- Apr 2, 2009
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Comments of
Scott D. Ballin, JD
Health Policy Consultant
Panel Discussion on Building a Comprehensive Nicotine Regulatory Policy
Annual Meeting of the Food and Drug Law Institute
April 24-25
Washington DC
Good Morning. As many of you are well aware, up until about 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 from traditional products were often prohibited in the market place because the tobacco in them made them 'adulterated' or because the product made a therapeutic type claim. A tobacco based gum comes to mind.
It forced nicotine products, as NRT products (from which the nicotine was and still is derived from tobacco) to be developed only through drug and device regulatory channels, that unfortunately resulted in a very 'broken' almost schizophrenic regulatory system. That scenario, that existed for decades really perpetuated a public health challenge, giving us an environment in which cigarettes - the deadliest form of nicotine delivery thrived and remained protected from regulations at the expense of allowing and or encouraging potentially lower risk products to be developed and eventually marketed. And the tobacco industry, as has been so extensively documented in the Justice Departments lawsuit and the release of many internal documents wanted it that way. That 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.
It was in many ways a lose- lose situation, perpetuating a system that was not based so much on science but on 'war', rhetoric, legal and legislative maneuverings. In the last ten years and in spite of efforts by some in industry, tobacco control, policy makers, and the 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. New products, new manufacturers and most important new science, technologies and innovation are forcing a discussion that should have taken place at least ten years ago.
Change or the acceptance and embracing of change does not come easily for many individuals, organizations, policy makers or corporations for that matter. We still have our federal government, many in the scientific community and the tobacco control community at large viewing the tobacco issue as a 'war'. Government often makes sweeping statements such as 'tobacco' accounts for the deaths of over 400,000 Americans each year"-----an accurate statement but not very scientific- or specific. 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 that sex causes STD's, or eating meat will cause cardiovascular disease and strokes. It is not the tobacco that causes the harm but rather how that tobacco is grown, processed, cured, manufactured and most critically used that causes the harm. Tobacco is in fact being researched to develop new medicines and industrial enzymes. Nor is it the nicotine that causes the significant harm although many in the public believe that it is.
A few months ago I read an interesting article that made me pause and think about how polarized, cause- related, dogmatic and driven by emotion we can be as a society -- and we see it all around us. What if instead of tobacco being 'smoked' in the form of cigarettes in order to obtain nicotine it was the coffee bean that was processed to be smoked to obtain caffeine and what if it is was tobacco that was used in the form of a drink and or tea? Flavored tobacco tea might not be so far fetched. How would we as a nation choose to regulate those products? Might we be here today talking about coffee bean regulation because of the burning and inhalation of the bean produces thousands of chemical toxins that cause harm to health? And might we be regulating 'tobacco tea' as a food or as any other tea in the market place?
I give this as an example because I believe that with FDA oversight now in place, its time to focus more on the products and less on who makes them even though I know that that is asking too much from many of my public health colleagues. I can say this because I was on the front lines in this war for many years and saw and experienced first hand the tricks, manipulations and power of the 'tobacco lobby'.
With the advent of FDA oversight we have to begin to talk about issues in a more open and scientific manner through meetings like this one--- rather than in terms of rhetoric and to actually look into how we might develop a more uniform and rational approach to regulating all tobacco, nicotine and alternative products and doing so based on the risks, relative risks and intended uses of such products. Doing so can only benefit the public health and accomplish what has long been the public health communities goal of reducing disease and death. Other sessions at this conference are also very relevant to what we are talking about here today. Later today for example, there is a session entitled 'Innovation in FDA- Regulated Industries -- They're not your father's food and drug industries anymore'. How pertinent to what is transpiring in the tobacco and nicotine industries!
