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Reconsidering and Revising Terminologies and Definitions to Adapt to a Changing tobacco, Nicotine, and Alternative Products Regulatory Environment
An Observational Piece
Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW
Washington DC 20015
Tel: 202 686-8898
Email: ScDBa@aol.com
www.tobaccoatacrossroads.com
August 1, 2011
1. Introduction
2. What is a 'Tobacco Product'?
3. Who and What is the 'Tobacco Industry'?
4. Who and What is the 'Tobacco Control/Public Health' community?
5. What do we mean by 'Cessation' ?
6. What do we mean by 'Claims and health claims' ?
7. What is 'Harm Reduction' ?
8. Conclusions
1. Introduction:
Several months ago in an observational piece about the critical role that science will be playing in terms of tobacco, nicotine and alternative product regulation, I indicated that I was planning on doing something concerning the increasing confusion over the various uses of words and terms in the tobacco, nicotine and alternative products environment. As with the other observational pieces I have done, this piece is designed to make some observations, to generate further discussion, and to hopefully initiate some new thinking.
The FDA’s acquisition of regulatory authority over tobacco products (and it previous existing authorities over therapeutic nicotine replacement products), the importance of science in setting regulations, and the obvious fact that we are in a ‘new era’ of tobacco, nicotine and alternative product regulations, make it important at this juncture that we clearly define our terms and reconsider how we might best approach policy decisions in the coming months and years.
I have been in 'tobacco control' (I am not even entirely sure what that means in today's environment) for more than 30 years. In the early years it was relatively simple to use terms - it was a 'war' between two interests, good and evil. We in public health wore the white hats of course and the tobacco industry wore the black hats. The tobacco industry, later to be branded BIG TOBACCO, was relatively easy to define. We knew their deceitful and deceptive practices. We knew how extensive their influences were and the extent to which their money influenced decision- making. We knew that they worked hand in hand following well laid out strategies. We considered any one associated with tobacco, including tobacco farmers, retailers, advertisers etc. as a part of the tobacco industry. Today while these two extremes continue to exist there is a much larger 'gray' area that has emerged --- an area that often goes unrecognized by those who remain severely polarized and content on keeping the old ‘ tobacco wars’ of the 80's and 90's alive.
In the mid-1990's, through a project funded by the Robert Wood Johnson Foundation, and managed by the Institute for Environmental Negotiation (IEN) at the University of Virginia that brought tobacco growers and the public health community together, I quickly learned and came to appreciate that things are not so black and white as they appear.
Much of the 'war' in the early years was focused on 'smoking', and companies manufacturing combustible products that contained thousands of chemical constituents, many of them known carcinogens and highly toxic. Cigarettes without question remain by far the most significant cause of harm (both for the individual and for the population as a whole) from the use of tobacco, far above and beyond the traditional 'smokeless' products but even more so in comparison with the growing number of extremely lower risk noncombustible tobacco, nicotine and alternative products which I prefer to call Smoking Replacement Products (SRP's) rather 'smokeless' products or nicotine replacement products (NRT). In spite of the fact that innovation, technology, science, competition, and most importantly regulatory oversight are challenging and changing the market place, many of the traditional stakeholders intentionally or unintentionally choose to cling to the past.
In today's radically altered environment there are so many terms and definitions being used that you need a scorecard to figure it all out. On top of that, the terms are no longer very 'defining' , and have become broad-sweeping and are often used interchangeably. Even the FDA statute and the confusion as to what is and what is not a tobacco product reflects the confusion that exists and the dire need to sit down and revisit not only the terminalogy but the statute itself - to make it a more rational and workable statute for defining and regulating all tobacco, nicotine and alternative products. This radically changing environment, so different (here in the US) from the 'tobacco wars' of the 70's,80's and 90's is why I have gone so far as to suggest that the FSTPC Act (with all is positive attributes) was outdated in many areas even before President Obama's signature was dry. Below are a number of examples where the confusion exists and will only get worse unless some serious, rational and prospective thinking takes place.
2. What is a 'Tobacco Product' ?
Before discussing 'tobacco products', let me first make a note that ‘tobacco’ is an agricultural based plant, grown in many varieties, and having a spectrum of differing properties . It is also critical in today's environment to recognize that it is what is done to the tobacco, how it is grown, processed, cured, refined, treated, manufactured and most importantly ‘used’ ( i.e. combusted versus non-combusted) that has a significant impact on determining the level of risk. Tobacco, often called the 'white rat' of the plant world is also being used to develop medicines, industrial enzymes and other potential products. So, it is prudent to not use the term too broadly, especially in talking in a public health context. It is also prudent and wise to ensure that as we discuss tobacco (and tobacco products made or derived from tobacco )we are involve, agronomists, growers, and other scientists into the discussion and not ignore these important experts.
