FDA to hold public hearing Dec. 17 on NRT regulation

[TrueNews]

On my earlier read-through, I noticed their verbiage about THR but didn't notice the subtleties here. I thought maybe they had some scientists involved.

Danger danger Will Robinson. They are talking about regulating any product that claims ANY of the following:

-- Claims smoking fewer cigarettes is beneficial
-- Claims to be safer than smoking

Note they are talking about having the power to do PREMARKET evaluation -- they are hoping that someone will tell them they can stop things before they go to market.

I'm worried that this needs expert response. I know the FDA is going to want to keep every iota of power they have, that is the nature of human organizations, so extreme care is needed. But I need to know by Dec 6 whether I should:
1. sign up and book a flight
2. contribute to a temporary fund to send better folks than I to the meeting
3. submit electronically
4. Shut up and let senior CASAA folks handle this.
5. Keep an eye open for when they report to congress and ask the same questions again at that time.

Thank Goodness

ECF needs a 'Lawyers' forum lol.

Seriously, CASAA needs legal advice before broaching this one.

 

[Racehorse]

FWIW could they have picked a WORSE time to hold a hearing?

Less than 10 days before Christmas, the busiest time of the entire year in airlines, hotels, families, etc?

The % of people precluded from physically going to show their support will be vastly reduced due to this, IMHO.

I can't help but think that when an issue is given such an *unusual* time-slot (between Thanksgiving and Christmas) that this speaks to its perceived political significance.

 

[NorthOfAtlanta]

FWIW could they have picked a WORSE time to hold a hearing?

Less than 10 days before Christmas, the busiest time of the entire year in airlines, hotels, families, etc?

The % of people precluded from physically going to show their support will be vastly reduced due to this, IMHO.

I can't help but think that when an issue is given such an *unusual* time-slot (between Thanksgiving and Christmas) that this speaks to its perceived political significance.

Kind of like releasing bad news late on Friday afternoon?

 

[kristin]

NO NO NO
This is the part that you don't uinderstand.
THR = YES
NRT = NO

E-Cigs are and MUST be an ALTERNATIVE to smoking - no ifs and no butts (pun)

Anything else makes them NRT (medical) devices and in the REST of the DEVELOPED World that means 5 years and squillions of Dollars to get any device registered and many more squillions of Dollars for each and every change to that device.

What you do in the USA has much wider consequences than you realise.

Please, for goodness sake, stop being so introvert, vaping is GLOBAL.

If this is in response to my post then you need to please go back and re-read what I said. I said we absolutely are NOT trying to get e-cigs to be NRT. And we are quite aware that vaping is global, that what happens in one country affects others and the mess the FDA creates worldwide. CASAA communicates with groups and researchers around the world and we probably knew what was happening in your country long before you did. We have been doing this since 2009. Maybe you should get to know us a bit better before making assumptions? CASAA is in no way myopic. The fact that you think that and think that CASAA would testify at this hearing to get e-cigs regulated as NRT tells me you are quite unfamiliar with us and our history.

 

[TrueNews]

If this is in response to my post then you need to please go back and re-read what I said. I said we absolutely are NOT trying to get e-cigs to be NRT. And we are quite aware that vaping is global, that what happens in one country affects others and the mess the FDA creates worldwide. CASAA communicates with groups and researchers around the world and we probably knew what was happening in your country long before you did. We have been doing this since 2009. Maybe you should get to know us a bit better before making assumptions? CASAA is in no way myopic. The fact that you think that and think that CASAA would testify at this hearing to get e-cigs regulated as NRT tells me you are quite unfamiliar with us and our history.

We aren't trying to get e-cigs recognized as NRT!" Absolutely not! The main interest vapers would have with this testimony is advancing tobacco harm reduction policies. The greater implication of the FDA allowing long term use of NRT is that it would essentially be acknowledging the validity of THR and the fact that "quit or die" all nicotine policy isn't working. If long term, (as long as needed) NRT use is permitted and promoted, vaping definitely benefits from that. Testimony or comments from vapers would be that having an effective, satisfying, smoke-free nicotine product, without the expectation to have to quit all nicotine (either short or long term) has worked far better than "quit or die." So we'd be supporting THR policies through long term NRT use, NOT turning e-cigs into ineffective NRTs.

