FDA to hold public hearing Dec. 17 on NRT regulation

[JENerationX]

If I had the funds and time to get there, I'd be going. Can we submit written comments?

 

[kristin]

Here is more info from CASAA: CASAA: Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

 

[Placebo Effect]

I just submitted the following testimony for the December 17th meeting. The FDA essentially asked us to send an oral transcript of what we are planning on saying at Monday's meeting (with about 3 days notice of our speaking times). I was debating just sending in rough bullet points because of my schedule, but decided I should just get some thoughts out on paper -- 7 minutes on NRTs is a bit more difficult than 3 minutes on dissolvables.

This is going to be quite the interesting meeting.

Gregory Conley, J.D. / M.B.A.
. . .
. . .

December 10, 2012


Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

TESTIMONY REGARDING NRT & INNOVATIVE tobacco CESSATION

Members of the Panel:

For more than two decades, one of the most prominent facets of tobacco control in the United States has been the promotion of nicotine replacement therapy (NRT) to smokers. However, during the entirety of this time period, NRT packaging has perpetuated the false myth that nicotine is the harmful part of smoking by warning users: (1) not to use any NRT product for more than 12 weeks; and (2) not to use any NRT in combination with a tobacco product.

Approximately two years ago, the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) held a two-day scientific workshop focusing on the risks and benefits associated with the long-term use of NRT products. Over the course of those two days, there was wide agreement among attendees and speakers that NRTs are far less hazardous than smoking, that use of NRTs beyond the 12-week window currently recommended would be beneficial to some smokers, and that packaging on NRT should be updated to truthfully inform smokers that long-term use of NRTs is one option that can be considered.

Unfortunately, in the two years since that hearing, no action has been taken to improve public health by loosening these unnecessarily rigorous standards. With this hearing, the CDER again has the opportunity to push to revamp the outdated mechanisms that govern NRT products in the United States. It is vital that the panel and the Secretary of the Department of Health & Human Services recognize that Section 918(b) of the Tobacco Control Act (Pub. L. 111-31) does not just require a report be produced covering innovative products and treatments to achieve “[t]otal abstinence from tobacco use.” The panel and the Secretary must also consider innovations and changes to current law to foster two other goals: (1) reductions in consumption of tobacco; and (2) reductions in the harm associated with continued tobacco use.

The fact that a sizeable minority of NRT users wisely ignore warnings and use NRTs for as long as necessary to avoid a relapse back into smoking tobacco should come as a surprise to no one on this panel. Indeed, early trials of the nicotine gum showed that between 2% and 9% of patients were still using the gum at 12 months. (Hajek 1988). Studies of this subset of the NRT user population show that, in addition to withdrawal relief, long-term users also find use of smoke-free nicotine products helpful in weight control and in aiding concentration. (Hakej 2007). Furthermore, a pooling of studies that randomized patients to NRT or placebo for long-term maintenance concluded that “se of NRT . . . appears to be effective in preventing relapse following an initial period of abstinence.” (Agboola 2010). Two other recent studies have concluded similarly. Steinberg, et. al (2009) found that “flexibly dosed triple-combination pharmacotherapy for up to 6 months” was more successful in preventing relapse than use of the nicotine patch for the standard duration in a population of outpatient smokers with medical illnesses. Schnoll, et. al (2010) determined that among patients who had been assigned to use the nicotine patch for 8 weeks and 24 weeks, those who used the patch longer had a higher likelihood of smoking abstinence.

In regards to the health effects of long-term use of NRTs, a succinct summary of the evidence was given by Dr. Neal Benowitz to the CDER on October 26, 2010. (Benowitz) Because of the novel nature of NRTs and the lack of studies regarding long-term use of these products, NRT safety has traditionally been judged by examining data on the health effects of smokeless tobacco. After reviewing existing evidence regarding smokeless tobacco user outcomes, Dr. Benowitz noted, “The lack of increase in common cancers in lifelong [smokeless tobacco] users indicates that nicotine is not a general cancer promoter.” On the topic of cardiovascular disease (CVD), Dr. Benowitz found that studies of users of Swedish snus – a tobacco product that is low in TSNAs and can be adequately compared to modern NRTs – “indicate minimal if any increased risk of CVD with [smokeless tobacco].” This clear evidence is further buttressed by the tremendous work performed by advocates of tobacco harm reduction. For example, one study found that, for the average smoker, two months of smoking is worse than a lifetime of smokeless tobacco use. (Phillips 2010).

The panel should also make two other recommendations as it relates to NRTs and Chantix. First, in recognition of the dismal success rates of NRTs when used for the treatment of “tobacco dependence” and as a “smoking cessation aid,” the panel should recommend that existing NRTs be unapproved for these functions. A recent study by Alpert, et. al. (2012) found that “using NRT is no more effective in helping people stop smoking cigarettes in the long-term than trying to quit on one’s own,” a finding that supported by a wide body of evidence. Second, the panel should act swiftly in recommending that Chantix be unapproved as a treatment for “tobacco dependence,” and most importantly, that smokers be warned of suicide and cardiovascular risks posed by using the product. The pressing need for more warnings is demonstrated by the Department of Health & Human Services’ outdated and inaccurate “Be Tobacco Free” website on electronic cigarettes (“Electronic Cigarettes” 2012), which recommends would-be quitters use Chantix instead of electronic cigarettes. While the “Be Tobacco Free” website spends several paragraphs on warnings about the hypothetical risks posed by electronic cigarettes, the Department fails to dedicate even a single sentence to warning smokers of the very well known risks associated with Chantix use.

