After more than half a century of debate and discussion, itis likely that during the coming year, Congress will pass legislationbringing tobacco products under the regulatory authority ofthe Food and Drug Administration (FDA). The regulatory statusof cigarettes arguably represents one of the most paradoxicalstories in American medicine and public health: the single mostdangerous legal product in U.S. consumer society has eludedvirtually all federal regulation until now. Using a combinationof scientific misinformation, intensive political lobbying,and a culturally resonant argument that smokers must take personalresponsibility for harms they incur from its product, the tobaccoindustry has fought off all attempts to bring the manufacture,marketing, and sale of cigarettes under the authority of theFDA or any other federal agency.1 While competing aggressivelyagainst one another for market share (see historical cigaretteads), the tobacco companies drew together for the purposes ofdenying the harms of smoking and exerting their political influenceto deflect any serious form of regulation. Indeed, in responseto the proposal put forward by former FDA Commissioner DavidKessler in the mid-1990s that tobacco be regulated as a drug,the industry fought tooth and nail to deny the FDA this authority.After a protracted legal battle, in 2000 the Supreme Court foundin a 5-to-4 decision that the FDA did not have statutory authorityto regulate cigarettes. If the agency were to begin regulatingtobacco, it would require explicit legislative approval fromCongress.2
Lucky Strike addressed early health concerns by claiming that "toasting" offered a less irritating smoke. Many early theories of carcinogenesis emphasized the significance of irritants.
Although scientists have well understood for more than 50 yearsthat cigarettes cause lung cancer and other fatal diseases,we still do not have regulations concerning product content.Even now, tobacco companies are not required to inform the publicabout the additives in their cigarettes. Nor have we ever hadconsistent scientific monitoring or control of the carcinogenic"tars" or the content of highly addictive nicotine in cigarettes.Furthermore, the companies have continued to make claims thatare widely regarded as deceptive, calling some brands "low-tar,""light," or "ultra-light," falsely implying that they conferless risk.
All this could change soon with the passage of the Family SmokingPrevention and Tobacco Control Act, which the House Energy andCommerce Committee approved in April by a vote of 38 to 12.Introduced in February 2007 by longtime tobacco-control advocateRepresentative Henry Waxman (D-CA), the bill would strengthenadvertising restrictions and prohibitions on marketing to youth;require new and more prominent warning labels; compel companiesto disclose all ingredients in tobacco products; and authorizethe FDA to restrict harmful additives, as well as monitor andreduce nicotine yields. A new division of the agency, fundedby user fees paid by the industry, would implement and enforcethese regulations. The legislation explicitly prohibits companiesfrom making claims that their products are approved by the FDA.The bill bans candy and fruit flavorings that have recentlybeen used to make cigarettes more appealing to young people,but its failure to prohibit the use of menthol has drawn considerablecriticism from tobacco-control groups and former health officials.The bill treats menthol as it does other potentially harmfulsubstances in cigarettes: if the FDA were to find that it wasdangerous, it could limit or ban its use in the future. Thelegislation prohibits the FDA from banning tobacco sales orthe use of nicotine in tobacco products, but the agency couldeventually mandate the reduction of nicotine to nonaddictivelevels.3
As new evidence of the serious harms of smoking accrued, this prominent advertising campaign claimed that Camels were the preferred cigarette of American physicians.
Although the bill has attracted bipartisan support, it has aconsiderable number of detractors within Congress and the Bushadministration, as well as among major tobacco companies. Lastyear, even though a White House advisory panel recommended thattobacco be regulated as a drug, FDA Commissioner Andew von Eschenbachrejected the idea of saddling his agency with this additionalburden, and it now appears that the Bush administration willoppose the bill. Strikingly, the threat of FDA regulation oftobacco is dividing the once virtually unbreakable allianceof major tobacco companies, which have a long history of cooperationand collusion in fighting regulation wherever and whenever itwas proposed. Philip Morris, the dominant player among the U.S.tobacco companies, has endorsed the bill, whereas the othermajor companies vigorously oppose it. Some, arguing that FDAregulation would cement Philip Morris's sizable market advantage,have dubbed the proposed legislation the "Marlboro MonopolyAct."