For many the term 'tobacco product' conjures up the more traditional products of cigarettes, cigars, smokeless, pipe tobacco, roll your own, etc. products made by the 'evil empire', products which many, (including many people in public health who should know better), claim (inaccurately) all carry the same health hazards and risks. In fact such a term and its presumed definition really no longer fits today's environment.
The FDA statute defines a tobacco product as something as having a much broader application and as we shall see covers much much more than our traditional views:
(rr)(1) The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).
(2) The term 'tobacco product' does not mean an article that is a drug under subsection(g)(1), a device under subsection (h), or a combination product described in section 503(g).
(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or dietary supplement).
The broad definition, then qualified with exceptions is in today’s environment filled with confusion, complications, a potential nightmare for the Agency, and a field day for private sector FDA lawyers. It is further complicated by the definitions under Title IX that seek to define some specific products but which is unclear about others. It might have made some (but even then not much) sense to segment out tobacco/nicotine products into different Centers at the FDA at one time but with the establishment of the new Center for Tobacco Products, a serious rethinking should have taken place in Congress -- one that would have brought a more rational approach to the regulation of all of the tobacco, nicotine and alternative products. This idea of regulating these products under one umbrella or as part of a more consistent set of standards based on risk is not new and has been referenced, suggested and advocated by many highly respected individuals for more than 10 years. Yet many (for many assorted reasons which I will not go into here) today seem to oppose and resist any new thinking on the subject.
The ‘tobacco product’ has evolved over many years and is continuing to evolve and there is no reason for its definition not to be revised from time to time as is the case today. Prior to the late 19th century there was no such thing as a ‘cigarette’. Most tobacco was either used in pipes, large cigars or in raw noncombustible forms (such as chewing tobacco or snuff). The cigarette was really discovered by accident (and later capitalized on) when soldiers during the Crimea War in the middle of the 19th century rolled tobacco in pieces of newspaper and called the little cigar a 'cigar-ette', a name formally given in France. It is no wonder that compared to today’s devastating tobacco- related lung cancer rates, the tobacco related lung cancer rates were comparatively small until the cigarette became so widely available made possible by lower prices and mass production using the Bonsack machine in the 1880's.
The recent discussion, debate and court determinations (with FDA acquiescence) over e-cigarettes helps us further realize and recognize that absent therapeutic claims the definition of a tobacco product will (and should) be more broadly interpreted. The FDA's 'letter' to Star Scientific concerning its Ariva and Stonewall BDL products is another example, where some (I don’t agree) read it to suggest these products are not tobacco products. While some members of the public health community were actively fighting the e-cigarette from being considered a tobacco product at all, they simultaneously sought to make the case that Ariva and Stonewall BDL should be regulated under the tobacco statute. There is no question in my mind that the dissolvable sticks, orbs, and strips are and will remain tobacco products under the Act so long as no therapeutic claims are made.
Using the scope of the definition of a tobacco product, I would go one step further to also suggest that many other nicotine based products from which the nicotine is derived from tobacco (which is I believe all of them are) will also be considered tobacco products and not 'drugs' or ‘devices’ absent therapeutic claims. Pharmaceutical companies could in my view make the case that their existing patches, gums, lozenges etc. could also be sold as products not subject to the drug provisions but rather as tobacco products under the FDA statute as long as they did not make the therapeutic claims. These products are just as much 'tobacco products' as defined by the statute as are e-cigarettes, or as are dissolvable or other products containing tobacco. It may be just a matter of time before the pharmaceutical products cross over the line to also be sold as tobacco products. And there are products that call themselves 'cigarettes' such as one I recently read about called Elusion being developed in New Zealand which comes in both a nicotine (derived from tobacco) and non-nicotine form.
Just as we see Big Tobacco companies moving into developing other forms of nicotine products, we thus could feasibly see pharmaceutical companies moving to produce a wider spectrum of products, some of which may be even more 'tobacco' based than the NRT products currently on the market. Once again this points out that we do indeed a more rational regulatory approach that regulates the growing spectrum of products based on risks, relative risks and intended use and less on the ‘entity’ making manufacturing them.