OK Kristin – TRUCE

I have absolutely no intention of starting an argument, it would be counterproductive and pointless because we both want similar outcomes.

I will however point out my main areas of concern regarding NRT and the FDA and also attempt to clarify two of the misconceptions you appear to have about my post.

Firstly, I have never thought, neither do I think now, of CASAA as myopic, the term I used in my post was “Globally Myopic” and it was directed at the thread in general, not at CASAA specifically. It was more a reference to the damage that occurs in other countries when they replicate FDA legislation verbatim.

Secondly, I do a lot of research, I do know a little bit about CASAA, I know some of your aims as an organisation, your position there, and how much representation you have in the southern hemisphere, and yes, (in reference to your comment) maybe I should get to know you guys a little better.

Regarding my areas of concern, it is easier for me to enunciate my concerns if I break them down point by point from your initial reply to me.

“We aren't trying to get e-cigs recognized as NRT!" Absolutely not! The main interest vapers would have with this testimony is advancing tobacco harm reduction policies.”

I Agree with you totally.


“The greater implication of the FDA allowing long term use of NRT is that it would essentially be acknowledging the validity of THR and the fact that "quit or die" all nicotine policy isn't working”.

OK, my logic on this, because I am sorry, I cannot get my head around this statement.
My logic is based on the fact that NRT requires some sort of medical certification and that this is not the case for THR therapy, unless it makes certain (medical or therapeutic) claims.
Leave aside the ‘quit or die’ part for now, that is a separate health, and possibly governmental ‘healthcare budget’ issue.

1. NRT is designed by its very nature to be, and automatically becomes, THR therapy.
2. THR does not necessarily have any association with, and in the case of E-Cigs, should definitely not in any way shape or form be associated with, NRT.
Any association in this area will result in stringent, and most probably worldwide, over regulation of E-Cigs as medical devices.
(WHO would love that- COP5 implemented in full – thank you)


“If long term, (as long as needed) NRT use is permitted and promoted, vaping definitely benefits from that.”

I cannot see how vaping benefits here unless we are considering vaping as a form of NRT.


“Testimony or comments from vapers would be that having an effective, satisfying, smoke-free nicotine product, without the expectation to have to quit all nicotine (either short or long term) has worked far better than "quit or die."”

No argument fro me here, as long as it is in reference to THR and not NRT.


“So we'd be supporting THR policies through long term NRT use, NOT turning e-cigs into ineffective NRTs.”

This is the one statement that makes me nervous, the only way that I can see for THR policies to be supported by, or even associated with, long term NRT use, is if the THR policy included within it, an FDA certified NRT device.

I know the FDA references new and innovative devices in their document, they also mention regulation on many occasions.

Do you think the FDA consider our vaping equipment to be new and innovative, or could they possibly be just smoothing the way for the upcoming big pharma NRT inventions such as the new ‘vape like’ inhaler that uses pyruvic acid (instead of a battery) to create a cloud of “deep lung penetrating” vapor.
(it is not on the market yet as far as I know, It has only been in testing since 2010).


Kristin, last point, (from your second post)

“CASAA communicates with groups and researchers around the world and we probably knew what was happening in your country long before you did”

NO, Sorry, can’t agree with that - Our own Government doesn’t know what is happening in our country, so they couldn’t tell you could they


Good luck with the FDA

 

[Bill Godshall]

The purpose of FDA's hearing is to consider alternative FDA policies for NRT, including its use for THR.

It will probably be similar to FDA's 2010 hearing on long term risks of nicotine use, which was a truly ironic and historic lovefest where government health officials and drug industry funded researchers, lobbyists and PR folks finally agreed with a dozen of us THR activists that long term use of nicotine poses negligable if any disease risks, and that the FDA should approve the sale of NRT products for long term use as a harm reduction alternative for smokers (as the products are now only approved for 12 weeks usage), and to change the warning labels on NRT products to provide more helpful information (as current NRT warning labels confuse and scare most readers to believe that nicotine and NRT are as hazardous as smoking cigarettes).