Moreover, even as Altria (the domestic parent company of PhilipMorris USA) has at last acceded to FDA regulation, it has recentlyspun off the far more profitable Philip Morris International(PMI). Although Altria is working to maintain its dominant positionin the substantial but considerably reduced U.S. market, PMIand the other tobacco companies well understand that futureprofits in the cigarette trade will come largely from salesabroad. As a result, the stabilization and "normalization" ofwhat has come to be widely regarded as a rogue industry mayoffer considerable advantages as the market for tobacco productsmoves predominantly into the developing world. While Altriais promoting FDA regulation, PMI is test-marketing a new high-tar,high-nicotine cigarette in Southeast Asia. Even if FDA regulationfulfills its promise of further reducing smoking-related morbidityand mortality domestically, in the future it will be criticalthat public health efforts take a global approach to tobaccocontrol.
The World Health Organization (WHO) estimates that in the pastcentury, 100 million smokers died worldwide from smoking-relateddiseases, but 10 times as many (1 billion) are expected to diethis century if current rates of smoking are merely maintained— this, despite all we know about the harms of smoking.In 2003, WHO promulgated its first-ever treaty, the FrameworkConvention on Tobacco Control, which was designed to combatthis coming pandemic by creating an alliance of countries committedto tobacco control through a series of common public healthmeasures and tax policies. The treaty has now been signed andratified by more than 150 countries. Notably, the Bush administrationhas not sent the treaty to the Senate for ratification.
Given the opportunity to put tobacco control back on the federalagenda, virtually all major public health and medical specialtygroups, including the American Cancer Society, the AmericanHeart Association, the American Lung Association, and the AmericanMedical Association, strongly support the FDA bill. Nonetheless,a few prominent tobacco-control advocates such as Stanton Glantzof the University of California, San Francisco, have expressedskepticism, arguing that Philip Morris's support indicates thatthe legislation would probably benefit its corporate interests.And certainly, from a historical point of view, Congressionallegislation passed under the rubric of "regulation" has oftencome back to haunt public health advocates. The weak and largelyineffective warning labels on cigarette packages are perhapsthe best manifestation of the tobacco industry's knack for turningregulatory efforts to its own interest. Once tobacco productsbegan to sport such labels, the industry repeatedly argued inlitigation, with considerable success, that its product waspreempted from liability by Congressional mandate. Althoughthere is no evidence that such legal protections were intendedby earlier tobacco legislation, we now know from previouslysecret internal documents that the industry actually favoredsuch legislation as a weapon in its defense against lawsuits.4
Philip Morris introduced the Marlboro Man in the 1950s as the symbol of a new "rugged and masculine" filtered brand, in an effort to address increasing public concerns about the risks of smoking.
Thus, it behooves public health advocates and Congress to morefully understand all the implications of FDA regulation. Somecritics have referred to the inherent compromises required toenact such a bill as "dancing with the devil." In this case,the devil will be in the details. Will FDA regulation lead tointerventions that further reduce the prevalence of smokingin the United States and its effect on the burden of disease?Currently, more than one of five adults is a regular smoker,and more than 430,000 deaths occur each year as a result ofcigarette use. The proposed legislation, if passed, would beonly the beginning; for regulation to succeed from a publichealth perspective, ongoing vigilance would be required on thepart of Congress and tobacco-control advocates to ensure thatthe statute protected the public from the harms of smoking throughprevention and cessation efforts, as well as through the criticaland independent scientific assessment of conventional and newproducts. Nonetheless, despite its initial limitations, thebill offers important new federal leverage for reducing smoking-relateddisease, disability, and deaths.
As Congress debates the regulation of tobacco by the FDA, itwould be wise to consider ways of tying serious efforts to reducetobacco use in this country to efforts to reduce the burdenof tobacco-related diseases throughout the world. Saving livesfrom the manifold harms of tobacco should not be viewed as azero-sum game. Nor should FDA regulation of U.S. tobacco productsbe seen as offering new respectability to an industry that,as a federal judge has ruled, has been committing racketeeringand fraud for more than half a century.5
Dr. Brandt reports serving as an expert witness for the Departmentof Justice in United States v. Philip Morris et al. in 2004and receiving funding from the Flight Attendant Medical ResearchInstitute for research on secondhand smoke. No other potentialconflict of interest relevant to this article was reported.
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Dr. Brandt is a professor of the history of medicine at Harvard Medical School, Boston, and dean of the Graduate School of Arts and Sciences at Harvard University, Cambridge, MA.
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