FDA reply from Public affairs specialist

[OutWest]

Well... and we can't forget that right now the FDA is leaderless AND Sharfstein (sp) who is slated to take over, used to work in Waxman's office and helped to write the Waxman bill. There are several levels working against us here. (Still not the end of the world.)

Oh... and Outie did you see... the Kennedy bill is up now: Search Results - THOMAS (Library of Congress)

no i hadnt, thank you. Will give it a good reading. At first glance, this tidbit looks a little bit promising Search Results - THOMAS (Library of Congress)

[LaceyUnderall]

no i hadnt, thank you. Will give it a good reading. At first glance, this tidbit looks a little bit promising Search Results - THOMAS (Library of Congress)

My understanding is that it is 90%+ the Waxman bill... but I am just starting to read it now... so we shall see. There are apparently some good provisions in there that might apply to us.

[IntoxiNation]

The best place to follow the status of this bill is here:

S. 982: Family Smoking Prevention and Tobacco Control Act (GovTrack.us)

That's where all the non-governmental sites that track this stuff pulls their data from.

[TropicalBob]

Lacey, you don't have to get far beyond definitions of "adulterated" and "misbranded" to get an idea of the impossible task e-cigs face. Is there any e-product anywhere that can meet the legal requirements to avoid those two definitions and subsequent removal from the market order?

The bill also makes smaller companies like Star Scientific, maker of my dissolvables, throw up its arms and sell out.

If you have a yellow marker, see how many paragraphs are a death knell. After awhile, I stopped counting.

[LaceyUnderall]

Lacey, you don't have to get far beyond definitions of "adulterated" and "misbranded" to get an idea of the impossible task e-cigs face. Is there any e-product anywhere that can meet the legal requirements to avoid those two definitions and subsequent removal from the market order?

The bill also makes smaller companies like Star Scientific, maker of my dissolvables, throw up its arms and sell out.

If you have a yellow marker, see how many paragraphs are a death knell. After awhile, I stopped counting.

This whole thing makes me want to puke. On so many different levels... wipe away the issue of ecig and blah... I still want to puke.

But... you know me... nothing is impossible. (I added the rolleyes so you didn't have too!)

[TropicalBob]

Me, too. I'm really, really hard hit if this becomes unamended law.

But .. and this is a big one .. it all pertains to tobacco products. The FDA claims it has sufficient authority over drugs and drug delivery devices, which is what it says e-cigs are. By definitions in this bill, we are NOT a tobacco product.

So how do we want that SE lawsuit to end up? If we're tobacco, we are doomed, doomed, doomed. If we're not, we're a drug product and still await the FDA decision. Me? We're a drug product. Get to work on your studies, liquid makers.

This is the only section that directly applies to e-smoking. We're an "innovative product".

‘(b) Report on Innovative Products-

‘(1) IN GENERAL- Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--

‘(A) total abstinence from tobacco use;

‘(B) reductions in consumption of tobacco; and

‘(C) reductions in the harm associated with continued tobacco use.

And .. just for the record .. in the looooong list of reasons why this law is necessary, this is the number one, top reason:

SEC. 2. FINDINGS.

The Congress finds the following:

(1) The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.

Number ONE. It's all about the children, folks. It's all about "not one more generation hooked on nicotine". No small matter, eh, as it was belittled here in some threads.

[Vicks Vap-oh-Yeah]

Number ONE. It's all about the children, folks. It's all about "not one more generation hooked on nicotine". No small matter, eh, as it was belittled here in some threads.

That's a tall order, as long as tobacco products remain on the market.... and they will, for the revenue streams alone.

In fact, I'd say their goal is unobtainable and a pipe dream.....

Not belittling, not an aggressive, and I'm not mocking.....as long as tobacco remains a substance that you can purchase, there will be new generations of people hooked on them....period. That's human nature.

[Glock]

Hmmm but Cheerios makes the same claim and they can still be sold? That seems rather curious.

Perhaps you missed this thread:
http://www.e-cigarette-forum.com/for...ally-acts.html

[TropicalBob]

You're right, Vicks. Prohibition won't work. For an article I wrote, I did a short history of tobacco. There have been countries where smokers had their hands cut off, their tongues cut out, etc., yet still smoking by others continued.

Tobacco's use, form and popularity has risen and fallen over many years. We're hitting another low point, where villagers carrying torches are stampeding streets to root out Demon Nicotine.

Unfortunately, I'm living in this down time! It's painful.

The Kennedy bill is horrendous in its requirements and ramifications. I got a headache just reading it ....

[IntoxiNation]

Perhaps you missed this thread:
http://www.e-cigarette-forum.com/for...ally-acts.html

I saw that thread (and the few others about the same thing) and was my point exactly. The FDA has said Cheerios is "making 'drug' claims" exactly like they are saying about E-Cigs. Yet Cheerios is still on the market and selling. They were given a moratorium and time to correct their labeling. I don't remember seeing at any point in time where the FDA contacted a supplier and said "hey you really need to change your labeling, and if its not done by this date then your in trouble". Instead they just blocked the shipments. Now that's a pretty big double standard.

And actually it really this seems to go into the claim SE has made in their lawsuit against the FDA and not being given time to adhere (or whatever it was called). In other words, it seems the FDA gave SE an awesome piece of evidence on the very week they go to court.