I remember years ago, when working on food labeling issues when I was at the American Heart Association, that a somewhat similar challenge occurred when food products that had significantly lower levels of cholesterol, fat, salt etc were being marketed as aiding in the reduction of cardiovascular disease--- a type of statement that would have landed those products in FDA drug category. The AHA tried to put its seal of approval on foods only to have the agency tell the Association that doing so would make the product a drug. It was a time when science, technology, innovation and competition in the market place were forcing both the public and private sectors to deal with something they had not adequately been dealt with and it eventually required a change and clarification in the statute. And as all of you in this room know far better than I do, the Food Drug and Cosmetic Act is always changing and being amended to adapt to changes in science, technology, innovation, public health and consumer demands. The issue of tobacco, nicotine and alternative products is no different.
What I am suggesting today, is that because of regulatory oversight, because of scientific advances, innovation and competition, because of new players entering the market place, we need to step back and consider bringing all of the growing spectrum of products under the same regulatory umbrella. We need to look at regulating products based on risk, relatives risks, and intended uses and assigning every product a risk profile. The more harm the product causes the more regulations that should be imposed. On the other hand the lower the risk, the fewer or more flexible the regulations. We need to define our terms more accurately and even develop some new ones. What for example is 'cessation'? Who and what is a tobacco manufacturer? What is a tobacco product? A nicotine product?
This is no longer the black and white world that has existed for decades. Today there are many factors at work and there many opportunities now available to promote public health through product modification and innovation. I believe that in this 'new era' :
REGULATION + Science+ Competition+ Innovation +Incentives can be a very effective way of not only promoting and protecting public health but in changing corporate behaviors as well.
Even the IOM, who had statutory constraints and limitations put on it in considering the development of scientific standards to be applied to MRTPs noted :
The Committee was particularly wary of making 'perishable' recommendations that may lose relevance as time passes and scientific methods and technologies evolve.
At a number of recent FDA/ TPSAC and other CTP meetings I noticed that some of the members, participants etc were raising questions and trying to get a better handle on how products should be defined including some acknowledgement that there are inconsistencies and questions about how the law might or should be applied to the growing spectrum of tobacco and nicotine products on the market.
A couple years ago when CDER (Center for Drug Evaluation and Research) was holding a workshop on long term nicotine use, the topic would often shift back to the issue of tobacco based products.
The need for a more rational, balanced regulatory structure for all tobacco, nicotine and alternative products will bring some predictability to the environment, serve the interests of public health, promote competition, and reward those, whoever they might be, for producing measurably significantly lower risk products.
I have suggested that the current Center for Tobacco Products at the FDA be renamed the Center for Tobacco, Nicotine and Alternative Products ending the long outdated system that puts some products in the tobacco center and others in Center for Drug Evaluation and Research , and still others in limbo. I have suggested that by doing this not only does the FDA 's job become somewhat easier but that it gives any one manufacturing any of these spectrum of products a better roadmap. Consumers too benefit because for the first time there would be some consistency in how the products interrelate and how their risks and intended uses vary.
I have suggested that within this expanded and consolidated Center that there might be three regulatory review panels, one for combustible products, one for noncombustible products (which I suggest be called Smoking Replacement Products (SRP's), and one for therapeutics type products. Scientific evidence would be used to determine how these products would be labeled and marketed. I don't think its too far fetched to suggest that a tobacco based product might one day have the same kind of risk/therapeutic profile as does an NRT product currently on the market. 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.
Given the dynamically changing environment, Section 911 of the statute concerning MRTPs and other tobacco, nicotine and alternative products needs to be revisited- especially in light of the need for a more uniform and rational tobacco, nicotine and alternative products regulatory policy.
This could be done by the FDA bn convening workshops, in the private sector through dialogue and discussion, as well as in Congress. FDA needs to be given enough specificity but at the same time flexibility to deal with the dynamically changing environment on an ongoing basis and to avoid making perishable recommendations and regulations that may (as the IoM suggested) 'lose relevance as time passes and scientific methods and methodologies evolve'.