Additionally, while not required by the Tobacco Control Act, the CDER should go further in their recommendations. With the recent explosion in use of electronic cigarettes and snus, as well as the publicity firestorm erupted by the tobacco industry’s decision to market what are essentially nicotine lozenges as a “dissolvable” tobacco product, there has never been a moment in our history where tobacco harm reduction has such wide visibility. There are no signs that interest by smokers in quitting or reducing their smoking habit, while not necessarily giving up nicotine use all together, will abate.

With this in mind, the CDER should recognize that all existing evidence points to the long-term use of smokeless tobacco, dissolvable tobacco, and electronic cigarettes being nearly or just as non-hazardous as the use of NRTs. In conjunction with this finding, the CDER should recommend that agencies of the Department of Health & Human Services, including the FDA Center for Tobacco Products and the Centers for Disease Control, stop misinforming the public about the health effects of these products.

I would like to thank the panel for seriously investigating these important issues.



REFERENCES:

Agboola S (2010), et. al. A systematic review of the effectiveness of smoking relapse prevention interventions for abstinent smokers. Addiction, 105:1362–1380.

Alpert H.R., et. al. (2012). A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tobacco Control 2012; doi:10.1136/tobaccocontrol-2011-050129.

Benowitz (2010). Smokeless Tobacco and Disease: Evidence Related to Long-term Safety of Nicotine. Presentation before CDER. October 26, 2010. <http://www.fda.gov/downloads/Drugs/NewsEvents/UCM232147.pdf>

“Electronic Cigarettes” (2012). Department of Health & Human Services.
<http://betobaccofree.hhs.gov/about-tobacco/Electronic-Cigarettes/index.html>

Hajek et al. (1988). Long-term use of nicotine chewing gum. Occurrence, determinants, and effects on weight gain. JAMA, 260:1593-1596

Hajek et al. (2007). Dependence potential of nicotine replacement treatments: Effects of product type, patient characteristics, and cost to user. Preventive Medicine, 44:230-234

Phillips, C.V. (2009). Debunking the claim that abstinence is usually healthier for smokers than switching to a low-risk alternative and other observations about anti-tobacco-harm-reduction arguments. Harm Reduction Journal. 2009, 6:29.

Schnoll et al. (2010) Effectiveness of extended duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. Feb 2;152(3):144-51.

Steinberg, et. al. (2009). Randomized trial of triple combination extended duration pharmacotherapy versus standard duration nicotine patch alone for smokers with medical illness. Annals of Internal Medicine 2009 150(7): 447-454

 

[Berylanna]

I just submitted the following testimony for the December 17th meeting. Absurdly, the FDA expects us to essentially send an oral transcript of what we are planning on saying at Monday's meeting (with about 3 days notice!).

Ummm, I hope that is not so they can cull out "undesirable" testimony!

 

[Vocalek]

The CASAA CTA has been updated to clarify the process and the deadline for submitting written comments.

Regardless of attendance at the public hearing, interested persons may submit written comments in one of two ways. Printed comments can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

To submit a comment electronically, on the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0001, click the “Comment Now” button. Electronic or written comments will be accepted after the public hearing until January 2, 2013.

 

[sonicdsl]

I just submitted the following testimony for the December 17th meeting. The FDA essentially asked us to send an oral transcript of what we are planning on saying at Monday's meeting (with about 3 days notice of our speaking times). I was debating just sending in rough bullet points because of my schedule, but decided I should just get some thoughts out on paper -- 7 minutes on NRTs is a bit more difficult than 3 minutes on dissolvables.

This is going to be quite the interesting meeting.

Looks great Greg! Thank you for your time & expertise, as always!

I just noticed too that Carl Phillips has posted his testimony on his Anti-THR Lies blog:
Phillips testimony for FDA hearing on recognizing tobacco harm reduction | Anti-THR Lie of the Day

More great stuff!

 

[Bill Godshall]

Here's my testimony.

Food and Drug Administration

[Docket No. FDA-2012-N-1148]

Public Hearing: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence

December 17, 2012

Testimony
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
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 ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers. In 2007, I convinced Sen. Mike Enzi to amend to FSPTCA to require graphic warnings on cigarette packs.

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

I’m here to once again urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree alternatives, to correct or clarify FDA’s many inaccurate and misleading claims about low risk smokefree tobacco and nicotine alternatives, and to keep all smokefree tobacco alternatives legal and affordable for smokers.

More than ninety nine percent of all tobacco attributable mortality and 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. Epidemiological evidence indicates that cigarettes are at least 100 times more hazardous than smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco, electronic cigarettes and NRT products.

While quitting all tobacco/nicotine use is an effective 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. Survey and sales data indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, that several million smokers have switched to smokefree e-cigarettes in the past several years, and that many smokers use NRT products as temporary or long term alternatives to cigarettes.

Since there have been many reports of suicide, suicidal thoughts, violence and adverse cardiovascular events associated with Chantix, I urge the FDA to consider removing Chantix from the market, or at least require additional warnings to better inform consumers of its risks. I also urge the FDA to NOT fast-track the approval process for any new drug for treating “tobacco dependence”.

Although FDA has approved many NRT products to treat tobacco dependence, NRT products have had a 95+% failure rate for treating tobacco dependence and for smoking cessation.