At that conference, many of the same goverment funded and drug industry funded folks who have publicly opposed smokeless tobacco and/or e-cigarettes for THR (e.g. Benowitz, Hatzukami, Zeller) were endorsing the THR benefits of NRT (and they cited research on Swedish snus as evidence that long term use of nicotine posed negligable if any health risks).

This upcoming hearing poses no risks, but instead provides many opportunities, for e-cigarette and THR advocates (and other truth tellers) to not only endorse NRT products as very low risk for long term and temporary substitutes for cigarettes, but to also point out that e-cigarettes and smokeless tobacco products are even more effective, more consumer friendly, and lower cost substitutes for cigarettes (than are NRT products).

We should also point out the many false and misleading fear mongering claims the FDA has made (and still makes on its websites) about e-cigarettes and claims that all tobacco products are just as hazardous as cigarettes, urge FDA to correct their false claims, chastise FDA for trying to ban e-cigarettes from 2009-2011, urge FDA to not impose any unwarranted regulations in Chapter IX of the FSPTCA on e-cigarettes, and urge them to remove the misleading warning on smokeless tobacco products that claims "This product is not a safe alternative to cigarettes."

This hearing on NRT provides lots of opportunities to shame the FDA for its past misdeeds, and to encourage the agency to begin acknowledging that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes (not just NRT).

 

[kristin]

OK, my logic on this, because I am sorry, I cannot get my head around this statement.
My logic is based on the fact that NRT requires some sort of medical certification and that this is not the case for THR therapy, unless it makes certain (medical or therapeutic) claims.
Leave aside the ‘quit or die’ part for now, that is a separate health, and possibly governmental ‘healthcare budget’ issue.

1. NRT is designed by its very nature to be, and automatically becomes, THR therapy.
2. THR does not necessarily have any association with, and in the case of E-Cigs, should definitely not in any way shape or form be associated with, NRT.
Any association in this area will result in stringent, and most probably worldwide, over regulation of E-Cigs as medical devices.
(WHO would love that- COP5 implemented in full – thank you)


“If long term, (as long as needed) NRT use is permitted and promoted, vaping definitely benefits from that.”

I cannot see how vaping benefits here unless we are considering vaping as a form of NRT.


“Testimony or comments from vapers would be that having an effective, satisfying, smoke-free nicotine product, without the expectation to have to quit all nicotine (either short or long term) has worked far better than "quit or die."”

No argument fro me here, as long as it is in reference to THR and not NRT.


“So we'd be supporting THR policies through long term NRT use, NOT turning e-cigs into ineffective NRTs.”

This is the one statement that makes me nervous, the only way that I can see for THR policies to be supported by, or even associated with, long term NRT use, is if the THR policy included within it, an FDA certified NRT device.

I know the FDA references new and innovative devices in their document, they also mention regulation on many occasions.

OK, I can see where the confusion may be.

As far as the FDA and US health groups are concerned:

Long term nicotine use = tobacco use (they do not acknowledge a difference)
NRT = nicotine use short term for the goal of complete abstinence of all nicotine/tobacco
THR = using nicotine or tobacco in the least harmful form. That means using ANY nicotine or tobacco product which reduces harm. That could be a pharmaceutical nicotine gum, a tobacco lozenge or e-cigarettes.

E-cigarettes are used by most vapers as THR, but a lot of people actually do use them as an NRT, as well. We just don't want to have them regulated in the same manner as legal NRT are currently regulated, because that CURRENTLY means short term use and a lot of hoops to jump through. That is why they wanted to regulate e-cigs as NRT - so they could control not only the production but also regulate the time it can be used.

NOTE: The FDA does NOT currently acknowledge ANY form of THR. It's either quit all nicotine and tobacco use or you are still high risk. There is not one product on the market approved by the FDA for use as a THR product.

