According to an article in yesterday's Wall Street Journal, the pharmaceutical company GlaxoSmithKline urged the FDA to remove dissolvable tobacco products from the market.
According to the article: "GlaxoSmithKline PLC called for the U.S. government to remove so-called dissolvable smokeless-tobacco products from the market, a move that shows emerging battle lines between pharmaceutical and tobacco companies aiming to sell alternatives to cigarettes. GlaxoSmithKline, which markets quit-smoking aids such as Nicorette gum, said Monday that it urged the Food and Drug Administration to take oral dissolvable tobacco products from store shelves until companies that make such products, including tobacco giant Reynolds American Inc., 'can demonstrate to the FDA that their marketing is appropriate for the protection of public health.'"
The Rest of the Story
This story demonstrates that Big Pharma views alternative tobacco products - such as dissolvable smokeless tobacco - as a threat to its profits because such products may be used as an alternative to nicotine replacement therapy among smokers who want to quit or cut down on their smoking and reduce their health risks.
But a more important implication of the story, and one which is not generally being reported elsewhere, is that it demonstrates why it is inexcusable to have individuals on the Tobacco Products Scientific Advisory Committee (TPSAC) who have financial conflicts of interest with Big Pharma.
The next major issue that TPSAC will consider (after menthol), in fact, is dissolvable tobacco products. Now that GlaxoSmithKline has come out in strong opposition to these products and directly petitioned the FDA to remove these products from the market, it is not possible for any TPSAC member who has a financial conflict of interest with Glaxo (or similar companies that manufacture smoking cessation products) to impartially participate in discussions on this matter.
Due to the FDA's ignoring financial conflicts of interest in appointing the TPSAC panel, however, it turns out that Glaxo essentially has a seat on the panel.
A GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - was appointed to the Tobacco Products Scientific Advisory Committee. Pinney Associates is a pharmaceutical consulting firm that provides consulting support to GlaxoSmithKline on an exclusive basis regarding tobacco dependence treatment. GlaxoSmithKline is the manufacturer of Zyban and NiQuitin.
In addition to his serving as an exclusive consultant to GlaxoSmithKline specifically on the issue of tobacco dependence treatment, Dr. Henningfield also has a personal financial interest in smoking cessation treatment, as he has a financial interest in a potential new oral nicotine replacement therapy product.
To make matters even worse, Dr. Henningfield has testified in court as an expert witness on behalf of GlaxoSmithKline.
To make matters worse still, the chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer.
And to make matters even more unacceptable, a third member of the panel - Dr. Neal Benowitz - has consulted for GlaxoSmithKline.
Dr. Benowitz also co-authored a study on the use of Chantix in smoking cessation which was funded by Pfizer and has served as a Pfizer consultant. In particular, Dr. Benowitz served as a Pfizer consultant on how to develop a scientific base to support the use of Chantix in smoking cessation. In addition to consulting for Glaxo, Benowitz has also consulted for Nabi Pharmaceuticals.
To make matters downright ugly, a fourth member of the panel - Dr. Dorothy Hatsukami - has received grant support from a pharmaceutical company to study the nicotine vaccine for use in smoking cessation.
Given GlaxoSmithKline's direct request to the FDA and given these four panel members' significant conflicts of interest with Big Pharma, I call on these panel members to withdraw from the Tobacco Products Scientific Advisory Committee.
Short of that, I call on the FDA to remove these members from the Committee and to replace them with unconflicted scientists who can make unbiased decisions about federal regulatory policy.
Wednesday, September 29, 2010
Monday, September 27, 2010
Members of TPSAC Acknowledge There is No Science Base to Support Redution of Nicotine as Measure to Have Profound Effect on Tobacco-Related Disease
Three members of the FDA Tobacco Products Scientific Advisory Committee (TPSAC), in an article published in the current issue of Tobacco Control, acknowledge the lack of a scientific basis for mandating reduced nicotine levels as a means to achieve a profound reduction of tobacco-related morbidity and mortality (see: Hatsukami DK, Perkins KA, LeSage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tobacco Control 2010;19:e1-e10).
The paper reviews the scientific basis for the idea of requiring reductions in nicotine levels in cigarettes. The FDA Tobacco Act allows the Agency to reduce, but not to eliminate nicotine in cigarettes. Anti-smoking groups, such as the Campaign for Tobacco-Free Kids and the American Cancer Society, have boasted that this is going to result in millions of lives being saved. The paper, however, reviews the actual research and demonstrates that there is presently little scientific evidence to support the contention that reducing nicotine levels will save any lives, much less millions of lives.
First of all, the article points out that there is no known threshold below which nicotine is not addictive and below which cigarettes would not be addictive:
"Although studies of the threshold for nicotine discrimination have been conducted, to date no systematic human study has examined the threshold dose for the development or maintenance of nicotine addiction nor directly examined the best approach for reducing levels of nicotine in cigarettes to maximise public health benefits."
Moreover, the article points out that existing evidence indicates that cigarettes with very low nicotine levels are still effective in reducing nicotine craving and still produce pharmacologic effects associated with nicotine. Apparently, the article concludes, even very low doses of nicotine are capable of binding to receptors and causing pharmacologic effects:
"Laboratory studies show that denicotinised cigarettes produce acute subjective effects similar to those of nicotine cigarettes. For example, denicotinised cigarettes have been shown to reduce craving and negative affect due to withdrawal during short-term abstinence periods from usual brand cigarettes. The acute withdrawal relieving effects are found not to be due to expectancies for nicotine or the simple motor aspects of smoking (eg, handling), highlighting the importance of smoke inhalation per se. Denicotinised cigarettes and standard nicotine cigarettes can produce similar self-reported liking and satisfaction in smokers although another study found results to the contrary, and can produce similar delays in the latency to smoke (ie, the time to smoke a cigarette) or reductions in the amount of subsequent smoking of nicotine cigarettes. Denicotinised cigarettes may also be as acutely reinforcing as nicotine cigarettes in dependent smokers, suggesting that denicotinised cigarettes may serve as an effective short-term substitute for nicotine-containing cigarettes when the latter are unavailable." ...
"The responses observed with denicotinised cigarettes may be because non-nicotine sensory aspects have acquired reinforcing effects, non-nicotine constituents other than nicotine are reinforcing, or that low levels of nicotine are sufficient to maintain smoking behaviour because these levels can produce effects of physiological significance, at least acutely. For example, recent brain imaging studies show that smoking a single very low nicotine cigarette results in significant (23%) occupancy of α4β2 nicotinic receptors, which are considered the primary receptor subtype mediating nicotine's reinforcing and other behavioural effects. Thus, the reinforcing and mood effects of very low nicotine cigarettes may be attributable, in part, to nicotine's pharmacological effects. Other evidence also suggests that very low level nicotine exposure may have important pharmacological effects. This includes in vitro studies showing that significant nicotinic receptor desensitisation, a potential contributor to nicotine addiction, can occur with nicotine doses below a threshold for activating receptors, which mediates nicotine's acute reinforcing effects. In summary, abrupt switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement in the short term."
The article also points out that animal studies indicate that extremely low doses of nicotine in animals are still capable of producing nicotine dependence:
"While NSA in animals typically decreases at unit doses below 0.01 mg/kg, unit doses as low as 0.003 mg/kg have been shown to maintain NSA in rats above saline extinction levels when substituted for a higher training dose (eg, 0.03 mg/kg), though variability between subjects is apparent (see also De Noble and Mele and Donny et al). No animal studies have specifically characterised the reinforcement threshold dose of nicotine during acquisition of NSA in adolescents or in the context of progressively reducing the unit nicotine dose during maintenance of NSA in adults."
The paper also points out that it is unknown whether reducing nicotine levels would have any effect on decreasing youth smoking:
"The dose of nicotine that will lead to extinction of smoking may not be the dose that is associated with the onset of dependence symptoms or nicotine addiction. Studies conducted with adolescent smokers suggest that the potential threshold for onset of nicotine addiction is likely to be substantially lower than the five standard nicotine cigarettes per day suggested by earlier research. Several cross-sectional and longitudinal studies have shown that youth smoking on a less than daily basis nevertheless report onset of dependence symptoms. About half the youth smokers who reported 1 or more symptoms reflective of a loss of autonomy over smoking had smoked on average 2 cigarettes 1 day per week, and half of those who met WHO International Classification of Diseases, 10th edition (ICD-10)-defined dependence reported smoking cigarettes a month, or 1–2 cigarettes per day. That symptoms of dependence can develop with low rates of smoking is consistent with results from a small study of adults demonstrating about 50% occupancy of α4β2 nicotinic acetylcholine receptors (nAChRs) for 3 h after just 1–2 puffs on a 1.2–1.4 mg nicotine yield cigarette. Similarly, other prolonged brain effects (long-term potentiation of the excitatory transmission to the brain reward centres) have been observed after brief application of low concentrations of nicotine (0.5–1.0 μM). Human and animal studies have shown that the adolescent brain is more vulnerable and sensitive to nicotine's effects. For example, adult smokers who initiated smoking during adolescence exhibit greater cigarette consumption, lower likelihood of trying to quit and increased risk of relapse compared to those who started smoking later in life. Adolescent rats and mice might also be more sensitive than adults to the rewarding and reinforcing effects of nicotine, as indexed by greater conditioned place preference, faster acquisition of nicotine self-administration (NSA) and higher baseline NSA rates compared to adults (see also Shram et al). What remains unknown are the effects of low dose nicotine cigarettes in adolescents and whether there is a dose that reduces the probability of sustained cigarette use."
Importantly, the article points out that there could be adverse consequences of reducing nicotine levels in cigarettes:
"In the literature concerning human and animal trials, there is a scarcity of data on the effects of reduced nicotine doses on smoking or nicotine intake and on other responses. Even if a threshold reinforcing nicotine dose is identified and a non-addictive cigarette can be produced, it will be important to determine whether there are other adverse effects from the nicotine exposure that occurs in adolescents who nonetheless experiment with such cigarettes. The threshold for nicotine's reinforcing effects may be higher than the threshold for nicotine's other potentially adverse effects, including enhancing vulnerability to other drug use. ... Therefore, low level nicotine exposure in adolescents experimenting with cigarettes designed to prevent nicotine addiction could potentially produce risk of addiction to other drugs of abuse." ...
"Among potential concerns are: (1) a switch to other drugs of abuse, particularly among populations smoking for social reinforcement, self-identity, or self-medication purposes; (2) dual use of tobacco products, such as reduced nicotine cigarettes with oral tobacco or small cigars, which may lead to greater exposure to toxicants, especially if these other tobacco products continue to contain higher nicotine levels; (3) use of reduced nicotine cigarettes as starter products. Just as low freebase nicotine smokeless tobacco products served as starter products for higher nicotine and more toxic smokeless tobacco products, these reduced nicotine cigarettes may lead to the use of other tobacco products with higher levels of nicotine, unless these other products also contain low nicotine levels; (4) illicit cigarette marketing and smuggling including through the internet and through territories that do not require reduced nicotine content of cigarettes; (5) product tampering or manipulation (such as adding nicotine to the product); and (6) industry manipulations (eg, nicotine analogues, companion products to increase nicotinic effects)."
Ultimately, the article concludes that reducing nicotine levels would not necessarily result in an improvement in the public's health, and that surveillance would be necessary to determine the effects of such a policy:
"If nicotine reduction is enacted, then large-scale surveillance is needed in order to understand the population-level impact of such changes. Marketplace monitoring and assessing unintended consequences (smuggling, nicotine spiking, new product introductions, etc) will also involve broad surveys."
The Rest of the Story
Once again, the anti-smoking groups have been tricked by Philip Morris into supporting federal legislation that does more for Philip Morris than for the public's health. The Campaign for Tobacco-Free Kids, in negotiating the legislation with Philip Morris, agreed to the clause that prohibited the FDA from eliminating the nicotine in cigarettes, and only allowed the agency to reduce nicotine levels. As a result, the agency is powerless to mandate changes in cigarettes which would actually result in a dramatic reduction in their addictive potential. As is clear from the article, even with low levels of nicotine, cigarettes retain strong addictive potential as only a minute amount of nicotine is necessary to occupy enough nicotine receptors to produce a pharmacologic effect.
Even more troubling than the fact that the Campaign for Tobacco-Free Kids was duped by Philip Morris in the negotiations over the tobacco legislation is the fact that the Campaign is boasting about how this provision in the law is going to save millions of lives. The Campaign is apparently unaware of the science which demonstrates, quite convincingly, that even low levels of nicotine are capable of producing reinforcing pharmacologic effects.
But the most troubling aspect of the story is the conclusion of the paper: "Reduction of nicotine in tobacco products could potentially have profound impact on reducing tobacco-related morbidity and mortality. ... an organised and multidisciplinary effort should be established to set priorities and goals..., engage appropriate scientific, research and government communities/organizations, shape the direction of research, and ensure that efforts stay focused on the ultimate goal of understanding how nicotine reduction could impact the morbidity and mortality of tobacco use."
After a comprehensive review of the literature in which the authors convincingly demonstrate that the science base does not support the idea that reducing nicotine levels will substantially reduce the addictive potential of cigarettes and that such a policy could have severe negative public health consequences, they still conclude that reducing nicotine levels is a desired public health policy which should be vigorously pursued, and that millions of dollars of taxpayer money should be funneled into research to study a policy which quite likely might be doomed to failure from the get-go.
There is a strange disconnect between the scientific evidence presented in the review and the conclusions and recommendations of the article.
For example, while the authors state that: "switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement," they nevertheless conclude that reduction of nicotine levels could have a profound impact on tobacco-related mortality. If the levels of smoking reward and reinforcement are not substantially reduced in very low-nicotine cigarettes, then how would such a reduction have a profound impact on tobacco-related mortality? The conclusion just doesn't follow from the scientific evidence.
In trying to understand why the science is so divorced from the recommended policies and the strategic agenda, I can only point to two possibilities.
First, as researchers in the area of nicotine science, the authors have a vested interest in promoting research funding into their area of expertise. This is a financial conflict of interest that appears to be influencing the conclusions and recommendations of the article.
Second, all three of the TPSAC authors and two additional authors of the paper have a vested financial interest in maintaining the paradigm that nicotine is the agent responsible for smoking addiction because they have financial ties to pharmaceutical companies which manufacture nicotine replacement or smoking cessation pharmaceutical products:
"DKH has received grant funding from Nabi Biopharmaceuticals to conduct nicotine vaccine clinical trials. JEH provides consulting support for GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment, has financial interest in a potential new oral nicotine replacement product and serves as an expert witness in litigation against tobacco companies. NLB serves as a consultant for Pfizer and as an expert witness in litigation against tobacco companies. MZ provides consulting support to GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment. KAP has served as a consultant to Cypress Bioscience."
That pretty much says it all. With this magnitude of conflict among the study authors, there is no way we could expect an objective set of recommendations and conclusions. And, by the way, this is exactly the reason why I have argued that scientists with financial conflicts of interest should not be making national policy recommendations.
