FDA changes NRT warning labels to encourage more usage by smokers

[Bill Godshall]

FDA changes labels to encourage use of nicotine gums, lozenges and patches
Nicotine Replacement Therapy Labels May Change


It didn't take Mitch Zeller very long to reward his former employer (GlaxoSmithKline) with a regulatory change intended to increase consumption of nicotine gums, lozenges and patches.

I've been urging FDA to eliminate its mandatory and counterproductive warnings on NRT products that state:
- Do not use if you continue using tobacco. and
- Stop using after 12 weeks.

But the agency's new warning label statements falsely imply that NRT is an effective treatment for smoking cessation, and fail to warn consumers that NRT has a 95% failure rate for smoking cessation and for treating tobacco dependence (which is what FDA approves it for treating).

The new warnings also fail to inform consumers that NRT can be used as a temporary and/or long term substitute for cigarettes and other tobacco products, and that many smokeless tobacco and other new smokefree alternatives are very similar to FDA approved NRT products.

The FDA notice included a photo of a doctor in white lab coat with a patient, and the following statement.

Patients should consult with their health care professional to select the most appropriate smoking cessation method to suit their needs, and to discuss any questions about the use of OTC nicotine replacement products. FDA has not seen evidence to support the statement that these products are safe for all smokers.

 

[thew92]

So was this there "deeming" plan for April? and is it safe to say they are no going after Ecigs in the near-future?

 

[Liv2Ski]

Well Bill you could also end up like I was about three years ago ------ Attempted to quit and did using the gum. I then followed the directions and stopped the gum. That lasted about two weeks before the "I will only have one cig" mind game kicked in. Quickly back to 1.5 PAD and since I fly often I was buying the gum too. Soon I was smoking and chewing nicorette everyday! While tearing my car apart and freaking out that I did not have any gum I realized I was also smoking a cigarette while I doing this and felt like something had change. The next day I saw a e-cig sign at the local gas station and tried it. Yes is sucked but it made me do some research and now it is almost three years and not one smoke. Vaping is the only thing that made me drop the smokes (and the gum). The FDA can put that in their gum, lozenges and patches and chew on it.

BTW - Thanks for all that you do and for keeping us informed

 

[Petrodus]

 

[Lessifer]

Well, doesn't this at least mean that they're no longer saying that extended use of alternative nicotine sources is inherently harmful? I know we still have to wait and see what they're going to say about PV's, but at least it's not "no nicotine or die."

 

[Horselady154]

Thank you so much for all you do, Bill.

 

[Bill Godshall]

Two news articles

AP: FDA says longer use of nicotine gum is OK
http://www.huffingtonpost.com/huff-wires/20130401/us-fda-nicotine-replacement/

Meanwhile, the FDA said it is missing a Monday deadline to submit three tobacco-related reports to Congress, which the agency said are nearing completion. It also is missing another deadline to publish a consumer-friendly list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives.

There are no penalties for forgoing the deadlines outlined in the 2009 law that gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing

Winston Salem Jrnl: FDA changes oversight on nicotine-replacement therapy products
FDA changes oversight on nicotine-replacement therapy products - Winston-Salem Journal: Local

 

[Bill Godshall]

The FDA's announcement in the Federal Register is at

FDA: Modifications to Labeling of Nicotine Replacement Therapy Products for Over-the-Counter
Human Use
http://www.ofr.gov/OFRUpload/OFRData/2013-07528_PI.pdf

 

[Talyon]

Yes thanx Bill for all u do for us, many grats. My freedom will not be taken from me.

 

[FloridaNoob]

with this being a positive turn by the FDA I almost thought it was an April Fools joke. LOL

 

[Bill Godshall]

Here's another notice by FDA about this change
Nicotine-Containing Products

 

[Fiamma]

Those non profits who petitioned are all shills for BP. BP needs smokers to be deceived and pay through the nose for longer periods of time so their profits grow. Where is the language in the labeling that warns, "this product is only 07% effective in helping you quit smoking for good". I'd call that truth in advertising.

//edit. First go was in a hurry and I meant 93% ineffective. Thanks Junkman

 

[junkman]

Those non profits who petitioned are all shills for BP. BP needs smokers to be deceived and pay through the nose for longer periods of time so their profits grow. Where is the language in the labeling that warns, "this product is only 07% effective in helping you quit smoking for good". I'd call that truth in advertising.

Fixed it for you...

 

[junkman]

FDA changes labels to encourage use of nicotine gums, lozenges and patches
Nicotine Replacement Therapy Labels May Change


It didn't take Mitch Zeller very long to reward his former employer (GlaxoSmithKline) with a regulatory change intended to increase consumption of nicotine gums, lozenges and patches.
[/COLOR]

No kidding.

 

[DC2]

Patients should consult with their health care professional to select the most appropriate smoking cessation method to suit their needs, and to discuss any questions about the use of OTC nicotine replacement products. FDA has not seen evidence to support the statement that these products are safe for all smokers.

The one good thing I see from this is that if "patients" actually do consult their health care professionals, they may be encouraged to try electronic cigarettes.

While the rest of the "health care professionals" and "health care advocacy groups" are actively discouraging their use...
The real doctors on the front lines of patient care are OVERWHELMING behind our efforts from everything I can tell.

 

[DC2]

So was this there "deeming" plan for April? and is it safe to say they are no going after Ecigs in the near-future?

No, this has nothing to do with the upcoming "deeming regulations" which are still pending.

 

[DC2]

We often say around here that maybe Hon Lik should get a Nobel Prize some day.
But it just occurred to me that perhaps Bill Godshall, one day, might be looked to as someone deserving as well.

There are so few that fight so hard for what they truly believe is right, even against all the power and money that opposes them.
You may have some detractors, Mr. Godshall, but nobody fights harder every day for what they think is right.

 

[DC2]

Am I the only one that wonders if the hardcore "quit smoking forums" that hate electronic cigarettes have heard this news?

 

[Mowgli]

The one good thing I see from this is that if "patients" actually do consult their health care professionals, they may be encouraged to try electronic cigarettes.

While the rest of the "health care professionals" and "health care advocacy groups" are actively discouraging their use.
The doctors on the front lines of patient care are OVERWHELMING behind our efforts from everything I can tell.

I spoke with my cardiologist today and he's psyched that I switched from Morleys to vapor.
I had a mild heart attack (clogged cardiac artery) Dec 2011, quit for 17 days on the patch and slowly crept back to 1.5 PAD.
He said hiking 20+ miles/week is probably the only thing preventing another HA.
I still hike 2-5 miles almost every day and noticed breathing was easier within a few days of smoking less.
It's even better now. No more clearing my throat a few times per minute and no more wheezing/crackling.

He always seemed that he cared more than just CYA and he asked me a ton of questions about vaping today.
He's one of the good guys and promotes anything is better than smoking.
He's a totally busy SOB already but I'll try to steer him towards vaping policies.
10 out of 10 doctors prefer vaping to smoking --- someday...

 

[Fiamma]

Am I the only one that wonders if the hardcore "quit smoking forums" that hate electronic cigarettes have heard this news?

Funny you should mention that. I've been running around today like a one armed paper hanger trying to get ready to go back down to LA for the rest of the week to work and one of the things that was buzzing around in what I laughingly call my brain was.. "I wonder if all the alphabet soup agencies are having anxiety attacks today".