This hearing is the FDA finally acknowledging that nicotine alone CAN be a form of THR, but since they only acknowledge NRT products (gums, patches, lozenges) as a "safe" source of nicotine, this hearing is about using NRT products long term; thereby making it allowable to use gums, patches, lozenges, etc., as a THR product, rather than just as a short-term product with abstinence as the goal. (Actually, they still want to put on a time limit, just make it longer. CASAA's argument here would be NO limit, because even using gums, patches, etc., long term is far, far better than making people quit the NRT after a short period and have them returning to smoking.)

So, the argument is, if you are going to FINALLY consider long-term use of SOME nicotine products (that are currently limited to use as NRT) as THR, then do NOT put time limits on it. Once the FDA actually acknowledges that THR is a valid policy and it's OK with SOME nicotine products, then in the future it will be very difficult for them to argue that e-cigarettes are NOT also a valid THR product.

But the whole point of our involvement in this hearing is to support the use of products currently RESTRICTED to use as NRT for abstinence only to be used as THR products instead or in addition. That opens the door for other nicotine and low risk tobacco products to be approved as THR.

The other confusion can come from the actual term "Tobacco Harm Reduction." It should really be called "Smoking Harm Reduction," because not all nicotine and tobacco products have high health risks.

 

[Vocalek]

@TrueNews:

Perhaps some definitions will help to clear up the confusion.

NRT stands for Nicotine Replacement Therapy. However it would be more accurate to state that NRT stands for Nicotine Reduction Therapy. They have no intention of actually replacing the nicotine we got from smoking. They believe that the disease they are treating is nicotine addiction. They were careful to keep nicotine levels well below the amount that folks take in from smoking. (Which is one reason why many folks who switch to NRTs go into withdrawal.)

They designed the treatment plan to gradually (over an 8 to 12 week period) reduce the quantity of nicotine to zero. The ultimate goal of NRT treatment is nicotine abstinence.

THR stands for Tobacco Harm Reduction. THR involves providing the nicotine that smokers crave via a delivery system that is not as hazardous to health as smoking. THR is not intended to treat "nicotine addiction" because nicotine is not the problem. It's the SMOKE. The ultimate goal of THR is to reduce the health consequences of smoking.

Currently the only government-approved use of NRTs is to treat nicotine addiction. This hearing will, in essence, consider whether nicotine gum, lozenges, patches, etc. can be used for the purpose or reducing the harm caused by smoking.

If the government approves NRTs for long term use, they will be forced to acknowledge that research shows that using nicotine indefinitely does not create any serious health problems as long as smoking is not the delivery mechanism.

If they admit that, then it becomes much easier for us to promote the use of other products that contain nicotine.

There really is very little difference between a dissolvable tobacco pellet such as Camel Orbs and a Nicorette Lozenge. An e-cigarette delivers nicotine via inhalation. So does a Nicotrol inhaler.

NRTs are considered pharmaceutical products and are regulated under the Food, Drug, and Cosmetics Act. Currently there is no such thing as an "approved" THR product.

The Smoking Everywhere & Sottera, Inc (dba NJOY) versus FDA case determined that whether a product can be regulated as a drug depends totally on intended use. If an e-cigarette vender makes no health claims, the FDA (currently) cannot ban them. If the vendor says, "My e-cigarette can help you stop smoking", the FDA considers that a health claim and will yank the product off the market until the vendor can scientifically prove that his product is "safe and effective" to help people stop smoking.

A lot of the confusion is caused by the government itself in talking about "smoking cessation" when what they really mean is "nicotine cessation."


If the FDA issues a deeming regulation and states that it will regulate e-cigarettes as a tobacco product, the Agency can devastate the market if it mindlessly applies all of the requirements of the FSPTCA, such as forbidding the sale of any tobacco product that was introduced to the market after February 15, 2007.

 

[Vocalek]

Addendum:

Congress gave a strong indication that they would like to see an overall approach to tobacco harm reduction developed. This hearing deals with using NRT medications as reduced-risk temporary or permanent replacement for smoking.