There is also this ongoing unscientific 'myth' perpetuated by many (that I noted above), that all 'tobacco products' are equally dangerous. This unscientific approach to looking at various products needs to be put to bed. Unfortunately however, there has not been any conscious effort to correct the misperceptions, to provide truthful and accurate statements, or to define what a tobacco product is and is not. It seems that science continues to often be sacrificed (misused or distorted) for advocacy and public relations purposes. We seem to see it in many statements from the tobacco control sector and even in government publications that highlight the serious dangers of smoking , only to in the next line or paragraph broaden the statement to include all tobacco—implying that all tobacco is equally harmful or just being sloppy in not making clearer, more understandable distinctions as to how the approximately 440,000 tobacco related deaths are caused. This is not only confusing but misleading and only adds to the confusion that consumers face every day as they try and sort out the wall of products behind the counter in their convenience store or pharmacy. Given this continuing confusion we urgently need to be looking at the risks, relative risks and intended uses of all tobacco, nicotine and alternative products and setting labeling and marketing standards, distribution and sales requirements, packaging requirement, etc. based on those risks.
Comments and Suggestions:
Given that the term 'tobacco product', as historically interpreted, is becoming more and more confusing and anachronistic in the current regulatory environment, I suggest that an impartial group of experts be convened to try and sort out definitions and look at 'categories' and products based on risks, relative risks and intended uses. This should and must include the growing spectrum of all tobacco, nicotine and alternative products. I believe that it is not too far off in the future when a tobacco based or tobacco containing product might be able to make a therapeutic claim and take its place as a serious competitor to the more traditional NRT products. In some instances those risk profiles are already comparable. I have suggested in other presentations I have made that the FDA tobacco center be reconstituted as the Center for Tobacco, Nicotine, and Alternative Products and that products be placed into three categories - 1. Combustible Products, 2. Noncombustible Products (Smoking Replacement Products (SRP's) and 3. Therapeutic Products. It may be one of the reasons why some, who aren't sure how to handle these changes, want to keep the ‘tobacco wars’ going and continue to rely on broad sweeping statements and nebulous definitions that in today’s age really aren’t helpful to public health objectives.
3. Who and What is the 'Tobacco Industry' ?
As I noted above in the introduction, the marketplace both in the US and elsewhere has the potential for having a broad spectrum of both traditional and nontraditional tobacco, nicotine, and alternative products which should make us think about the need to redefine who and what we are talking about when we use the term, 'tobacco industry'. For more than five years now I have suggested that there would be a convergence of interests between the tobacco industry and the pharmaceutical industry with tobacco becoming more pharmaceutical-like and pharmaceutical companies potentially focusing more on the development of consumer-oriented nicotine products, some that might be tobacco based or have other components (in addition to nicotine) that are derived from tobacco. That is clearly happening.
For the last several decades it served our purposes very well to refer to the 'tobacco industry' -- that easily defined bastion of deception and deceit. We successfully and rightfully demonized the 'industry'. The term is still being used and will continue to be used for public relations and public advocacy purposes, both in the US and in the rest of the world and I take no offense at that. In fact, for many countries, absent effective regulatory oversight, it is probably very appropriate to be using the term ‘tobacco industry’. The battles that are being waged on a global level however, differ greatly and each country must decide what tactics and stratgies work best for them. But in terms of regulating an expanding number of tobacco, nicotine and alternative products in the US, as well as Europe, we need to consider undertaking a paradigm shift, making changes that could be precedent setting and eventually be applied elsewhere in the world. In retrospect, the US Congress missed a tremendous opportunity when it limited it’s discussion to merely tobacco and the tobacco industry, relying on legislation proposals and approaches that had first been introduced in the 1990’s and were clearly outdated.
While it is important to put all of this into a historical context, it should not distract us from the fact that it is now time to consider what should have been considered 10-15 years ago. With a regulatory agency now overseeing tobacco, nicotine and alternative products we indeed have some opportunities before us, albeit not without challenges. So with respect to our use of the words ‘tobacco industry’, let’s think about how we might redefine our terms by asking a few questions.
· Is the 'tobacco industry' made up of only those who we call Big Tobacco?
· Does it include the hundreds if not thousands of small manufacturers scattered throughout the world? Even these manufacturers are very diverse and it might be impossible to try and stereotype them.
· Does it include tobacco growers, leaf dealers, and anyone who deals in tobacco in any shape or form? Are for example those in the flavors and fragrance business to be considered tobacco companies? Are the private sector laboratories doing testing and evaluation of tobacco related products for a spectrum of companies to be considered the 'tobacco industry'?