Therefore, I urge the FDA to disapprove NRT products as treatments for tobacco dependence, or to at least require manufacturers to notify consumers of the six month success rates the product was found to have for both smoking cessation and for achieving nicotine abstinence.

But since NRT products are far less hazardous alternatives to cigarettes, since most NRT products are consumed for “off label” use as a temporary and/or a long term substitute for cigarettes, the FDA should approve all NRT products as temporary and long term harm reduction alternatives to cigarettes. Also, warning labels on NRT products should state that the product is far less hazardous alternative to cigarettes, and should encourage (instead of discourage) smokers to continue using NRT as long as they continue to smoke.

If FDA implements these regulatory changes, manufacturers of e-cigarettes, dissolvables, smokeless tobacco products and other new smokefree alternatives might consider applying to the FDA to market their products as NRT tobacco harm reduction alternatives.

NRT manufacturers should consider more aggressively marketing their products to smokers. In contrast to most NRT products that are sold in $40+ packages at pharmacies, RJ Reynolds’ Niconovum is test marketing Zonnic nicotine gum in $3 ten-packs at convenience stores throughout Des Moines, IA.

Regardless of regulatory changes for NRT products, the FDA should never again consider banning, or imposing unwarranted or unreasonable regulations on e-cigarettes, dissolvables, or smokeless tobacco products because these products have nearly identical health/safety risk/benefit profiles as NRT products.

In 2009, in an attempt to justify its unwarranted and unlawful import ban on e-cigarettes, then FDA Deputy Commissioner Josh Sharfstein misrepresented the agency’s laboratory test findings on e-cigarettes to scare the public, and to falsely claim the products were target marketed to youth.

But even after the FDA concurred with Judge Leon’s ruling prohibiting FDA from banning e-cigarettes as unapproved drugs, the FDA has refused to correct or clarify its inaccurate and misleading claims about e-cigarettes. Even worse, the agency has issued even more misleading claims about e-cigarettes.

And yet, e-cigarette sales continue to skyrocket and should surpass NRT sales next year, whose sales have remained stagnant at $1 billion annually for the past decade.

The FDA has repeatedly stated its intent to propose a “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes. But Sections 905 and 910 would ban all e-cigarettes, and other provisions of Chapter IX would also decimate the e-cigarette industry, protect cigarette markets and otherwise threaten public health. The FDA should NOT propose or approve that or any other regulation that would deny cigarette smokers legal or affordable access to less hazardous smokefree alternatives.

The FDA has also denied the growing body of scientific evidence and consensus among experts by falsely stating on a webpage about MRTP titled Health Fraud “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

Many other FDA and DHHS websites also contain false and misleading fear mongering claims that exaggerate the risks and deny the benefits of smokeless tobacco products for smokers.

One week after FDA’s TPSAC issued a report that truthfully acknowledged dissolvable tobacco products are less hazardous than cigarettes and can reduce risks of smoking, the FDA issued a draft guidance for MRTP Applications that denied the scientific evidence and that would require smokeless tobacco companies to spend tens of millions of dollars on unnecessary studies before the FDA may allow the company to truthfully inform smokers that a smokeless product is a less hazardous than cigarettes.

Smokers have a human right to truthful health information and legal access to less hazardous alternatives, and the FDA has an ethical duty to inform smokers that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes.

Abstinence-only prohibition policies and propaganda didn’t work for alcohol, ......... or sex, and they don’t work for tobacco either.

 

[Vocalek]

View attachment CASAA-Testimony-Long-Term-Use-NRT.pdf

Here's mine.

 

[Bill Godshall]

Of the approximately 25 individuals/organizations that signed up to testify at FDA's December 17 hearing, at least 11 are THR activists, including 8 vapers.

Elaine Keller
Greg Conley
Carl Phillips
Ron Ward
Lorie McClung
Linc Williams
Lou Ritter
Spike Babaian
Mark Anton
Bill Godshall
Gil Ross at ACSH

I also invited the tobacco companies (which all support THR) to testify, but not sure how many have signed up.

Most of the other testifiers will likely be drug companies that market smoking cessation aids, their researchers, lobbists and their funded anti-tobacco groups. I predict that all or most of them will urge FDA to deregulate NRT and approve its use for THR. In response to our THR advocacy, these drug industry funded folks now support NRT for THR (but not e-cigs or smokeless tobacco).

Will be disgusting to listen to e-cigarette prohibitoinists hypocritically advocate NRT for tobacco harm reduction, and I wouldn't be surprised if FDA actually proposes regulating and approving NRT as a THR alternative to cigarettes.

 

[MrsCasey]

Bill, Elaine, Greg and Kristen - I just want to express my gratitude for all the hard work you do fighting for THR! I am so glad you are in our corner. A big thank you to all who will be testifying at the hearing. Thanks to:

Elaine Keller
Greg Conley
Carl Phillips
Ron Ward
Lorie McClung
Linc Williams
Lou Ritter
Spike Babaian
Mark Anton
Bill Godshall
Gil Ross at ACSH

 

[Bill Godshall]

FDA issued the agenda for the December 17 hearing at
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM331857.pdf

Of the 23 speakers, 15 are THR advocates, 7 are drug industry funded/affiliated, and one (Kathleen Dachille) is campaigning to ban flavorings in smokefree tobacco products.

