UPDATE: US Senate Panel Approves FDA Tobacco-Regulation Measure

[saintgadreel]

On a lighter note, I noticed that the Marijuana amendment only got voted down by 3 votes in the HELP session yesterday. That would have been a nice poison pill for the bill on the senate floor. Surprisingly (my jaw dropped) Senator McCain voted YES to adding that amendment. Might have been a bit of his geriatric memory issues (see his campaign), but at the same time, thats almost a glimmer of hope. The bill still only has 52 co-sponsors, so a filibuster (sp?) is still possible, and there may be a chance that the remaining non-supporting dems don't agree with the bill. If the remainder of congress votes no to passing the bill, we may have a very very slim chance to win this battle. Then it would just be down to the SE/njoy vs FDA case. Here's crossing my fingers (unfortunately both my senators basically blew me off when I tried to convince them to change their mind, and both are now co-sponsors of the bill).

 

[Wally]

I do understand, Ivisi. I've read the bill, and watched the hearings. It's a tobacco bill. As for SE, IMO it has a chance only on technicalities of notification. Its "this is a tobacco product" argument is laughable and will be dismissed. Again, IMO. I cannot take that as a serious argument, the FDA doesn't, and I doubt even Judge Judy would. njoy's involvement is evidence only of desperation.

And, yes, the bill does affect us indirectly as a new technology for nicotine delivery. I was intensively interested in this for personal reasons of using snus and dissolvables, but saw an accurate measure of how hated tobacco is and the future is full of "not one more generation hooked on tobacco" rhetoric. I heard it in those hearings.

Some have been grabbing at any false hope for a long time, so I guess we can cling to the notion that the full Senate will come to its senses and vote down the bill. To me, things must be viewed realistically, however. Project today's trend lines. What you will see is further regulation of tobacco and nicotine, restricted and ultimately limited availability of tobacco and nicotine, and a rejection of all new methods -- reduced harm or not -- of nicotine delivery.

That's why I'm depressed after viewing the hearings.

But at least the uncertainties disappear like fading smoke day by day.

I think that the real significance of this bill passing is the confirmation of a complete hostility to harm reduction approaches and the implications of that for the e-cig, as well as snus and the dissolvables. Unfortunately harm reduction issues were woven only into the Burr amendment which had many other things wrong with it (it was a P. Lorillard/RJR amendment, I guess). This unmodified bill throws the 45 million current U.S. smokers to the wolves--better to have them dead (so they can't influence the children) than to offer (very significant) harm reduction alternatives. On the e-cig, I think our next battle will be in trying to influence the FDA as they attempt to control it as a drug-device. Margaret Hamburg as Commissioner is a good sign though. She was a big harm-reduction proponent in NYC and understands the issues. The hope is that she will see the value in considering in e-cig in the terms of tobacco rather than in the terms of pharmaceuticals.

 

[RandallFlagg]

On the e-cig, I think our next battle will be in trying to influence the FDA as they attempt to control it as a drug-device.

Did you see this thread?
E-Cig safety confirmed by Medical Study!
http://www.e-cigarette-forum.com/fo...ety-confirmed-medical-study-2.html#post294233

 

[SSRob]

I started smokin my grandma's Vantage 100's...the ones with the funny hole in the filter.

Yech.

 

[Vicks Vap-oh-Yeah]

Maybe Michael Moore can do a documentary on e-cigs?

OK...Cudos for thinking outside the box, but you don't want that WACKO talking about E-Cigs....

 

[Momof3]

TY Bill for the link for Wed. I missed it and was having trouble finding it. I was yelling so much during the first one you would have thought I was watching a football game. The dissolvables and flavor discussions had me screaming the most.

I would love to try the orbs in caramel. Short of your home and for some not even there, you about can't smoke anywhere. Kids my hiney, I see a large adult market for the dissolvables. And someone please tell me where they ever got the idea that the more you restrict something, the less likely a teen is to do it?

Well off to watch the next installment while I vape my cappuccino from my metallic red 901 that couldn't possibly have been meant to appeal to me, an adult smoker. 8-o

 

[Momof3]

What a train wreck. Why do I even bother teaching my children to read? Apparently they don't need to know how to become US Senators.

I honestly don't know why they are even bothering. It seems to be running "Don't even make any attempt to listen, just support your party. Screw the voters." So why waste the time.

Was it a slip or quite telling when the one senator said the point of the bill was to prevent people from quitting?

 

[TurtlsPace]

My father grew up on a 200 acre tobacco farm. he started smoking at like 12. it had nothing to do with ads or gimmicks. I started smoking at maybe 13, it had nothing to do with ads or flavors. We didn't have flavors. I watched my father die of lung cancer from years of inhaling the poisons that are added to commercial cigarettes. He was in hospice, on oxygen and would take it off long enough to smoke another cigg. Nicotine is addictive, I will admit I'm addicted. But if you are considering taking away a safer, healthier option then start with the nicotine gum, patches, snus, snuff etc. Let's have a level playing field. How about controlling every single ingredient that goes into commercial analogs? Slap a warning label on my vaper and leave me to puff in peace!
Sorry my first post, kinda long winded, lol.