The rest of the story is that there is a complete disconnect between the scientific base and the policy agenda in tobacco control today. Financial and political influences have wrested the policy agenda in tobacco control firmly away from the science base.
The paper reviews the scientific basis for the idea of requiring reductions in nicotine levels in cigarettes. The FDA Tobacco Act allows the Agency to reduce, but not to eliminate nicotine in cigarettes. Anti-smoking groups, such as the Campaign for Tobacco-Free Kids and the American Cancer Society, have boasted that this is going to result in millions of lives being saved. The paper, however, reviews the actual research and demonstrates that there is presently little scientific evidence to support the contention that reducing nicotine levels will save any lives, much less millions of lives.
First of all, the article points out that there is no known threshold below which nicotine is not addictive and below which cigarettes would not be addictive:
"Although studies of the threshold for nicotine discrimination have been conducted, to date no systematic human study has examined the threshold dose for the development or maintenance of nicotine addiction nor directly examined the best approach for reducing levels of nicotine in cigarettes to maximise public health benefits."
Moreover, the article points out that existing evidence indicates that cigarettes with very low nicotine levels are still effective in reducing nicotine craving and still produce pharmacologic effects associated with nicotine. Apparently, the article concludes, even very low doses of nicotine are capable of binding to receptors and causing pharmacologic effects:
"Laboratory studies show that denicotinised cigarettes produce acute subjective effects similar to those of nicotine cigarettes. For example, denicotinised cigarettes have been shown to reduce craving and negative affect due to withdrawal during short-term abstinence periods from usual brand cigarettes. The acute withdrawal relieving effects are found not to be due to expectancies for nicotine or the simple motor aspects of smoking (eg, handling), highlighting the importance of smoke inhalation per se. Denicotinised cigarettes and standard nicotine cigarettes can produce similar self-reported liking and satisfaction in smokers although another study found results to the contrary, and can produce similar delays in the latency to smoke (ie, the time to smoke a cigarette) or reductions in the amount of subsequent smoking of nicotine cigarettes. Denicotinised cigarettes may also be as acutely reinforcing as nicotine cigarettes in dependent smokers, suggesting that denicotinised cigarettes may serve as an effective short-term substitute for nicotine-containing cigarettes when the latter are unavailable." ...
"The responses observed with denicotinised cigarettes may be because non-nicotine sensory aspects have acquired reinforcing effects, non-nicotine constituents other than nicotine are reinforcing, or that low levels of nicotine are sufficient to maintain smoking behaviour because these levels can produce effects of physiological significance, at least acutely. For example, recent brain imaging studies show that smoking a single very low nicotine cigarette results in significant (23%) occupancy of α4β2 nicotinic receptors, which are considered the primary receptor subtype mediating nicotine's reinforcing and other behavioural effects. Thus, the reinforcing and mood effects of very low nicotine cigarettes may be attributable, in part, to nicotine's pharmacological effects. Other evidence also suggests that very low level nicotine exposure may have important pharmacological effects. This includes in vitro studies showing that significant nicotinic receptor desensitisation, a potential contributor to nicotine addiction, can occur with nicotine doses below a threshold for activating receptors, which mediates nicotine's acute reinforcing effects. In summary, abrupt switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement in the short term."
The article also points out that animal studies indicate that extremely low doses of nicotine in animals are still capable of producing nicotine dependence:
"While NSA in animals typically decreases at unit doses below 0.01 mg/kg, unit doses as low as 0.003 mg/kg have been shown to maintain NSA in rats above saline extinction levels when substituted for a higher training dose (eg, 0.03 mg/kg), though variability between subjects is apparent (see also De Noble and Mele and Donny et al). No animal studies have specifically characterised the reinforcement threshold dose of nicotine during acquisition of NSA in adolescents or in the context of progressively reducing the unit nicotine dose during maintenance of NSA in adults."
The paper also points out that it is unknown whether reducing nicotine levels would have any effect on decreasing youth smoking:
"The dose of nicotine that will lead to extinction of smoking may not be the dose that is associated with the onset of dependence symptoms or nicotine addiction. Studies conducted with adolescent smokers suggest that the potential threshold for onset of nicotine addiction is likely to be substantially lower than the five standard nicotine cigarettes per day suggested by earlier research. Several cross-sectional and longitudinal studies have shown that youth smoking on a less than daily basis nevertheless report onset of dependence symptoms. About half the youth smokers who reported 1 or more symptoms reflective of a loss of autonomy over smoking had smoked on average 2 cigarettes 1 day per week, and half of those who met WHO International Classification of Diseases, 10th edition (ICD-10)-defined dependence reported smoking cigarettes a month, or 1–2 cigarettes per day. That symptoms of dependence can develop with low rates of smoking is consistent with results from a small study of adults demonstrating about 50% occupancy of α4β2 nicotinic acetylcholine receptors (nAChRs) for 3 h after just 1–2 puffs on a 1.2–1.4 mg nicotine yield cigarette. Similarly, other prolonged brain effects (long-term potentiation of the excitatory transmission to the brain reward centres) have been observed after brief application of low concentrations of nicotine (0.5–1.0 μM). Human and animal studies have shown that the adolescent brain is more vulnerable and sensitive to nicotine's effects. For example, adult smokers who initiated smoking during adolescence exhibit greater cigarette consumption, lower likelihood of trying to quit and increased risk of relapse compared to those who started smoking later in life. Adolescent rats and mice might also be more sensitive than adults to the rewarding and reinforcing effects of nicotine, as indexed by greater conditioned place preference, faster acquisition of nicotine self-administration (NSA) and higher baseline NSA rates compared to adults (see also Shram et al). What remains unknown are the effects of low dose nicotine cigarettes in adolescents and whether there is a dose that reduces the probability of sustained cigarette use."
Importantly, the article points out that there could be adverse consequences of reducing nicotine levels in cigarettes:
"In the literature concerning human and animal trials, there is a scarcity of data on the effects of reduced nicotine doses on smoking or nicotine intake and on other responses. Even if a threshold reinforcing nicotine dose is identified and a non-addictive cigarette can be produced, it will be important to determine whether there are other adverse effects from the nicotine exposure that occurs in adolescents who nonetheless experiment with such cigarettes. The threshold for nicotine's reinforcing effects may be higher than the threshold for nicotine's other potentially adverse effects, including enhancing vulnerability to other drug use. ... Therefore, low level nicotine exposure in adolescents experimenting with cigarettes designed to prevent nicotine addiction could potentially produce risk of addiction to other drugs of abuse." ...
"Among potential concerns are: (1) a switch to other drugs of abuse, particularly among populations smoking for social reinforcement, self-identity, or self-medication purposes; (2) dual use of tobacco products, such as reduced nicotine cigarettes with oral tobacco or small cigars, which may lead to greater exposure to toxicants, especially if these other tobacco products continue to contain higher nicotine levels; (3) use of reduced nicotine cigarettes as starter products. Just as low freebase nicotine smokeless tobacco products served as starter products for higher nicotine and more toxic smokeless tobacco products, these reduced nicotine cigarettes may lead to the use of other tobacco products with higher levels of nicotine, unless these other products also contain low nicotine levels; (4) illicit cigarette marketing and smuggling including through the internet and through territories that do not require reduced nicotine content of cigarettes; (5) product tampering or manipulation (such as adding nicotine to the product); and (6) industry manipulations (eg, nicotine analogues, companion products to increase nicotinic effects)."
Ultimately, the article concludes that reducing nicotine levels would not necessarily result in an improvement in the public's health, and that surveillance would be necessary to determine the effects of such a policy:
"If nicotine reduction is enacted, then large-scale surveillance is needed in order to understand the population-level impact of such changes. Marketplace monitoring and assessing unintended consequences (smuggling, nicotine spiking, new product introductions, etc) will also involve broad surveys."
The Rest of the Story
Once again, the anti-smoking groups have been tricked by Philip Morris into supporting federal legislation that does more for Philip Morris than for the public's health. The Campaign for Tobacco-Free Kids, in negotiating the legislation with Philip Morris, agreed to the clause that prohibited the FDA from eliminating the nicotine in cigarettes, and only allowed the agency to reduce nicotine levels. As a result, the agency is powerless to mandate changes in cigarettes which would actually result in a dramatic reduction in their addictive potential. As is clear from the article, even with low levels of nicotine, cigarettes retain strong addictive potential as only a minute amount of nicotine is necessary to occupy enough nicotine receptors to produce a pharmacologic effect.
Even more troubling than the fact that the Campaign for Tobacco-Free Kids was duped by Philip Morris in the negotiations over the tobacco legislation is the fact that the Campaign is boasting about how this provision in the law is going to save millions of lives. The Campaign is apparently unaware of the science which demonstrates, quite convincingly, that even low levels of nicotine are capable of producing reinforcing pharmacologic effects.
But the most troubling aspect of the story is the conclusion of the paper: "Reduction of nicotine in tobacco products could potentially have profound impact on reducing tobacco-related morbidity and mortality. ... an organised and multidisciplinary effort should be established to set priorities and goals..., engage appropriate scientific, research and government communities/organizations, shape the direction of research, and ensure that efforts stay focused on the ultimate goal of understanding how nicotine reduction could impact the morbidity and mortality of tobacco use."
After a comprehensive review of the literature in which the authors convincingly demonstrate that the science base does not support the idea that reducing nicotine levels will substantially reduce the addictive potential of cigarettes and that such a policy could have severe negative public health consequences, they still conclude that reducing nicotine levels is a desired public health policy which should be vigorously pursued, and that millions of dollars of taxpayer money should be funneled into research to study a policy which quite likely might be doomed to failure from the get-go.
There is a strange disconnect between the scientific evidence presented in the review and the conclusions and recommendations of the article.
For example, while the authors state that: "switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement," they nevertheless conclude that reduction of nicotine levels could have a profound impact on tobacco-related mortality. If the levels of smoking reward and reinforcement are not substantially reduced in very low-nicotine cigarettes, then how would such a reduction have a profound impact on tobacco-related mortality? The conclusion just doesn't follow from the scientific evidence.
In trying to understand why the science is so divorced from the recommended policies and the strategic agenda, I can only point to two possibilities.
First, as researchers in the area of nicotine science, the authors have a vested interest in promoting research funding into their area of expertise. This is a financial conflict of interest that appears to be influencing the conclusions and recommendations of the article.
Second, all three of the TPSAC authors and two additional authors of the paper have a vested financial interest in maintaining the paradigm that nicotine is the agent responsible for smoking addiction because they have financial ties to pharmaceutical companies which manufacture nicotine replacement or smoking cessation pharmaceutical products:
"DKH has received grant funding from Nabi Biopharmaceuticals to conduct nicotine vaccine clinical trials. JEH provides consulting support for GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment, has financial interest in a potential new oral nicotine replacement product and serves as an expert witness in litigation against tobacco companies. NLB serves as a consultant for Pfizer and as an expert witness in litigation against tobacco companies. MZ provides consulting support to GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment. KAP has served as a consultant to Cypress Bioscience."
That pretty much says it all. With this magnitude of conflict among the study authors, there is no way we could expect an objective set of recommendations and conclusions. And, by the way, this is exactly the reason why I have argued that scientists with financial conflicts of interest should not be making national policy recommendations.
The rest of the story is that there is a complete disconnect between the scientific base and the policy agenda in tobacco control today. Financial and political influences have wrested the policy agenda in tobacco control firmly away from the science base.
New Study Concludes that Massachusetts Statewide Smoking Ban Caused 7% Decline in Heart Atttack Mortality Rate
A new study, published online ahead of print in the American Journal of Public Health, concludes that the Massachusetts statewide smoking ban, implemented in July 2004, caused a 7.4% reduction in the heart attack mortality rate in the state (see: Dove et al. The impact of Massachusetts' smoke-free workplace laws on acute myocardial infarction deaths. American Journal of Public Health 2010).
The study examined trends in the mortality rates from myocardial infarction (heart attacks) from 1999 through 2006. Using a regression model, the authors estimated the change in heart attack rate following the statewide smoking ban, controlling for the baseline trend. The major finding of the study was that the overall heart attack mortality rate decreased by an estimated 7.4% in the two years following the statewide smoking ban. The study concludes that this decline was attributable to the smoking ban.
The Rest of the Story
The rest of the story is that without a comparison group, it is not possible to conclude that the observed decline in heart attack mortality in Massachusetts from 2004 to 2006 was attributable to the statewide smoking ban, as opposed to some other factor, such as changes in the treatment of severe heart disease and increased use of statin drugs to control cholesterol.
While this study demonstrates quite convincingly that the rate of heart attack death in Massachusetts declined significantly from 2004 to 2006, might it be possible that heart attack mortality was declining significantly during that time period anyway, even without the smoking ban?
We can't answer that question unless we examine heart attack mortality data from some comparison group. Since the study lacks any comparison group, I do not believe it can draw the conclusion that the observed reduction in heart attack mortality was due to the smoking ban, rather than to other factors, such as the tremendous advances in treatment of severe heart disease, better control of hypertension and hypercholesterolemia, and reductions in other risk factors such as smoking.
To evaluate this issue, we can examine national heart attack mortality data during the same period (2004 to 2006) to find out what was occurring in the nation as a whole.
From 2004 to 2006, the age-adjusted acute myocardial infarction mortality rate in the United States dropped from 52.2 to 45.0, a decline of 13.8%. Thus, even without the smoking ban, one would have expected the heart attack mortality rate in Massachusetts to drop by 13.8% during the same time period examined in the study. In light of this rather dramatic nationwide decline in heart attack mortality, the Massachusetts data do not appear as impressive as when they are viewed in isolation.
The study actually found no significant change in the heart attack mortality rate during the first year in which the ban was in effect and then a large decline in the second year. If you look at similar rates for the nation as a whole, the decline in heart attack mortality rate from 2004 to 2005 was 5.9%, but from 2005 to 2006, the rate accelerated to 8.4%. Controlling for the baseline trend in heart attack deaths from 2004 to 2005, the decline in 2005 to 2006 nationally represented a drop of 5.1% in the mortality rate. Thus, the observed decline in Massachusetts of 7.4% no longer looks so impressive.
My point here is not that the Massachusetts statewide smoking ban had no effect on heart attack deaths. My point is simply that we cannot determine whether or not the smoking ban was the cause of the observed decline because we have no comparison group. One cannot rule out as an alternative explanation for the study findings the possibility that secular changes were occurring anyway by which there was an accelerated decline in heart attacks during the study period.
To demonstrate the dangers of drawing causal conclusions from a study such as this one, suppose we just look at the data from the first year after the smoking ban. In the United States as a whole, heart attack deaths dropped by 5.9% from 2004 to 2005. But in Massachusetts, heart attack deaths dropped by only 1.6%. Does this mean that the statewide smoking ban led to an increase in heart attack deaths in Massachusetts during its first year of implementation?
Might it not instead be the case that what we are seeing here is simply the quirks of a short follow-up period, where the true decline in heart attacks was relatively stable, but the data happen to show very little decline during the first year and then a huge decline in the second year? If you put too much stock in any one year of data, then you would be forced to conclude that the smoking ban actually led to a deceleration in the decline in heart attack deaths during its first year.