· Does it mean or imply that anyone and all entities that we brand as the 'tobacco industry' carry the same views and work as a single coordinated body and lobby?
· Aren't pharmaceutical companies (and others) that make nicotine based products, from which the nicotine is derived from tobacco, also in the tobacco -related business, being manufacturers of products regardless of where they sit on the risk reduction continuum ? And aren't these manufacturers today locked in a contentious competition with others to see who will dominate the tobacco, nicotine, and alternative products market place?
· Are not the traditional tobacco industry players (Big Tobacco) becoming more involved in expanding their product portfolios by researching and developing alternative nicotine delivery products? How is/will the pharmaceutical industry respond ?
· Are e-cigarette manufacturers who carry none to little of the traditional baggage of Big Tobacco part of the tobacco industry?
· Isn't it feasible/expected that we will continue to see new players (and more importantly new products) enter the tobacco, nicotine, and alternative products marketplace that might include biotech companies, food companies, dietary supplement companies, joint ventures involving research institutions and other entrepreneurs? If so, don't we need to establish the regulatory umbrella under which these players and products can compete in the market place and be regulated using similar and more consistent standards?
These considerations and possible trends can also be seen in the FSPTC Act where a number of sections take a broader perspective and focus on the product rather than on who the manufacturer is (i.e. a tobacco manufacturer will receive the same treatment and consideration and expected to provide the same level of science needed to support an application as would any other entity). Section 911 (Modified Risk Tobacco Products) for example talks about 'any person' seeking to get an approval for a modified risk product. It doesn't say big tobacco or the 'tobacco industry'. The filing of the application could come from a more traditional tobacco company but it could also come from a pharmaceutical company, a biotech company, a food company, a dietary supplement company, a joint venture that might even include an academic institution, or even an individual.
Comments and Suggestions: Just as we need to take a closer look at how we define tobacco, nicotine and alternative products in the future we also need to simultaneously look at how we are describing the companies and manufacturers who are doing the research, development and marketing of these products. The more traditional tobacco and pharmaceutical companies are at a crossroads of sorts, competing, not only amongst themselves but with a whole new breed of companies and research interests. They can perpetuate the past or they can be trail blazers in what will be an inevitable shift in their business practices and ways of doing business. Many of the players who ignore the science or their obligations will and should rightfully be driven off the playing field. I see the landscape continuing to radically change with more and more innovation, technology and product development that if managed in the proper regulatory setting will benefit public health.
We might want to define and categorize tobacco and nicotine manufacturers based on the type of products they make. For example:
· For those manufacturing cigarettes, cigars and other combustible products, the “Combustible or Cigarette Industry”;
· For those manufacturing the more traditional ‘smokeless’ products, the “Smokeless Industry”;
· For those manufacturing alternative products that are noncombustible and scientifically established to be significantly lower in risk than the combustible cigarette (and lower in risk than more traditional smokeless products), the “Smoking Replacement Products (SRP's) Industry”;
· For those manufacturing tobacco, nicotine and alternative products that are intended for therapeutic purposes, the Tobacco, Nicotine and Alternative Products Therapeutic Industry.
Whatever we come up with, we have to get beyond the stereotyping that has been used ( but which has been so critically important) in the 60’s, 70’s 80’ and even 90’s. It is indeed time to take a more pragmatic and rational approach to defining who these various industry segments are and are not if we are serious about improving the public health. Whoever the manufacturer is and what ever product is being considered, the most critical need is to ensure that the research conducted by any entity meets strict scientific criteria.
Just as a researcher, or research institution should not advocate the scientific research agenda of a corporate interest (tobacco, pharmaceutical, food, drug, medical device or other) so too must we be careful not to have scientists and researchers being asked to take and support advocacy and public policy position that go beyond their research conclusions. The research should speak for itself. At a recent conference at Harvard in June on tobacco science, one presenter suggested that researchers needed to "get out of their silos', something that if anyone has read things I have written knows, I agree wholeheartedly with. We need to get people and all stakeholders and experts out of their silos and into the sunlight of dialogue and discussion and to have them bring their insights and expertise to what is an increasingly complicated environment. But we should be careful, very careful about the scientific community in particular being co-opted and used by corporate interests as well as the tobacco control advocacy (who views and positions are not always based on or backed up with science). Dialogue and communication are essential but science and the scientist must seek to remain as independent as possible, yet actively be a part of the process.
