There are a couple of interesting current news stories about tobacco policy from the U.S. Food and Drug Administration, and they warrant an Unhealthful News type analysis so I am covering them here instead of the Tobacco Harm Reduction blog. The first I already wrote a bit about at the THR blog was the release of the report about menthol cigarettes by FDA's tobacco science advisory committee. The report basically said that having menthol cigarettes available increases the total public health impact of smoking. This is undoubtedly true, since it is true for anything that increases the net benefits from cigarettes for some people: The higher the quality of the product (measured in the only way that matters, how much people like it), the more consumption there is and so lowering quality will lower consumption.
However the report produced much sound and fury for a couple of reasons. First, the committee chose not to explicitly say "we recommend that menthol be banned from cigarettes", which some commentators insisted violated the law that empowered them to write that report and called for a recommendation. This failure to recommend a ban has also been interpreted as the reason that the market capitalization of menthol cigarette makers went up substantially after the report was released, though my hypothesis was that there was insider information about FDA's plans that was more solid than noticing the lack of the phrase "we recommend". On the other hand, the chair of the committee commented to the NYT to the effect that too much was read into the lack of the phrase, perhaps suggesting that my hypothesis was wrong, the lack of the phrase was not significant, and regulatory action is coming.
The second bit of sound and fury has to do with the concern about a restriction on menthol increasing black market sales, which it inevitably will do to some extent. Again, this is simply economic inevitability: Once a black market is viable, as it already is, than anything that lowers the net quality of the legal product (removing flavors that people like, increasing taxes, putting grotesque pictures on the packages) will increase black market sales at the expense of legal sales. For reasons that I explained in my previous posts, unless a menthol restriction triggers particular qualitative changes in the market, which is possible but would be unexpected, the net result will still be a reduction in consumption. However, the science committee quit reasonably punted on this point, saying they were not capable of analyzing it (they clearly do not have the necessary expertise on the committee and it is quite refreshing to see them admit that). But this was glommed onto by some commentators, some saying the black market was sufficient reason to predict that a ban would not have public health benefits (though this seems unlikely for the reasons I note) and others complaining about the fact that they punted on the point.
(I feel I need a conflict of interest disclosure here: As someone who advocates tobacco harm reduction, I have a bit of bias toward favoring reductions in the quality of cigarettes since they encourages more switching to low-risk alternatives. On the other hand, I subscribe to the underlying harm reduction ethics that tend to support individual liberty, encouraging harm reduction, but not wanting to criminalize the decision to not engage in it, or in abstinence. So I have a conflict within my own interests, and certainly both side of it leak into my analysis.)
The second current story relates more directly to THR, and that is the press release by Star Scientific (a company that functions in the market primarily as a patent holding company and spec biotech company but that is known in THR for its consumer goods). Star reports that FDA has ruled that their dissolvable tobacco products – lozenges of powdered tobacco, mint flavors, and binders that the user holds in his mouth like other smokeless tobacco or some pharmaceutical nicotine products – are not subject to the FDA regulation as tobacco products. One possible implication of this is that Star does not have to go through what many of us predict will be an incredibly difficult process required for low-risk tobacco products, which is built into the legislation that authorizes FDA to regulate tobacco, before they can claim that they are a low-risk alternative to cigarettes. Since meeting the standard in the legislation is arguably scientifically impossible, this would be good news. Allowing manufacturers to communicate "this product, while not harmless, is estimated to be about 99% less harmful than smoking and is undoubtedly at least 95% less harmful" would be one of the biggest low-cost victories for public health that can be imagined.
On the other hand, commercial speech that makes scientific claims is almost always regulated by someone. For years before FDA's recently granted jurisdiction, the U.S. Federal Trade Commission regulated such claims about low-risk tobacco products, and the manufacturers apparently believed they would not allow such claims, as evidenced by the fact that they never made them. It has been clear to anyone who honestly evaluates the science, for at least five years and arguably for ten, that mass market Western smoke-free nicotine products fit the description in that "99%" statement. That is true for all such products – Star's lozenges, Nicorette gum, Nicoderm patches, Skoal Bandits, Copenhagen, Red Man, Camel Snus, Marlboro Snus, e-cigarettes, etc. Star wants everyone to believe that their products are particularly low risk compared to others in that list – and more power to 'em if they can convince consumers to switch from cigarettes based on this rhetoric – but there is actually no scientific support for that claim.
Nevertheless, if the press release is to be believed, Star's products are for the moment in a unique position, not regulated by the FDA as pharmaceuticals that are not approved for long-term use (like Nicorette), nor as tobacco products (like Skoal or Camel Snus), nor in a weird limbo that seems to allow the product to be marketed as a substitute so long as there are no claims about risk reduction (like e-cigarettes). It is difficult to believe that uniqueness can persist since, e.g., the Camel line of dissolvable smokeless tobacco products is functionally the same as the products Star sells (indeed, there is an ongoing patent fight). But it is even more difficult to believe that a regulatory vacuum will be created. Government abhors a vacuum. (There is my libertarian side – look it up if you think that word means what certain current American politicians would have you believe it means – popping in). It is difficult to imagine that no one in the US government will assert the authority to regulate claims about THR. Someone will undoubtedly decide how those products will be taxed (and if they actually start to sell much, you can bet that states will want to get their taste).