I am well aware of the political environment under which the language in section 911 was developed and inserted into the statute and the few players who worked behind the scenes to come up with the language. That 'history' need not be discussed here, although I still believe however, that Congress would have been far better off long- term to have incorporated some of the primary recommendations of the IOM Clearing the Smoke report into section 911 rather than trying to micromanage a regulatory system for MRTPs that is already out of date.
As part of this need to rethink how we regulate the growing spectrum of tobacco, nicotine and alternative products I am today going to suggest that we take a closer look at varying levels of scientific evidence that might be used in deciding how products should be labeled as well as marketed. We already talked about the continuum of risk in which we differentiated the risks, relative risks and intended uses of the growing spectrum of products. I want to suggest that there is also a 'continuum of science'. There are varying degrees and levels of science that go into regulatory decision-making for products under the Food Drug and Cosmetic Act. We should consider models of how regulatory decisions are made with respect to the differentiations between something like prescription drugs and over-the-counter products for example. And I think that there is a great deal to learn about the varying levels of science that are used for foods---science that determines what can be said in the labeling and marketing of a product including a spectrum of different kinds of claims. Let's not forget that tobacco is a plant and there are some parallels to be considered between tobacco and regulations and guidance how we deal with food. It's time try and put the decades of animosity and distrust between stakeholders behind us. It can be done now that we have the regulatory agency in place to do so.
Abraham Lincoln once said,
"Do I not destroy my enemies when I make them my friend?"
I am not suggesting that some of the traditional adversaries become friends but I am suggesting that those who are serious and willing about developing a more uniform, coherent and flexible regulatory policy for tobacco, nicotine and alternative products do so in a more collaborative and engaging way. This should include a spectrum of players and experts including those in the tobacco and nicotine business, those in the scientific community, those in regulatory agencies as well as involving the consumer who so often gets left out of the discussions.
THANK YOU!
*********************************
Contact information:
Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW
Washington DC 20015
Tel: 202 686-8898
email: ScDBa@aol.com
For additional Information go to: www.tobaccoatacrossroads.com
Scott D. Ballin, JD
Health Policy Consultant
Panel Discussion on Building a Comprehensive Nicotine Regulatory Policy
Annual Meeting of the Food and Drug Law Institute
April 24-25
Washington DC
Good Morning. As many of you are well aware, up until about 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 from traditional products were often prohibited in the market place because the tobacco in them made them 'adulterated' or because the product made a therapeutic type claim. A tobacco based gum comes to mind.
It forced nicotine products, as NRT products (from which the nicotine was and still is derived from tobacco) to be developed only through drug and device regulatory channels, that unfortunately resulted in a very 'broken' almost schizophrenic regulatory system. That scenario, that existed for decades really perpetuated a public health challenge, giving us an environment in which cigarettes - the deadliest form of nicotine delivery thrived and remained protected from regulations at the expense of allowing and or encouraging potentially lower risk products to be developed and eventually marketed. And the tobacco industry, as has been so extensively documented in the Justice Departments lawsuit and the release of many internal documents wanted it that way. That 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.
It was in many ways a lose- lose situation, perpetuating a system that was not based so much on science but on 'war', rhetoric, legal and legislative maneuverings. In the last ten years and in spite of efforts by some in industry, tobacco control, policy makers, and the 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. New products, new manufacturers and most important new science, technologies and innovation are forcing a discussion that should have taken place at least ten years ago.
Change or the acceptance and embracing of change does not come easily for many individuals, organizations, policy makers or corporations for that matter. We still have our federal government, many in the scientific community and the tobacco control community at large viewing the tobacco issue as a 'war'. Government often makes sweeping statements such as 'tobacco' accounts for the deaths of over 400,000 Americans each year"-----an accurate statement but not very scientific- or specific. 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 that sex causes STD's, or eating meat will cause cardiovascular disease and strokes. It is not the tobacco that causes the harm but rather how that tobacco is grown, processed, cured, manufactured and most critically used that causes the harm. Tobacco is in fact being researched to develop new medicines and industrial enzymes. Nor is it the nicotine that causes the significant harm although many in the public believe that it is.