An Observational Piece
Scott D. Ballin, JD
Health Policy Consultant
6220 30th Street NW
Washington DC 20015
Tel: 202 686-8898
Email: ScDBa@aol.com
www.tobaccoatacrossroads.com
August 1, 2011
1. Introduction
2. What is a 'Tobacco Product'?
3. Who and What is the 'Tobacco Industry'?
4. Who and What is the 'Tobacco Control/Public Health' community?
5. What do we mean by 'Cessation' ?
6. What do we mean by 'Claims and health claims' ?
7. What is 'Harm Reduction' ?
8. Conclusions
1. Introduction:
Several months ago in an observational piece about the critical role that science will be playing in terms of tobacco, nicotine and alternative product regulation, I indicated that I was planning on doing something concerning the increasing confusion over the various uses of words and terms in the tobacco, nicotine and alternative products environment. As with the other observational pieces I have done, this piece is designed to make some observations, to generate further discussion, and to hopefully initiate some new thinking.
The FDA’s acquisition of regulatory authority over tobacco products (and it previous existing authorities over therapeutic nicotine replacement products), the importance of science in setting regulations, and the obvious fact that we are in a ‘new era’ of tobacco, nicotine and alternative product regulations, make it important at this juncture that we clearly define our terms and reconsider how we might best approach policy decisions in the coming months and years.
I have been in 'tobacco control' (I am not even entirely sure what that means in today's environment) for more than 30 years. In the early years it was relatively simple to use terms - it was a 'war' between two interests, good and evil. We in public health wore the white hats of course and the tobacco industry wore the black hats. The tobacco industry, later to be branded BIG TOBACCO, was relatively easy to define. We knew their deceitful and deceptive practices. We knew how extensive their influences were and the extent to which their money influenced decision- making. We knew that they worked hand in hand following well laid out strategies. We considered any one associated with tobacco, including tobacco farmers, retailers, advertisers etc. as a part of the tobacco industry. Today while these two extremes continue to exist there is a much larger 'gray' area that has emerged --- an area that often goes unrecognized by those who remain severely polarized and content on keeping the old ‘ tobacco wars’ of the 80's and 90's alive.
In the mid-1990's, through a project funded by the Robert Wood Johnson Foundation, and managed by the Institute for Environmental Negotiation (IEN) at the University of Virginia that brought tobacco growers and the public health community together, I quickly learned and came to appreciate that things are not so black and white as they appear.
Much of the 'war' in the early years was focused on 'smoking', and companies manufacturing combustible products that contained thousands of chemical constituents, many of them known carcinogens and highly toxic. Cigarettes without question remain by far the most significant cause of harm (both for the individual and for the population as a whole) from the use of tobacco, far above and beyond the traditional 'smokeless' products but even more so in comparison with the growing number of extremely lower risk noncombustible tobacco, nicotine and alternative products which I prefer to call Smoking Replacement Products (SRP's) rather 'smokeless' products or nicotine replacement products (NRT). In spite of the fact that innovation, technology, science, competition, and most importantly regulatory oversight are challenging and changing the market place, many of the traditional stakeholders intentionally or unintentionally choose to cling to the past.
In today's radically altered environment there are so many terms and definitions being used that you need a scorecard to figure it all out. On top of that, the terms are no longer very 'defining' , and have become broad-sweeping and are often used interchangeably. Even the FDA statute and the confusion as to what is and what is not a tobacco product reflects the confusion that exists and the dire need to sit down and revisit not only the terminalogy but the statute itself - to make it a more rational and workable statute for defining and regulating all tobacco, nicotine and alternative products. This radically changing environment, so different (here in the US) from the 'tobacco wars' of the 70's,80's and 90's is why I have gone so far as to suggest that the FSTPC Act (with all is positive attributes) was outdated in many areas even before President Obama's signature was dry. Below are a number of examples where the confusion exists and will only get worse unless some serious, rational and prospective thinking takes place.
2. What is a 'Tobacco Product' ?
Before discussing 'tobacco products', let me first make a note that ‘tobacco’ is an agricultural based plant, grown in many varieties, and having a spectrum of differing properties . It is also critical in today's environment to recognize that it is what is done to the tobacco, how it is grown, processed, cured, refined, treated, manufactured and most importantly ‘used’ ( i.e. combusted versus non-combusted) that has a significant impact on determining the level of risk. Tobacco, often called the 'white rat' of the plant world is also being used to develop medicines, industrial enzymes and other potential products. So, it is prudent to not use the term too broadly, especially in talking in a public health context. It is also prudent and wise to ensure that as we discuss tobacco (and tobacco products made or derived from tobacco )we are involve, agronomists, growers, and other scientists into the discussion and not ignore these important experts.