But an over-arching theme in all of this is an Unhealthful News point: Many people, myself included, are excited about these developments and their implications for public health (and science, and law, and policy, and freedom). But excitement creates the urge to try to divine meaning from each new bit of information, and for scientists or health policy advocates to try to become jailhouse lawyers or political tea leaf readers. But what we are dealing with is the messy business of policy-in-progress. The reason that e-cigarettes are in limbo is that a court ruled that FDA had to treat them as tobacco products (which they can regulate in specific limited ways) rather than drug delivery devices (which FDA is authorized to micromanage and ban outright), though e-cigarettes use only the nicotine from tobacco and deliver it in a novel way, and FDA has no policy within their tobacco regulation for regulating them. Meanwhile, apparently FDA has decided that the smokeless tobacco products that Star produces are not tobacco products. I will let you draw your own conclusions about these observations, and will resist the temptation to pretend I am qualified to interpret the law and just stick to the science and normative sides of the situation where I do claim expertise. (I was invited to sign onto a filing in the e-cigarette court case, but demurred because it was being decided based on legalistic points rather than the scientific or public health claims, and I could not claim relevant expertise.)
It is always tempting to treat today's news as if it always resolved outstanding conundrums. But just as I have note in this series that a new scientific study is typically not more informative than the existing scientific beliefs, the news of the day on tobacco policy is far from definitive. It would be nice to think that the ruling Star just reported means that anything in their category – the category that is often attacked by anti-tobacco extremists as "tobacco candy" – will be legally marketed as a low-risk alternative to smoking. It would be wonderful if scientific truth would be allowed to carry the day. But anti-harm-reduction activists simply have too much power to be very optimistic about that. FDA is foundering through the process of figuring out how to regulate tobacco, and are not issuing careful oracular pronouncements like we might expect from the Fed (the US central bank, which controls certain interest rates and such). Tea leaf reading about the Fed is perhaps warranted, but FDA does not necessarily have the manpower, skill, or mindset to be quite so careful and oracular. Legalistic analyses of some government policies are warranted, but it should be pretty clear that there are a lot of contradictions to work out in this case, and courts are being just as ad hoc as the FDA.
The various relevant corners of the US government have a long way to go before they rough out what they think of the mint leaves in the tobacco – deadly? candy? attractive to children? innocuous? not even tobacco? – and until they do, we should focus on the evolving scientific and normative analyses (and for those who must, which way the big-picture political winds are blowing) rather believing there is much to be found in the tea leaves.
However the report produced much sound and fury for a couple of reasons. First, the committee chose not to explicitly say "we recommend that menthol be banned from cigarettes", which some commentators insisted violated the law that empowered them to write that report and called for a recommendation. This failure to recommend a ban has also been interpreted as the reason that the market capitalization of menthol cigarette makers went up substantially after the report was released, though my hypothesis was that there was insider information about FDA's plans that was more solid than noticing the lack of the phrase "we recommend". On the other hand, the chair of the committee commented to the NYT to the effect that too much was read into the lack of the phrase, perhaps suggesting that my hypothesis was wrong, the lack of the phrase was not significant, and regulatory action is coming.
The second bit of sound and fury has to do with the concern about a restriction on menthol increasing black market sales, which it inevitably will do to some extent. Again, this is simply economic inevitability: Once a black market is viable, as it already is, than anything that lowers the net quality of the legal product (removing flavors that people like, increasing taxes, putting grotesque pictures on the packages) will increase black market sales at the expense of legal sales. For reasons that I explained in my previous posts, unless a menthol restriction triggers particular qualitative changes in the market, which is possible but would be unexpected, the net result will still be a reduction in consumption. However, the science committee quit reasonably punted on this point, saying they were not capable of analyzing it (they clearly do not have the necessary expertise on the committee and it is quite refreshing to see them admit that). But this was glommed onto by some commentators, some saying the black market was sufficient reason to predict that a ban would not have public health benefits (though this seems unlikely for the reasons I note) and others complaining about the fact that they punted on the point.
(I feel I need a conflict of interest disclosure here: As someone who advocates tobacco harm reduction, I have a bit of bias toward favoring reductions in the quality of cigarettes since they encourages more switching to low-risk alternatives. On the other hand, I subscribe to the underlying harm reduction ethics that tend to support individual liberty, encouraging harm reduction, but not wanting to criminalize the decision to not engage in it, or in abstinence. So I have a conflict within my own interests, and certainly both side of it leak into my analysis.)