 

[Momof3]

My father grew up on a 200 acre tobacco farm. he started smoking at like 12. it had nothing to do with ads or gimmicks. I started smoking at maybe 13, it had nothing to do with ads or flavors. We didn't have flavors. I watched my father die of lung cancer from years of inhaling the poisons that are added to commercial cigarettes. He was in hospice, on oxygen and would take it off long enough to smoke another cigg. Nicotine is addictive, I will admit I'm addicted. But if you are considering taking away a safer, healthier option then start with the nicotine gum, patches, snus, snuff etc. Let's have a level playing field. How about controlling every single ingredient that goes into commercial analogs? Slap a warning label on my vaper and leave me to puff in peace!
Sorry my first post, kinda long winded, lol.

Welcome to ECF TurtlsPace.

Don't worry, they've got their eye on reducing the ingredients in analogs. Starting with nicotine. That way people will smoke more! Isn't it great that they're looking out for our health.

 

[MacZapIt]

Going to send a few emails out to gov't officials - to celebrate memorial day....hehehehee

 

[LuckyCharm]

Was it a slip or quite telling when the one senator said the point of the bill was to prevent people from quitting?

Was this something on TV?

~~Cheryl

 

[Smokin'Sandy]

Please, can someone explain this to me?

‘(c) Tobacco Dependence Products- A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of chapter V.

This is under section 911 MODIFIED RISK TOBACCO PRODUCTS.

Why couldn't the e-cig be allowed if it was decided to be a tobacco product and not a smoking cessation device? It's not approved to be such.

This part here makes me think it would be marketable if it were found to be a modified risk tobacco product. Does the nicotine come from tobacco?

‘(1) MODIFIED RISK TOBACCO PRODUCT- The term ‘modified risk tobacco product’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

Thanks anyone and everyone for helping me out here.

 

[LaceyUnderall]

Sandy -

It is my understanding that this is exactly what SE is trying to do with the lawsuit against the FDA. Prove that the ecig is not a medical device and that it is a "reduced risk tobacco product".

What this section says is if it HAS been approved or deemed to be a cessation product by the FDA, then it can no longer fall into the category of tobacco product.

If this SE/nJoy case comes out that the ecig is in fact an alternative to smoking and a tobacco product, then it could be argued that it is a "modified use product" like the smokeless tobacco products and be sold along side cigarettes instead of being forced to be sold only in pharmacies.

For instance, gums, patches etc cannot be sold in tobacco shops, they can only be sold in businesses with pharmacies. If the ecig is found to be a medical device, you will only be able to purchase them where you can purchase the other NRT's.

Many disagree, including myself, that NRT's should be restricted to pharmacies. Personally, I think the restrictions on NRT's should be lessened so someone going to a gas station would see cigarettes, smokeless products, NRT's AND ecigs and make their own decision how they wish to get their nicotine. Just like we have coolers that sell caffeine sodas, we should have shelves that sell ALL of the nicotine products as well.

 

[Smokin'Sandy]

Sandy -

It is my understanding that this is exactly what SE is trying to do with the lawsuit against the FDA. Prove that the ecig is not a medical device and that it is a "reduced risk tobacco product".

What this section says is if it HAS been approved or deemed to be a cessation product by the FDA, then it can no longer fall into the category of tobacco product.

If this SE/nJoy case comes out that the ecig is in fact an alternative to smoking and a tobacco product, then it could be argued that it is a "modified use product" like the smokeless tobacco products and be sold along side cigarettes instead of being forced to be sold only in pharmacies.

For instance, gums, patches etc cannot be sold in tobacco shops, they can only be sold in businesses with pharmacies. If the ecig is found to be a medical device, you will only be able to purchase them where you can purchase the other NRT's.

Many disagree, including myself, that NRT's should be restricted to pharmacies. Personally, I think the restrictions on NRT's should be lessened so someone going to a gas station would see cigarettes, smokeless products, NRT's AND ecigs and make their own decision how they wish to get their nicotine. Just like we have coolers that sell caffeine sodas, we should have shelves that sell ALL of the nicotine products as well.

Thank you Lacey and I agree with you about having them available everywhere cigarettes are sold.

 

[orlampagal]

Bill Nelson and Mel Martinez are going to get a lot of mail from me today!!! Thanks for reminding me to do my part!

 

[Bill Godshall]

The US Senate is likely to consider S. 982 (Kennedy's FDA tobacco bill) during the week of June 2.

It is important to know that passage of the legislation will have no negative legal or regulatory impact on e-cigarettes. One of my goals, which now appears unlikely, was to amend the legislation to prevent the FDA from banning e-cigarettes as drug devices (by defining e-cigarettes as a new category of tobacco product).