For many the term 'tobacco product' conjures up the more traditional products of cigarettes, cigars, smokeless, pipe tobacco, roll your own, etc. products made by the 'evil empire', products which many, (including many people in public health who should know better), claim (inaccurately) all carry the same health hazards and risks. In fact such a term and its presumed definition really no longer fits today's environment.
The FDA statute defines a tobacco product as something as having a much broader application and as we shall see covers much much more than our traditional views:
(rr)(1) The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).
(2) The term 'tobacco product' does not mean an article that is a drug under subsection(g)(1), a device under subsection (h), or a combination product described in section 503(g).
(3) The products described in paragraph (2) shall be subject to chapter V of this Act.
(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or dietary supplement).
The broad definition, then qualified with exceptions is in today’s environment filled with confusion, complications, a potential nightmare for the Agency, and a field day for private sector FDA lawyers. It is further complicated by the definitions under Title IX that seek to define some specific products but which is unclear about others. It might have made some (but even then not much) sense to segment out tobacco/nicotine products into different Centers at the FDA at one time but with the establishment of the new Center for Tobacco Products, a serious rethinking should have taken place in Congress -- one that would have brought a more rational approach to the regulation of all of the tobacco, nicotine and alternative products. This idea of regulating these products under one umbrella or as part of a more consistent set of standards based on risk is not new and has been referenced, suggested and advocated by many highly respected individuals for more than 10 years. Yet many (for many assorted reasons which I will not go into here) today seem to oppose and resist any new thinking on the subject.
The ‘tobacco product’ has evolved over many years and is continuing to evolve and there is no reason for its definition not to be revised from time to time as is the case today. Prior to the late 19th century there was no such thing as a ‘cigarette’. Most tobacco was either used in pipes, large cigars or in raw noncombustible forms (such as chewing tobacco or snuff). The cigarette was really discovered by accident (and later capitalized on) when soldiers during the Crimea War in the middle of the 19th century rolled tobacco in pieces of newspaper and called the little cigar a 'cigar-ette', a name formally given in France. It is no wonder that compared to today’s devastating tobacco- related lung cancer rates, the tobacco related lung cancer rates were comparatively small until the cigarette became so widely available made possible by lower prices and mass production using the Bonsack machine in the 1880's.
The recent discussion, debate and court determinations (with FDA acquiescence) over e-cigarettes helps us further realize and recognize that absent therapeutic claims the definition of a tobacco product will (and should) be more broadly interpreted. The FDA's 'letter' to Star Scientific concerning its Ariva and Stonewall BDL products is another example, where some (I don’t agree) read it to suggest these products are not tobacco products. While some members of the public health community were actively fighting the e-cigarette from being considered a tobacco product at all, they simultaneously sought to make the case that Ariva and Stonewall BDL should be regulated under the tobacco statute. There is no question in my mind that the dissolvable sticks, orbs, and strips are and will remain tobacco products under the Act so long as no therapeutic claims are made.
Using the scope of the definition of a tobacco product, I would go one step further to also suggest that many other nicotine based products from which the nicotine is derived from tobacco (which is I believe all of them are) will also be considered tobacco products and not 'drugs' or ‘devices’ absent therapeutic claims. Pharmaceutical companies could in my view make the case that their existing patches, gums, lozenges etc. could also be sold as products not subject to the drug provisions but rather as tobacco products under the FDA statute as long as they did not make the therapeutic claims. These products are just as much 'tobacco products' as defined by the statute as are e-cigarettes, or as are dissolvable or other products containing tobacco. It may be just a matter of time before the pharmaceutical products cross over the line to also be sold as tobacco products. And there are products that call themselves 'cigarettes' such as one I recently read about called Elusion being developed in New Zealand which comes in both a nicotine (derived from tobacco) and non-nicotine form.
Just as we see Big Tobacco companies moving into developing other forms of nicotine products, we thus could feasibly see pharmaceutical companies moving to produce a wider spectrum of products, some of which may be even more 'tobacco' based than the NRT products currently on the market. Once again this points out that we do indeed a more rational regulatory approach that regulates the growing spectrum of products based on risks, relative risks and intended use and less on the ‘entity’ making manufacturing them.
