Corporate Governance and Social Responsibility
The Federal Drug Administration (FDA) could very well classify nicotine as a drug and cigarettes as the device used to deliver the drug to the human body, using the definitions employed by the Food, Drug, and Cosmetics Act of 1938. According to this Act, drugs are “(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals” (The FDA and Tobacco Regulation). Working with this definition, nicotine is certainly a drug because it has several effects on bodily functions. Specifically, it has been defined as an alkaloid which has been found to increase a person’s “heart rate, heart stroke volume, and oxygen consumption by the heart muscle.” It has also been found to produce certain “psychodynamic effects” like euphoria, heightened alertness, and a feeling of relaxation (MedicineNet.com 2008). The Encarta Dictionary definition of an Alkaloid, on the other hand, is “a group of nitrogen-containing compounds that are physiologically active as poisons or drugs.” It has also been defined as an “addictive drug…which causes changes in the brain that make people want to use it more and more” (American Heart Association, 2008). FDA could also cite the report of the Surgeon General of the United States which was issued in 1988 which declared that:
· Cigarettes and other forms of tobacco are addicting.
· Nicotine is the drug that causes addiction.
· Pharmacologic and behavioral characteristics that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine (American Heart Association, 2008).
A cigarette, on the other hand, could easily qualify as the device which introduces the drug nicotine into the system of the smoker. This is very clear in the definition of a “device” according to the Food, Drug, and Cosmetics Act of 1938, i.e.:
[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is….intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Clearly, a cigarette is an instrument which affects the functions of the human body by introducing nicotine into the system because cigarette-smoking is the only means through which smokers absorb nicotine. Cigarette as a carrier of nicotine was also clearly established by the testimony provided by “Deep Cough” who claimed that his or her former employer, R. J. Reynolds, would create a “slurry from old tobacco scraps, added nicotine, and then put this reconstituted tobacco into cigarettes.” The process described by “Deep Cough” indicated that R. J. Reynolds used cigarettes as tools in delivering nicotine to the human body (The FDA and Tobacco Regulation).
The FDA did everything it thought possible under the circumstances. However, certain miscalculations in the way it handled the problem could be observed. Just as a general prepares for battle by utilizing intelligence information about enemy strength and location – in other words, knowing the enemy, the FDA should have prepared for its battle the same way. If FDA was able to gather enough information, it could have realized that the Justices of the Supreme Court were not against the idea of the FDA regulating the tobacco industry. What they could not agree to was for FDA to regulate without authority from Congress. Associate Justice Sandra Day O’Connor stated this explicitly enough when she wrote the majority decision, i.e.:
By no means do we question the seriousness of the problem that the FDA has sought to address. The agency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States. Nonetheless, no matter how “important, conspicuous, and controversial” the issue …an administrative agency’s power to regulate in the public interest must always be grounded in a valid grant of authority from Congress (The FDA and Tobacco Regulation).
In other words, what Justice O’Connor was trying to convey was that the issue pursued by FDA was legitimate but it had chosen the wrong course of action.
Unfortunately, the tobacco industry wielded a very strong influence on Congress. Going through that route, therefore, would not have been viable. However, there is another political recourse which should have been taken by the FDA – the ballot initiative. Many controversial issues were already settled through this manner. A ballot initiative is the only recourse for the people who want to pass a law which Congress do not want to or could not pass owing to the influence of lobby groups. It could have been a sure win at the ballot for the FDA since the issue concerning tobacco regulation for the sake of safeguarding the health of Americans – especially children and adolescents – is one issue that American voters would have readily voted for. Given that all that the Supreme Court wanted was an authority from Congress, a win from a ballot initiative should have appeased them – a fact that would have ruled out a win on appeal for the tobacco industry.
The legitimacy of the ballot initiative is recognized by the federal government. It is constitutional. As a matter of fact, the founding fathers recognized it as well. As James Madison once said:
As the people are the only legitimate fountain of power, and it is from them that the Constitutional Charter under which the several branches of government hold their power is derived, it seems strictly consonant to the republican theory to recur to the same original authority whenever it may be necessary to enlarge, diminish, or new-model the powers of government (Cato Policy Report, 2000).