But the legislation's ban on new smokefree tobacco products (and the false claims by Senate Democrats that Reynolds is target marketing these products to youth) could encourage the FDA to further crack down on e-cigarettes (than if the tobacco legislation weren't enacted).

Sen. Coburn offered, then withdrew, his amendment (i.e. the ECA amendment) that would exempt e-cigarettes from the definition of a tobacco product, during Wednesday night's HELP Cmte markup session (the session that isn't available on the committee's website). Coburn will try negotiating an agreement with Dodd on that amendment prior to Senate floor consideration.

But since S. 982 doesn't define e-cigarettes as a tobacco product (or otherwise apply to e-cigarettes), I'm not convinced that passage of the Coburn amendment would provide any legal or regulatory benefits for e-cigarettes (as the FDA could still rule that e-cigarettes, or certain e-cigarette products, are unapproved drug devices, and take action).

 

[Kamanjah]

I sent a letter to both of my senators yesterday opposing S. 982 and got this weird (automated? or uninformed intern?) response:

"Dear...:

Thank you for writing to me regarding the Food and Drug Administration's citizen petition process. I appreciate the time you took to contact me and welcome the opportunity to respond.

I understand your concerns that pharmaceutical companies may be inappropriately influencing the Food and Drug Administration (FDA) through the petition process. As you may know, anyone may request or petition the FDA to change agency policies or regulations. All petitions are subject to public examination. I believe that all decisions made by the FDA should be based on the best available scientific evidence. Please know that I will keep your comments in mind as I continue to monitor the actions of the FDA.

Again, thank you for writing. If you have any further questions or concerns, please do not hesitate to contact my Washington, D.C. office at (202) 224-3841.

Sincerely yours,

Dianne Feinstein
United States Senator

So, I sent another one today, simply stating please oppose S. 982. Wonder if that's simple enough to understand?!

Anyway, the information about the citizen petition process is interesting and could be VERY useful! That seems to be the format ASH used in their anti e-cig rant, er, I mean petition.

I don't see why we can't submit our own petitions - how to info here and here.

First link says Small Business, but I don't think that's pertinent to the process.

Maybe ECA could submit for the community as a whole? Lacey?

Heck, if each and every one of us submitted a petition, we could just bury them in paperwork for the next 100 years!

Seriously though, is anyone here familiar with the citizen petition process?

_____________
based on 2008 prices

 

[Momof3]

Lets try this again.

Tuesday's HELP Cmte markup is at:
Welcome - U.S. Senate Committee on Health, Education, Labor and Pensions

The first part of Wednesday's markup is at:
Welcome - U.S. Senate Committee on Health, Education, Labor and Pensions

Here are the links if you wish to view Luckycharm.


Brownback's office was the usual, "Can't really say until it's actually brought up on the floor what his official position is." Gave my statement, etc. I've never been his biggest fan, but I'm not horribly worried about him. At least all the form letters I've gotten back in the past have been on point.

Robert's office I had a long chat with. Told his intern how appalling I thought some of the comments were during the mark-up. Strong urging to actually read the bill and Burr and Hagen's substitution. Gave some of the finer points and highlights. She was surprised when I told her Nicorette and Commit in all their FDA approved flavored glory are readily available and accessible to my 10yr old, but Orbs behind the counter only available for purchase by an adult, well no, those need to be banned. We chatted. Nothing official of course other than his votes are primarily against S. 982. I'm not terribly concerned about Robert's office either.

It's those who haven't bothered to actually read and are just voting the party line I'm worried about. It's doubtful even half of the co-sponsers have actually read let alone have any idea what S. 982 says or is really about. "Hey, it's Kennedy. Of course we agree! It's for the kids!"

 

[TropicalBob]

The ban on smokeless products is so short-sighted. Without less harmful, but effective, alternatives available in tobacco shops, a smoker wanting to quit cigarettes will have a single option on shelves: Packs of cigarettes.

The legislation, far from saving lives, will kill thousands in the next few years.

Thanks for your work, Bill. You tried. I agree with your conclusion that e-cigs are not directly affected. They are not a tobacco product. But this legislation will likely force action soon from the FDA, since these "addictive" e-cigs can't be allowed to fall into the hands of "the children" being so protected by the new law.

If forces demand a ban on 4mg pellets, what will they rule on a device that delivers 36mg liquid? I bet janitors are finding cartridges in high school trash dumps ...

 

[jim420]

I am glad to see the discussion on how the government works, but this bill is bound to whizz through and pass. What member of Congress is going to vote against a bill to "protect our children "*that's it..that't the one more time that made me puke*. The only way this bill wouldn't pass is if they attached so many riders (that would never pass on their own merit) that congress would vote against it. Unlikely, but it could happen. Seldom has congress voted down a bill because they had the honesty to vote against the riders and pork that is attached.