FDA Accepting Comments on NRT until Dec 2010

[chadizzy1]

http://www.regulations.gov/search/Re...00006480b42fc6

[GoVegan]

Like they are really going to give a crap about what we think. Usually, with stuff like that some decision has already been made and they are just seeking support to bolster their own opinion.

[dreed2]

States are losing millions, if not billions, of dollars because of people who, somehow, manage to quit smoking by finding safer alternatives. The FDA is OWNED by special interest groups who have financial stakes in all of this. I agree with GoVegan that "some decision has already been made and they are just seeking support to bolster their own opinion". They win, we lose, as usual...

PS: We might really have to start growing our own tobacco and making our own snus... Only problem is that I'll need to build a greenhouse... And then they'll probably make it illegal for me to grow it.

PS again: Get out there and vote tomorrow!

[Tristik]

~~
Pretty sure that has to do with nicotine replacement products (like it says) and not products that offer nicotine in an alternative fashion such as snus, or e-cigs. Sounds like they're looking for feedback on long term use of prescription pills and things of that nature that most use to quit smoking.
~~

[Bill Godshall]

While this FDA comment period pertains to NRT, it really is an evaluation of the scientific evidence on the health risks (and lack thereof) of long term nicotine usage, which primarily involves research on smokeless tobacco usage. Following is info about the FDA's two day workshop, and my testimony at the workshop.

FDA holds Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products
http://www.fda.gov/Drugs/NewsEvents/ucm221185.htm
http://www.fda.gov/downloads/Drugs/N.../UCM230910.pdf
All twelve public hearing speakers urge FDA to approve the marketing of NRT for long term usage
http://www.fda.gov/downloads/Drugs/N.../UCM230876.pdf
FDA accepting public comments until December 27, 2010
http://www.regulations.gov/search/Re...00006480b42fc6

Testimony by CASAA's Elaine Keller:
http://www.casaa.org/files/CASAA_NRT_Testimony.pdf

My testimony is below and at:
http://www.e-cigarette-forum.com/for...erm-usage.html

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for their egregious past actions, preserve civil justice remedies for those injured by cigarettes, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither I nor Smokefree Pennsylvania have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

I’m here to urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree nicotine and tobacco products.

More than ninety nine percent of all tobacco attributable mortality and more than ninety nine percent of tobacco attributable health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Existing evidence also indicates that cigarettes are at least 100 times more hazardous than the smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco products, electronic cigarettes and nicotine products marketed to treat tobacco dependence.

While quitting all tobacco/nicotine use may be the best way for smokers to improve their health, switching to smokefree tobacco/nicotine products reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use. Surveys indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and sales reports indicate that nearly a half million smokers have switched to electronic cigarettes in just the past several years. Nonsmokers also benefit when smokers switch to or substitute smokefree alternatives, as they emit NO tobacco smoke.

As currently regulated by the FDA to treat tobacco dependence, nicotine products have had a 95% failure rate. But these products are deceptively promoted by drug companies, public health agencies and drug industry funded anti-tobacco organizations as the most effective way to quit smoking.

Although the FDA has only approved nicotine products for short term (10-12 weeks) usage to treat tobacco dependence, research and sales data indicate that a large percentage (probably a majority) of nicotine gum and lozenges are used for “off label” purposes as either long term or temporary nicotine maintenance alternatives to cigarettes.

But instead of taking actions to reduce current “off label” usage of nicotine products, the FDA should encourage and approve the marketing of nicotine products to smokers as long term and as temporary cigarette alternatives, similar to the way smokeless tobacco and electronic cigarettes are marketed to smokers.

Concurrently, the FDA should eliminate the current warning on nicotine products that urge consumers to discontinue use if they also use a tobacco product, and instead should encourage smokers to continue substituting nicotine products for cigarettes as often as possible.

The FDA also should allow the sale of $5-$10 packages of nicotine products, allow sales at all retail stores that sell cigarettes, and allow higher levels of nicotine in the products to satisfy the cravings of most smokers.

If the FDA doesn’t take these long overdue actions to protect public health, the most effective way for companies to increase nicotine product usage by smokers would be to market their products as tobacco products under the FSPTCA.

The FDA also should stop trying to ban electronic cigarettes by misclassifying them as drug devices, which Federal Judge Richard Leon has already struck down, and instead the FDA should classify and reasonably regulate e-cigarettes as tobacco products in accordance with the FSPTCA.

Josh Sharstein’s misleading fear mongering claims about e-cigarettes at a July 22, 2009 press conference, which have been repeated hundreds of times and have appeared in dozens of news articles, also should be clarified and corrected by the agency. The FDA has an ethical duty to inform smokers that nicotine is addictive, but that all smokefree tobacco and nicotine products are far less hazardous long term and temporary alternatives to cigarettes.

Smokers have a human right to truthful health information and legal access to far less hazardous alternatives. The FDA should provide for that.

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 412-351-5881
smokefree@compuserve.com

[Darwin]

Good on you Mr. Bill. You are definitely among friends here but I lament the fact that even collectively we are a mere few plaintive voices calling out in a howling cacaphony of anti-tobacco activism. Best of luck with your efforts.