Interpreting this type of data is tricky and I believe that this paper goes too far by drawing a causal conclusion. The paper goes so far as to estimate the exact number of heart attack deaths averted because of the smoking ban. I believe this is over-stating what the data actually show.
There is no question that the heart attack death rate in Massachusetts declined significantly following the statewide smoking ban in 2004. But the same can be said of the heart attack death rate in the United States as a whole, in the absence of any nationwide smoking ban.
Finally, I would point out that the entire basis for the conclusion in this paper is the last four months of data. To me, it would make more sense to at least wait until the 2007 data are available before drawing any definitive conclusions. The 2007 data will tell us whether or not the marked decline in heart attack deaths in the later half of 2006 was a real change in the trend, or just an anomaly.
While I would love to be able to conclude that the statewide smoking ban in Massachusetts caused the observed decline in heart attack mortality, I do not feel that the data presented in this study allow such a conclusion to be drawn. Without any comparison group, it is impossible to draw conclusions about what would have been expected in the absence of the statewide smoking ban. I don't see how one can draw such a conclusion without at very least examining the secular trends in heart attack mortality occurring elsewhere.
The study examined trends in the mortality rates from myocardial infarction (heart attacks) from 1999 through 2006. Using a regression model, the authors estimated the change in heart attack rate following the statewide smoking ban, controlling for the baseline trend. The major finding of the study was that the overall heart attack mortality rate decreased by an estimated 7.4% in the two years following the statewide smoking ban. The study concludes that this decline was attributable to the smoking ban.
The Rest of the Story
The rest of the story is that without a comparison group, it is not possible to conclude that the observed decline in heart attack mortality in Massachusetts from 2004 to 2006 was attributable to the statewide smoking ban, as opposed to some other factor, such as changes in the treatment of severe heart disease and increased use of statin drugs to control cholesterol.
While this study demonstrates quite convincingly that the rate of heart attack death in Massachusetts declined significantly from 2004 to 2006, might it be possible that heart attack mortality was declining significantly during that time period anyway, even without the smoking ban?
We can't answer that question unless we examine heart attack mortality data from some comparison group. Since the study lacks any comparison group, I do not believe it can draw the conclusion that the observed reduction in heart attack mortality was due to the smoking ban, rather than to other factors, such as the tremendous advances in treatment of severe heart disease, better control of hypertension and hypercholesterolemia, and reductions in other risk factors such as smoking.
To evaluate this issue, we can examine national heart attack mortality data during the same period (2004 to 2006) to find out what was occurring in the nation as a whole.
From 2004 to 2006, the age-adjusted acute myocardial infarction mortality rate in the United States dropped from 52.2 to 45.0, a decline of 13.8%. Thus, even without the smoking ban, one would have expected the heart attack mortality rate in Massachusetts to drop by 13.8% during the same time period examined in the study. In light of this rather dramatic nationwide decline in heart attack mortality, the Massachusetts data do not appear as impressive as when they are viewed in isolation.
The study actually found no significant change in the heart attack mortality rate during the first year in which the ban was in effect and then a large decline in the second year. If you look at similar rates for the nation as a whole, the decline in heart attack mortality rate from 2004 to 2005 was 5.9%, but from 2005 to 2006, the rate accelerated to 8.4%. Controlling for the baseline trend in heart attack deaths from 2004 to 2005, the decline in 2005 to 2006 nationally represented a drop of 5.1% in the mortality rate. Thus, the observed decline in Massachusetts of 7.4% no longer looks so impressive.
My point here is not that the Massachusetts statewide smoking ban had no effect on heart attack deaths. My point is simply that we cannot determine whether or not the smoking ban was the cause of the observed decline because we have no comparison group. One cannot rule out as an alternative explanation for the study findings the possibility that secular changes were occurring anyway by which there was an accelerated decline in heart attacks during the study period.
To demonstrate the dangers of drawing causal conclusions from a study such as this one, suppose we just look at the data from the first year after the smoking ban. In the United States as a whole, heart attack deaths dropped by 5.9% from 2004 to 2005. But in Massachusetts, heart attack deaths dropped by only 1.6%. Does this mean that the statewide smoking ban led to an increase in heart attack deaths in Massachusetts during its first year of implementation?
Might it not instead be the case that what we are seeing here is simply the quirks of a short follow-up period, where the true decline in heart attacks was relatively stable, but the data happen to show very little decline during the first year and then a huge decline in the second year? If you put too much stock in any one year of data, then you would be forced to conclude that the smoking ban actually led to a deceleration in the decline in heart attack deaths during its first year.
Interpreting this type of data is tricky and I believe that this paper goes too far by drawing a causal conclusion. The paper goes so far as to estimate the exact number of heart attack deaths averted because of the smoking ban. I believe this is over-stating what the data actually show.
There is no question that the heart attack death rate in Massachusetts declined significantly following the statewide smoking ban in 2004. But the same can be said of the heart attack death rate in the United States as a whole, in the absence of any nationwide smoking ban.
Finally, I would point out that the entire basis for the conclusion in this paper is the last four months of data. To me, it would make more sense to at least wait until the 2007 data are available before drawing any definitive conclusions. The 2007 data will tell us whether or not the marked decline in heart attack deaths in the later half of 2006 was a real change in the trend, or just an anomaly.
While I would love to be able to conclude that the statewide smoking ban in Massachusetts caused the observed decline in heart attack mortality, I do not feel that the data presented in this study allow such a conclusion to be drawn. Without any comparison group, it is impossible to draw conclusions about what would have been expected in the absence of the statewide smoking ban. I don't see how one can draw such a conclusion without at very least examining the secular trends in heart attack mortality occurring elsewhere.
Thursday, September 23, 2010
D.C. Court of Appeals Has Made It Clear that Drug Definition Under FDCA Relies Upon Primary Intended Use of a Product
I have argued that except in extreme cases where electronic cigarettes are marketed with the primary intent of relieving or treating symptoms of nicotine withdrawal, they do not fall under the FDA's jurisdiction under the Food, Drug, and Cosmetic Act (FDCA) because they are tobacco products, rather than drugs or devices, under the law. Here, I demonstrate that the courts in general - and the D.C. Court of Appeals in particular - have made it clear that the definition of a drug or device under FDCA relies upon the primary intended use of the product, consistent with my interpretation of the law. For this reason, I believe that the D.C. Court of Appeals ought to rule that electronic cigarettes marketed by NJOY are not subject to jurisdiction by the FDA under FDCA.
In 1977, Action on Smoking and Health (under the direction of John Banzhaf) filed a petition with the FDA demanding that it regulate cigarettes as drugs under FDCA because they contain nicotine which clearly affects the structure and function of the body (one of the definitions of a drug under FDCA). The FDA declined, arguing that it is the manufacturer's intent in its marketing, not the actual use of the product by consumers, which determines the intended use of a product.
Then FDA Commissioner Donald Kennedy wrote: "The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are 'intended to affect the structure or any function of the body of man...' Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies are not evidence of such intent by the manufacturers or vendors of cigarettes...".
In response to the denial of its petition, ASH filed a lawsuit in the D.C. District Court challenging the FDA's decision. The judge issued a summary judgment on the part of the defendant and dismissed the case. ASH appealed, sending the case to the D.C. Court of Appeals (see: Action on Smoking and Health v. Harris. 655 F.2d 236 [1980]).
The appellate court ruled that ASH failed to establish that manufacturers or vendors intended cigarettes to affect the structure or function of the body, even though consumers were using the product in such a way. Therefore, the court ruled, cigarettes do not meet the definition of a drug under FDCA and need not be regulated by the FDA as such. The court thus affirmed the decision of the district court.
In making its ruling, the D.C. Court of Appeals reviewed the legislative history of the Food, Drug, and Cosmetic Act, noting that Congress made it very clear that only when a product is marketed by the manufacturer as affecting the structure or function of the body or having a therapeutic effect is the product considered to be a drug subject to regulation under FDCA. The court cited an exchange between the FDA commissioner and a Congressman in which the commissioner explains that "a chiropractor's table would not be a drug under the Act unless the manufacturer 'were to ship that table into interstate commerce, and say that that table would cure various ills.'"
The D.C. Court of Appeals stated quite clearly that: "the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their intent. ... Such an understanding has now been accepted as a matter of statutory interpretation. As the Second Circuit has noted, 'the vendors' intent in selling the product to the public is the key element in this statutory definition.'"
Perhaps the most important opinion expressed by the D.C. Court of Appeals in ASH v. Harris is that consumers must use the product nearly exclusively with the intent alleged by the Agency in order for that intent to be inferred under FDCA. Specifically, the D.C. Circuit wrote: "In cases such as the one at hand, consumers must use the product predominantly--and in fact nearly exclusively--with the appropriate intent before the requisite statutory intent can be inferred."
Furthermore, the appellate court held that this requirement for near exclusivity of product use held for both prongs of the definition of drugs and devices in FDCA: "In similar cases involving the determinative intent under section 201(g)(1)(B) of the Act, for example, 'articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...', courts have accorded limited discretion to the Administration in its attempt to establish the requisite intent based primarily upon consumer use."
The appellate court concludes its argument by emphasizing that: "ASH did not establish, and arguably cannot establish, the near-exclusivity of consumer use of cigarettes with the intent 'to affect the structure or any function of the body of man...".
The second Circuit, in FTC v. Liggett & Myers Tobacco Co. (203 F.2d 955 [1953]), emphasized the absurdity of an interpretation that any product which affects the structure or function of the body could be regulated as a drug: "Anything which stimulates any of the senses may be said, in some perhaps insignificant degree, to affect the functions of the body of man. Consequently any article which, used in the manner anticipated by the manufacturer thereof, comes into contact with any of the sense may be said to be an article 'intended to affect the functions of the body of man' ... . Surely, the legislators did not mean to be as all-inclusive as a literal interpretation of this clause would compel us to be."
The Rest of the Story
The D.C. Circuit's standard of "near exclusivity" of consumer use is one which is not met by the FDA in its assertion of jurisdiction over electronic cigarettes. In the case of NJOY electronic cigarettes, the FDA has failed to cite any evidence that the intended use of the product is to affect the structure or function of the body or to treat any disease. In the case of other brands, the FDA has failed to show that the product is used nearly exclusively by consumers with the intent that the Agency alleges.
To be sure, the primary use of electronic cigarettes by consumers is as an alternative to cigarettes. Most vapers are using e-cigarettes specifically because they are unable to quit smoking but want a safer alternative. Thus, they have switched over - either in whole or in part - to electronic cigarettes.
While it is true that some consumers have made statements about the use of e-cigarettes in quitting smoking or the alleviation of nicotine withdrawal symptoms, it does not appear to be the case that consumers are using electronic cigarettes nearly exclusively with a therapeutic intent. Nor does it appear that most manufacturers are marketing the product with a primary - or nearly exclusive - intent of treating nicotine dependence or nicotine withdrawal.
For these reasons, I believe that the FDA has failed to meet the requisite statutory burden in demonstrating that electronic cigarettes are intended to affect the structure and function of the body and/or to treat a disease under the FDCA as amended recently by the Tobacco Act. Without such a showing, electronic cigarettes fall under the definition of tobacco products under the law, and must be regulated as such.
In 1977, Action on Smoking and Health (under the direction of John Banzhaf) filed a petition with the FDA demanding that it regulate cigarettes as drugs under FDCA because they contain nicotine which clearly affects the structure and function of the body (one of the definitions of a drug under FDCA). The FDA declined, arguing that it is the manufacturer's intent in its marketing, not the actual use of the product by consumers, which determines the intended use of a product.
Then FDA Commissioner Donald Kennedy wrote: "The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are 'intended to affect the structure or any function of the body of man...' Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies are not evidence of such intent by the manufacturers or vendors of cigarettes...".
In response to the denial of its petition, ASH filed a lawsuit in the D.C. District Court challenging the FDA's decision. The judge issued a summary judgment on the part of the defendant and dismissed the case. ASH appealed, sending the case to the D.C. Court of Appeals (see: Action on Smoking and Health v. Harris. 655 F.2d 236 [1980]).
The appellate court ruled that ASH failed to establish that manufacturers or vendors intended cigarettes to affect the structure or function of the body, even though consumers were using the product in such a way. Therefore, the court ruled, cigarettes do not meet the definition of a drug under FDCA and need not be regulated by the FDA as such. The court thus affirmed the decision of the district court.
In making its ruling, the D.C. Court of Appeals reviewed the legislative history of the Food, Drug, and Cosmetic Act, noting that Congress made it very clear that only when a product is marketed by the manufacturer as affecting the structure or function of the body or having a therapeutic effect is the product considered to be a drug subject to regulation under FDCA. The court cited an exchange between the FDA commissioner and a Congressman in which the commissioner explains that "a chiropractor's table would not be a drug under the Act unless the manufacturer 'were to ship that table into interstate commerce, and say that that table would cure various ills.'"
The D.C. Court of Appeals stated quite clearly that: "the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their intent. ... Such an understanding has now been accepted as a matter of statutory interpretation. As the Second Circuit has noted, 'the vendors' intent in selling the product to the public is the key element in this statutory definition.'"
Perhaps the most important opinion expressed by the D.C. Court of Appeals in ASH v. Harris is that consumers must use the product nearly exclusively with the intent alleged by the Agency in order for that intent to be inferred under FDCA. Specifically, the D.C. Circuit wrote: "In cases such as the one at hand, consumers must use the product predominantly--and in fact nearly exclusively--with the appropriate intent before the requisite statutory intent can be inferred."
Furthermore, the appellate court held that this requirement for near exclusivity of product use held for both prongs of the definition of drugs and devices in FDCA: "In similar cases involving the determinative intent under section 201(g)(1)(B) of the Act, for example, 'articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...', courts have accorded limited discretion to the Administration in its attempt to establish the requisite intent based primarily upon consumer use."
The appellate court concludes its argument by emphasizing that: "ASH did not establish, and arguably cannot establish, the near-exclusivity of consumer use of cigarettes with the intent 'to affect the structure or any function of the body of man...".
The second Circuit, in FTC v. Liggett & Myers Tobacco Co. (203 F.2d 955 [1953]), emphasized the absurdity of an interpretation that any product which affects the structure or function of the body could be regulated as a drug: "Anything which stimulates any of the senses may be said, in some perhaps insignificant degree, to affect the functions of the body of man. Consequently any article which, used in the manner anticipated by the manufacturer thereof, comes into contact with any of the sense may be said to be an article 'intended to affect the functions of the body of man' ... . Surely, the legislators did not mean to be as all-inclusive as a literal interpretation of this clause would compel us to be."
The Rest of the Story
The D.C. Circuit's standard of "near exclusivity" of consumer use is one which is not met by the FDA in its assertion of jurisdiction over electronic cigarettes. In the case of NJOY electronic cigarettes, the FDA has failed to cite any evidence that the intended use of the product is to affect the structure or function of the body or to treat any disease. In the case of other brands, the FDA has failed to show that the product is used nearly exclusively by consumers with the intent that the Agency alleges.
