Thursday, November 03, 2005

FDA Tobacco Legislation: Where Will the Tobacco Control Movement Be if it Passes?

I think that an important consideration in evaluating the merit of the proposed FDA tobacco legislation is the likely effect that the legislation would have on the tobacco control movement as a whole. It is not enough to simply bombard the public and tobacco control practitioners with propaganda about the great things that the legislation would do. One needs to take a step back and look at the larger picture.

Where will we be if the FDA legislation is enacted compared to where we would likely be if it is not enacted?

That’s the question I attempt to address in this post. I’ll examine what I think are the likely effects of the FDA legislation on six major areas – the DOJ lawsuit, existing tobacco litigation, future tobacco litigation, state tobacco control legislation, state funding for tobacco control, and local tobacco control efforts.


I believe that enactment of the FDA legislation would decimate the DOJ tobacco lawsuit. If the advertising, marketing, and production of tobacco products is placed under the jurisdiction of the federal government, then there is simply no credible argument that can be made to support the assertion that there is a high likelihood of RICO violations continuing in the future. And there would certainly be no strong argument remaining that judicially-imposed restrictions on cigarette marketing would be required to restrain future RICO violations, since the federal government would then have jurisdiction over this aspect of cigarette company behavior. Thus, at very least the non-monetary remedies in the case would become indefensible and at worst, the DOJ would lose the lawsuit entirely because it would be difficult to convince the court that RICO violations are likely to continue.


Enactment of the FDA legislation would provide cigarette companies with a very strong argument to shield themselves from any significant punitive damages in existing litigation. They could argue, quite correctly, that they are now under the jurisdiction of the FDA. Thus, there is no need to impose substantial punitive damages upon them as an incentive for them to change their behavior. I believe that the unavailability of punitive damages would decimate most existing tobacco litigation.


As I have previously argued, the FDA legislation would provide effective immunity for the cigarette companies. It states that:

"no State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."

But the courts have established that this type of preemption of state and local regulation applies not only to legislation (i.e., laws passed by the state) but that it is broad enough to also preempt litigation (i.e., common law claims brought by citizens against the companies).

I believe that the FDA legislation would therefore provide immunity for the tobacco companies from any claims related to product safety or lack thereof. Obviously, this would preclude virtually all the major areas that would be necessary to rely upon to bring any meaningful claims against the tobacco companies: "tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."

In addition, the preemption clause in the FDA legislation would make it very unlikely that any claims regarding tobacco companies' failure to make their products safer would be allowable. Thus, a whole range of lawsuits based on claims that cigarette companies could have, but did not, produce safer cigarettes would be precluded.

Also, since the tobacco product standards are so broad and encompass ingredients, additives, and smoke components, there are few areas left to make any claim of health damage based on the toxic effects of any tobacco constituent.

Moreover, since modified risk tobacco products are included in the preemption, there would be no possible claims that could be brought against tobacco companies for misleading health claims related to such products. All of their public statements, advertising, etc. concerning these products would be regulated by FDA; thus, there would literally be no possible cause of action related to damages caused by these products or any deceptive advertising or marketing practices.

Putting points 1-3 together, I think it is quite clear that enactment of the FDA legislation would essentially be the end of tobacco litigation in this country. Existing cases would of course continue, but there would be little threat of substantial punitive damages, taking the meat out of these cases. Future litigation would be largely paralyzed. It is no wonder that Philip Morris highly desires this legislation.


I believe that enactment of the FDA legislation would bring the successful promotion of state tobacco control legislation to a grinding halt. It is enough of an obstacle to try to promote effective state tobacco control legislation now. Enactment of FDA legislation would simply make it impossible to accomplish anything more at the state level.

State legislators are already reluctant to take on the tobacco issue, since they tend to believe this is something that should be addressed on a federal level. But once FDA is granted jurisdiction over tobacco products, it will create a even stronger sense that the action is at the federal level and that there is no reason for states to intervene.


For similar reasons as outlined in #4, I think it will become impossible to obtain state funding for tobacco control if the FDA legislation is enacted. Efforts to get state legislatures to allocate tobacco settlement monies for tobacco control are already quite dismal. If the federal government is charged with the major responsibility for addressing the tobacco problem, it will be impossible to convince state legislators that their states need to allocate a substantial amount of funding (that could be used for other purposes) to tobacco control.