There is also this ongoing unscientific 'myth' perpetuated by many (that I noted above), that all 'tobacco products' are equally dangerous. This unscientific approach to looking at various products needs to be put to bed. Unfortunately however, there has not been any conscious effort to correct the misperceptions, to provide truthful and accurate statements, or to define what a tobacco product is and is not. It seems that science continues to often be sacrificed (misused or distorted) for advocacy and public relations purposes. We seem to see it in many statements from the tobacco control sector and even in government publications that highlight the serious dangers of smoking , only to in the next line or paragraph broaden the statement to include all tobacco—implying that all tobacco is equally harmful or just being sloppy in not making clearer, more understandable distinctions as to how the approximately 440,000 tobacco related deaths are caused. This is not only confusing but misleading and only adds to the confusion that consumers face every day as they try and sort out the wall of products behind the counter in their convenience store or pharmacy. Given this continuing confusion we urgently need to be looking at the risks, relative risks and intended uses of all tobacco, nicotine and alternative products and setting labeling and marketing standards, distribution and sales requirements, packaging requirement, etc. based on those risks.
Comments and Suggestions:
Given that the term 'tobacco product', as historically interpreted, is becoming more and more confusing and anachronistic in the current regulatory environment, I suggest that an impartial group of experts be convened to try and sort out definitions and look at 'categories' and products based on risks, relative risks and intended uses. This should and must include the growing spectrum of all tobacco, nicotine and alternative products. I believe that it is not too far off in the future when a tobacco based or tobacco containing product might be able to make a therapeutic claim and take its place as a serious competitor to the more traditional NRT products. In some instances those risk profiles are already comparable. I have suggested in other presentations I have made that the FDA tobacco center be reconstituted as the Center for Tobacco, Nicotine, and Alternative Products and that products be placed into three categories - 1. Combustible Products, 2. Noncombustible Products (Smoking Replacement Products (SRP's) and 3. Therapeutic Products. It may be one of the reasons why some, who aren't sure how to handle these changes, want to keep the ‘tobacco wars’ going and continue to rely on broad sweeping statements and nebulous definitions that in today’s age really aren’t helpful to public health objectives.
3. Who and What is the 'Tobacco Industry' ?
As I noted above in the introduction, the marketplace both in the US and elsewhere has the potential for having a broad spectrum of both traditional and nontraditional tobacco, nicotine, and alternative products which should make us think about the need to redefine who and what we are talking about when we use the term, 'tobacco industry'. For more than five years now I have suggested that there would be a convergence of interests between the tobacco industry and the pharmaceutical industry with tobacco becoming more pharmaceutical-like and pharmaceutical companies potentially focusing more on the development of consumer-oriented nicotine products, some that might be tobacco based or have other components (in addition to nicotine) that are derived from tobacco. That is clearly happening.
For the last several decades it served our purposes very well to refer to the 'tobacco industry' -- that easily defined bastion of deception and deceit. We successfully and rightfully demonized the 'industry'. The term is still being used and will continue to be used for public relations and public advocacy purposes, both in the US and in the rest of the world and I take no offense at that. In fact, for many countries, absent effective regulatory oversight, it is probably very appropriate to be using the term ‘tobacco industry’. The battles that are being waged on a global level however, differ greatly and each country must decide what tactics and stratgies work best for them. But in terms of regulating an expanding number of tobacco, nicotine and alternative products in the US, as well as Europe, we need to consider undertaking a paradigm shift, making changes that could be precedent setting and eventually be applied elsewhere in the world. In retrospect, the US Congress missed a tremendous opportunity when it limited it’s discussion to merely tobacco and the tobacco industry, relying on legislation proposals and approaches that had first been introduced in the 1990’s and were clearly outdated.
While it is important to put all of this into a historical context, it should not distract us from the fact that it is now time to consider what should have been considered 10-15 years ago. With a regulatory agency now overseeing tobacco, nicotine and alternative products we indeed have some opportunities before us, albeit not without challenges. So with respect to our use of the words ‘tobacco industry’, let’s think about how we might redefine our terms by asking a few questions.
· Is the 'tobacco industry' made up of only those who we call Big Tobacco?
· Does it include the hundreds if not thousands of small manufacturers scattered throughout the world? Even these manufacturers are very diverse and it might be impossible to try and stereotype them.
· Does it include tobacco growers, leaf dealers, and anyone who deals in tobacco in any shape or form? Are for example those in the flavors and fragrance business to be considered tobacco companies? Are the private sector laboratories doing testing and evaluation of tobacco related products for a spectrum of companies to be considered the 'tobacco industry'?