To be sure, the primary use of electronic cigarettes by consumers is as an alternative to cigarettes. Most vapers are using e-cigarettes specifically because they are unable to quit smoking but want a safer alternative. Thus, they have switched over - either in whole or in part - to electronic cigarettes.
While it is true that some consumers have made statements about the use of e-cigarettes in quitting smoking or the alleviation of nicotine withdrawal symptoms, it does not appear to be the case that consumers are using electronic cigarettes nearly exclusively with a therapeutic intent. Nor does it appear that most manufacturers are marketing the product with a primary - or nearly exclusive - intent of treating nicotine dependence or nicotine withdrawal.
For these reasons, I believe that the FDA has failed to meet the requisite statutory burden in demonstrating that electronic cigarettes are intended to affect the structure and function of the body and/or to treat a disease under the FDCA as amended recently by the Tobacco Act. Without such a showing, electronic cigarettes fall under the definition of tobacco products under the law, and must be regulated as such.
Wednesday, September 22, 2010
IN MY VIEW: Primary Intended Use of Electronic Cigarettes in Their Marketing Must be the Basis for Determining if They Can Be Regulated Under FDCA
Previously, I have argued that electronic cigarettes cannot be regulated by the FDA under the Food, Drug, and Cosmetic Act (FDCA) simply because they deliver nicotine, which is a pharmacologically active drug. I noted that electronic cigarettes, like regular cigarettes, smokeless tobacco, and nicotine replacement (NRT) products, meet the initial definition of "tobacco product" under the Tobacco Act because a constituent of the product - nicotine - is derived from tobacco.
What separates nicotine replacement products out from cigarettes and smokeless tobacco, I argued, is the fact that NRT products are marketed specifically for a therapeutic purpose - treating nicotine dependence. Since cigarettes and smokeless tobacco are marketed simply for recreational purposes, they cannot fall under FDA jurisdiction under FDCA. In contrast, NRT products are marketed for the specific purpose of treating a medical condition - nicotine dependence - and therefore can be regulated by the FDA under FDCA.
If the FDA is correct in asserting that electronic cigarettes are subject to FDCA solely because they deliver nicotine which is pharmacologically active and intended to affect the structure and function of the body, then the FDA must also regulate cigarettes and smokeless tobacco under FDCA, I argued, because those products also deliver nicotine that is intended to affect the structure and function of the body.
In today's commentary, I argue that there is an additional reason why the FDA's argument for regulation of all electronic cigarettes does not hold water: the FDA's argument asks that we look solely at the nature of the product, absent any marketing claims. The FDA appellate brief in the NJOY case demonstrates that the Agency is admitting that NJOY is not marketing its electronic cigarettes for any therapeutic purpose. The company makes no claim that NJOY is intended to, or will help its customers quit smoking. Nevertheless, the FDA has asserted jurisdiction over the product. That, I argue here, runs counter to logic as well as to legal precedent established by the Supreme Court itself.
The Rest of the Story
To understand why the primary, intended use of a product -- established through its marketing -- is the central element in evaluating the definition of a drug or device, consider the following example:
Why is the FDA not regulating potatoes as a drug?
Potatoes, it can be shown, contain nicotine, which is a pharmacologically active substance. Why, then, are potatoes not subject to regulation as drugs under FDCA?
The answer is simple: because they are being marketed as foods, not as drugs.
Now consider this variation:
I have just applied for a patent on a new product I developed. It's called Nic-A-Spud. By combining Idaho and Maine potatoes in the correct proportion (sorry, I can't reveal what that is), I have developed a product that I believe can relieve the symptoms of nicotine withdrawal. I plan to begin marketing it tomorrow as a useful strategy for smokers who are trying to quit. By taking my special Nic-A-Spud remedy, which consists solely of Maine and Idaho potatoes in a certain proportion that only I know, I believe that the user ingests a very small amount of nicotine which is able to quell any symptoms of nicotine dependence and thus help her to quit smoking with greater success.
Now, the question: is my Nic-A-Spud product - which is ingested like a food and consists of nothing other than potatoes - subject to regulation as a drug?
The answer is: yes. I am clearly making drug claims about the product. I am marketing it with the primary intended use of treating nicotine dependence and helping smokers to quit. I am claiming that by ingesting Nic-A-Spud, you will be exposed to nicotine which will have the pharmacologic effect of binding to nicotine receptors and altering the structure and function of the body.
Already, I hope that you can see why it is that the primary intended use of a product is instrumental in determining how a product can or cannot be regulated by the FDA.
Potatoes cannot be regulated by the FDA simply because they contain nicotine, which is a pharmacologically active drug. However, if those very same potatoes are marketed with the primary intent of treating a medical condition - nicotine dependence - then the product all of the sudden becomes a drug that can be regulated under FDCA.
If potatoes deliver pharmacologically active nicotine but are not regulated by the FDA as a drug, then why can electronic cigarettes be regulated by the FDA as a drug?
Clearly, the answer has something to do with the way in which the product is marketed, not solely what is in the product.
Now, let's examine another scenario. Suppose that Philip Morris decides to market Marlboros as a way to treat schizophrenia. There is evidence that nicotine helps reduce the symptoms of psychotic disorders. Obviously, if Philip Morris wanted to market Marlboros as a treatment for schizophrenia, it would have to prove that the product is safe and effective. The product would clearly be regulated under FDCA.
So the fact that a product is a tobacco product and supposedly not subject to regulation under FDCA does not actually mean that it is not subject to regulation under FDCA. It simply means that the fact that the product contains and delivers a pharmacologically active drug - nicotine - cannot be used as a basis for the FDA asserting jurisdiction over the product under FDCA. But if the product makes specific, primary drug claims, then all bets are off.
In other words, what I'm trying to demonstrate is that the issue of whether the FDA can assert jurisdiction over electronic cigarettes is dependent upon the way in which these products are marketed. You cannot simply look at the ingredients and assert such jurisdiction. You must look at the marketing claims and determine whether the primary intended use of the product is to treat a medical condition.
Now here's where I am going to extend my argument a bit. There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM-IV.
I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.
Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.
In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.
In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.
As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.
Now let's move to the final facet of my argument: why do I say the "primary" intended use of a product is what is important?
Take this example: suppose that a cigarette company posts on its website articles about how cigarette smoking has been found to reduce the risk of inflammatory bowel disease. Suppose that some customers make comments on a tobacco company web site indicating that they are using the product, in part, because they believe it will reduce their risk of inflammatory bowel disease. Suppose the company even asserts, on its web site, that cigarette smoking reduces the risk of inflammatory bowel disease.
Does this mean that the company's cigarettes are drugs and can be regulated under FDCA?
I think the answer is clearly "no." The company is making a secondary claim about cigarettes, not a primary claim. The primary intended use of the cigarettes is a recreational one. They are not being marketed for the primary intended purpose of preventing inflammatory bowel disease. Does this mean that the manufacturer cannot note that the product may reduce the risk of inflammatory bowel disease? I don't believe so, and it certainly does not give the FDA authority to regulate the product as a drug.
Clearly, the FTC could intervene (and the FDA could now intervene on marketing grounds) if it felt that the claim was deceptive marketing. But the fact that the company made such a claim would not put the cigarette into the category of a drug that could be regulated under FDCA unless the company was making a primary claim that the product was intended to prevent inflammatory bowel disease.
What does this mean? It means that unless an electronic cigarette company is making a claim that the primary purpose of its products is to treat nicotine dependence or nicotine withdrawal, then I do not believe the product is a drug subject to regulation under FDCA. Just because an electronic cigarette company posts a customer comment noting that some individual was able to quit smoking, that does not mean that the product is subject to jurisdiction under FDCA. Even if the company were to cite data showing that a significant number of consumers reported that the product helped them quit smoking, that would not make the product a drug, unless the primary aim of the product was to treat nicotine withdrawal. If marketed primarily as an alternative to smoking, I do not believe that electronic cigarettes are a drug.
The final point I would like to make is that there is strong precedent, in Supreme Court rulings, lower court rulings, and FDA rulings, which establishes that FDA must consider the intended use of a product in making a determination whether that product is a drug under FDCA. Perhaps most relevant is the Supreme Court's ruling that tobacco products cannot be regulated as drugs under FDCA absent a therapeutic or drug claim by the manufacturer.
As the Supreme Court noted in FDA v. Brown & Williamson Tobacco Corp.: "In 1977, ASH filed a citizen petition requesting that the FDA regulate cigarettes, citing many of the same grounds that motivated the FDA's rulemaking here. ... ASH asserted that nicotine was highly addictive and had strong physiological effects on the body'; that those effects were 'intended' because consumers use tobacco products precisely to obtain those effects; and that tobacco causes thousands of premature deaths annually. In denying ASH's petition, FDA Commissioner Kennedy stated that 'the interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors.' ... After the matter proceeded to litigation, the FDA argued in its brief to the Court of Appeals that 'cigarettes are not comprehended within the statutory definition of the term drug absent objective evidence that vendors represent or intend that their products be used as a drug.'"
What separates nicotine replacement products out from cigarettes and smokeless tobacco, I argued, is the fact that NRT products are marketed specifically for a therapeutic purpose - treating nicotine dependence. Since cigarettes and smokeless tobacco are marketed simply for recreational purposes, they cannot fall under FDA jurisdiction under FDCA. In contrast, NRT products are marketed for the specific purpose of treating a medical condition - nicotine dependence - and therefore can be regulated by the FDA under FDCA.
If the FDA is correct in asserting that electronic cigarettes are subject to FDCA solely because they deliver nicotine which is pharmacologically active and intended to affect the structure and function of the body, then the FDA must also regulate cigarettes and smokeless tobacco under FDCA, I argued, because those products also deliver nicotine that is intended to affect the structure and function of the body.
In today's commentary, I argue that there is an additional reason why the FDA's argument for regulation of all electronic cigarettes does not hold water: the FDA's argument asks that we look solely at the nature of the product, absent any marketing claims. The FDA appellate brief in the NJOY case demonstrates that the Agency is admitting that NJOY is not marketing its electronic cigarettes for any therapeutic purpose. The company makes no claim that NJOY is intended to, or will help its customers quit smoking. Nevertheless, the FDA has asserted jurisdiction over the product. That, I argue here, runs counter to logic as well as to legal precedent established by the Supreme Court itself.
The Rest of the Story
To understand why the primary, intended use of a product -- established through its marketing -- is the central element in evaluating the definition of a drug or device, consider the following example:
Why is the FDA not regulating potatoes as a drug?
Potatoes, it can be shown, contain nicotine, which is a pharmacologically active substance. Why, then, are potatoes not subject to regulation as drugs under FDCA?
The answer is simple: because they are being marketed as foods, not as drugs.
Now consider this variation:
I have just applied for a patent on a new product I developed. It's called Nic-A-Spud. By combining Idaho and Maine potatoes in the correct proportion (sorry, I can't reveal what that is), I have developed a product that I believe can relieve the symptoms of nicotine withdrawal. I plan to begin marketing it tomorrow as a useful strategy for smokers who are trying to quit. By taking my special Nic-A-Spud remedy, which consists solely of Maine and Idaho potatoes in a certain proportion that only I know, I believe that the user ingests a very small amount of nicotine which is able to quell any symptoms of nicotine dependence and thus help her to quit smoking with greater success.
Now, the question: is my Nic-A-Spud product - which is ingested like a food and consists of nothing other than potatoes - subject to regulation as a drug?
The answer is: yes. I am clearly making drug claims about the product. I am marketing it with the primary intended use of treating nicotine dependence and helping smokers to quit. I am claiming that by ingesting Nic-A-Spud, you will be exposed to nicotine which will have the pharmacologic effect of binding to nicotine receptors and altering the structure and function of the body.
Already, I hope that you can see why it is that the primary intended use of a product is instrumental in determining how a product can or cannot be regulated by the FDA.
Potatoes cannot be regulated by the FDA simply because they contain nicotine, which is a pharmacologically active drug. However, if those very same potatoes are marketed with the primary intent of treating a medical condition - nicotine dependence - then the product all of the sudden becomes a drug that can be regulated under FDCA.
If potatoes deliver pharmacologically active nicotine but are not regulated by the FDA as a drug, then why can electronic cigarettes be regulated by the FDA as a drug?
Clearly, the answer has something to do with the way in which the product is marketed, not solely what is in the product.
Now, let's examine another scenario. Suppose that Philip Morris decides to market Marlboros as a way to treat schizophrenia. There is evidence that nicotine helps reduce the symptoms of psychotic disorders. Obviously, if Philip Morris wanted to market Marlboros as a treatment for schizophrenia, it would have to prove that the product is safe and effective. The product would clearly be regulated under FDCA.
So the fact that a product is a tobacco product and supposedly not subject to regulation under FDCA does not actually mean that it is not subject to regulation under FDCA. It simply means that the fact that the product contains and delivers a pharmacologically active drug - nicotine - cannot be used as a basis for the FDA asserting jurisdiction over the product under FDCA. But if the product makes specific, primary drug claims, then all bets are off.
In other words, what I'm trying to demonstrate is that the issue of whether the FDA can assert jurisdiction over electronic cigarettes is dependent upon the way in which these products are marketed. You cannot simply look at the ingredients and assert such jurisdiction. You must look at the marketing claims and determine whether the primary intended use of the product is to treat a medical condition.
Now here's where I am going to extend my argument a bit. There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM-IV.
I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.
Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.
In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.
In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.
As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.
Now let's move to the final facet of my argument: why do I say the "primary" intended use of a product is what is important?
Take this example: suppose that a cigarette company posts on its website articles about how cigarette smoking has been found to reduce the risk of inflammatory bowel disease. Suppose that some customers make comments on a tobacco company web site indicating that they are using the product, in part, because they believe it will reduce their risk of inflammatory bowel disease. Suppose the company even asserts, on its web site, that cigarette smoking reduces the risk of inflammatory bowel disease.
Does this mean that the company's cigarettes are drugs and can be regulated under FDCA?
I think the answer is clearly "no." The company is making a secondary claim about cigarettes, not a primary claim. The primary intended use of the cigarettes is a recreational one. They are not being marketed for the primary intended purpose of preventing inflammatory bowel disease. Does this mean that the manufacturer cannot note that the product may reduce the risk of inflammatory bowel disease? I don't believe so, and it certainly does not give the FDA authority to regulate the product as a drug.
Clearly, the FTC could intervene (and the FDA could now intervene on marketing grounds) if it felt that the claim was deceptive marketing. But the fact that the company made such a claim would not put the cigarette into the category of a drug that could be regulated under FDCA unless the company was making a primary claim that the product was intended to prevent inflammatory bowel disease.
What does this mean? It means that unless an electronic cigarette company is making a claim that the primary purpose of its products is to treat nicotine dependence or nicotine withdrawal, then I do not believe the product is a drug subject to regulation under FDCA. Just because an electronic cigarette company posts a customer comment noting that some individual was able to quit smoking, that does not mean that the product is subject to jurisdiction under FDCA. Even if the company were to cite data showing that a significant number of consumers reported that the product helped them quit smoking, that would not make the product a drug, unless the primary aim of the product was to treat nicotine withdrawal. If marketed primarily as an alternative to smoking, I do not believe that electronic cigarettes are a drug.