Several others have endorsed the ballot initiative as a legislative exercise. David S. Broder, a columnist for the Washington Post, considered it a tool designed to enable the people to directly write laws thereby, checking the influence of lobby groups in the legislative process. On the other hand, the chairman of the Cato Institute, William A. Niskanen, stressed that the initiative process is a system of checks and balances which regulates the power of Congress. Dane Waters, president of the Initiative and Referendum Institute, explained that ballot initiatives were meant to enrich the American system of government (Cato Policy Report, 2000).
The decision of the Supreme Court, although somewhat disconcerting when the hazards of cigarette smoke is taken into account, took refuge behind the constitution. Justice O’Connor, in writing the majority decision, took extra care in explaining about the legitimacy of the FDA cause but stressed its unconstitutionality. In other words, it was not really a judicial decision but a purely political one. It failed to consider the fact that the main purpose of the Food, Drug, and Cosmetics Act of 1938 was the protection of the health of the people. As aptly pointed out by the dissenting opinion written by Justice Stephen G. Breyer and concurred in by Justices David Souter, John Paul Stevens, and Ruth Bader Ginsburg, “Since cigarettes posed a clear danger to public health, the statute had to be interpreted in a way that was ‘consistent with [this] overriding purpose’” (The FDA and Tobacco Regulation).
In other words, for the four justices who composed the minority, laws should always be read according to the objectives for which they were enacted in the first place. The function of the Supreme Court is to interpret laws. In order to do what it was mandated to do, the Court should not be very conscious about political processes. Its sole concern should be to judge whether the laws enacted by Congress are serving their intended purposes, whether they serve the welfare of the public, and not to get involved in political squabbles. In this case, therefore, I believe that the decision taken by the majority was flawed and inconsistent with the underlying principles of the Constitution of the United States.
The story, therefore, is revealing of the flawed system of government existing in the country today. This is a perfect example of a case of buck-passing. Federal government officials are allowed by the system to read the laws of the land as they wish. In this case, one court stated that an administering agency should be “entitled to deference in its reading of the statute” which it has been authorized to administer. Another, higher court, however, declared that an administering agency should always confine itself to what Congress intended when it enacted the law, thereby interpreting the law almost literally. This differences of opinions among the judges of the land shows that the system of doing things in the country is inconsistent where important decisions are swayed either by the influence of interest groups or affected by the moods of decision-makers. The Supreme Court itself had been a picture of contradictions. In this case, it refused to decide in favor of a noble cause – that of allowing the FDA to regulate an industry which has been killing people – simply because a political requirement has been bypassed. On the other hand, in some of its past cases, it was seen to decide to let criminals go free just because they were improperly arrested by police officers.
The question of whether Congress should enact FDA regulation of tobacco products at the expense of giving due advantage to Philip Morris over its competitors is an ethical one. While it could safeguard the welfare of children and adolescents, it could also benefit Philip Morris because it holds the largest share of the market. In other words, if Congress allows the FDA to restrict advertising of cigarettes, Philip Morris would not be hurt as bad as its competitors because more smokers already know about it and are in fact smoking the brand. In fact, even if all cigarette manufacturers are not allowed to advertise, Philip Morris would still have the edge. Advertising is not the only issue here, however. The actual selling of cigarettes is also affected. Regulation would mean, for instance, that vending-machine selling would be prohibited. This kind of regulation, however, would also benefit Philip Morris due to the fact that it has more outlets, therefore it reaches more customers.
This paints a grim picture. Unfortunately, this is a reality that has to be faced. Regulation should be effected as soon as possible for the sake of the children and adolescents. Lives must be saved even if one company profits more than others from the act. What is at issue here is not the profits that Philip Morris is expected to realize. What matters is that lives would be saved.
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References
Cato Policy Report, 2000. Do Ballot Initiatives Undermine Democracy? Available from:
http://www.cato.org/pubs/policy_report/v22n4/initiatives.pdf [Accessed 18
February 2008].
American Heart Association, 2008. Nicotine Addiction. Available from:
http://www.americanheart.org/presenter.jhtml?identifier=4753 [Accessed 18
February 2008].
MedicineNet.com, 2008. Definition of Nicotine. Available from:
http://www.medterms.com/script/main/art.asp?articlekey=22807 [Accessed
18 February 2008].
The FDA and Tobacco Regulation. Federal Regulation of Business, chapter 10. (Order
#71139734 attachment).