The FDA put mostly e-cig consumers in the first group of testifiers in the morning

Greg Conley

Lorie McClung

Carl Phillips

Ron Ward

Linc Williams

Elaine Keller

Phil Daman (lawyer for e-cig company)


Second group of testifiers is a mix

Jonathan Foulds (advocates smokeless tobacco as THR for smokers)

Michael Steinberg (drug industry funded NRT and smoking cessation drug promoters, urged FDA to ban e-cigs, probably supports NRT for THR)

Danny McGoldrick (CTFK - drug industry funded abstinence-only e-cig prohibitionists, probably supports NRT for THR)

Angela Jones (ACS - drug industry funded abstinence-only tobacco and e-cig prohibitionists, probably supports NRT for THR)

David Abrams (Legacy - drug industry and MSA funded abstinence-only tobacco and e-cig prohibitionist, probably supports NRT for THR).

Bill Godshall (Smokefree Pennsylvania -supports all smokefree alternatives for THR)


Third group of testifiers is also a mix

Kathleen Dachille (law professor who is campaigning to ban flavorings in all tobacco products, but supports flavored NRT for THR)

John Hughes (drug industry funded researcher and promoter of NRT for cessation, probably supports NRT for THR),

Gil Ross (ACSH - supports smokeless tobacco and e-cigarettes for THR and smoking cessation)

Scott Ballin (support THR, will urge FDA to merge its NRT regulatory office with its tobacco regulatory office, establish fair regs for e-cigs and other smokefree alternatives)

James Dillard (Philip Morris - will advocate THR products, but will advocate strict and expensive FDA regs to squeeze out smaller competitors)

James Walmsley (Johnson & Johnson- will advocate drug industry products for treating tobacco dependence and probably also for THR)

Howard Marsh (GSK - will advocate NRT products and maybe other drugs for treating tobacco dependence and for THR)


Fourth Panel of testifiers are e-cigarette companies and AEMSA)

Mark Anton (What a Smoke - e-cig manufacturer/distributor and is researching/developing dissolvables)

Robert Jack (e-liquid manfucturer/vendor)

Lou Ritter (American E-liquid Manufacturing Standards Association - AEMSA)

 

[Bill Godshall]

Here is Scott Ballin's testimony for Dec 17 FDA hearing.

Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW Washington DC 20015
Tel: 202 686-8898 Mobile 202 258-2419
email: ScDBa@aol.com

I greatly appreciate the opportunity to be able to submit this statement to the Food and Drug Administration in response to the Federal Register Notice:

Docket No. FDA-2012-N-1148: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence.

The hearing and the agency's request for comments represents a very important step forward in what must be a more serious and on-going discussion about how ALL tobacco, nicotine, and alternative products should be regulated in a more consistent manner. The series of questions that the FDA has outlined actually raise more questions that need to be addressed in considering future policy decisions- not only within the agency but in Congress as well. While addressing some of the questions presented in the Federal Register Notice, I plan to broaden the discussion by suggesting a number of areas, topics and issues that need consideration.

I Putting Section 918 (as well as other sections of the FSPTCA) into an Historical Context -- The Need to Look to the Future and Not Try to Perpetuate the Past
II Definitions and Terminologies
III Why is the consumer always seemingly left out of the discussions?
IV What Can FDA and Congress Do to Bring Tobacco, Nicotine and Alternative Products Regulation into the 21 Century? Isn't it time to bring all tobacco, nicotine and alternative products under a single regulatory umbrella?
V Observations and Recommendations



I Putting Section 918 (as well as other sections of the FSPTCA) into an Historical Context -- The Need to Look to the Future and not Try to Perpetuate the Past

Up until a little over three years ago traditional 'tobacco' products were for the most part unregulated by any governmental agency and what regulation there was tended to be piecemeal. Products that were attempted to be put on the market that were somewhat different or 'innovative' were often prohibited because the 'tobacco' in them made them 'adulterated' or because they made some therapeutic type claim.

It forced nicotine products such as NRT (from which the nicotine was and still is derived from tobacco) to be developed through the drug and device regulatory channels. That scenario which existed for several decades, really perpetuated a public health challenge, giving us an environment in which cigarettes - the deadliest (and most efficient) form of nicotine delivery thrived and remained protected from regulation at the expense of allowing and/or encouraging potentially lower risk products to be developed and marketed. That schizophrenic environment gave us the 'low tar and low nicotine' debacle which by all accounts from a public health standpoint turned out to be a disaster. While in some ways NRT was at a disadvantage in that these products were subject to FDA regulations (that cigarettes were not) that restricted dosage, required extensive labeling, product size, controls over sales and marketing etc. these products also had an advantage over other products due to costs, and other barriers.

As long as cigarettes remained outside of the FDA's purview the pharmaceutical companies retained a unique competitive advantage for the sale, distribution and marketing of what were not only smoking cessation products but in today's environment might better be referred to as 'harm reduction' products. But that is changing, and changing rapidly.

The scenario that existed for so many years was also in many ways a lose-lose situation perpetuating an imbalanced system that was not always based on science or product comparisons, but on 'war' -- that included rhetoric, legal and legislative maneuverings by and with Big Tobacco.

In the last ten or so years however (things do move slowly) and in spite of efforts by some in industry, tobacco control, policy makers, governmental agencies, and even the media to keep the 'war' of the 1980's and 90's going, change has been and is continuing to take place. Today's environment is a radically altered one demanding new ideas and consideration of how we regulate all tobacco, nicotine and alternative products with greater consistency and based on risks, relative risks, and intended uses—keeping in mind there are new opportunities for reducing the disease and death toll caused by the use of tobacco products. New products (whether tobacco, nicotine or alternative products) , new manufacturers and most importantly new science, technologies and innovation are forcing a discussion on the need for policy changes that should have taken place some years ago.