The final point I would like to make is that there is strong precedent, in Supreme Court rulings, lower court rulings, and FDA rulings, which establishes that FDA must consider the intended use of a product in making a determination whether that product is a drug under FDCA. Perhaps most relevant is the Supreme Court's ruling that tobacco products cannot be regulated as drugs under FDCA absent a therapeutic or drug claim by the manufacturer.
As the Supreme Court noted in FDA v. Brown & Williamson Tobacco Corp.: "In 1977, ASH filed a citizen petition requesting that the FDA regulate cigarettes, citing many of the same grounds that motivated the FDA's rulemaking here. ... ASH asserted that nicotine was highly addictive and had strong physiological effects on the body'; that those effects were 'intended' because consumers use tobacco products precisely to obtain those effects; and that tobacco causes thousands of premature deaths annually. In denying ASH's petition, FDA Commissioner Kennedy stated that 'the interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors.' ... After the matter proceeded to litigation, the FDA argued in its brief to the Court of Appeals that 'cigarettes are not comprehended within the statutory definition of the term drug absent objective evidence that vendors represent or intend that their products be used as a drug.'"
Monday, September 20, 2010
Oregon Study Suggests that Tobacco Tax Initiatives and Anti-Smoking Programs May Be Harming, Not Helping Lower-Income Populations
Although Oregon enacted a substantial cigarette tax increase in 1996, a new report shows that there has been no decrease in smoking prevalence among lower-income Oregonians, which remained steady at about 35% from 1996 through 2007.
The report found substantial declines in smoking prevalence among all adults and a striking decline in smoking among youth, but no significant change in smoking prevalence among adults earning less than $15,000 a year. Although the number of cigarettes sold in Oregon fell by 46% between 1996 and 2007, this doesn't translate into any reduction in smoking prevalence among the lowest-income Oregonians.
According to the Statesman Journal article, while lower-income individuals apparently did not benefit from the tax initiative and resulting programs, their families did suffer an economic burden, paying out a greater proportion of their income for cigarettes: "The report notes the economic impact of smoking hits lower-income families harder."Tobacco is so addictive that some Oregon families reduce the amount of money spent on food to buy cigarettes," it said."
The Rest of the Story
This report should serve as a cautionary note to anti-smoking groups which continue to indiscriminately support cigarette tax increases to fund state budget shortfalls. While reducing cigarette smoking is a public health priority, so is reducing income-based health disparities. The evidence from Oregon suggests that current anti-smoking strategies may actually be harming the poorest groups and increasing health disparities. These groups may end up spending more of their income on cigarettes, making it harder to buy food. At the same time, they appear not to benefit from the tax increase and programs, as smoking prevalence was unchanged among this group over a ten-year period.
It may be that addiction to cigarettes is higher among lower-income smokers and that these smokers are less sensitive to changes in cigarette prices, in contrast to the conventional wisdom, which holds the exact opposite. It also appears that for some reason, anti-smoking interventions are either not reaching or are not effective among lower-income populations in Oregon.
Clearly, anti-smoking programs need to altered so that they focus specifically on reaching and effectively impacting lower-income populations. In addition, anti-smoking groups need to consider the potential impact of cigarette tax increases on low-income families and not jump to support cigarette taxes as a means of funding every government program under the sun, especially if revenues are not specifically earmarked for anti-smoking programs, services, or treatment that focus on aiding low-income populations.
The report found substantial declines in smoking prevalence among all adults and a striking decline in smoking among youth, but no significant change in smoking prevalence among adults earning less than $15,000 a year. Although the number of cigarettes sold in Oregon fell by 46% between 1996 and 2007, this doesn't translate into any reduction in smoking prevalence among the lowest-income Oregonians.
According to the Statesman Journal article, while lower-income individuals apparently did not benefit from the tax initiative and resulting programs, their families did suffer an economic burden, paying out a greater proportion of their income for cigarettes: "The report notes the economic impact of smoking hits lower-income families harder."Tobacco is so addictive that some Oregon families reduce the amount of money spent on food to buy cigarettes," it said."
The Rest of the Story
This report should serve as a cautionary note to anti-smoking groups which continue to indiscriminately support cigarette tax increases to fund state budget shortfalls. While reducing cigarette smoking is a public health priority, so is reducing income-based health disparities. The evidence from Oregon suggests that current anti-smoking strategies may actually be harming the poorest groups and increasing health disparities. These groups may end up spending more of their income on cigarettes, making it harder to buy food. At the same time, they appear not to benefit from the tax increase and programs, as smoking prevalence was unchanged among this group over a ten-year period.
It may be that addiction to cigarettes is higher among lower-income smokers and that these smokers are less sensitive to changes in cigarette prices, in contrast to the conventional wisdom, which holds the exact opposite. It also appears that for some reason, anti-smoking interventions are either not reaching or are not effective among lower-income populations in Oregon.
Clearly, anti-smoking programs need to altered so that they focus specifically on reaching and effectively impacting lower-income populations. In addition, anti-smoking groups need to consider the potential impact of cigarette tax increases on low-income families and not jump to support cigarette taxes as a means of funding every government program under the sun, especially if revenues are not specifically earmarked for anti-smoking programs, services, or treatment that focus on aiding low-income populations.
Thursday, September 16, 2010
Mayor Bloomberg Proposes Complete Outdoor Smoking Ban for All New York City Parks and Public Plazas
New York City Mayor Michael Bloomberg announced yesterday that he will seek approval for an ordinance that would ban outdoors smoking in all city parks - including Central Park - and on streets and sidewalks that are part of traffic-free city plazas, such as that in Times Square.
According to an article in the Globe and Mail, the reason for the smoking ban is to protect the public from brief exposure to secondhand smoke and its associated health risks:
"Officials said they are basing the proposed law on claims that even brief exposure to secondhand smoke can pose health risks. “The science is clear: prolonged exposure to secondhand smoke, whether you're indoors or out, hurts your health,” Mr. Bloomberg said in a statement. “Today, we're doing something about it.” ... Officials cited a May 2007 Stanford University study that found a person sitting within three feet of a smoker outdoors can be exposed to levels of secondhand smoke similar to indoor levels."
The Rest of the Story
My readers should be well aware that I agree with Mayor Bloomberg's contention that prolonged exposure to secondhand smoke is harmful and I also agree that secondhand smoke exposure outdoors can be significant if you are within three feet of a smoker. However, the question I have is this: Why would a nonsmoker in Central Park be within three feet of a smoker? Couldn't the person simply move away? Why would the exposure be prolonged? Wouldn't the nonsmoker simply walk away?
There seems to be a disconnect behind the scientific data being cited and the actual proposal. The scientific data would support a ban on outdoors smoking in locations where nonsmokers have little choice but to be within close proximity of someone smoking, such as in a stadium or arena with fixed seating where the nonsmoker can't simply move away. It would also support a ban on smoking in outdoor areas of restaurants, where the seats are fixed and a nonsmoker might not easily be able to avoid the exposure.
But the argument does not extend to wide open areas like Central Park and hundreds of other large parks in New York City where there is plenty of room for nonsmokers to walk away from someone who is smoking if they wish to avoid the exposure.
While I would still oppose the ordinance, I would have greater respect for the officials proposing it if they would simply tell the truth about the reasons for the proposal: They simply don't want nonsmokers to have to even see smokers in public places. They don't want nonsmokers to ever have to even breathe in one whiff of secondhand smoke. This is not about any serious threat of public health harm.
According to an article in the Globe and Mail, the reason for the smoking ban is to protect the public from brief exposure to secondhand smoke and its associated health risks:
"Officials said they are basing the proposed law on claims that even brief exposure to secondhand smoke can pose health risks. “The science is clear: prolonged exposure to secondhand smoke, whether you're indoors or out, hurts your health,” Mr. Bloomberg said in a statement. “Today, we're doing something about it.” ... Officials cited a May 2007 Stanford University study that found a person sitting within three feet of a smoker outdoors can be exposed to levels of secondhand smoke similar to indoor levels."
The Rest of the Story
My readers should be well aware that I agree with Mayor Bloomberg's contention that prolonged exposure to secondhand smoke is harmful and I also agree that secondhand smoke exposure outdoors can be significant if you are within three feet of a smoker. However, the question I have is this: Why would a nonsmoker in Central Park be within three feet of a smoker? Couldn't the person simply move away? Why would the exposure be prolonged? Wouldn't the nonsmoker simply walk away?
There seems to be a disconnect behind the scientific data being cited and the actual proposal. The scientific data would support a ban on outdoors smoking in locations where nonsmokers have little choice but to be within close proximity of someone smoking, such as in a stadium or arena with fixed seating where the nonsmoker can't simply move away. It would also support a ban on smoking in outdoor areas of restaurants, where the seats are fixed and a nonsmoker might not easily be able to avoid the exposure.
But the argument does not extend to wide open areas like Central Park and hundreds of other large parks in New York City where there is plenty of room for nonsmokers to walk away from someone who is smoking if they wish to avoid the exposure.
While I would still oppose the ordinance, I would have greater respect for the officials proposing it if they would simply tell the truth about the reasons for the proposal: They simply don't want nonsmokers to have to even see smokers in public places. They don't want nonsmokers to ever have to even breathe in one whiff of secondhand smoke. This is not about any serious threat of public health harm.
Wednesday, September 15, 2010
FDA Letter to ECA Appears to Assert Jurisdiction Over All E-Cigs Under the Food, Drug, and Cosmetic Act; Legal Basis is Questionable
In a letter sent to the Electronic Cigarette Association (ECA) on September 8, the Food and Drug Administration (FDA) appears to be exerting jurisdiction over all electronic cigarettes under the Food, Drug and Cosmetic Act (FDCA), regardless of the claims made by manufacturers or distributors of these products.
In the letter, the FDA refers not only to the specific electronic cigarettes addressed in its warning letters, but to all "similar products." The FDA states: "Although the agency has been granted separate authority to regulate tobacco products that are not drugs, devices, or combination products under the recently enacted Family Smoking Prevention and Tobacco Control Act, the e-cigarettes that FDA addressed in the warning letters, and similar products, meet the definitions in the Act for drugs and devices, with a drug primary mode of action."
Note that the letter does not state: "and products marketed in a similar way." Moreover, the letter mentions only that electronic cigarettes must meet the requirements for new drugs under the FDCA. It makes no mention of the possibility that if electronic cigarette companies make no drug claims, their products will be regulated as tobacco products rather than as drug-device combinations.
Clearly, the FDA is asserting jurisdiction over electronic cigarettes because these products deliver pharmacologically active nicotine and not merely because of drug claims made by specific companies.
In the letter, the FDA places an onerous burden on electronic cigarette companies in terms of what they must show prior to approval of their products: "FDA notes that an NDA [new drug application] would need to provide information including: a description of the chemistry of the drug substance and drug product, their manufacturing processes (which must comply with FDA requirements for Good Manufacturing Practices) and their controls (including in process and end product specifications); a description and characterization of the device; a characterization of the pharmacokinetic delivery of nicotine, including site of absorption and pharmacokinetic parameters associated with use at the recommended dosing level; non-clinical toxicology studies to support the safety of the proposed route of administration (note that the pulmonary route is considered a novel route of administration); any novel excipients and drug substance/drug product impurities; and data from adequate and well-controlled clinical trials to support the safety and efficacy of the product for the intended use."
The Rest of the Story
There are two aspects to the rest of the story.
First, the FDA lacks appropriate legal grounds to assert jurisdiction over electronic cigarettes as indicated in this letter. While the FDA could potentially argue that if electronic cigarette companies make direct drug claims about their products, these devices could be regulated under FDCA, I do not believe there is a legal basis for the FDA regulating electronic cigarettes under FDCA in the absence of marketing claims which establish that the primary intended use of the product is to aid smokers in achieving smoking cessation (and therefore, that the primary purpose of the product is to treat a medical condition: smoking dependence).
While I have discussed this in previous commentaries, it is worth repeating here. A major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. A tobacco product is: "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)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
The second aspect of the rest of the story is that although the FDA states in its letter that it "intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health," it is actually doing the exact opposite.
The onerous burden that the FDA outlines for electronic cigarette approval ensures that these products will never be approved and will never have a chance to compete in the market place. The costs required to produce the kind of data that the FDA is demanding are prohibitive. These are a collection of very small companies and it is unlikely that these companies could produce the kind of funding required to carry out the clinical trials and other studies necessary to gain approval under FDCA.
More importantly, it would take a minimum of five years, and probably closer to eight years, to plan and conduct the necessary studies and to obtain the necessary data. Most of the electronic cigarette companies are reliant upon their current sales and could not afford to suspend their sales for 8 years while waiting for these studies to be completed. I believe that it would result in the de facto end of the electronic cigarette market in the United States.
In other words, while the language being used is couched in legalese, what the FDA is actually indicating here is that it has no intention to approve electronic cigarettes and that it favors an approach by which these products are taken off the market and tobacco cigarettes are allowed unfettered reign over the market for smokers' business.
To express it another way, the FDA is essentially banning or putting insurmountable obstacles in front of the relatively safer electronic cigarettes, but approving - without any regulatory burden - the deadly real ones.
This is the exact opposite of regulating electronic cigarettes "in a manner consistent with its mission of protecting the public health." In fact, it represents regulating tobacco products and electronic cigarettes in a manner inconsistent with its mission of protecting the public health.
What this does is help to ensure that smokers do not quit smoking and that they do not switch away from their Marlboros, Camels, Kools, Salems, and Newports over to much safer tobacco-free products that have no known risks beyond the nicotine delivery. It helps ensure that smokers who want to quit have no choice other than to use the dismally effective nicotine replacement products which offer them no better than about an 8% long-term success rate. It helps ensure that cigarette profits will remain strong at the expense of the health of smokers. It protects the profits of Big Tobacco and Big Pharma at the expense of the protection of the public's health.
In the letter, the FDA refers not only to the specific electronic cigarettes addressed in its warning letters, but to all "similar products." The FDA states: "Although the agency has been granted separate authority to regulate tobacco products that are not drugs, devices, or combination products under the recently enacted Family Smoking Prevention and Tobacco Control Act, the e-cigarettes that FDA addressed in the warning letters, and similar products, meet the definitions in the Act for drugs and devices, with a drug primary mode of action."
Note that the letter does not state: "and products marketed in a similar way." Moreover, the letter mentions only that electronic cigarettes must meet the requirements for new drugs under the FDCA. It makes no mention of the possibility that if electronic cigarette companies make no drug claims, their products will be regulated as tobacco products rather than as drug-device combinations.
Clearly, the FDA is asserting jurisdiction over electronic cigarettes because these products deliver pharmacologically active nicotine and not merely because of drug claims made by specific companies.