NRTs are regulated by the FDA's Center for Drug Evaluation and Research (CDER). In contrast, tobacco products are regulated by the FDA's Center for Tobacco Products.

Another section of the FSPTCA addresses the development of what the law calls "modified risk" tobacco products. Unfortunately, the CTP has issued guidance on the approval process for tobacco products to make a modified risk claim, and that process is far from "fast track." It is substantially similar to the approval process required by CDER to introduce a new drug. The process they describe will take millions of dollars and many years before any smoker will benefit.

 

[Berylanna]

Addendum:

Congress gave a strong indication that they would like to see an overall approach to tobacco harm reduction developed. This hearing deals with using NRT medications as reduced-risk temporary or permanent replacement for smoking.

NRTs are regulated by the FDA's Center for Drug Evaluation and Research (CDER). In contrast, tobacco products are regulated by the FDA's Center for Tobacco Products.

Another section of the FSPTCA addresses the development of what the law calls "modified risk" tobacco products. Unfortunately, the CTP has issued guidance on the approval process for tobacco products to make a modified risk claim, and that process is far from "fast track." It is substantially similar to the approval process required by CDER to introduce a new drug. The process they describe will take millions of dollars and many years before any smoker will benefit.

So, the CTP needs to get reined in, right? Do you think issue #4 is an attempt to speed this up or justify a continued stranglehold?

 

[TrueNews]

Kristin, Bill, Vocalek

Thank you for your clarifications and explainations.

I can now also see where the confusion has arisen, I incorrectly assumed (probably from reading too many World Health Organisation and European documents) that the criteria that defined NRT was universal.

I can now see that there may be some subtle differences between the US interpretation and application of NRT with that of the EU and other countries.

I hope the following snippets, regarding E-Cigs, will illustrate why I was so concerned.

EU Report on the public consultation on the
possible revision of the Tobacco Products
Directive (2001/37/EC)

Those Member States in favour of extending the scope of the Directive argued that all tobacco
and nicotine products presented hazards to public health, both directly and indirectly. They
argued that the most desirable option would be to include all products containing tobacco or
nicotine in the Tobacco Products Directive, with the exception of those products exclusively
and purposefully designed to assist in smoking and nicotine cessation. While the present
Tobacco Products Directive has the objectives of facilitating the functioning of the internal
market while ensuring a high level of health protection, it was also argued that the Directive is
not functioning satisfactorily in this respect.
As regards the future regulation of 'electronic cigarettes’ in tobacco legislation, Member
States seemed to be more divided, with some presenting arguments for regulating the product
as a pharmaceutical or medical device, and others arguing for the inclusion of electronic
cigarettes in the Tobacco Products Directive.

... Public health organisations universally supported regulating tobacco and nicotine products, on
the grounds of the potential health dangers of these products. Many argued for the strict
limitation of novel forms of nicotine delivery systems, whereby these nicotine systems should
only be sold as smoking cessation aids, subject to the regulatory framework on
pharmaceutical products.

Conference of the Parties to the
WHO Framework Convention on Tobacco Control
Fifth session - FCTC/COP/5/13
Seoul, Republic of Korea, 12–17 November 2012

...They urged regulators of medical and tobacco products to collaborate in assessing the
regulatory framework within their own countries to determine the most effective means of regulating
(or possibly banning) ENDS to protect public health. They also recommended that in instances where
health and/or therapeutic claims are being made or implied, quality, safety and efficacy data
substantiating those claims should be presented to the appropriate national regulatory body

Guys, if you have not already read the submisssion from Clive Bates to the delegages of the above WHO conference then please do, It contains a lot of cogent points, (including "quit or die"), that might also be relevant to your FDA meeting.
Clive Bates is the Former Executive Director of 'ASH' Action on Smoking Health (UK) (1997-2003).
and a Founder member of the 'WHO' Framework Convention Alliance (1999-2003).

Open letter to delegates to the WHO Framework Convention on Tobacco Control COP-5 « Clive Bates blog

 

[Stubby]

TrueNews: Fortunately the Tobacco Products Directive is for the moment derailed, and no doubt you are aware of the reason why so I won't get into that.

