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July 25, 2007 -
With the Democrats
once again in control of Congress, the issue of the Food and Drug Administration
regulation of the tobacco industry is very much back on the legislative agenda.
Unfortunately, the legislation being offered this time round by Senators Kennedy
(D), Cornyn (R)and Representatives Davis (R) and Waxman ( D) is essentially the
same as that proposed three years ago when the idea of FDA regulation was linked
to legislation on tobacco quotas.
The campaign to
bring the tobacco industry under the regulatory authority of the FDA began three
decades ago with a 1977 ASH petition to the agency asking it to assert its
jurisdiction over cigarettes on the grounds that they were a drug. Rebuffed by
the FDA, ASH brought suit in federal court seeking to overturn the
administration’s decision, but the suit failed.
It was only with
David Kessler’s arrival as FDA commissioner that the issue of FDA regulation of
the industry was revived through the novel claim in 1996 that the industry not
only manipulated nicotine levels, but that this manipulation was “intended” to
affect the smoker’s body and together this meant that cigarettes were
effectively drugs subject to FDA regulation.
Kessler who
believed that the key to tobacco control was to be found in preventing youth
smoking, proposed a series of regulations which focused on youth access to
tobacco and tobacco marketing, and included sweeping restrictions on young
people’s access to tobacco products and a virtual elimination of tobacco
marketing that could be construed in any way to influence young people.
Challenged by the
industry in court, the FDA eventually lost its bid for regulatory authority when
the Supreme Court in 2000 rejected its claim that the industry’s marketing
claims implicitly acknowledged that it was selling a drug. Writing for the
court, Justice O-Connor concluded that if Congress had wished to provide the FDA
with authority to regulate tobacco it would have done so in the relevant
legislation. The Kennedy and Co legislation is an attempt to provide that
relevant legislation.
At a Capitol Hill
news conference announcing the legislation, the curiously titled Family Smoking
Prevention and Tobacco Control Act, Kennedy said that “Congress cannot in good
conscience allow the federal agency most responsible for protecting the public
health to remain powerless to deal with the enormous risks of tobacco, the most
deadly of all consumer products.”
So just why is the
revival of the legislation aimed at giving the FDA regulatory over the tobacco
industry unfortunate? The proposal is unfortunate for two reasons: first because
of the FDA’s regulatory philosophy and its deep links to the prohibitionists in
the anti-tobacco movement and second because of the specific features of the
bill.
To begin with
there is the general problem of the FDA’s regulatory philosophy about tobacco.
There is little evidence that even after Kessler’s departure the FDA has moved
on from his belief that the goal of tobacco regulation was not to prod the
industry and its customers into developing, producing and consuming less risky
products, but rather to provide the agency with a cudgel big enough to destroy
the industry. In effect, the problem with FDA regulation is that it is not at
all clear that this agency does not see regulation as the route to effective
prohibition.
For instance, at
the end of his memoir on his time at the FDA ( A Question of Intent, 2001),
Kessler observes that “My understanding of the industry’s power finally forced
me to see that, in the long term, the solution to the smoking problem rests with
the bottom line, prohibiting the tobacco companies from continuing to profit
from the sale of a deadly, addictive drug. If public health is to be the
centerpiece of tobacco control… the tobacco industry, as currently configured,
needs to be dismantled.” (p. 392) That sounds much less like regulation than
prohibition.
Kessler’s views
are by no means unique, either in their extremity or in their wrong-headedness.
Anti-tobacco activists have recently advocated the nationalization of the
tobacco industry in Canada, in order to allow the public health community to
produce tobacco products that smokers will not wish to consume, and there have
also been increasing calls for a total prohibition of tobacco.