In the letter, the FDA places an onerous burden on electronic cigarette companies in terms of what they must show prior to approval of their products: "FDA notes that an NDA [new drug application] would need to provide information including: a description of the chemistry of the drug substance and drug product, their manufacturing processes (which must comply with FDA requirements for Good Manufacturing Practices) and their controls (including in process and end product specifications); a description and characterization of the device; a characterization of the pharmacokinetic delivery of nicotine, including site of absorption and pharmacokinetic parameters associated with use at the recommended dosing level; non-clinical toxicology studies to support the safety of the proposed route of administration (note that the pulmonary route is considered a novel route of administration); any novel excipients and drug substance/drug product impurities; and data from adequate and well-controlled clinical trials to support the safety and efficacy of the product for the intended use."
The Rest of the Story
There are two aspects to the rest of the story.
First, the FDA lacks appropriate legal grounds to assert jurisdiction over electronic cigarettes as indicated in this letter. While the FDA could potentially argue that if electronic cigarette companies make direct drug claims about their products, these devices could be regulated under FDCA, I do not believe there is a legal basis for the FDA regulating electronic cigarettes under FDCA in the absence of marketing claims which establish that the primary intended use of the product is to aid smokers in achieving smoking cessation (and therefore, that the primary purpose of the product is to treat a medical condition: smoking dependence).
While I have discussed this in previous commentaries, it is worth repeating here. A major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. A tobacco product is: "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)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
The second aspect of the rest of the story is that although the FDA states in its letter that it "intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health," it is actually doing the exact opposite.
The onerous burden that the FDA outlines for electronic cigarette approval ensures that these products will never be approved and will never have a chance to compete in the market place. The costs required to produce the kind of data that the FDA is demanding are prohibitive. These are a collection of very small companies and it is unlikely that these companies could produce the kind of funding required to carry out the clinical trials and other studies necessary to gain approval under FDCA.
More importantly, it would take a minimum of five years, and probably closer to eight years, to plan and conduct the necessary studies and to obtain the necessary data. Most of the electronic cigarette companies are reliant upon their current sales and could not afford to suspend their sales for 8 years while waiting for these studies to be completed. I believe that it would result in the de facto end of the electronic cigarette market in the United States.
In other words, while the language being used is couched in legalese, what the FDA is actually indicating here is that it has no intention to approve electronic cigarettes and that it favors an approach by which these products are taken off the market and tobacco cigarettes are allowed unfettered reign over the market for smokers' business.
To express it another way, the FDA is essentially banning or putting insurmountable obstacles in front of the relatively safer electronic cigarettes, but approving - without any regulatory burden - the deadly real ones.
This is the exact opposite of regulating electronic cigarettes "in a manner consistent with its mission of protecting the public health." In fact, it represents regulating tobacco products and electronic cigarettes in a manner inconsistent with its mission of protecting the public health.
What this does is help to ensure that smokers do not quit smoking and that they do not switch away from their Marlboros, Camels, Kools, Salems, and Newports over to much safer tobacco-free products that have no known risks beyond the nicotine delivery. It helps ensure that smokers who want to quit have no choice other than to use the dismally effective nicotine replacement products which offer them no better than about an 8% long-term success rate. It helps ensure that cigarette profits will remain strong at the expense of the health of smokers. It protects the profits of Big Tobacco and Big Pharma at the expense of the protection of the public's health.
Tuesday, September 14, 2010
FDA's Actions on Electronic Cigarettes Show Absurdity of Entire Tobacco Regulatory Scheme: Asking FDA to Regulate Cigarettes Was a Huge Mistake
The Food and Drug Administration (FDA) used to be responsible for assuring that the food and drugs consumed by Americans are safe. Now, it is also responsible for approving the sale and marketing of products which kill more than 400,000 Americans each year. Although people are dying by the hundreds each day from tobacco products, the FDA has so far taken no action to make cigarettes safer, reduce the number of youths who start smoking, or reduce the number of adults who smoke. While the FDA has comprehensive authority over the production, marketing, and sale of cigarettes, it has taken no actions that have had any effect on improving the public's health by decreasing tobacco-related morbidity or mortality.
In contrast, the FDA has taken significant efforts to remove electronic cigarettes - a much safer alternative to tobacco cigarettes - from the market. The Agency has seized various shipments of electronic cigarettes, threatened to remove electronic cigarettes from the market, warned consumers about the dangers of electronic cigarettes, scared the public into thinking that electronic cigarettes are loaded with carcinogens, convinced many people that all electronic cigarettes contain deadly anti-freeze, and taken other public efforts to highly discourage the use of these products by addicted smokers who would like to quit smoking but have been unsuccessful using other methods (including FDA-approved pharmacotherapy).
The net result is a complete inconsistency and absurdity in the FDA's actions. On the one hand, the agency is approving the sale and marketing of a product that kills hundreds of thousands of Americans each year and has taken no action to significantly reduce the number of cigarette smokers. On the other hand, the agency has threatened to ban a much safer alternative to cigarettes which many ex-smokers are finding useful to keep them off cigarettes and which have greatly improved their health. The agency has also taken efforts which have resulted in encouraging vapers to switch back to regular cigarettes by declaring that they should not use electronic cigarettes at this time.
There is no logical consistency or public health justification for the FDA's actions. Moreover, the agency's actions to date have produced no tangible public health benefits. Even worse, the agency's actions have caused demonstrable public health harm by discouraging many current or potential e-cigarette users from vaping and convincing them to return to cigarette smoking. In other words, the FDA's actions have actually resulted in a prevention of the loss of customers for the tobacco industry.
Philip Morris couldn't be happier with the FDA's actions to date. The agency is protecting the company's dominant market share of the deadliest consumer products on the market and preventing or discouraging the use of a much safer alternative which would otherwise threaten to make a dent in the company's profits.
Big Pharma also couldn't be happier with the FDA's actions, as the agency has protected the pharmaceutical industry's terribly ineffective smoking cessation products from competition from what may just be a much more effective alternative for individuals who want to quit smoking but are having extreme difficulty in doing so.
The only one who hasn't benefited from the agency's actions is the public, which continues to die by the hundreds each day - due not to electronic cigarettes but to the damn real ones.
The Rest of the Story
The rest of the story is that the absurd regulatory system created by Philip Morris, the health groups, and the politicians is nothing more than a huge public scam. The system is set up to make it look like the nation's leading tobacco company, the health groups, and the politicians who supported the law are taking action to protect the public's health and to fight Big Tobacco profits. Instead, the actual effect of the new regulatory system is to make the government a true partner and accomplice in the deaths of hundreds of thousands of Americans each year, to fend off potential less hazardous products that could compete with the market share leaders, and to set up a cozy deal by which existing market share is essentially frozen, existing cigarettes are institutionalized and protected, and new products which could have real public health benefits are thwarted.
The system is working beautifully so far, and the story of the handling of electronic cigarettes under the new regulatory framework is a perfect example. Like clockwork, the FDA has stepped in to protect the deadly cigarette market from potential threats caused by a much safer alternative that has proven to help thousands of smokers to stay off cigarettes or greatly reduce their cigarette consumption.
The status quo is preserved, the profits of Big Tobacco and Big Pharma are protected, yet the one group which is harmed is the public.
Vapers are harmed because they are either deprived of the opportunity to switch to a safer alternative that will improve their health or they are encouraged to return from relatively safe vaping back to very hazardous smoking. Smokers are harmed because they are discouraged from trying a potentially life-saving device and instead, are convinced to keep smoking. Nonsmokers are harmed because instead of benefiting from the absence of secondhand smoke associated with vaping, they continue to be exposed to smoke from smokers who decide, at the advice of the FDA, not to use electronic cigarettes but to stick with their Marlboros. Children are harmed because parents who might otherwise be vaping in the home are now smoking in the home.
There are plenty of politicians and groups which have spoken up to protect the interests of Philip Morris and Big Pharma. But few are speaking up to protect the interests of the public. The Rest of the Story will continue to fight for the welfare of the public, and unlike the politicians and anti-smoking groups which joined hands with Philip Morris in setting up this absurd regulatory scheme, will not be bought off by political or financial interests.
In contrast, the FDA has taken significant efforts to remove electronic cigarettes - a much safer alternative to tobacco cigarettes - from the market. The Agency has seized various shipments of electronic cigarettes, threatened to remove electronic cigarettes from the market, warned consumers about the dangers of electronic cigarettes, scared the public into thinking that electronic cigarettes are loaded with carcinogens, convinced many people that all electronic cigarettes contain deadly anti-freeze, and taken other public efforts to highly discourage the use of these products by addicted smokers who would like to quit smoking but have been unsuccessful using other methods (including FDA-approved pharmacotherapy).
The net result is a complete inconsistency and absurdity in the FDA's actions. On the one hand, the agency is approving the sale and marketing of a product that kills hundreds of thousands of Americans each year and has taken no action to significantly reduce the number of cigarette smokers. On the other hand, the agency has threatened to ban a much safer alternative to cigarettes which many ex-smokers are finding useful to keep them off cigarettes and which have greatly improved their health. The agency has also taken efforts which have resulted in encouraging vapers to switch back to regular cigarettes by declaring that they should not use electronic cigarettes at this time.
There is no logical consistency or public health justification for the FDA's actions. Moreover, the agency's actions to date have produced no tangible public health benefits. Even worse, the agency's actions have caused demonstrable public health harm by discouraging many current or potential e-cigarette users from vaping and convincing them to return to cigarette smoking. In other words, the FDA's actions have actually resulted in a prevention of the loss of customers for the tobacco industry.
Philip Morris couldn't be happier with the FDA's actions to date. The agency is protecting the company's dominant market share of the deadliest consumer products on the market and preventing or discouraging the use of a much safer alternative which would otherwise threaten to make a dent in the company's profits.
Big Pharma also couldn't be happier with the FDA's actions, as the agency has protected the pharmaceutical industry's terribly ineffective smoking cessation products from competition from what may just be a much more effective alternative for individuals who want to quit smoking but are having extreme difficulty in doing so.
The only one who hasn't benefited from the agency's actions is the public, which continues to die by the hundreds each day - due not to electronic cigarettes but to the damn real ones.
The Rest of the Story
The rest of the story is that the absurd regulatory system created by Philip Morris, the health groups, and the politicians is nothing more than a huge public scam. The system is set up to make it look like the nation's leading tobacco company, the health groups, and the politicians who supported the law are taking action to protect the public's health and to fight Big Tobacco profits. Instead, the actual effect of the new regulatory system is to make the government a true partner and accomplice in the deaths of hundreds of thousands of Americans each year, to fend off potential less hazardous products that could compete with the market share leaders, and to set up a cozy deal by which existing market share is essentially frozen, existing cigarettes are institutionalized and protected, and new products which could have real public health benefits are thwarted.
The system is working beautifully so far, and the story of the handling of electronic cigarettes under the new regulatory framework is a perfect example. Like clockwork, the FDA has stepped in to protect the deadly cigarette market from potential threats caused by a much safer alternative that has proven to help thousands of smokers to stay off cigarettes or greatly reduce their cigarette consumption.
The status quo is preserved, the profits of Big Tobacco and Big Pharma are protected, yet the one group which is harmed is the public.
Vapers are harmed because they are either deprived of the opportunity to switch to a safer alternative that will improve their health or they are encouraged to return from relatively safe vaping back to very hazardous smoking. Smokers are harmed because they are discouraged from trying a potentially life-saving device and instead, are convinced to keep smoking. Nonsmokers are harmed because instead of benefiting from the absence of secondhand smoke associated with vaping, they continue to be exposed to smoke from smokers who decide, at the advice of the FDA, not to use electronic cigarettes but to stick with their Marlboros. Children are harmed because parents who might otherwise be vaping in the home are now smoking in the home.
There are plenty of politicians and groups which have spoken up to protect the interests of Philip Morris and Big Pharma. But few are speaking up to protect the interests of the public. The Rest of the Story will continue to fight for the welfare of the public, and unlike the politicians and anti-smoking groups which joined hands with Philip Morris in setting up this absurd regulatory scheme, will not be bought off by political or financial interests.
Monday, September 13, 2010
IN MY VIEW: FDA's Grounds for Jurisdiction Over Electronic Cigarettes are Inappropriate and Being Inconsistently Applied
Last week, the Food and Drug Administration (FDA) asserted jurisdiction over electronic cigarettes under the United States Food, Drug and Cosmetic Act (FDCA) and sent warning letters to five electronic cigarette companies threatening to seize their products or remove their products from the market if they do not obtain FDA approval of these products as drugs and devices under FDCA. Such approval would require expensive, large-scale clinical trials designed to test the absolute safety of the product and its effectiveness in smoking cessation.
In these letters, the FDA asserts jurisdiction over electronic cigarettes under FDCA on two grounds:
First, that electronic cigarettes are "capable of delivering nicotine."
Second, that the products in question are marketed "as smoking deterrents or to reduce dependence on traditional tobacco products."
In asserting that some of the companies are making smoking deterrent claims, the FDA relies in part upon testimonials by consumers placed on the companies' web sites. For example, in asserting that Johnson Creek Enterprises is making smoking cessation claims, the FDA cites a web site testimonial from a customer who states: "I have been off tobacco cigarettes for a week" and from another who states: "If I had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again with as good as I feel right now."
In asserting that Ruyan is making smoking cessation claims, the FDA cites a web site testimonial from a customer stating: "My grandmother smoked like a chimney. After I bought her the Ruyan products, she reduced her cigarette smoking remarkably."
Furthermore, the FDA relies upon 21 CFR 310.544 to argue that any claim that a product helps reduce smoking makes the product a smoking deterrent drug product. That section reads: "Any product that bears labeling which claims that it helps stop or reduce the cigarette urge, helps break the cigarette habit, helps stop or reduce smoking, or similar claims is a smoking deterrent drug product."
The Rest of the Story
In this commentary, I argue that a major basis for the grounds used by the FDA to assert jurisdiction over electronic cigarettes under FDCA is flawed and does not hold up when viewed in light of the overall regulatory scheme that has now been established for tobacco products under the Family Smoking Prevention and Tobacco Control Act's amendments to FDCA (which I will refer to as the Tobacco Act). Furthermore, I argue that the FDA's invocation of 21 CFR 310.544 is being inconsistently applied and could lead to absurd consequences if applied in this way.
First, a major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. A tobacco product is: "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)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
Thus, a major ground for the FDA's assumption of jurisdiction over electronic cigarettes in these warning letters is legally flawed and inappropriate. And I believe this aspect of the FDA's argument for jurisdiction over NJOY cigarettes under FDCA will be rejected by the D.C. Court of Appeals.
Now to the second major ground for the FDA's assumption of jurisdiction over these electronic cigarette brands: that they make claims (often through customer testimonials) that they can reduce the amount of cigarettes smoked and therefore are smoking deterrents under 21 CFR 310.544.
While I agree that an electronic cigarette company which makes direct marketing claims that the primary intended use of its product is to achieve smoking cessation is making drug claims for which the FDA could assert jurisdiction under FDCA, I do not believe that 21 CFR 310.544 is the appropriate grounds for such a claim of jurisdiction. Also, I do not believe that the basis for the conclusion that two of the companies - Johnson Creek Enterprises and Ruyan - are making drug claims is appropriate because it relies upon customer testimonials rather than direct marketing claims made by the manufacturer or distributor. Moreover, I do not believe the FDA is consistently applying the reasoning it is using in asserting jurisdiction over electronic cigarettes under this legal ground and that application of this reasoning could lead to absurd (or at least unintended) regulatory consequences.