The second current story relates more directly to THR, and that is the press release by Star Scientific (a company that functions in the market primarily as a patent holding company and spec biotech company but that is known in THR for its consumer goods). Star reports that FDA has ruled that their dissolvable tobacco products – lozenges of powdered tobacco, mint flavors, and binders that the user holds in his mouth like other smokeless tobacco or some pharmaceutical nicotine products – are not subject to the FDA regulation as tobacco products. One possible implication of this is that Star does not have to go through what many of us predict will be an incredibly difficult process required for low-risk tobacco products, which is built into the legislation that authorizes FDA to regulate tobacco, before they can claim that they are a low-risk alternative to cigarettes. Since meeting the standard in the legislation is arguably scientifically impossible, this would be good news. Allowing manufacturers to communicate "this product, while not harmless, is estimated to be about 99% less harmful than smoking and is undoubtedly at least 95% less harmful" would be one of the biggest low-cost victories for public health that can be imagined.
On the other hand, commercial speech that makes scientific claims is almost always regulated by someone. For years before FDA's recently granted jurisdiction, the U.S. Federal Trade Commission regulated such claims about low-risk tobacco products, and the manufacturers apparently believed they would not allow such claims, as evidenced by the fact that they never made them. It has been clear to anyone who honestly evaluates the science, for at least five years and arguably for ten, that mass market Western smoke-free nicotine products fit the description in that "99%" statement. That is true for all such products – Star's lozenges, Nicorette gum, Nicoderm patches, Skoal Bandits, Copenhagen, Red Man, Camel Snus, Marlboro Snus, e-cigarettes, etc. Star wants everyone to believe that their products are particularly low risk compared to others in that list – and more power to 'em if they can convince consumers to switch from cigarettes based on this rhetoric – but there is actually no scientific support for that claim.
Nevertheless, if the press release is to be believed, Star's products are for the moment in a unique position, not regulated by the FDA as pharmaceuticals that are not approved for long-term use (like Nicorette), nor as tobacco products (like Skoal or Camel Snus), nor in a weird limbo that seems to allow the product to be marketed as a substitute so long as there are no claims about risk reduction (like e-cigarettes). It is difficult to believe that uniqueness can persist since, e.g., the Camel line of dissolvable smokeless tobacco products is functionally the same as the products Star sells (indeed, there is an ongoing patent fight). But it is even more difficult to believe that a regulatory vacuum will be created. Government abhors a vacuum. (There is my libertarian side – look it up if you think that word means what certain current American politicians would have you believe it means – popping in). It is difficult to imagine that no one in the US government will assert the authority to regulate claims about THR. Someone will undoubtedly decide how those products will be taxed (and if they actually start to sell much, you can bet that states will want to get their taste).
But an over-arching theme in all of this is an Unhealthful News point: Many people, myself included, are excited about these developments and their implications for public health (and science, and law, and policy, and freedom). But excitement creates the urge to try to divine meaning from each new bit of information, and for scientists or health policy advocates to try to become jailhouse lawyers or political tea leaf readers. But what we are dealing with is the messy business of policy-in-progress. The reason that e-cigarettes are in limbo is that a court ruled that FDA had to treat them as tobacco products (which they can regulate in specific limited ways) rather than drug delivery devices (which FDA is authorized to micromanage and ban outright), though e-cigarettes use only the nicotine from tobacco and deliver it in a novel way, and FDA has no policy within their tobacco regulation for regulating them. Meanwhile, apparently FDA has decided that the smokeless tobacco products that Star produces are not tobacco products. I will let you draw your own conclusions about these observations, and will resist the temptation to pretend I am qualified to interpret the law and just stick to the science and normative sides of the situation where I do claim expertise. (I was invited to sign onto a filing in the e-cigarette court case, but demurred because it was being decided based on legalistic points rather than the scientific or public health claims, and I could not claim relevant expertise.)
It is always tempting to treat today's news as if it always resolved outstanding conundrums. But just as I have note in this series that a new scientific study is typically not more informative than the existing scientific beliefs, the news of the day on tobacco policy is far from definitive. It would be nice to think that the ruling Star just reported means that anything in their category – the category that is often attacked by anti-tobacco extremists as "tobacco candy" – will be legally marketed as a low-risk alternative to smoking. It would be wonderful if scientific truth would be allowed to carry the day. But anti-harm-reduction activists simply have too much power to be very optimistic about that. FDA is foundering through the process of figuring out how to regulate tobacco, and are not issuing careful oracular pronouncements like we might expect from the Fed (the US central bank, which controls certain interest rates and such). Tea leaf reading about the Fed is perhaps warranted, but FDA does not necessarily have the manpower, skill, or mindset to be quite so careful and oracular. Legalistic analyses of some government policies are warranted, but it should be pretty clear that there are a lot of contradictions to work out in this case, and courts are being just as ad hoc as the FDA.
The various relevant corners of the US government have a long way to go before they rough out what they think of the mint leaves in the tobacco – deadly? candy? attractive to children? innocuous? not even tobacco? – and until they do, we should focus on the evolving scientific and normative analyses (and for those who must, which way the big-picture political winds are blowing) rather believing there is much to be found in the tea leaves.
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