There is no one in the US trying to make e-cigs into a NRT product except for the FDA in 2009 when they tried to classify e-cigs as a drug delivery device. They lost that one in the courts.

Labeling NRT products for long term use would be a significant change in policy. Up to this point the government has only supported the abstinence, quit of die approach to tobacco. By labeling NRT for long term use they would for the first time acknowledge harm reduction as a viable alternative. It is true that they would be doing it with an NRT product, which is the least effective harm reduction product, but just crossing that line into THR is a major step.

If this happens it would difficult to not eventually include smokeless tobacco and e-cigs in a government THR policy, especially as they are much more effective in getting people off cigarettes. Labeling NRT for long term use opens the door to THR. The downside is that it is the most ineffective products that would be recognized, but with the current anti-tobacco zealots in control, for now it is the probably the best we can hope for.

 

[kristin]

Kristin, Bill, Vocalek

Thank you for your clarifications and explainations.

I can now also see where the confusion has arisen, I incorrectly assumed (probably from reading too many World Health Organisation and European documents) that the criteria that defined NRT was universal.

I can now see that there may be some subtle differences between the US interpretation and application of NRT with that of the EU and other countries.

Guys, if you have not already read the submisssion from Clive Bates to the delegages of the above WHO conference then please do,
Open letter to delegates to the WHO Framework Convention on Tobacco Control COP-5 « Clive Bates blog

I know that Bill, Elaine and I have read Clive's letter. Elaine even has a comment posted on it and has been in touch with him.

I think a lot of confusion is that the term "NRT" is often used two ways. NRT is a classification of products, meaning: products which are approved by the FDA for use as smoking cessation ie., NICOTINE cessation; aka treatment for nicotine addiction. But we also tend to use the term "NRT" as a quick reference to the products themselves: nicotine gums, patches and lozenges. Such as "That product is an approved NRT (classification)" vs. "NRT (products such as gums, patches and lozenges that fall under the NRT classification) should be considered for use as THR products, too." The former is the classification itself and the latter is a type of product that falls under the classification.

A product can be both an NRT or THR, depending upon how it is used. If you are using the product to treat nicotine addiction and are weaning off of nicotine, then you are using the product as an NRT. If you are using the product indefinitely, as a lower risk nicotine alternative and may never quit nicotine altogether, then you are using that product as THR. So, we don't want e-cigarettes CLASSIFIED as NRT, while we do want currently approved NRT PRODUCTS (gums, patches, lozenges) to be allowed to be USED as THR products, as well.

You are correct that the WHO wants ALL non-tobacco nicotine products to act and be regulated as NRT and be used solely to become nicotine and tobacco abstinent, including e-cigarettes. And it doesn't want anything approved as NRT unless the product jumps through all of the testing hoops - so that way they can ban e-cigarettes, which are just too close to smoking for their comfort. The WHO does not support THR policies and probably objects to the FDA even considering the use of nicotine gums, patches and lozenges in any way other than NRT. So the WHO would not even accept e-cigarettes as NRT until someone PROVES that e-cigarettes are as or more safe and effective for causing nicotine abstinence as existing approved NRT products.

If any e-cigarette manufacturer wants to get their product approved as an NRT, they would have to do all of the testing, etc. Even if they do get approved, that would NOT automatically put ALL e-cigarettes in the NRT category. Each company would have to have testing done and get separate approval. If the FDA does allow gums, patches and lozenges to ALSO be used for THR, then the WHO loses and there isn't reason we couldn't argue that e-cigarettes are also THR. But we have to get at least ONE product accepted as THR before anything else. That is most likely to happen with a product already approved by the FDA, such as nicotine gum, patches or lozenges.

 

[Racehorse]

there are topics like this one on ECF, and many more, just print out the pages and send it in.

http://www.e-cigarette-forum.com/forum/new-members-forum/355624-why-did-you-start-vaping.html

amazing stories here, and every day, more topics with more such stories.

Isn't this *testimony*? These are all real people.

