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There are two essential elements of a policy analysis: (1) it should provide an accounting of all harms and benefits of a proposed policy and then weigh these harms and benefits1–3; and (2) it should be evidence based—it should assess the likelihood of policy effects not from the perspective of what could happen based on hypothetical considerations or pure speculation, but on documented effects or theoretical or conceptual research.1–3
Any analysis that fails to identify both harms and benefits of a policy, fails to weigh these in drawing its overall conclusion, or is not evidence based, is likely to be flawed and highly subject to bias. Thus, my approach here is to provide an accounting of the harms and benefits of the US Senate Food and Drug Administration (FDA) Bill, using an evidence based approach to assess the likely policy effects.
PROVISIONS OF BILL FOR WHICH THERE IS EVIDENCE OF A POSITIVE EFFECT ON PUBLIC HEALTH
Strengthening of warning labels
For only one provision of the Bill—the strengthening of cigarette warning labels (chapter 2, section 21(4)(a)(1))—is there solid evidence that a positive effect on public health is likely. Research from Canada suggests that strong, graphic cigarette warning labels may increase smokers’ motivation to quit.4,5
PROVISIONS OF BILL FOR WHICH THERE IS EVIDENCE OF A NEGATIVE EFFECT ON PUBLIC HEALTH
Overall regulatory framework
The way in which the Bill frames the problem of tobacco use will lead to an erosion of public perception of the inherent harms posed by cigarettes. The Bill frames tobacco use as a problem only insofar as tobacco companies introduce new products, make misleading health claims, or fail to comply with FDA performance standards. The Bill will result in consumers perceiving that FDA has given a stamp of approval to tobacco products, and the public’s perceived level of the health risk posed by tobacco products will therefore decline.
Second, the Bill will create the public perception that the tobacco problem is taken care of. It will be virtually impossible to convince state legislators to allocate the funds necessary to support effective, statewide tobacco control programmes, interventions which have been shown to be among the most successful in reducing tobacco use.6
Third, the Bill will end any serious threat to the tobacco companies posed by current and future litigation. Tobacco companies will be able to successfully argue that they are already regulated and that there is therefore no need for any further substantial punitive damages or injunctive relief.
Fourth, the Bill will improve the public image and goodwill of tobacco companies because they will be able to use the fact of being regulated by FDA to achieve improved public opinion. Improved public image translates into an improved bottom line—increased cigarette consumption.7
Modified risk product provisions
These provisions of the Bill (section 911) would have two adverse effects on public health. First, they would make it virtually impossible for any truly reduced risk product to enter the market (section 911(g)(1)). The Bill removes any incentive for the development of reduced risk products; instead, it freezes the market as it is.
Second, the Bill allows reduced exposure products (those which only claim to reduce exposure, not health risks) to be marketed so long as the manufacturer states that it expects the product to reduce health risks (section 911(g)(2)(A)). Since the public is going to perceive that a reduced exposure product will reduce health risk, this essentially allows the company to market products as reducing health risks without any substantiation. This institutionalises the very problem that the Bill is trying to solve.
PROVISIONS OF BILL FOR WHICH THERE IS NO EVIDENCE OF AN EFFECT ON PUBLIC HEALTH, DESPITE CLAIMS TO THE CONTRARY
Overall regulatory framework
There is no evidence that giving FDA authority to regulate tobacco products will improve health. Supporters of the 1970 Federal Cigarette Labeling and Advertising Act8 thought that by giving the Federal Trade Commission the authority to regulate cigarette advertising and banning ads from television and radio, the Act would improve public health. Instead, the Bill had a detrimental effect on public health, as youth smoking increased because of the discontinuation of aggressive anti-smoking ads,9 cigarette companies were given de facto immunity from litigation for nearly three decades, and television advertising for cigarettes remained, in the form of sponsored motor sports and other sporting events.10,11
Disclosure of cigarette constituents and arthority to issue performance standards
Knowing the names and amounts of the thousands of tobacco smoke constituents (section 904) and being able to require reductions or elimination of some of these constituents (section 907) is not going to save lives. Instead, it represents a quite absurd approach to tobacco control policy. We simply do not know which carcinogens of the more than 40 carcinogens in tobacco smoke and which toxins of the more than 4000 chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemical will be, as well as how the combination of chemicals removed will affect disease risk, if at all, and whether the processes used to alter the chemical makeup of cigarette smoke will introduce new chemicals that may even be more hazardous to health.
Regulation of nicotine (section 907)
Although some have argued that the FDA would be able to reduce nicotine levels to below a threshold level required for addiction, the Bill contains a clause that prohibits the FDA from lowering the nicotine level to zero (section 907(b)(3)(B)), which will likely be interpreted by the courts as intending to reserve to Congress the right to make decisions regarding the requirement that tobacco products be non-addictive. This issue will certainly be tied up in the courts should the FDA decide to take such an action.
Advertising restrictions (sections 906 and 12)
Until the Supreme Court rules on what cigarette advertising restrictions, if any, will be considered constitutional, there is simply no evidence that the particular advertising restrictions in the Bill will be upheld. Philip Morris has already indicated that it will challenge these restrictions in court.12
Youth access regulations (sections 906, 12, and 13)
SUMMARY AND WEIGHING OF POSITIVE AND NEGATIVE EFFECTS
Based on the evidence, the Bill will likely have one positive effect—increasing adult smoking cessation slightly through stronger warning labels—and six negative effects: eroding the public perception of the inherent harms posed by cigarettes; creating the public perception that the problem is taken care of and reducing the allocation of state funding for effective tobacco control programmes and media campaigns; ending any serious threat to tobacco companies of damage from litigation; improving the public image of tobacco companies; ending the incentive for the development of truly reduced risk tobacco products; and institutionalising the problem of unsubstantiated health risk claims by cigarette marketers. There seems little doubt that on balance, the negative effects outweigh the positive. I conclude that the Family Smoking Prevention and Tobacco Control Act will be detrimental to the public’s health.
IMPLICATIONS OF FINDINGS
Enactment of the Senate FDA Bill will have a chilling effect on tobacco control interventions that we know are effective, including comprehensive state level programmes,6 anti-smoking media campaigns,6,9,17,18 and tobacco litigation.19–21 By diverting resources to any area where it is simply not politically feasible to achieve success, the promotion of FDA legislation is not only a waste of energy, but it is detracting from the state and local practice of tobacco control, which has been, and continues to be, tremendously successful in changing social norms and reducing tobacco use.21–23 Focusing our efforts on this doomed pathway instead of on interventions that are politically feasible and have been successful is simply snatching defeat from the jaws of victory.
There are no conflicts of interest involving this work. No funding was involved in the preparation of this manuscript.
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