SAN FRANCISCO--Tobacco use causes more than 400,000 deaths each year in the United States, yet no comprehensive tobacco control approach has been developed at the federal level. The Food and Drug Administration (FDA) has been frustrated in its attempts to more closely regulate tobacco products.

Progress against tobacco use is being made at the local level. But what else the federal government could do to control tobacco manufacture, sales, or use is the subject of considerable debate. In fact, much of the recent progress in tobacco control has come from state government. For instance, the California Tobacco Control Program, a successful statewide program implemented in 1989 to reduce cigarette use, combined a $0.25-per-pack increase in the cigarette tax with an aggressive education program.

In a study published in New England Journal of Medicine, Caroline Fichtenberg, MS, and Stanton A. Glantz, PhD, of the University of California, San Francisco (UCSF), reported that the California Tobacco Control Program reduced the number of deaths attributable to coronary heart disease by 59,000 between 1989 and 1997.[1] In addition, Ms. Fichtenberg, a postgraduate researcher, and Dr. Glantz, a Professor of Cardiology, demonstrated that weakening of the educational program (the result of changes instituted by the state’s governor beginning in 1992) caused an excess 15,000 deaths between 1993 and 1997.

“This is the first time that anyone has shown that one of these tobacco control programs actually affected how many people lived and died,” Dr. Glantz told PULMONARY REVIEWS. He also emphasized that “when the program was scaled back, the effect went away both in terms of changes in consumption and also in changes in death rates.”

WHAT ROLE FOR THE FDA?

The federal government can still play a part, wrote Matthew L. Myers, JD, Executive Vice President of the National Center for Tobacco-Free Kids, in an accompanying editorial.[2] One approach is for Congress to grant the FDA the authority to regulate tobacco products.

During the 1990s the FDA, acting on new evidence regarding the addictive properties of nicotine that included previously confidential tobacco-company documents, attempted to regulate cigarettes as drug-delivery devices. The tobacco companies challenged this attempt in court; ultimately, the Supreme Court ruled that the FDA cannot regulate tobacco products because these products have no intended therapeutic purpose and are inherently unsafe. The Court noted that the FDA had previously decided that the available evidence did not warrant regulatory activity on its part.

However, Mr. Myers said, the FDA had been unable to pursue tobacco control in part because much important evidence of tobacco’s harmful effects remains confidential. “In essence, the Supreme Court’s decision rewards the tobacco industry for its deceptive practices,” Mr. Myers stated, arguing that the FDA is “the only federal agency with the breadth of scientific expertise and regulatory experience” to oversee the manufacture and marketing of tobacco products.

Others disagree. In a second editorial, Leonard H. Glantz, JD, and George J. Annas, JD, MPH, of Boston University noted that the authority granted to the FDA by Congress does not extend to all hazardous substances; the FDA ensures the efficacy and safety of therapeutic drugs and devices.[3] “It should be emphasized that the Supreme Court’s ruling was not about whether the FDA should have jurisdiction over tobacco products, but about whether Congress had, in fact, given the FDA such jurisdiction,” the authors wrote.

Mr. Glantz, a Professor and Associate Dean of Boston University’s School of Public Health, and Mr. Annas, a Professor of Health Law, advocate the creation of a new agency with the goal of reducing smoking. “Creating a federal agency with broad power that can be active, can regulate the manufacture of tobacco products, and can create, fund, and assess large-scale programs for the reduction of smoking is an appropriate use of federal power,” they said.

There is an alternative to tobacco-control legislation, says Ellen Wertheimer, JD, Professor of Law at Villanova University School of Law in Pennsylvania: litigation. Many courts have adopted the position that manufacturers should not be liable for injuries caused by a product unless the product could be made safe—or at least safer. As Professor Wertheimer told PULMONARY REVIEWS, cigarettes cannot be made safe, and thus the courts have been reluctant to find tobacco manufacturers liable for the damage that their products cause.

PRODUCT LIABILITY AND LITIGATION

An alternative would be to re-adopt what Professor Wertheimer described as a “strict product liability” approach, under which a product is considered defective when the risks and dangers of the product outweigh its utility. When the manufacturer is held liable for the injuries that its defective product causes, the price of the product increases; thus, the costs of smoking would be passed on to those who smoke.

“If the price of cigarettes goes up so high that people stop smoking, then so be it. But if that’s the real cost of the cigarettes, then that’s what smokers should be paying,” Professor Wertheimer said. Although this strict product liability approach could be an effective tool in tobacco litigation, it has not been widely adopted by courts, she added.

CONCERNS ABOUT FEDERAL POLICY

UCSF’s Glantz noted that tobacco-control advocates are concerned about the current administration’s tobacco policy. For example, Dr. Glantz expressed concern about the appointment of former Wisconsin Governor Tommy G. Thompson to the position of Secretary of the Department of Health and Human Services because Thompson’s ties with the tobacco industry are close.

In addition, even if the FDA is granted congressional authority to regulate tobacco products, the ensuing regulation could actually benefit tobacco companies.

“[The tobacco companies] want FDA regulation because they have figured out that well-crafted, weak regulation could provide them with a huge amount of legal and political protection,” Dr. Glantz explained. “The way you reduce cigarette consumption isn’t through FDA regulations. It’s through strong community-based activities and strong counteradvertising campaigns,” he emphasized.

--Mark Bowes, PhD

References
1. Fichtenberg CM, Glantz SA. Association of the California Tobacco Control Program with declines in cigarette consumption and mortality from heart disease. N Engl J Med. 2000;343:1772-1777.

2. Myers ML. Protecting the public health by strengthening the Food and Drug Administration’s authority over tobacco products [editorial]. N Engl J Med. 2000;343:1806-1809.

3. Glantz LH, Annas GJ. Tobacco, the Food and Drug Administration, and Congress. N Engl J Med. 2000;343:1802-1806.

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