· Does it mean or imply that anyone and all entities that we brand as the 'tobacco industry' carry the same views and work as a single coordinated body and lobby?
· Aren't pharmaceutical companies (and others) that make nicotine based products, from which the nicotine is derived from tobacco, also in the tobacco -related business, being manufacturers of products regardless of where they sit on the risk reduction continuum ? And aren't these manufacturers today locked in a contentious competition with others to see who will dominate the tobacco, nicotine, and alternative products market place?
· Are not the traditional tobacco industry players (Big Tobacco) becoming more involved in expanding their product portfolios by researching and developing alternative nicotine delivery products? How is/will the pharmaceutical industry respond ?
· Are e-cigarette manufacturers who carry none to little of the traditional baggage of Big Tobacco part of the tobacco industry?
· Isn't it feasible/expected that we will continue to see new players (and more importantly new products) enter the tobacco, nicotine, and alternative products marketplace that might include biotech companies, food companies, dietary supplement companies, joint ventures involving research institutions and other entrepreneurs? If so, don't we need to establish the regulatory umbrella under which these players and products can compete in the market place and be regulated using similar and more consistent standards?
These considerations and possible trends can also be seen in the FSPTC Act where a number of sections take a broader perspective and focus on the product rather than on who the manufacturer is (i.e. a tobacco manufacturer will receive the same treatment and consideration and expected to provide the same level of science needed to support an application as would any other entity). Section 911 (Modified Risk Tobacco Products) for example talks about 'any person' seeking to get an approval for a modified risk product. It doesn't say big tobacco or the 'tobacco industry'. The filing of the application could come from a more traditional tobacco company but it could also come from a pharmaceutical company, a biotech company, a food company, a dietary supplement company, a joint venture that might even include an academic institution, or even an individual.
Comments and Suggestions: Just as we need to take a closer look at how we define tobacco, nicotine and alternative products in the future we also need to simultaneously look at how we are describing the companies and manufacturers who are doing the research, development and marketing of these products. The more traditional tobacco and pharmaceutical companies are at a crossroads of sorts, competing, not only amongst themselves but with a whole new breed of companies and research interests. They can perpetuate the past or they can be trail blazers in what will be an inevitable shift in their business practices and ways of doing business. Many of the players who ignore the science or their obligations will and should rightfully be driven off the playing field. I see the landscape continuing to radically change with more and more innovation, technology and product development that if managed in the proper regulatory setting will benefit public health.
We might want to define and categorize tobacco and nicotine manufacturers based on the type of products they make. For example:
· For those manufacturing cigarettes, cigars and other combustible products, the “Combustible or Cigarette Industry”;
· For those manufacturing the more traditional ‘smokeless’ products, the “Smokeless Industry”;
· For those manufacturing alternative products that are noncombustible and scientifically established to be significantly lower in risk than the combustible cigarette (and lower in risk than more traditional smokeless products), the “Smoking Replacement Products (SRP's) Industry”;
· For those manufacturing tobacco, nicotine and alternative products that are intended for therapeutic purposes, the Tobacco, Nicotine and Alternative Products Therapeutic Industry.
Whatever we come up with, we have to get beyond the stereotyping that has been used ( but which has been so critically important) in the 60’s, 70’s 80’ and even 90’s. It is indeed time to take a more pragmatic and rational approach to defining who these various industry segments are and are not if we are serious about improving the public health. Whoever the manufacturer is and what ever product is being considered, the most critical need is to ensure that the research conducted by any entity meets strict scientific criteria.
Just as a researcher, or research institution should not advocate the scientific research agenda of a corporate interest (tobacco, pharmaceutical, food, drug, medical device or other) so too must we be careful not to have scientists and researchers being asked to take and support advocacy and public policy position that go beyond their research conclusions. The research should speak for itself. At a recent conference at Harvard in June on tobacco science, one presenter suggested that researchers needed to "get out of their silos', something that if anyone has read things I have written knows, I agree wholeheartedly with. We need to get people and all stakeholders and experts out of their silos and into the sunlight of dialogue and discussion and to have them bring their insights and expertise to what is an increasingly complicated environment. But we should be careful, very careful about the scientific community in particular being co-opted and used by corporate interests as well as the tobacco control advocacy (who views and positions are not always based on or backed up with science). Dialogue and communication are essential but science and the scientist must seek to remain as independent as possible, yet actively be a part of the process.
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