This is the one area of tobacco control activity that I think would continue with any meaning, largely because it has taken on a life of its own and become independent in many ways from the tobacco control infrastructure. In addition, it is one of the few major areas of tobacco control activity that is not preempted by the FDA legislation and is not really addressed by the FDA legislation directly, since it relates to secondhand smoke not active smoking.

Nevertheless, the FDA legislation would likely hinder efforts to promote local smoke-free laws. As Billy J. Williams, a member of the Lay Advisory Board of the Flight Attendant Medical Research Institute (FAMRI), pointed out in an analysis published by The Rest of the Story, the bill may be interpreted as giving FDA the authority to set a standard for secondhand smoke since it grants FDA authority to regulate any and all tobacco smoke constituents. At very least, the legislation is likely to be perceived by state and local policy makers as occupying the field of regulation of secondhand smoke. In this way, the bill will undermine state and local efforts to regulate secondhand smoke, even though the bill does not explicitly preempt such measures.

If FDA has the authority to regulate the constituents in tobacco smoke, then it also has, effectively, authority to address the issue of the safety of secondhand smoke, since the constituents in tobacco smoke are those in secondhand smoke. Williams points out, I believe correctly, that local policy makers will likely view this as a situation where the federal government has decided to occupy the field. There is clearly no explicit preemption of local clean indoor air laws, but I believe that enactment of the FDA legislation could have a chilling effect on local clean indoor air efforts.

Putting all of this together, I think it is quite clear that enactment of the FDA legislation will put the entire focus of tobacco control at the federal level. But in doing that, it will also have the effect of decimating the practice of tobacco control at the state and local levels. The grassroots of the tobacco control movement would be eroded, and over time, I think would dissipate.

In contrast, the action in tobacco control would shift to the national level. There would be a huge need for the Washington, D.C.-based national organizations (ironically, the very same organizations that are supporting the bill – Tobacco-Free Kids, ACS, AHA, and ALA) to monitor the actions of FDA and its Scientific Advisory Panel and tobacco industry consultants, as well as the actions of Congress (since the FDA legislation contains an escape clause by which Congress must essentially approve any proposed FDA regulations and the tobacco companies would certainly use their political influence with Congress to block any meaningful FDA regulations).

In essence, the entire tobacco control movement would be shifted from its grassroots, local structure to a centralized, national structure based within, and operating within the Beltway.

In other words, we would be putting all of our eggs in one basket. Sometimes that may be a risk worth taking. But I think it would suicide for the movement to put all our eggs in the FDA’s basket right now.

Might there be a situation in which it would be worth giving up the bulk of state and local tobacco control and putting all of our focus at the federal level? Perhaps. But not now. And not with this bill.

Perhaps if the FDA were going to be given unfettered authority to regulate tobacco products and if the most critical decisions were going to be made on scientific, rather than political grounds, it would be an acceptable idea. But the authority in the FDA bill is hardly unfettered. The loopholes in the legislation are the size of a truck. And the placement of the most critical decisions about the public’s health into the hands of politics, rather than science, is simply unacceptable.

Where will we be if the FDA legislation is enacted? We’ll be nowhere. The grassroots, state and local infrastructure of tobacco control will be largely gone, or at least largely immobilized. They, on the other hand (Big Tobacco Control – Tobacco-Free Kids, ACS, AHA, and ALA) will be in great shape. They’ll have years of work cut out for them – fighting the tobacco industry in court over every little provision of every proposed FDA regulation, trying to convince Congress not to overturn each proposed regulation as it comes out, trying to dissuade the FDA from following the advice of its required tobacco industry consultants.

Big Tobacco Control will be plenty busy – managing the FDA Circus. But that circus, at its best, will achieve only one measure that will have any meaningful effect on the public’s health (strengthening cigarette warning labels).

The real tobacco control movement will be quite immaterial at that point. And the shame of it all is that it is the public’s health that will pay the price. The rest of us will have to simply watch as Philip Morris, with its federal stamp of approval for its products and for its introduction, with immunity, of new reduced risk products that will further its market dominance, achieves its dream of a near monopoly. Smaller companies will be forced out and any competition that might otherwise encourage the development of truly reduced risk products will be eliminated.

And the FDA stamp of approval for tobacco products along with the tobacco company's newly-found ability to publicly disseminate the fact that tobacco products are now stringently regulated by the federal government will undermine the public's appreciation of the health hazards of smoking and therefore lead to increased smoking initiation and reduced smoking cessation. As I argued last week, you can't erode the public's perception of the harms of cigarettes without also eroding the public's health.

And ultimately, that is what I think the FDA legislation will do.

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