My argument here is a bit more complex than my refutation of the FDA's claim of jurisdiction over electronic cigarettes under the grounds that they deliver pharmacologically active nicotine, so I will approach this by providing some examples to illustrate my points.
Under the FDA's reasoning, a company can be said to be making drug claims about its tobacco product if that company puts testimonials on its web site indicating that a consumer of the product has quit smoking or reduced the amount of cigarettes consumed as a result of using that alternative tobacco product. Well, if that's the case, then Camel Snus could just as easily be said to be making drug claims. Why? Because on the Camel Snus web site, a customer testimonial boasts about how the use of Camel Snus helped her to sustain her attempt to stay off cigarettes and is helping her to breathe better and have less symptoms of smoking withdrawal:
Why is the FDA not writing a warning letter to R.J. Reynolds stating that Camel Snus is being marketed (based on this customer testimonial) as a smoking deterrent or smoking cessation aid and that under 21 CFR 310.544 it is therefore a smoking deterrent drug over which the FDA is going to assert jurisdiction under FDCA?
I'm not arguing that the FDA should do this; I'm merely pointing out that the precise reasoning being used by the FDA to assert jurisdiction over Johnson Creek and Ruyan electronic cigarettes under FDCA could just as easily be used to assert jurisdiction over R.J. Reynolds' Camel Snus under FDCA.
Here is another example: Where are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit? These products are clearly being marketed as smoking cessation aids. The title of the web page is: "Quit Smoking Cigarettes." The company claims: "Mint Snuff Pouches are the perfect alternative to cigarettes and smokeless tobacco and they freshen your breath, too! The next time you reach for a cigarette, Pop a Pouch instead." A similar product - Mint Snuff Chew - is being marketed as helping smokeless tobacco users to quit: "Mint Snuff Chew is a non-tobacco chew made of mint instead of tobacco which has helped thousands of tobacco users quit tobacco."
What I'd like to know is where is the FDA's evidence that Mint Snuff Chew is effective for quitting smokeless tobacco? Where, FDA, are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit?
The company is making direct claims that the primary purpose of the product is to help users quit smoking cigarettes or quit chewing tobacco. Clearly, then, the product is intended for use in treating nicotine dependence and it therefore is intended to cure, mitigate, treat, or prevent disease, under the precise arguments made by the FDA in its warning letters to the electronic cigarette companies.
Yet, where is the FDA's warning letter to this company, demanding that the company carry out clinical trials to establish the effectiveness of the product in helping smokers quit?
Once again, I'm not arguing here that the Oregon Mint Snuff Company should be required to conduct clinical trials demonstrating that its mint snuff pouches are effective in helping smokers quit. But I am demonstrating that the FDA is being quite inconsistent in applying 21 CFR 310.544 and in invoking smoking cessation claims to assert jurisdiction over products.
If anything, I would argue that the Oregon Mint Snuff Company's claims are definitively drug claims under FDCA and they are stronger claims than those being made by at least two of the electronic cigarette companies which received warning letters. The mint snuff company's marketing claims make it very clear that the primary and only intended use of the product is to help quit smoking or quit using smokeless tobacco. In contrast, the electronic cigarettes are being marketed primarily as smoking alternatives with a secondary mention of reduction or elimination of smoking. Regardless, any kind of consistent application of 21 CFR 310.544 would have the FDA demanding clinical trials from the Oregon Mint Snuff Company demonstrating that its products are effective in both smoking cessation and smokeless tobacco cessation.
Yet another example is Bacc-Off, which is clearly being marketed with the direct and primary purpose of quitting smokeless tobacco use. In fact, the company claims that: "If you are trying to quit the use of smokeless tobacco, but need something as a substitute, Bacc-Off is the perfect solution."
So where is the warning letter to the manufacturer of Bacc-Off, demanding to see the clinical trials which demonstrate that smokeless tobacco users who try the product are significantly more likely to quit than those who try a placebo? Where are those clinical trials?
I'm also interested in seeing the clinical trials demonstrating that Ciga-Mint helps smokers quit. The company is making unequivocal drug claims: smoking cessation claims. Yet I don't see any FDA warning letter to the Ciga-Mint company demanding to see the clinical trials of this product's effectiveness in smoking cessation.
Similarly, where are the warning letters demanding to see the clinical trial data showing that the following products, each of which is clearly making drug claims under 21 CFR 310.544, are effective in helping smokers quit:
Altoids ("Great tool for quitting smoking")
Stress Mints (They "reduce" the "craving" to smoke)
DX Mint Cigarettes ("helps you effortlessly quit smoking")
E-Z Quit Artificial Cigarettes ("When you inhale through an E-Z QUIT, the cartridge releases a flavor that refreshes your mouth and occupies your taste buds. Through psychological mechanisms it "fools you" into thinking you are smoking the real thing, and as a result it helps you to quit smoking. You just inhale through this device whenever you get the next urge to smoke, and it helps carry you over each crisis.")
Ice Breakers Mints and Gum ("For the individual trying to quit smoking, Ice Breakers Mints and Gum provide an alternative, especially during those difficult first weeks. Pop an Ice Breaker into your mouth to deal with that cigarette desire.")
I'm not aware of any clinical trials demonstrating that these cigarette alternatives, which are being marketed as smoking deterrent drugs, are effective for smoking cessation. Yet the FDA is not taking action against these companies to ensure that the products are not marketed until they are proven to be effective for smoking cessation.
Taken to its extreme, the FDA's invocation of 21 CFR 310.544 and its determination of intended use based on customer testimonials could lead to absurd consequences, where if a customer writes on a web site that he found a breath mint helping in reducing smoking the company could be cited as being in violation of the Food, Drug, and Cosmetic Act.
The rest of the story is that the FDA's assertion of jurisdiction over electronic cigarettes is problematic for two reasons. First, the fact that these products deliver nicotine is being used improperly as a grounds for regulating the product under FDCA. Second, the secondary use of electronic cigarettes as a smoking cessation tool is being construed improperly from customer testimonials and the invocation of 21 CFR 310.544 is being inconsistently applied.
Of course, the greatest problem with the FDA's treatment of electronic cigarettes is the absurdity of its efforts to take these products off the market while approving the sale and marketing of the far more dangerous real cigarettes. That will be the subject of tomorrow's post.
In these letters, the FDA asserts jurisdiction over electronic cigarettes under FDCA on two grounds:
First, that electronic cigarettes are "capable of delivering nicotine."
Second, that the products in question are marketed "as smoking deterrents or to reduce dependence on traditional tobacco products."
In asserting that some of the companies are making smoking deterrent claims, the FDA relies in part upon testimonials by consumers placed on the companies' web sites. For example, in asserting that Johnson Creek Enterprises is making smoking cessation claims, the FDA cites a web site testimonial from a customer who states: "I have been off tobacco cigarettes for a week" and from another who states: "If I had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again with as good as I feel right now."
In asserting that Ruyan is making smoking cessation claims, the FDA cites a web site testimonial from a customer stating: "My grandmother smoked like a chimney. After I bought her the Ruyan products, she reduced her cigarette smoking remarkably."
Furthermore, the FDA relies upon 21 CFR 310.544 to argue that any claim that a product helps reduce smoking makes the product a smoking deterrent drug product. That section reads: "Any product that bears labeling which claims that it helps stop or reduce the cigarette urge, helps break the cigarette habit, helps stop or reduce smoking, or similar claims is a smoking deterrent drug product."
The Rest of the Story
In this commentary, I argue that a major basis for the grounds used by the FDA to assert jurisdiction over electronic cigarettes under FDCA is flawed and does not hold up when viewed in light of the overall regulatory scheme that has now been established for tobacco products under the Family Smoking Prevention and Tobacco Control Act's amendments to FDCA (which I will refer to as the Tobacco Act). Furthermore, I argue that the FDA's invocation of 21 CFR 310.544 is being inconsistently applied and could lead to absurd consequences if applied in this way.
First, a major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. A tobacco product is: "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)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
Thus, a major ground for the FDA's assumption of jurisdiction over electronic cigarettes in these warning letters is legally flawed and inappropriate. And I believe this aspect of the FDA's argument for jurisdiction over NJOY cigarettes under FDCA will be rejected by the D.C. Court of Appeals.
Now to the second major ground for the FDA's assumption of jurisdiction over these electronic cigarette brands: that they make claims (often through customer testimonials) that they can reduce the amount of cigarettes smoked and therefore are smoking deterrents under 21 CFR 310.544.
While I agree that an electronic cigarette company which makes direct marketing claims that the primary intended use of its product is to achieve smoking cessation is making drug claims for which the FDA could assert jurisdiction under FDCA, I do not believe that 21 CFR 310.544 is the appropriate grounds for such a claim of jurisdiction. Also, I do not believe that the basis for the conclusion that two of the companies - Johnson Creek Enterprises and Ruyan - are making drug claims is appropriate because it relies upon customer testimonials rather than direct marketing claims made by the manufacturer or distributor. Moreover, I do not believe the FDA is consistently applying the reasoning it is using in asserting jurisdiction over electronic cigarettes under this legal ground and that application of this reasoning could lead to absurd (or at least unintended) regulatory consequences.
My argument here is a bit more complex than my refutation of the FDA's claim of jurisdiction over electronic cigarettes under the grounds that they deliver pharmacologically active nicotine, so I will approach this by providing some examples to illustrate my points.
Under the FDA's reasoning, a company can be said to be making drug claims about its tobacco product if that company puts testimonials on its web site indicating that a consumer of the product has quit smoking or reduced the amount of cigarettes consumed as a result of using that alternative tobacco product. Well, if that's the case, then Camel Snus could just as easily be said to be making drug claims. Why? Because on the Camel Snus web site, a customer testimonial boasts about how the use of Camel Snus helped her to sustain her attempt to stay off cigarettes and is helping her to breathe better and have less symptoms of smoking withdrawal:
"I'm a girl... I quit smoking and was having a bad day of it and my son ran out to the store and came home with Camel Snus Frost... Told me not to give up, Wow! Thank God I know no tobacco is "good" for me but at least I can breath[e] and not want to kill everyone."
This individual is clearly boasting on the R.J. Reynolds Camel Snus web site of the effectiveness and usefulness of the product in helping her to sustain a cigarette quit attempt. The individual is also boasting about how the product is helping to improve her health: she can breathe better. Furthermore, the individual boasts how the product is helping to reduce the symptoms of cigarette/nicotine withdrawal: she no longer wants to kill everyone.Why is the FDA not writing a warning letter to R.J. Reynolds stating that Camel Snus is being marketed (based on this customer testimonial) as a smoking deterrent or smoking cessation aid and that under 21 CFR 310.544 it is therefore a smoking deterrent drug over which the FDA is going to assert jurisdiction under FDCA?
I'm not arguing that the FDA should do this; I'm merely pointing out that the precise reasoning being used by the FDA to assert jurisdiction over Johnson Creek and Ruyan electronic cigarettes under FDCA could just as easily be used to assert jurisdiction over R.J. Reynolds' Camel Snus under FDCA.
Here is another example: Where are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit? These products are clearly being marketed as smoking cessation aids. The title of the web page is: "Quit Smoking Cigarettes." The company claims: "Mint Snuff Pouches are the perfect alternative to cigarettes and smokeless tobacco and they freshen your breath, too! The next time you reach for a cigarette, Pop a Pouch instead." A similar product - Mint Snuff Chew - is being marketed as helping smokeless tobacco users to quit: "Mint Snuff Chew is a non-tobacco chew made of mint instead of tobacco which has helped thousands of tobacco users quit tobacco."
What I'd like to know is where is the FDA's evidence that Mint Snuff Chew is effective for quitting smokeless tobacco? Where, FDA, are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit?
The company is making direct claims that the primary purpose of the product is to help users quit smoking cigarettes or quit chewing tobacco. Clearly, then, the product is intended for use in treating nicotine dependence and it therefore is intended to cure, mitigate, treat, or prevent disease, under the precise arguments made by the FDA in its warning letters to the electronic cigarette companies.
Yet, where is the FDA's warning letter to this company, demanding that the company carry out clinical trials to establish the effectiveness of the product in helping smokers quit?
Once again, I'm not arguing here that the Oregon Mint Snuff Company should be required to conduct clinical trials demonstrating that its mint snuff pouches are effective in helping smokers quit. But I am demonstrating that the FDA is being quite inconsistent in applying 21 CFR 310.544 and in invoking smoking cessation claims to assert jurisdiction over products.
If anything, I would argue that the Oregon Mint Snuff Company's claims are definitively drug claims under FDCA and they are stronger claims than those being made by at least two of the electronic cigarette companies which received warning letters. The mint snuff company's marketing claims make it very clear that the primary and only intended use of the product is to help quit smoking or quit using smokeless tobacco. In contrast, the electronic cigarettes are being marketed primarily as smoking alternatives with a secondary mention of reduction or elimination of smoking. Regardless, any kind of consistent application of 21 CFR 310.544 would have the FDA demanding clinical trials from the Oregon Mint Snuff Company demonstrating that its products are effective in both smoking cessation and smokeless tobacco cessation.
Yet another example is Bacc-Off, which is clearly being marketed with the direct and primary purpose of quitting smokeless tobacco use. In fact, the company claims that: "If you are trying to quit the use of smokeless tobacco, but need something as a substitute, Bacc-Off is the perfect solution."
So where is the warning letter to the manufacturer of Bacc-Off, demanding to see the clinical trials which demonstrate that smokeless tobacco users who try the product are significantly more likely to quit than those who try a placebo? Where are those clinical trials?
I'm also interested in seeing the clinical trials demonstrating that Ciga-Mint helps smokers quit. The company is making unequivocal drug claims: smoking cessation claims. Yet I don't see any FDA warning letter to the Ciga-Mint company demanding to see the clinical trials of this product's effectiveness in smoking cessation.
Similarly, where are the warning letters demanding to see the clinical trial data showing that the following products, each of which is clearly making drug claims under 21 CFR 310.544, are effective in helping smokers quit:
Altoids ("Great tool for quitting smoking")
Stress Mints (They "reduce" the "craving" to smoke)
DX Mint Cigarettes ("helps you effortlessly quit smoking")
E-Z Quit Artificial Cigarettes ("When you inhale through an E-Z QUIT, the cartridge releases a flavor that refreshes your mouth and occupies your taste buds. Through psychological mechanisms it "fools you" into thinking you are smoking the real thing, and as a result it helps you to quit smoking. You just inhale through this device whenever you get the next urge to smoke, and it helps carry you over each crisis.")
Ice Breakers Mints and Gum ("For the individual trying to quit smoking, Ice Breakers Mints and Gum provide an alternative, especially during those difficult first weeks. Pop an Ice Breaker into your mouth to deal with that cigarette desire.")
I'm not aware of any clinical trials demonstrating that these cigarette alternatives, which are being marketed as smoking deterrent drugs, are effective for smoking cessation. Yet the FDA is not taking action against these companies to ensure that the products are not marketed until they are proven to be effective for smoking cessation.