[WickedKitchen]

~~
Pretty sure that has to do with nicotine replacement products (like it says) and not products that offer nicotine in an alternative fashion such as snus, or e-cigs. Sounds like they're looking for feedback on long term use of prescription pills and things of that nature that most use to quit smoking.
~~

I think you're right on that Tristik, but it's also a slippery slope. Snus can be considered a NRT if used in that fashion, but I think it's a stand-alone product. Hell, Nicorette gum is a NRT, but can (and is) used as a stand-alone product. I think, to the powers that be, any product containing the leaf or any part of the tobacco plant is the same. The public is taught to believe that smokeless tobacco is not only just as bad as cigarettes, but much worse. Most people think snus is the same as dip and that my jaw is going to just fall off soon. Ha!

I think that if NRT products are approved for long term use then that opens the door to a possible classification of snus as a NRT. Sure, it's a long shot, but that's the way things go sometimes. After all, I do really like Mr. Bill's approach. Solid, proper, detailed information about the FACTS concerning tobacco and nicotine should be disclosed openly and fully without bias. Problem is, there's a buck to be made here and when there's money involved then the right thing often ends up going to hell in a hand basket. Too bad.

Good luck Bill. I'm a supporter.

[chadizzy1]

Good to see you Bill! Thanks for sharing and feel free to drop in anytime!

[raptor]

Glad to see that your campaign realizes that there are less harmful tobacco products instead of blatantly painting all tobacco as evil and deadly as inhaled cigarettes. Kudos, Bill!

[Snusdog]

Holy shit Bill

that is spot on!!!!

Unfortunately it is far too sane, correct, and forthright to ever work

But on a positive note................I hear that Walmart is taking applications...............you know.............just in case this whole FDA truth and integrity thing doesn't work out

Seriously, please keep us posted and let us know what we can do to help

[Snusdog]

Oh and Bill..........................every member here on this forum is currently being penalized by our own government for using snus...........instead of cigarettes or big pharmaceutical's unsuccessful alternatives.

We are being charged what amounts to a dissuasion fee

[stubby2]

I know the workshop overwhelmingly voted to let NRT products to be labeled for long term use. If the FDA actually takes that advice is another question.... but still it's a step in the right direction. It would be a big thing if the FDA did so as it would be the first step in acknowledging tobacco harm reduction as a legitimate approach to tobacco use as opposed to abstinence only. It gets a lot harder to argue against low TSNA smokeless tobacco when they have already approved nicotine gum and patches for long term use. It's the concept of long term use of nicotine products as a harm reduction approach that's important. Approving nicotine gum for long term use is a logical place to start.

[dreed2]

Bill, can I have permission to repost that on my blog in its entirety?

[GoVegan]

An anti tobacco group that is being realistic about tobacco use and how to reduce harmful side effects? I AM AMAZED!!!

[Bill Godshall]

Thanks for the kudos, and anyone may freely reprint or forward my postings.

That FDA workshop was helpful since it was attended (and partially run) by several members of the FDA's Tobacco Product Scientific Advisory Committee (TPSAC), who acknowledged that smokeless tobacco is significantly less hazardous than cigarettes.

For six years (2003-2009) I tried to amend the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to eliminate the intentionally misleading mandatory warnings on smokeless tobacco products (i.e. This product is not a safe alternative to cigarettes, This product may cause mouth cancer, This product may cause gum disease and tooth loss), to require a warning on all cigarette packs informing smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and to require the FDA to truthfully inform the public about the comparable health risks of different tobacco products.

Unfortunately for public health and human rights, Philip Morris, CTFK, ACS, AHA, ALA, Waxman and Kennedy aggressively opposed these amendments to their previously negotiated and agreed upon legislation (that was agreed to in 2004 before Philip Morris bought UST).

One amendment that was added to the legislation in 2009 requires the FDA to study and issue a report next year on dissolvable smokeless tobacco products (e.g. Star's Ariva and Stonewall, RJR's Orbs, Strips and Sticks). Unfortunately, the FDA's TPSAC cancelled its scheduled meeting on the issue back in July several days after I and another tobacco harm reduction advocate signed up to testify in support of ALL smokeless tobacco products marketed in the US and Scandanavia as far less hazardous alternatives to cigarettes.

Will keep folks informed about this and other important opportunities to educate federal, state and local health officials about the vastly different comparable risks of cigarettes, smokeless tobacco products, electronic cigarettes and NRT products (the latter three of which are 99% less hazardous than cigarettes).

Virtually all anti tobacco activists are fully aware that smokeless tobacco products (especially snus) are far less hazardous alternatives to cigarettes (as I've been informing them about these facts for the past decade).

Unfortunately, the heads of the most anti tobacco organizations and many government health agencies are not public health advocates, but rather are abstinence-only anti-tobacco prohibitionists whose goal is to eliminate all tobacco products, companies and usage.

In sharp contrast, my goal and the goal of public health is to reduce preventable diseases and deaths, and 99% of all tobacco diseases and deaths are caused by repeated inhalation of lots of tobacco smoke.