA.

The companies sued the government after regulators began halting shipments of electronic cigarettes last year. The FDA said it found cancer-causing ingredients in the products, despite manufacturers' claims that the products are safer than tobacco cigarettes.

Electronic cigarettes use a battery-operated vaporizer to produce a nicotine mist that simulates inhalable smoke. Manufacturers have touted the products as a healthier alternative to smoking because there is no burning involved.

The FDA argued that electronic cigarettes are in fact a combination drug-device, and therefore subject to stricter safety standards than cigarettes.

But Judge Leon rejected that reasoning, agreeing with manufactures that electronic cigarettes are "the functional equivalent of traditional cigarettes."

"This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices," states Leon's ruling. "Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable."

[Jkimbo]

Two words best describe the FDA,

Nanny State

[Christopher]

QT makes an excellent point. One of the main reasons the FDA is going after electronic cigarette companies is due to A. Unsupported health claims B. Un supported claims the electronic cigarette is a quite smoking product.

While most, if not all of us, no longer use traditional tobacco, we are still dependent upon nicotine and cannot technically under the currently law, call electronic cigarette a quit product. Not without years of human and clinical studies.

[FTJoe]

But then the alternative is calling it a drug delivery device which they do have control over, I think? I understand and approve of what the judge has to say but I think all along the FDA's stance has not been in regards to controlling nicotine but controlling how nicotine is delivered. We know its proving to be fine, but the uninformed will be swayed by talk of contaminants, overdose, etc.

Stupid I know, I can pop 50 pieces of nic gum in my mouth, but at least the package has a package insert saying not to. That's a major difference here and is what the FDA is supposed to do, make sure those inserts are correct and there.