For these zealots
the major success of the last fifty years in tobacco control –dramatically fewer
smokers smoking cigarettes with substantially reduced tar levels- has not been
brought about by providing smokers with information about the risks of smoking
but instead through vigourous government regulations about smoking in public
places, increased taxes, and denormalization campaigns. For these anti-tobacco
crusaders the focus of tobacco control has always been the creation of a
smoke-free utopia- not by the decision of individuals deciding not to smoke, but
through the coercive power of government. And while Kessler might no longer be
at the FDA, many of the true believers in the smoke-free society still are, as
well as being close by, and there is no evidence that they would not use their
new found “regulatory” powers to begin a process of prohibition by stealth.
Such a
prohibitionist agenda founders, however, on a number of stubborn facts. For
instance, the FDA’s belief in the efficacy of advertising bans to prevent youth
smoking or even substantially reduce it is contradicted by the fact that smoking
has flourished in societies without any advertising and continues and indeed has
increased in some countries which have had advertising bans for years.
Again there is
considerable evidence that shows that the predisposition of youth people to
risk-taking and the existence of cigarettes will always result in some youth
smoking. Similarly, the way in which cigarettes, and not just nicotine satisfy a
variety of needs for many people means that there will also always be adult
smokers. And if there are smokers, the needs of these smokers together with the
immense profitability of the tobacco market will continue to insure that
entrepreneurs, whatever their legitimacy, will wish to serve that market. All of
these things count against an effective prohibition of cigarettes and smoking.
But it is more
than just the FDA’s prohibitionist tendencies that count against the new
legislation, it is also what the legislation proposes to allow the FDA to do.
Indeed, in this respect the Kennedy legislation gets tobacco control wrong at
every turn in that it proposes a policy of not only ineffective but
counterproductive measures that will do nothing to address the legislation’s
primary concern- underage smokers.
First, the
legislation is driven by the assumption that “tobacco advertising and marketing
contributes significantly to the use of nicotine-containing tobacco products by
adolescents.” Indeed, as Kennedy put it at the news conference introducing the
legislation “The tobacco industry currently spends over $ 15 billion a year to
promote its products. Much of that money is spent in ways designed to tempt
children to start smoking.” (NYT 16/2/07) While such talk is at least
understandable if not acceptable as a politician’s sound-bite, it is however a
travesty as policy. For one thing there is a wealth of econometric evidence that
disproves the claim that tobacco advertising either leads to smoking initiation
or increased consumption. Indeed, most studies of youth smoking do not even
focus on advertising as a major predictor of smoking uptake. Further, despite
claims like Kennedy’s the Government was unable during its recent racketeering
trial to produce any credible evidence that showed a causal link between tobacco
advertising and young people becoming smokers, or indeed, that proved Kennedy’s
claim that tobacco advertising is “designed to tempt children to start smoking.”
Most importantly, the focus on advertising is a distraction which diverts
attention away from the wealth of research which shows that the most reliable
predictors of whether a young person will become a smoker are factors such as
living in single parent home, living in poverty, and dropping out of school.
Then too there is
the additional problem that advertising restrictions bring with their risk of
freezing market share as well as making difficult the entry of new players in a
market already over half owned by Philip Morris. While PM claims that it
supports FDA regulation because of its commitment to “reasonable regulation”, a
position driven at least in part by its desire to use regulation as a means to
reposition itself as a normal and responsible business, a less flattering
reading sees anti-competitive reasons as the real driving force behind the
industry giant’s support for FDA regulation. Indeed it is hard to see just how
FDA regulation restores industry legitimacy since the regulation could more
naturally be seen as a sanction imposed for past and continuing misconduct.
Second, the
proposed legislation provides the FDA authority to ban terms like light and mild
on the spurious grounds that such cigarettes do not provide a genuine health
benefit to smokers. As we have argued before, there is considerable
epidemiological evidence that reductions in tar levels since the 1940’s- from 46
mg average to about 12 mg in the 1990’s- have resulted in substantial reductions
in lung cancer risks- reductions of 20-30%. This is true even with compensation,
which much evidence shows to not be a significant issue for most smokers. It is
difficult to see how a measure that would result in banning such descriptors
could plausibly be construed as a health measure.