A few months ago I read an interesting article that made me pause and think about how polarized, cause- related, dogmatic and driven by emotion we can be as a society -- and we see it all around us. What if instead of tobacco being 'smoked' in the form of cigarettes in order to obtain nicotine it was the coffee bean that was processed to be smoked to obtain caffeine and what if it is was tobacco that was used in the form of a drink and or tea? Flavored tobacco tea might not be so far fetched. How would we as a nation choose to regulate those products? Might we be here today talking about coffee bean regulation because of the burning and inhalation of the bean produces thousands of chemical toxins that cause harm to health? And might we be regulating 'tobacco tea' as a food or as any other tea in the market place?
I give this as an example because I believe that with FDA oversight now in place, its time to focus more on the products and less on who makes them even though I know that that is asking too much from many of my public health colleagues. I can say this because I was on the front lines in this war for many years and saw and experienced first hand the tricks, manipulations and power of the 'tobacco lobby'.
With the advent of FDA oversight we have to begin to talk about issues in a more open and scientific manner through meetings like this one--- rather than in terms of rhetoric and to actually look into how we might develop a more uniform and rational approach to regulating all tobacco, nicotine and alternative products and doing so based on the risks, relative risks and intended uses of such products. Doing so can only benefit the public health and accomplish what has long been the public health communities goal of reducing disease and death. Other sessions at this conference are also very relevant to what we are talking about here today. Later today for example, there is a session entitled 'Innovation in FDA- Regulated Industries -- They're not your father's food and drug industries anymore'. How pertinent to what is transpiring in the tobacco and nicotine industries!
I remember years ago, when working on food labeling issues when I was at the American Heart Association, that a somewhat similar challenge occurred when food products that had significantly lower levels of cholesterol, fat, salt etc were being marketed as aiding in the reduction of cardiovascular disease--- a type of statement that would have landed those products in FDA drug category. The AHA tried to put its seal of approval on foods only to have the agency tell the Association that doing so would make the product a drug. It was a time when science, technology, innovation and competition in the market place were forcing both the public and private sectors to deal with something they had not adequately been dealt with and it eventually required a change and clarification in the statute. And as all of you in this room know far better than I do, the Food Drug and Cosmetic Act is always changing and being amended to adapt to changes in science, technology, innovation, public health and consumer demands. The issue of tobacco, nicotine and alternative products is no different.
What I am suggesting today, is that because of regulatory oversight, because of scientific advances, innovation and competition, because of new players entering the market place, we need to step back and consider bringing all of the growing spectrum of products under the same regulatory umbrella. We need to look at regulating products based on risk, relatives risks, and intended uses and assigning every product a risk profile. The more harm the product causes the more regulations that should be imposed. On the other hand the lower the risk, the fewer or more flexible the regulations. We need to define our terms more accurately and even develop some new ones. What for example is 'cessation'? Who and what is a tobacco manufacturer? What is a tobacco product? A nicotine product?
This is no longer the black and white world that has existed for decades. Today there are many factors at work and there many opportunities now available to promote public health through product modification and innovation. I believe that in this 'new era' :
REGULATION + Science+ Competition+ Innovation +Incentives can be a very effective way of not only promoting and protecting public health but in changing corporate behaviors as well.
Even the IOM, who had statutory constraints and limitations put on it in considering the development of scientific standards to be applied to MRTPs noted :
The Committee was particularly wary of making 'perishable' recommendations that may lose relevance as time passes and scientific methods and technologies evolve.
At a number of recent FDA/ TPSAC and other CTP meetings I noticed that some of the members, participants etc were raising questions and trying to get a better handle on how products should be defined including some acknowledgement that there are inconsistencies and questions about how the law might or should be applied to the growing spectrum of tobacco and nicotine products on the market.