For decades, pharmaceutical interests have also given much financial support to the tobacco control community, NGO's, and the research community, providing significant resources for combating smoking, sponsoring conferences, developing 'cessation programs' and 'quit lines', developing joint lobbying strategies, funding research, and filing complementary petitions to agencies such as the Food and Drug Administration. These were all commendable initiatives especially during a period when there was no oversight over traditional tobacco products. After years of effort and work and in spite of tremendous opposition from some Big Tobacco companies (Altria/Philip Morris broke ranks with the other companies to support the legislation), the Tobacco Control Act was finally enacted and while much of the Act is meritorious, other provisions of the Act were destined to become 'outdated' as soon as the President signed it into law. With enactment of the new law we entered a 'new era' which many it seems are finding difficult to accept.

Congress, as it often does, laid out a series of mandatory deadlines for the FDA. The FDA should be commended for making a concerted effort to meet deadlines in such a short period of time. The Section 918 report is one of those mandatory obligations. But the time and energy spent on meeting these mandatory obligations has also prevented the FDA from doing some 'out of the box' thinking that is so needed in developing a more workable, coherent and rational national tobacco and nicotine policy.

Smoking has been and should for the moment remain the primary concern to public health (but not the only one) as it accounts for over 400,000 deaths in the US and millions globally. The primary focus of the pharmaceutical industry efforts were (and still are) focused on smoking and not on tobacco or nicotine per se. Let's not forget that one could argue that nicotine replacement (NRT) products that do not make a therapeutic claim could be classified as 'tobacco' products in today's environment.

While we often use the word tobacco, it is really the toxic 'cigarette' and the chemicals found in the smoke that causes the serious damage from tobacco use. Change the product and you can change the risk. There are significant differences in the level of risk between the spectrum of tobacco, nicotine and alternative and innovative products. Governmental agencies, tobacco control advocates, NGO's, and the media often make sweeping all inclusive statements such as 'tobacco accounts for the deaths of over 400,000 Americans each year' ---- an accurate statement but misleading and certainly one that is not very scientific or specific. This isn't just about there being two categories of products-- nicotine and tobacco, but about a growing spectrum of products—all having differing levels of risks. The reality is that it is the combustible cigarette that causes the overwhelming majority of the premature deaths. It would be like saying automobiles kill or having sex causes STD's, using alcohol kills both the user and nonuser, or eating meat will cause cardiovascular disease and strokes*. All true but not very specific or useful to those seeking to reduce harm.


* It is of some relevance that a meat (ham) that I often consume called 'Healthy Ones' carries the American Heart Associations CHECK for being 'extra lean' with a further statement , "While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease". Could similar approaches and thinking be used by the FDA to convey information (labeling and educational programs) to consumers about the risks, relative risks and uses of nicotine, tobacco, and alternative products? I think they could.

We need to accept that its not the tobacco per se that causes the significant harm but rather how that tobacco had been grown, processed, cured, manufactured and most critically used that causes the harm. Nor is it the nicotine that causes the significant harm, although many in the public erroneously believe that it is.

Tobacco is being researched to develop new medicines and industrial enzymes and is often called the 'white rat' of the plant world. Such research may also yield new innovative products that might be used in the development of smoking replacement products. Simply attacking ‘tobacco’ simply misses the point.

CDER's consideration of long term nicotine use as a means of smoking cessation and the issues raised in Section 918 are obviously interrelated and should be considered in the broader context of a changing tobacco, nicotine and alternative products regulatory environment. NRT ended up under CDER's purview because there was no other place to put it. Today there is. ** Many have suggested that NRT is very different than other more traditional prescription/pharmaceutical products. I would agree with that assessment.

We therefore need to rise above the constraints and limitations of the statute, dispense with the rhetoric on the 1990's, as well as the protracted discussion of long term nicotine use and begin serious dialogue about the need for establishing a more rational,
uniform and coherent regulatory policy governing all tobacco, nicotine and alternative products --- a regulatory structure based less on who the manufacture is and more on the product itself. (See below).

The issues being raised by Section 918 are important but they are in part based on a 'past era' and also reflect the influence of pharmaceutical interests in an effort to retain and maintain a competitive advantage and to discourage the development of new lower risk products that could//should include tobacco based products. This is/was also the case for Section 911 concerning modified risk tobacco products, where the bar has been raised so high that it discourages the development of innovative lower risk tobacco products. In deciding how to develop a more flexible regulatory policy for nicotine/NRT type products consideration must also be given to allowing a more workable policy with respect to other products even those containing tobacco.


**A younger generation may not remember that in the 1990's a concerted effort was made by health groups (Coalition on Smoking OR Health) and the FDA to 'level the playing' by bringing cigarettes under FDA's drug and device authorities (since no separate authorities existed for tobacco) and to therefore regulate all tobacco and nicotine products in a more rational and consistent manner. The US Supreme Court eventually ruled that FDA did not have jurisdiction. Today we have the Center for Tobacco Products and it is logical that all tobacco and nicotine products should now be regulated under a single regulatory umbrella through the CTP.