Third, the Kennedy
legislation allows the FDA to reduce nicotine levels, as well as giving it
control over cigarette ingredients-both unsound policy options. For one thing,
Senator Kennedy and his colleagues appear not to have read the Institute of
Medicine’s 2001 report which noted the importance of “retaining nicotine at
pleasurable or addictive levels while reducing the more toxic components of
tobacco…” (p. 29) Or maybe they have and understand its implications all too
well.
By mandating
reduced nicotine levels, the FDA can gradually make legal cigarettes less
palatable, thus furthering not a harm reduction strategy but a prohibition by
regulation strategy. The goal is not safer smoking- whatever the rhetoric- but
no smoking, with nicotine reductions being the key tool to make smoking
unattractive. Since smokers smoke in part for nicotine, reducing nicotine will
drive determined smokers to either smoke more cigarettes or smoke black market
cigarettes with traditional nicotine levels, neither of which benefits their
health.
Equally dangerous
is the move to give the FDA authority over cigarette ingredients since once
again this appears to be nothing more than prohibition by stealth since it is an
attempt to re-engineer cigarettes to make them unsmokeable rather than
attempting to develop less risky products. One can already see where this is
leading in the moves by the proponents of the FCTC to discover whether brand
ingredient differences are linked to brand sales so that popular ingredients can
be banned.
Fourth, the move
toward changed warnings- particularly graphics- envisioned in the legislation,
offers little prospect of providing a genuine health benefit since graphic
health warnings have been shown not only to be ineffective in reducing smoking
initiation, consumption and prevalence but also have the potential to increase
smoking in reactant smokers. For instance, the results of an extensive survey
for the Government of Canada, found that graphic warnings in Canada had
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failed to produce
a statistically significant decline in the incidence of adolescent smoking;
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failed to produce
a statistically significant decline in adolescent consumption- indeed one year
after their introduction occasional adolescent consumption was higher than
before;
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failed to produce
a statistically significant change in adult prevalence or consumption;
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led to a decrease
in the number or adult smokers who looked at the warnings several times a day;
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led to an increase
in the number of both smokers and nonsmokers who never look at or read the
warnings. (For a fuller discussion of the problems of graphic warnings see my A
Picture of Health? Why Graphic Health Warnings Don’t Work Democracy Institute,
2006)
Finally, the
legislation’s provisions that would vest final authority on the development of
less risky tobacco products with the FDA are ill-considered since it is unclear
that the FDA is genuinely interested in harm reduction. For example, it has
never embraced the IOM report, despite the fact that it commissioned it.
Moreover, a good portion of the anti-tobacco movement has actively opposed harm
reduction because of its implications for prohibition. Indeed, this provision
seems far more intended to eliminate the prospect of harm reduction than to
enhance it since it places harm reduction under the control of an agency whose
authority is to be deployed much more toward eliminating smoking, not making it
safer. Thus while the legislation purports to allow reduced risk products, what
it really suggests is a regulatory environment and agenda that is profoundly
hostile to them. Allowing for the gradual reduction of nicotine combined with
banning descriptors such as light and mandating graphic health warnings which do
not convey accurate information about the risks of smoking, signals a policy
agenda designed to stop smoking, not to allow smokers who wish to continue to
smoke with greater safety.
A much sounder
policy would be to create a regulatory philosophy and framework that would
allow, indeed encourage vigourous competition to create innovative, reduced tar
products and which ensures that individuals who choose to smoke have the best
available information about the relative health risks of these products.
Both the tobacco
industry and its customers could benefit enormously from an FDA regulatory
framework that takes into account the realities of smoking in the United States
as opposed to some smoke-free utopia, and is interested in the public health
needs of the millions of Americans who continue to smoke. The “Family Smoking
Prevention and Tobacco Control Act, a legacy of Dr. Kessler’s time at the DFA,
is very sadly not that framework.
John Luik
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