 

[kristin]

Racehorse - they deem that "anecdotal evidence" that doesn't count, because the testimonies aren't collected by people in lab coats and published in a peer-reviewed journal.

But you are right - all of the people who have posted their stories here should be sharing how harm reduction, rather than NRT/abstinence, has helped them!

there are topics like this one on ECF, and many more, just print out the pages and send it in.

http://www.e-cigarette-forum.com/forum/new-members-forum/355624-why-did-you-start-vaping.html

amazing stories here, and every day, more topics with more such stories.

Isn't this *testimony*? These are all real people.

 

[Bill Godshall]

Last call to sign up to testify at Dec. 17 FDA hearing. Today is deadline, and it would be best to do so before close of business today (although the FDA may accept registrations until midnight).

The FDA will hold a public hearing December 17 at Silver Spring, MD (and requests written comments) "on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence."
Federal Register, Volume 77 Issue 229 (Wednesday, November 28, 2012)

Tobacco harm reduction advocates are encouraged to testify and/or submit written comments. To register to testify, please send an e-mail to Section918PublicMeeting@fda.hhs.gov requesting to testify, and provide your contact information as stipulated in the FDA's announcement.

The hearing will likely attract many drug companies, drug industry funded researchers and drug industry funded anti tobacco groups to endorse NRT products (gums, lozenges, patches) for tobacco harm reduction, somewhat similar to the FDA conference that was held in October, 2010 (see below).

Suggested recommendations for FDA:
- Acknowledge and inform smokers that long term use of nicotine poses negligible if any disease risks,
- Approve NRT products for long term and temporary use as a harm reduction substitutes for cigarettes,
- Amend warning labels on NRT products to provide more helpful information (as current NRT warning labels confuse and scare many readers to believe that NRT and nicotine are as hazardous as cigarettes),
- Acknowledge and require NRT warnings to inform consumers that NRT products are NOT very effective for treating tobacco dependence (as NRT products have >95% failure rate treating nicotine dependence).
- Acknowledge and inform smokers that all smokefree tobacco/nicotine products (including smokeless tobacco and electronic cigarettes) are far less hazardous alternatives to cigarettes.
- Acknowledge and inform smokers that evidence indicates millions of cigarette smokers have quit smoking and/or sharply reduced cigarette consumption by switching to e-cigarettes, smokeless tobacco products and/or NRT,
- Propose a regulation to eliminate the intentionally deceptive warning on smokeless tobacco products "This product is not a safe alternative to cigarettes,"
- Correct/clarify all false, misleading and fear mongering propaganda about the health risks of smokeless tobacco products and e-cigarettes at each of the following FDA and DHHS websites:
Health Fraud
Less Risky Tobacco Product? Only if the Science Says So
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
FDA Warns of Health Risks Posed by E-Cigarettes
Electronic Cigarettes (e-Cigarettes)
Electronic Cigarettes | BeTobaccoFree.gov
Smoked Tobacco Products | BeTobaccoFree.gov
http://betobaccofree.hhs.gov/about-tobacco/smokeles- tobacco/index.html
Smokeless Tobacco and Your Health | BeTobaccoFree.gov
Tobacco and Nicotine | BeTobaccoFree.gov

Below is my testimony at FDA's conference in 2010 (when we were still battling against FDA in court over its attempted e-cigarette ban). I'll be pleased to assist anyone in drafting their testimony for the December 17 hearing.


Food and Drug Administration
Center for Drug Evaluation and Research

Risks and Benefits of Long-Term Use of
Nicotine Replacement Therapy Products

October 27, 2010

Testimony
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
SMOKEFREE@COMPUSERVE.COM

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 Sharfstein’s misleading fear mongering claims about e-cigarettes at a July 22, 2009 press conference 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]

Please note that you don't have to submit any testimony to the FDA today.

 

[Berylanna]

Do we have to register in order to provide written comments?

 

[bob1960]

I did submit a comment to the FDA today, using the talking points from CASAA

 

[Placebo Effect]

I signed up yesterday to speak at the meeting. Looking forward to it.