As FDA notes (page nine of the Federal Register Notice) one of the basic questions (and in my mind the most critical for the future) that needs to be addressed in its report to Congress(and in my mind the most critical to the future of public health) is:

"how best to regulate, promote, and encourage the development of 'innovative products and treatments." (whether nicotine based or non-nicotine based)

As part of those considerations FDA (and Congress for that matter) might want to revisit the Institute of Medicine's landmark report, Clearing the Smoke. That was a report requested by the FDA and unfortunately virtually ignored when the writing of the FDA tobacco statute took place (I could not find a single reference to the report in the Findings of the legislation).

In that report which focused on tobacco, nicotine and other potential alternative products the IOM made the following recommendations:

- Manufacturers have the necessary incentive to develop and market products that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of -tobacco-related disease;

- Consumers are fully and accurately informed of all of the known, likely, and potential consequences of using these products;

- Promotion, advertising and labeling of these products are firmly regulated to prevent false or misleading claims explicit or implicit;

- Health and behavioral effects of using PREPS are monitored on a continuing basis;

- Basic, clinical and epidemiological research is conducted to establish their potential for harm reduction for individuals and populations; and

- Harm reduction is implemented as a component of a comprehensive national tobacco control program that emphasizes abstinence orient prevention and treatment.


II Definitions and Terminologies

As I reviewed the Federal Register announcement I was, as I have been for a number of years now, struck by just how in need we are of refining and redefining the terms that we use in the tobacco and nicotine environment. Government agencies, NGO's and others use terms loosely and interchangeably. In a regulated environment there should be clearer definitions and understanding of the terminologies that we use. A reexamination of such terms needs to be conducted. Here are just a few of the questions I would suggest be addressed.

- What is a tobacco product?

- What is a smokeless tobacco product?

- What is a nicotine product?

- What is a nicotine replacement therapy? Should we be talking about and considering 'smoking replacement products' instead, that include a broader spectrum of products-- both nicotine and tobacco?

- What is an 'innovative' product? Can an 'innovative' product be a tobacco based product?

- What is 'cessation'? ------ 'smoking cessation?, tobacco cessation?, nicotine cessation?

- Is abstinence different than cessation? Abstinence from what ? -- smoking? ,tobacco? nicotine?

- What is 'relapse' ? Relapse from what to what?------ Smoking? Tobacco use? Nicotine?

- Are there distinctions to be made about how 'claims' might be classified depending on the level of science available about a particular class of products as well as a specific product? Can FDA, as is done with foods, develop a more consumer friendly system for the allowance of a variety of claims, including truthful and accurate information?

- What is a tobacco company? Can a tobacco manufacturer also be a pharmaceutical company? Or vice versa? Are there differences between the more traditional tobacco manufacturers (Big Tobacco) and new technology oriented companies that are doing research and developing new products? Some of the more traditional tobacco companies (Big Tobacco) are expanding their portfolios to include nicotine products as well. Does it matter in this day and age of regulatory oversight, where the focus should increasingly be on the product and less on who the manufacturer is?

- How should 'harm' or 'harm reduction' be defined? Should the 'cigarette' be used as the reference product by which the harms of all tobacco, nicotine and alternative products are assessed?

- How should 'risk', 'relative risk' be defined for tobacco, nicotine and alternative products? Should we be focusing on establishing 'risk profiles' for the spectrum of products along the continuum of risk?

- What is the public health goal? Is it reducing disease and death caused by the use of harmful tobacco products (i.e. one that incorporates a harm reduction strategy)?' Or, is it eliminating all risks (regardless of how negligible) including advocating prohibition of all tobacco, nicotine and alternative products? Could trying to achieve abstinence do more harm than good?


III Why is the consumer always seemingly ignored in the discussions?

I have been working and involved in tobacco control and public health for over three decades and it amazes me to this day that we have not done a very good job of involving the consumer in the discussions. We all seem to know what's best for them. Yet, many surveys of the public and consumers using both tobacco and nicotine products have shown that there is a deep lack of understanding and confusion about these products. Many think that noncombustible products are as harmful as or even more harmful than cigarettes. Many also believe that NRT products such as nicotine patches, gums, and lozenges are as harmful as using cigarettes and cause cancer and other diseases.

While the issues that I have been raising in this submission will need to be considered by a spectrum of interests, the consumer's interest needs to be seriously taken into account and FDA should look at other models it has used in the food and drug arenas where the agency has often involved consumers in the discussions.


IV What Can the FDA and Congress Do to Bring Tobacco, Nicotine, and Alternative Product Regulation into the 21st Century? Isn't it time to bring all tobacco, nicotine and alternative products under the same regulatory umbrella?

I have suggested that serious consideration needs to be given to bringing all tobacco, nicotine and alternative innovative products under a single regulatory umbrella at the FDA

At several of FDA/TPSAC, CTP and CDER meetings I attended and participated in, I noticed that some of the members, participants etc. were starting to get beyond the rhetoric and raising questions, trying to get a better handle on how products should be defined and classified including some acknowledgments that there are inconsistencies and questions about how the law might be applied to the growing spectrum of tobacco and nicotine products on the market. E-cigarettes are one example, but so are lozenges, inhalers etc.

A couple of years ago when CDER held its workshop on long term nicotine use, the topic would often shift to the issue of tobacco based products, even though CDER did not have jurisdiction over tobacco.

The same can be said of many of CTP's meetings where the discussion of tobacco would often drift and shift to issues related to NRT etc.

