FDA seeking information from electronic cigarette companies.

[thall12]

This may have been posted before.

http://www.tveca.com/PDF/fda-letter.pdf

They are really nosey huh? They don't ask any questions about positive reports, how many people reorder, or quit or cut down using e cigarettes. Interesting.

 

[TennDave]

Yes, it was posted before and quite a few comments in response to the article....similar to yours.
Glad you posted it though- a good reminder that the FDA doesn't play fairly at all...

 

[Vocalek]

Yes, we SHOULD provide useful information to the FDA.

Step 1: Customers: Write a message to your vendor, briefly telling your personal story about struggling to quit smoking, and finally substituting the e-cigarette for all your smoked cigarettes. If you have experienced positive health effects (e.g. better lung health, less coughing etc, mention this as well.) End by thanking the vendor for making a product available that helped to to improve your health and possibly save your life.

Step 2: Vendors: Collect every report, positive (as above) or negative (which will probably be of the type "the battery you just set me was DOA") and send them ALL to the FDA.

 

[Petrodus]

What I got from reading the pdf is the FDA is on a "Witch Hunt"
and couldn't care less about the effectiveness of e-cigarettes
as an alternative to smoking.

Did I miss something ???

 

[trepalium]

As someone who works for a pharmaceutical CRO. This is typical language for the FDA. They are always worried about the adverse events. They want to know how the product negatively impacts the consumer because that is the area where safety becomes a concern. Let's be honest the FDA is meant to keep products safe, not effective. I think this is typical language for the FDA and should not be any indication of their personal feeling toward these devices. Just think of them as a worrisome mother. They want to make sure it's safe. They could care less about the benefits. They are there for safety not to evaluate it's effectiveness. With any drug or other product the FDA looks at they rarely look at anything but 1.) is it reasonably safe to the consumer 2.) Does it do what it's advertised to do.
Beyond that the FDA doesn't care. This is typical with everything the FDA evaluates.

 

[milo hobo]

"Oh dang, your product has decreased my desire to smoke tobacco!"

I think that the FDA should require that this side effect be listed! Lol

 

[Petrodus]

As someone who works for a pharmaceutical CRO. This is typical language for the FDA. They are always worried about the adverse events. They want to know how the product negatively impacts the consumer because that is the area where safety becomes a concern. Let's be honest the FDA is meant to keep products safe, not effective. I think this is typical language for the FDA and should not be any indication of their personal feeling toward these devices. Just think of them as a worrisome mother. They want to make sure it's safe. They could care less about the benefits. They are there for safety not to evaluate it's effectiveness. With any drug or other product the FDA looks at they rarely look at anything but 1.) is it reasonably safe to the consumer 2.) Does it do what it's advertised to do.
Beyond that the FDA doesn't care. This is typical with everything the FDA evaluates.

Makes sense to me

Every time I see someone calling for an email or electronic petition campaign
to be sent to the FDA ... I cringe.

The FDA couldn't care less. The FDA's computer key boards have "Delete" keys
and macro function keys to send generic "thank you" replies.

The FDA knows the truth. They know where to find Google and they are aware
and follow the ECF as well as other e-cig discussion groups. The Internet is
Packed Full of success stories and the truth ... As trepalium pointed out
They could care less about the benefits.

What do you'all think ??



We send politicians to Washington (AKA: Crazyville, USA)
to make tough decisions. When they get there, they realize
if they do what is best for the country ... They won't be re-elected.

Example: Fix this (Click Here)
but do so without negatively impacting anyone's life style or "pet" projects.

 

[throatkick]

As someone who works for a pharmaceutical CRO. This is typical language for the FDA. They are always worried about the adverse events. They want to know how the product negatively impacts the consumer because that is the area where safety becomes a concern. Let's be honest the FDA is meant to keep products safe, not effective. I think this is typical language for the FDA and should not be any indication of their personal feeling toward these devices. Just think of them as a worrisome mother. They want to make sure it's safe. They could care less about the benefits. They are there for safety not to evaluate it's effectiveness. With any drug or other product the FDA looks at they rarely look at anything but 1.) is it reasonably safe to the consumer 2.) Does it do what it's advertised to do.
Beyond that the FDA doesn't care. This is typical with everything the FDA evaluates.

You make a good point and hopefully this is what the intentions are. Please keep in mind, the FDA did try to regulate e-cigs and it is only through court decisions that they had to back off.

 

[DC2]

While I can believe that what trepalium states is generally true, the FDA has already proven their intentions with respect to electronic cigarettes. They have already tried to ban them for no reason, and they have already taken steps to brainwash the public into thinking they are dangerous. These are not the actions of an agency that doesn't care one way or the other.

 

[MrsCasey]

As someone who works for a pharmaceutical CRO. This is typical language for the FDA. They are always worried about the adverse events. They want to know how the product negatively impacts the consumer because that is the area where safety becomes a concern. Let's be honest the FDA is meant to keep products safe, not effective. I think this is typical language for the FDA and should not be any indication of their personal feeling toward these devices. Just think of them as a worrisome mother. They want to make sure it's safe. They could care less about the benefits. They are there for safety not to evaluate it's effectiveness. With any drug or other product the FDA looks at they rarely look at anything but 1.) is it reasonably safe to the consumer 2.) Does it do what it's advertised to do.
Beyond that the FDA doesn't care. This is typical with everything the FDA evaluates.

Yet they fail to do that, witness the class action lawsuits and deaths that occur from many FDA approved medications. Vioxx, Fen-Phen, Fosamax, Avandia, Darvocet, Actos, Pelvic Mesh...... I took two drugs for over 5 years before they were pulled for heart attacks. Seems to me they are more interested in what makes them money than consumer safety. The FDA cannot be trusted in my opinion.