Taken to its extreme, the FDA's invocation of 21 CFR 310.544 and its determination of intended use based on customer testimonials could lead to absurd consequences, where if a customer writes on a web site that he found a breath mint helping in reducing smoking the company could be cited as being in violation of the Food, Drug, and Cosmetic Act.
The rest of the story is that the FDA's assertion of jurisdiction over electronic cigarettes is problematic for two reasons. First, the fact that these products deliver nicotine is being used improperly as a grounds for regulating the product under FDCA. Second, the secondary use of electronic cigarettes as a smoking cessation tool is being construed improperly from customer testimonials and the invocation of 21 CFR 310.544 is being inconsistently applied.
Of course, the greatest problem with the FDA's treatment of electronic cigarettes is the absurdity of its efforts to take these products off the market while approving the sale and marketing of the far more dangerous real cigarettes. That will be the subject of tomorrow's post.
Friday, September 10, 2010
Center for Regulatory Effectiveness Charges that TPSAC Tobacco Product Constituents Subcommittee Violates the Federal Advisory Committee Act
In an August 29 memorandum, the Center for Regulatory Effectiveness (CRE) charges that the Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee (TPSAC) is acting in violation of the Federal Advisory Committee Act (FACA) because the Subcommittee is structured so as to be unduly influenced by the FDA.
The TPSAC is an advisory committee to the FDA set up under the Family Smoking Prevention and Tobacco Control Act. One of its initial charges is to develop a list of hazardous constituents in tobacco smoke in order to guide the development of "safety standards" to make cigarettes safer by removing or reducing the levels of various toxic components. To accomplish this task, a subcommittee was formed.
According to the CRE memorandum: "the FDA has not established any guidelines to assure that the recommendations of the Subcommittee will not be inappropriately influenced by the FDA. In contrast, it seems the Subcommittee was established to achieve this very result—to be unduly influence by the FDA. The Subcommittee consists of fourteen members. Three of the members of the Subcommittee are currently employed by the FDA and six members are employees of the Federal Government. Furthermore, of the fourteen members of the Subcommittee, only one member is a voting member of the parent committee, TPSAC. Given the composition of the Subcommittee, it is quite difficult to find how any report or recommendation of the Subcommittee would not be inappropriately influenced by the FDA. The operation of the Subcommittee undermines the very independent judgment and expertise that Congress intended advisory committees to provide to executive agencies when it passed FACA."
The second charge made by CRE is that the membership of the Subcommittee violates FACA's requirement that the membership of advisory committees be "fairly balanced" in terms of the points of view represented in light of the functions to be performed. The memorandum argues that: "the Subcommittee is not “fairly balanced” because it is overrepresented by the FDA and the federal government. The overrepresentation by the FDA and the Federal government undermines the very spirit of FACA that Congress intended. By passing FACA, Congress intended to provide for advisory committee that were transparent, independent, and balanced that could provide agencies with technical expertise. FACA did not envision advisory committees that would rubberstamp agency policies, which is the very danger posed by the overrepresentation of the FDA on the Subcommittee. While Congress has provided little guidance on the metric of what constitutes fairly balanced, it is clear that the composition of the Subcommittee does not meet the fairly balanced requirement."
The memorandum concludes: "In sum, as a subcommittee, the Tobacco Product Constituents Subcommittee clearly falls under the definition of an “advisory committee” governed by FACA. As an advisory committee governed by FACA, the Subcommittee has been improperly established and has been operating in violation of FACA. Your response is requested not later than October 15, 2011."
The Rest of the Story
I have to admit that I was quite surprised when I learned of the Subcommittee's membership. I had assumed that like most subcommittees, this one would be a subset of TPSAC members designated to review the tobacco constituents. I was surprised when I read the CRE memo and learned that only one voting TPSAC member is on the Subcommittee and that three government officials and three FDA officials took part in the proceedings.
I tend to agree that with three FDA officials at these subcommittee meetings, it gives the Agency an undue influence on the proceedings. To truly be an advisory committee, the FDA itself shouldn't really serve on the committee or on any of its subcommittees. I certainly understand the value of having an FDA official present at the meetings to serve as a conduit for information in both directions, but what CRE describes above does seem a bit excessive.
While I appreciate CRE's concerns, I frankly am more concerned about the conflicts of interest of the members chosen to serve on the TPSAC. That, I believe, violates FDA's own standards for advisory committee membership and precludes the possibility of unbiased science being the driving force behind the committee's deliberations.
The TPSAC is an advisory committee to the FDA set up under the Family Smoking Prevention and Tobacco Control Act. One of its initial charges is to develop a list of hazardous constituents in tobacco smoke in order to guide the development of "safety standards" to make cigarettes safer by removing or reducing the levels of various toxic components. To accomplish this task, a subcommittee was formed.
According to the CRE memorandum: "the FDA has not established any guidelines to assure that the recommendations of the Subcommittee will not be inappropriately influenced by the FDA. In contrast, it seems the Subcommittee was established to achieve this very result—to be unduly influence by the FDA. The Subcommittee consists of fourteen members. Three of the members of the Subcommittee are currently employed by the FDA and six members are employees of the Federal Government. Furthermore, of the fourteen members of the Subcommittee, only one member is a voting member of the parent committee, TPSAC. Given the composition of the Subcommittee, it is quite difficult to find how any report or recommendation of the Subcommittee would not be inappropriately influenced by the FDA. The operation of the Subcommittee undermines the very independent judgment and expertise that Congress intended advisory committees to provide to executive agencies when it passed FACA."
The second charge made by CRE is that the membership of the Subcommittee violates FACA's requirement that the membership of advisory committees be "fairly balanced" in terms of the points of view represented in light of the functions to be performed. The memorandum argues that: "the Subcommittee is not “fairly balanced” because it is overrepresented by the FDA and the federal government. The overrepresentation by the FDA and the Federal government undermines the very spirit of FACA that Congress intended. By passing FACA, Congress intended to provide for advisory committee that were transparent, independent, and balanced that could provide agencies with technical expertise. FACA did not envision advisory committees that would rubberstamp agency policies, which is the very danger posed by the overrepresentation of the FDA on the Subcommittee. While Congress has provided little guidance on the metric of what constitutes fairly balanced, it is clear that the composition of the Subcommittee does not meet the fairly balanced requirement."
The memorandum concludes: "In sum, as a subcommittee, the Tobacco Product Constituents Subcommittee clearly falls under the definition of an “advisory committee” governed by FACA. As an advisory committee governed by FACA, the Subcommittee has been improperly established and has been operating in violation of FACA. Your response is requested not later than October 15, 2011."
The Rest of the Story
I have to admit that I was quite surprised when I learned of the Subcommittee's membership. I had assumed that like most subcommittees, this one would be a subset of TPSAC members designated to review the tobacco constituents. I was surprised when I read the CRE memo and learned that only one voting TPSAC member is on the Subcommittee and that three government officials and three FDA officials took part in the proceedings.
I tend to agree that with three FDA officials at these subcommittee meetings, it gives the Agency an undue influence on the proceedings. To truly be an advisory committee, the FDA itself shouldn't really serve on the committee or on any of its subcommittees. I certainly understand the value of having an FDA official present at the meetings to serve as a conduit for information in both directions, but what CRE describes above does seem a bit excessive.
While I appreciate CRE's concerns, I frankly am more concerned about the conflicts of interest of the members chosen to serve on the TPSAC. That, I believe, violates FDA's own standards for advisory committee membership and precludes the possibility of unbiased science being the driving force behind the committee's deliberations.
Thursday, September 09, 2010
Anti-Smoking Group Lying to Public in Attempt to Get Smoking Out of Movies
Breathe California of Sacramento-Emigrant Trails, an anti-smoking group which runs the SceneSmoking.org web site - which aims to get smoking out of movies - is lying to the public in support of its policy objectives.
The group claims on its web site that: "Smoking kills about 340 young people a day."
According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.
The Rest of the Story
While the initial posting of this false claim might be written off as a simple mistake, it has now been nearly 3 years since I first notified the organization of the "mistake." At this point, the false claim has transformed from a simple mistake to an outright lie.
Why? Because for 3 years, the group has knowingly been feeding false information to the public.
The group's initial explanation - that the false claim cannot be fixed because the webmaster is on vacation - is now beyond belief. While I could believe a three month vacation perhaps, a three year vacation is ridiculous. Moreover, the website is clearly maintained by a webmaster, as the site now has a fancy introduction which could only be produced by a professional web designer. Clearly, the organization could change the false statistic if they really cared about doing so.
I find it ironic that much of the basis for tobacco control is the premise that the tobacco companies have been communicating misleading and inaccurate information to the public for many years. Interestingly, there are few examples of outright material misrepresentations of facts by the tobacco industry. Mostly, the examples are those of misleading portrayal of information. But here, we have an example of outright dishonesty. I would argue that the statement in question is not merely misleading; it is demonstrably false. It is a lie.
Do we really need to stoop down so low, below the level of even the tobacco industry, to make our points to the public?
The group claims on its web site that: "Smoking kills about 340 young people a day."
According to Breathe California of Sacramento-Emigrant Trails, then, smoking kills more than 124,000 young people every year. Obviously, this is not true.
The Rest of the Story
While the initial posting of this false claim might be written off as a simple mistake, it has now been nearly 3 years since I first notified the organization of the "mistake." At this point, the false claim has transformed from a simple mistake to an outright lie.
Why? Because for 3 years, the group has knowingly been feeding false information to the public.
The group's initial explanation - that the false claim cannot be fixed because the webmaster is on vacation - is now beyond belief. While I could believe a three month vacation perhaps, a three year vacation is ridiculous. Moreover, the website is clearly maintained by a webmaster, as the site now has a fancy introduction which could only be produced by a professional web designer. Clearly, the organization could change the false statistic if they really cared about doing so.
I find it ironic that much of the basis for tobacco control is the premise that the tobacco companies have been communicating misleading and inaccurate information to the public for many years. Interestingly, there are few examples of outright material misrepresentations of facts by the tobacco industry. Mostly, the examples are those of misleading portrayal of information. But here, we have an example of outright dishonesty. I would argue that the statement in question is not merely misleading; it is demonstrably false. It is a lie.
Do we really need to stoop down so low, below the level of even the tobacco industry, to make our points to the public?
Wednesday, September 08, 2010
On Enstrom Firing, FIRE Asks UCLA: How Can It Be that Environmental Health Research Falls Outside the Mission of the Environmental Health Department?
In a September 2 press release, the Foundation for Individual Rights in Education (FIRE) has questioned the academic freedom and scientific integrity at the UCLA School of Public Health, in particular, in the Department of Environmental Health Sciences, asking how the Department could possibly have voted to terminate Dr. Enstrom's long-standing employment at UCLA on the basis that environmental health research falls outside the mission of the environmental health sciences department.
In the press release, FIRE writes: "The University of California, Los Angeles (UCLA) has temporarily halted its violations of the free expression rights of an environmental health sciences professor. The faculty of Dr. James Enstrom's department refused to reappoint him after Enstrom had engaged in successful whistleblowing against a member of the department—and after many years of disagreement between Enstrom and some of his colleagues over research on air pollution. After UCLA told Enstrom he was being let go because his controversial research failed to accord with the department's "mission," Enstrom turned to the Foundation for Individual Rights in Education (FIRE) for help."
FIRE also sent a letter to the UCLA chancellor expressing its concern about threats to freedom of speech, academic freedom, and due process posed by the non-reappointment of Dr. Enstrom on the grounds of his research not being aligned with the department's mission, even though it is environmental health research. FIRE writes that "all signs are that UCLA would not have made its non-rehire decision but for the apparent animus felt by many of his peers as a result of Enstrom's research and his whistleblowing-all instances of protected speech. As a public university, UCLA is both legally and morally bound by the First Amendment's guarantees of freedom of expression and academic freedom."
The Rest of the Story
I reiterate that the issue with Dr. Enstrom's non-reappointment is not the fact of his not being reappointed, but the faulty reasoning provided. His research on environmental health effects of fine particulate matter clearly fits into a department whose mission is to examine the health effects of environmental pollutants and whose research includes many studies of the effects of fine particulates on human health. Therefore, the only way to reconcile the stated reason for Dr. Enstrom's termination with the facts is to interpret the Department as viewing the findings, rather than the substance, of Dr. Enstrom's research as not aligning with the Department's mission. This is troublesome, as it threatens both academic freedom and scientific integrity.
In the press release, FIRE writes: "The University of California, Los Angeles (UCLA) has temporarily halted its violations of the free expression rights of an environmental health sciences professor. The faculty of Dr. James Enstrom's department refused to reappoint him after Enstrom had engaged in successful whistleblowing against a member of the department—and after many years of disagreement between Enstrom and some of his colleagues over research on air pollution. After UCLA told Enstrom he was being let go because his controversial research failed to accord with the department's "mission," Enstrom turned to the Foundation for Individual Rights in Education (FIRE) for help."
"For now, UCLA has granted Dr. Enstrom an eight-month reprieve while he seeks justice in his case," said FIRE President Greg Lukianoff. "But UCLA still has a lot of explaining to do. How is it possible that environmental health research is outside the mission of the Environmental Health Sciences department?"
"Enstrom has worked at UCLA as a researcher and professor since 1976, being rehired consistently each year. Since 2004, he has been rehired in UCLA's Department of Environmental Health Sciences (EHS). Over the years, he and a few of his colleagues have sometimes disagreed strongly about research on environmental health issues—for example, on the extent of the threat to public health posed by certain air pollutants, a topic of Enstrom's research which has been the subject of intense debate in California. Enstrom also was a successful whistleblower whose activism led to fellow EHS faculty member John Froines being replaced on a panel for the California Air Resources Board. Several members of the panel had been serving beyond the three-year legal limit on their terms of office, and Enstrom's whistleblowing provided part of the grounds for a lawsuit on the issue." ...
FIRE also sent a letter to the UCLA chancellor expressing its concern about threats to freedom of speech, academic freedom, and due process posed by the non-reappointment of Dr. Enstrom on the grounds of his research not being aligned with the department's mission, even though it is environmental health research. FIRE writes that "all signs are that UCLA would not have made its non-rehire decision but for the apparent animus felt by many of his peers as a result of Enstrom's research and his whistleblowing-all instances of protected speech. As a public university, UCLA is both legally and morally bound by the First Amendment's guarantees of freedom of expression and academic freedom."
The Rest of the Story
I reiterate that the issue with Dr. Enstrom's non-reappointment is not the fact of his not being reappointed, but the faulty reasoning provided. His research on environmental health effects of fine particulate matter clearly fits into a department whose mission is to examine the health effects of environmental pollutants and whose research includes many studies of the effects of fine particulates on human health. Therefore, the only way to reconcile the stated reason for Dr. Enstrom's termination with the facts is to interpret the Department as viewing the findings, rather than the substance, of Dr. Enstrom's research as not aligning with the Department's mission. This is troublesome, as it threatens both academic freedom and scientific integrity.
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