The establishment of a more rational, balanced, and flexible approach to regulating all tobacco, nicotine and alternative products would bring some predictability to the environment, serve the interests of public health, promote competition and reward those, whoever they might be, who produce significantly lower risk science -based products whether they are tobacco based, nicotine based or even some alternative.

I am suggesting (and that the FDA do so in its report to Congress) that the current Center for Tobacco Products (CTP) at the FDA be renamed the Center for Tobacco, Nicotine and Alternative Products ending the anachronistic system that puts some products in CTP, others at CDER and still others in limbo. I am suggesting that by doing this, not only does the FDA's job become somewhat easier but it gives manufacturers of any of the spectrum of products a better road map. Consumers too benefit because for the first time there would be some consistency in how these products relate to one another, how they are labeled and how they would be marketed.

I am also suggesting that within this expanded and consolidated Center that there might be three regulatory review panels --

- one for combustible products;
- one for non-combustible products(which I call Smoking Replacement Products (SRP's) and;
- one for therapeutics making disease specific related health claims.

Scientific evidence would be used to determine how these products would be labeled and marketed. I don't think it is too far fetched that a tobacco based product might one day have the same kind of therapeutic profile as does an NRT product currently on the market or that an NRT product on the market that doesn't make a therapeutic claim would be classified sold and market as a tobacco product.

Monitoring and surveillance across the broad spectrum of products would provide the FDA with a clearer view of who is using the various products and why and give the agency greater flexibility in working with manufacturers and others in the tobacco and nicotine marketing chain, as well as helping design more effective educational campaigns.

I believe that:

REGULATION + Science + Competition + Innovation + Incentives can be a very effective way of not only promoting and protecting public health but in changing the behaviors of manufacturers as well.


V Observations and Recommendations

There is a lot of work to be done both in the public and private sector. The issues and questions being raised (not only by Section 918 but sections like 911 as well) need to be aired and more fully discussed. The rhetoric that has dominated (and continues to dominate) the tobacco and nicotine environment must be toned down. FDA needs to take a leadership role. Leadership does not mean 'hiding' behind the statute or merely checking off the boxes on accomplishments. It should also entail looking at new opportunities for developing a more rational and workable regulatory system for all tobacco, nicotine and alternative products.

- FDA can begin by conveying to Congress in its report that a more uniform, coherent and comprehensive regulatory structure is needed governing all tobacco, nicotine and alternative products. This should include consideration of bringing these products under a reconstituted "Center for Tobacco, Nicotine and Alternative Products";

- FDA should convey to Congress that this more uniform approach to regulating all tobacco, nicotine and alternative products should be based on risks, relative risks and intended uses of each product (including categories);

- FDA should convey to Congress that outdated definitions and terminologies for all tobacco, nicotine and alternative products need to be updated both from a legislative/regulatory point of view and in helping the public better understand the risks, relative risks and intended uses of the various products on the market;

- FDA needs to independently convene an 'open educational meeting' of governmental agencies interested in the issue of tobacco and nicotine regulation that includes not only offices within FDA, the NIH, CDC, IOM etc but also the USDA and EPA. Such a meeting should also include public and private 'experts' familiar with labeling, and marketing issues and who are not only focused on the tobacco issue but who would bring added value to the discussions. There is much to be learned about how products should be developed, labeled, and marketed, and monitored from such experiences in the food and over the counter drugs (OTC) arenas. This includes how the spectrum of products can and cannot make claims (informational or health); how consumers receive and interpret labeling and marketing messages etc.; and what kind of 'educational' efforts should be designed and conducted to provide the public and users of these products with 'truthful, non- misleading' and understandable' information.

- A more open and transparent discussion should also include such issues on how to provide 'incentives' for new product development as well as removing barriers to the development of new innovative tobacco, nicotine and alternative products. Competition should be encouraged not suppressed in this new regulatory environment. One such 'incentive' might be consideration of establishing a system in a restructured CTP for fast-tracking products where there is a substantial degree of science and consensus to allow the approval for such products. This fast-tracking process could be based on FDA's Section 506 but at the same time be tailored to issues specifically related to tobacco, nicotine and other innovative products. Another might be to levy a 'risk -profile' tax on the highly toxic products or give tax credits to those products that are significantly lower in risk.

- Congress should be encouraged by the FDA to hold serious (not political or partisan) oversight hearings on how to develop a more workable, flexible and uniform statutory/ regulatory system governing all tobacco, nicotine and alternative products without micromanaging the agency's work ---- i.e. set the parameters and let the FDA and the public and privates sector do their work in this dynamically changing environment.

 

[jlew]

I am truly sorry for this rant but ....

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.

I honestly must agree with much of what you have said in your posts and I too, am taking a defensive.
Here is the way I see it happening:

The FDA will hold a Public Hearing to gain information to submit a report to the Government.
1) The "Scientists and Public Health Officials" that the FDA has "Hand Picked" are working for
the FDA - not us.
2) These same so-called pros are also the same ones who have helped to get all the propaganda
started that says "E-Cigs are dangerous and need more testing."
3) The majority of Public Health Officials have already stated their positions on e-cigs time and
time again -- and that position is "Ban from public use and/or in public places."
4) The FDA and their "panel" will hold all the power to put in and/or leave out whatever it feels
like in order to achieve their goal - not ours.
5) Because the FDA has been defeated before, they will now stop at nothing to win.
6) Considering the way things have been going in our political system, do you honestly believe
they will do anything that will jeopardize their position?
7) The FDA, their "Scientists", their "Public Health Officials", Pharmaceutical companies, and even
doctors stand too much to lose if anything goes in our favor.
8) The FDA for many many years has been approving things that have killed many people and
every time you read the paper, turn on the news, and search online, you can find ads saying:
"If you have taken this that or the other, you might have a lawsuit" -- The FDA's approval
and/or regulation of e-cigarettes could potentially cause more of those suits -- this time over
e-cigs (due to tampering)

They have done this before over multiple things.

