FDA severely limited by govt. shutdown

[Padre]

FDA warns shutdown will severely limit its operations - Apr. 7, 2011

the last sentence is the one that is just amazing!


NEW YORK (CNNMoney) -- A government shutdown will severely restrict food and drug inspections, an official with the Food and Drug Administration warned Thursday.
"We will be pretty severely limited. We're hopeful that a resolution is reached before it comes to that," the official said.


The price of a shutdown

However, the FDA will not be able to conduct specific inspections of drug or medical device manufacturing facilities that are required when a manufacturer files for a new product application with the agency.

The FDA's other centers, including the Center for Biologic Evaluation, Center for Veterinary Medicine, Center for Medical Devices and Radiological Health will also operate at reduced capacity.


Of the agency's nine centers, only the Center for tobacco Products, which employs 275 workers, will remain fully staffed in the event of a shutdown. That's because it is funded by the tobacco industry.

 

[Vocalek]

Well, that lets e-cigarettes off the hook, since the FDA refuses to regulate tham as tobacco products.

 

[Bill Godshall]

Since the budget negotiations include funding for operating the FDA's food, drug and cosmetics regulations, there is no reason for the FDA to shut down its Center for Tobacco Products (since its funded by tobacco industry payments).

Regarding Vocalek's comment, I suspect the FDA is now drafting, and will soon propose, regulations for e-cigarettes (and perhaps for other currently unregulated tobacco products). But I suspect that we won't be pleased with some/many/most/all regulations that the FDA proposes for e-cigarettes.

 

[Vapor Pete]

Since the budget negotiations include funding for operating the FDA's food, drug and cosmetics regulations, there is no reason for the FDA to shut down its Center for Tobacco Products (since its funded by tobacco industry payments).

Regarding Vocalek's comment, I suspect the FDA is now drafting, and will soon propose, regulations for e-cigarettes (and perhaps for other currently unregulated tobacco products). But I suspect that we won't be pleased with some/many/most/all regulations that the FDA proposes for e-cigarettes.

That is not good to hear...

-VP

 

[Demarko]

I have a feeling that we'll end up with cartos and nothing else, at some point.

 

[CountVapula]

cartos made by marlboro, camal, newport, etc. but if things get that bad, i look forward to being a part of an underground movement that doesnt play by the fda and governments rules.

 

[ancient puffer]

I found this announcement: FDA Launches New Center for Tobacco Products which says in part: As set forth in the Family Smoking Prevention and Tobacco Control Act, funding for the Center and other activities related to the regulation of tobacco will come from user fees paid by manufacturers and importers of tobacco products.

So, is this the fox guarding the hen house? I'm inclined to think that the fees may fund the operation, but I'm not sure that actually gives BT any *control* over it (other than their political clout)

 

[KDK]

cartos made by marlboro, camal, newport, etc. but if things get that bad, i look forward to being a part of an underground movement that doesnt play by the fda and governments rules.

Me too - where do I sign up! If worse comes to worse, I will mix my own juice, I just won't know how to get the nic.

 

[CountVapula]

ok, the fda's partially shutting down everything except the center for tobacco products, because its funded by BT. seems to me like thats the fda letting BT use all of its ammo too launch a large scale attack on e-cigs. id love if someone could say not true but thats the way it sounds too me. if big tobacco has the power we wont be using e-cigs much longer unless its a new product of theirs. this country disgusts me. theres no reason the center for tobacco products should get special treatment, while the other centers that could make a damn difference in the publics health and well being (if the fda could do their damn job in the first place) take a back seat.

 

[Vocalek]

Hey Count Vapula. You're gonna love me.

You're new here and I can understand why you might believe that Big Tobacco must be behind all the attacks on e-cigarettes. It sounds logical, because when people switch to e-cigarettes, they spend less on regular cigarettes.

However, you're forgetting the very lucrative business of selling "smoking cessation" aids, advising people to use them for 3 months, and then when it does not work for 93% to 98% of the customers, blame it on their lack of will-power. Several months later, repeat the same thing all over again. Some of the people who finally managed to stop lighting up by switching to e-cigarettes tried those approved "smoking cessation" drugs 10 times or more without success. E-cigarettes are a huge threat to the several billion dollar smoking cessation market. They put a stop to the wheel of misfortune.

Take a look around this forum, and you will find that the organizations coming after us are all of the Anti-Smoker groups: The American Lung Assocation, American Cancer Society, American Heart Association, Campaign for Tobacco-free Kids, Americans for Non-smokers Rights, Action on Smoking and Health. All of these organizations receive funding from Big Phama, including research grants.

Right now we are NOT on the radar of the FDA's Center for Tobacco Products because the FDA refuses to designate e-cigarettes as a tobacco product. They insist it is a drug-delivery device and needs to pony up the registration fees and clinicial trials to get approval as a drug -- just like Big Pharma had to do to get their NRTs approved.

 

[CountVapula]

thank you vocalek for the information, ive noticed your very active and play a great part in this section of the forums. im just so frustrated with the fact that EVERYONE is coming after us and it has nothing... NOTHING to do with health and everything to do with money, its sickening.

 

[Vocalek]

You are so right. It is sickening. Nothing to do with health, and everything to do with money and POWER.

 

[Demarko]

At least some state governments can work together even if our federal one can't:

 

[hairball]

You are so right. It is sickening. Nothing to do with health, and everything to do with money and POWER.

Always reading your posts on this topic Vocalek...it makes me understand all the aspects of it. All the discussion about it gets my blood pressure soaring but you always come to the rescue to give valuable insight. Thank you.

 

[UntamedRose]

Now there's a trade I can deal with No hubby's paycheck(he's military) for FDA shut down!

 

[sqirl1]

At least some state governments can work together even if our federal one can't:

that gives me an idea! we should rick roll the FDA until they finally leave E-cigs alone! it worked on Scientology so it might work on the FDA!

 

[Zal42]

cartos made by marlboro, camal, newport, etc. but if things get that bad, i look forward to being a part of an underground movement that doesnt play by the fda and governments rules.

If you're serious about this plan, then you may want to avoid announcing it in a pubic forum which can be read by law enforcement to develop a list of suspects when the laws change. Just sayin'.