A couple years ago when CDER (Center for Drug Evaluation and Research) was holding a workshop on long term nicotine use, the topic would often shift back to the issue of tobacco based products.
The need for a more rational, balanced regulatory structure for all tobacco, nicotine and alternative products will bring some predictability to the environment, serve the interests of public health, promote competition, and reward those, whoever they might be, for producing measurably significantly lower risk products.
I have suggested that the current Center for Tobacco Products at the FDA be renamed the Center for Tobacco, Nicotine and Alternative Products ending the long outdated system that puts some products in the tobacco center and others in Center for Drug Evaluation and Research , and still others in limbo. I have suggested that by doing this not only does the FDA 's job become somewhat easier but that it gives any one manufacturing any of these spectrum of products a better roadmap. Consumers too benefit because for the first time there would be some consistency in how the products interrelate and how their risks and intended uses vary.
I have suggested that within this expanded and consolidated Center that there might be three regulatory review panels, one for combustible products, one for noncombustible products (which I suggest be called Smoking Replacement Products (SRP's), and one for therapeutics type products. Scientific evidence would be used to determine how these products would be labeled and marketed. I don't think its too far fetched to suggest that a tobacco based product might one day have the same kind of risk/therapeutic profile as does an NRT product currently on the market. 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.
Given the dynamically changing environment, Section 911 of the statute concerning MRTPs and other tobacco, nicotine and alternative products needs to be revisited- especially in light of the need for a more uniform and rational tobacco, nicotine and alternative products regulatory policy.
This could be done by the FDA bn convening workshops, in the private sector through dialogue and discussion, as well as in Congress. FDA needs to be given enough specificity but at the same time flexibility to deal with the dynamically changing environment on an ongoing basis and to avoid making perishable recommendations and regulations that may (as the IoM suggested) 'lose relevance as time passes and scientific methods and methodologies evolve'.
I am well aware of the political environment under which the language in section 911 was developed and inserted into the statute and the few players who worked behind the scenes to come up with the language. That 'history' need not be discussed here, although I still believe however, that Congress would have been far better off long- term to have incorporated some of the primary recommendations of the IOM Clearing the Smoke report into section 911 rather than trying to micromanage a regulatory system for MRTPs that is already out of date.
As part of this need to rethink how we regulate the growing spectrum of tobacco, nicotine and alternative products I am today going to suggest that we take a closer look at varying levels of scientific evidence that might be used in deciding how products should be labeled as well as marketed. We already talked about the continuum of risk in which we differentiated the risks, relative risks and intended uses of the growing spectrum of products. I want to suggest that there is also a 'continuum of science'. There are varying degrees and levels of science that go into regulatory decision-making for products under the Food Drug and Cosmetic Act. We should consider models of how regulatory decisions are made with respect to the differentiations between something like prescription drugs and over-the-counter products for example. And I think that there is a great deal to learn about the varying levels of science that are used for foods---science that determines what can be said in the labeling and marketing of a product including a spectrum of different kinds of claims. Let's not forget that tobacco is a plant and there are some parallels to be considered between tobacco and regulations and guidance how we deal with food. It's time try and put the decades of animosity and distrust between stakeholders behind us. It can be done now that we have the regulatory agency in place to do so.
Abraham Lincoln once said,
"Do I not destroy my enemies when I make them my friend?"
I am not suggesting that some of the traditional adversaries become friends but I am suggesting that those who are serious and willing about developing a more uniform, coherent and flexible regulatory policy for tobacco, nicotine and alternative products do so in a more collaborative and engaging way. This should include a spectrum of players and experts including those in the tobacco and nicotine business, those in the scientific community, those in regulatory agencies as well as involving the consumer who so often gets left out of the discussions.
THANK YOU!
*********************************
Contact information:
Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW
Washington DC 20015
Tel: 202 686-8898
email: ScDBa@aol.com
For additional Information go to: www.tobaccoatacrossroads.com
WOW! 