There are ...... out there all over the world who do stupid things and mess it up for everyone
else - so to combat that, they don't regulate the idiot, they simply regulate and ban the item.
I am Very Surprised this hasn't happened yet with e-cigarettes but I sit and wait.
One day, some where, someone will do something stupid and get them taken from us for good
over it.

I learned a long long time ago that we really have no rights in the USA - the only rights we
have are "The rights we say you can have!"
It has happened with guns, food, clothing, property, and just about anything and everything
else... People are always having to Fight their own governments over things they
should be allowed to have without question. Especially when it comes to their own
lives, bodies, homes, property, and families!

I am sorry but I do not expect anything good to follow any of this.... and if it does... well
I guess I will have to take up yoga and gymnastics just so I can kiss my own (yep)

Again -- "Sure you can trust the Government. Ask Any Indian!"

I am sorry but --

Danger:
Danger: Will Robinson! is right!


The E-Cigarette idea was invented by a Doctor....

Oh that's right - the USA is trying to be an example for the rest of the world (by showing how to
oppress and take over everything and everyone). For God's sake they can't even get it right here
at home - what makes them think they can tell the rest of the world the right way to live?

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.

I also agree with that.
Just like any other form of "Court" if you will... No one wants to be there and even more
so when it is a holiday and such a gathering takes them from their shopping and families
and the "I could be doing something much better than this" attitude will fly all over the
place... so they will want to "adjourn" as fast as possible.



In all actuality though... I really Do hope this works to benefit everyone concerned and
I would hate to see anything adverse from it... but I cannot help thinking the way I do considering
the History of how the USA government has done the people over centuries.

Maybe the sheer fact that millions have e-cigs will be enough of a deterrent to keep the
FDA at bay -- You can't lock up a million people over something as trivial as a battery, tank,
and nicotine liquid....

It would be the epitome of Insanity to do so.

 

[Berylanna]

I learned a long long time ago that we really have no rights in the USA - the only rights we
have are "The rights we say you can have!"

Correction: EARTH. There are these durned homo sapiens everywhere.

What Adler called Will-To-Power is called, basically, Will-to-Effectiveness by the authors of Solomon's Choice (about how organizational burnout causes a paradoxical backward effect in Child Protective Services) and I agree.

People want to matter. That takes power. After awhile, confusion sets in as to whether "mattering" is about the person you are helping or your organisations's agenda. The organization becomes a tribe, and develops its own folklore. "Anybody who isn't with us is against us."

There are still good people in there, usually newbies, and they either burn out and join the tribe, or get banished, or suffer in silent desperation.

I still think the "tribe" can be reached if you can successfully give them a chance to be the heroes. But it requires deft work and is hard over the loud voice of their own crowd.

I don't hold a lot of hope for this, but I do believe it is not impossible to find the right lever to tip things back to sanity.

You can't lock up a million people over something as trivial as a battery, tank,
and nicotine liquid....

Battery and tank are safe. So are flavored liquids if they do not contain nicotine. Unfortunately, that pretty much covers what can be effectively DIY'd if they shut down access to the ingredients that make vaping work as THR.

It would be the epitome of Insanity to do so.

Sadly, this it not true. It would work for their tribe and organization, which makes it quite quite sane...but NOT heroic.

So, how do we make them feel that they can be the heroes? There is an excellent reason the FDA and the CDC have been historically respected world-over, respected for their dedication to science and truth! How can we get the FDA to reclaim their glory instead of basking in a mirage that the former glory can be preserved while dumping the dedication to truth that was the origin of the glory in the past?

 

[Bill Godshall]

Perhaps Barylanna and jlew submit written comments to the FDA.

 

[Berylanna]

I'll work on it tonight when I get off work but my idea is probably 'way too idiosyncratic and I want feedback before I mail it.

 

[Petrodus]

Politics and agendas
The FDA knows the truth

 

[Berylanna]

You would be astonished at the power of willful ignorance. Which I believe is more deeply evil than crass lying, since in means lying to a minimum of 1 more person (oneself) but gives veracity when speaking to others.

 

[Petrodus]

You would be astonished at the power of willful ignorance. Which I believe is more deeply evil than crass lying, since in means lying to a minimum of 1 more person (oneself) but gives veracity when speaking to others.

Washington and all its agencies are in a "class" all alone.
They do NOT operate based on common sense ... We do.
Trying to make common sense out of anything the say or do
or trying to communicate with them using truth and common sense
will drive you NUTS. (period)

George was right all along ... See my signature
He wasn't joking !!

 

[Berylanna]

I have too many friends from other countries that have their own freak shows. No nation, no culture, is immune, and crowding makes it worse. So far if there are any without, it might be Scandinavia and maybe New Zealand. Almost nobody where I work was born or even raised in the U.S., which makes lunchtime conversation very interesting.

Trust me, the problem homo sapiens is worldwide. And if you think we all use common sense, think back to junior high school. A minimum of half the population (in any country) never outgrows that age-group's mindset. And they clump together like cottage cheese.