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Gio B. Gori, The Health Policy Center, Bethesda, Maryland

After desultory attempts in prior legislations, Congress is poised to empower the Food and Drug Administration to regulate cigarettes and tobacco. Bills S.625 by Sen. Edward M. Kennedy (D., Massachusetts) and H.R. 1108 by Rep. Henry A. Waxman (D., California), now stand ready to be discussed by the full Senate and House.

The enabling innovation is a recognition that reduced-risk cigarettes can be produced and ought to be regulated and promoted. The Institute of Medicine of the National Academy of Sciences reckons that this legislation can save millions of lives, a feature that will prevail over contentious stakeholders.

Among the latter, official Public Health, antismokers, and long allied pharmaceutical interests will root for prohibition. Treasury will think of $40 billion in annual tax revenues. So would state governments addicted to taxes and to the Master Settlement Agreement, together worth another $20 billion a year. A divided cigarette industry remains fearful that regulation might disrupt established market share allocations. Tobacco growers hope against hope that regulation may not reduce leaf demand. The black market would welcome regulation that weakens the nicotine content of legal cigarettes.

Left without a voice are some 40 million US voters who smoke, and smokers worldwide rapidly approaching 1.5 billion, according to World Bank estimates. Congress has long been stalled amid contrasting worries about public health, tax revenues, farmers, and the social and economic repercussions of the monster black market that cigarette prohibition would unleash. In fact, prohibition is increasingly becoming a vanishing option, as the number of smokers on the planet is rising despite all right-minded efforts.

Enter a revolutionary 2001 report of the Institute of Medicine of the National Academy of Sciences, which shook the stalemate with irrefutable scientific arguments. The Institute found the risk of smoking is proportional to the doses of smoke inhaled, and concluded that a reduction of the smoke inhaled means a reduction of risk. It also highlighted evidence that nicotine is safe as experienced by smokers, noting that medical use of nicotine patches and gums – at doses similar to or higher than what smokers experience - are harmless even to smokers with cardiovascular disease, are certified as safe by the Food and Drug Administration, and are widely used without prescription.

According to the Institute, nicotine cannot compare with cocaine and other drugs of abuse, because smokers do not become intoxicated or engage in deranged or asocial behavior. Similarly, the Institute asserts that smokers find value in smoked nicotine because it improves mood, attention, and stress. Because tar and certain gas components of smoke are mostly responsible for the associated risks, the Institute concludes that a strategy for harm reduction is “retaining nicotine at pleasurable or addictive levels while reducing other toxic components of tobacco and smoke.”

The strategy is reinforced by the Institute noting that smokers seek a fixed amount of nicotine with every puff inhaled, and will inhale progressively less when the concentration of nicotine in smoke increases. Thus, reduced-risk cigarettes will deliver enough nicotine and less and less smoke. As a result, the concentration of nicotine relative to smoke becomes de facto the natural regulatory benchmark in ranking risk reduction expectations.

In a striking policy overturn, the Institute of Medicine notes that reduced-risk cigarettes would be pointless if not used by smokers, and recommends that manufacturers be permitted to market cigarettes with risk reduction claims, as regulated by the Food and Drug Administration. Significantly, the proposed legislation would limit this Agency to the regulation of smoke and its component, with the exception of nicotine. In recognition of its strategic role, any decisions about the reduction of nicotine are reserved to Congress.

An isolate inconsistency of the current bills is the prohibition of flavor additives, which conflicts with the need to make reduced-smoke cigarettes appealing to smokers. That provision merits reconsideration, especially in view of the Food and Drug Administration’s long experience in regulating the safety of additives. Attaining flavors that secure smoker acceptability is key to the development of reduced-smoke cigarettes, as is the need to design new devices that are visually appealing, easy to use, and disposal-friendly.

With traditional cigarettes fading away in a few years, they will be overcome by a diversity of high-tech devices. In the end, even a partial reduction of smoke intake would translate into major public health gains. Advancing technology can be expected to rapidly reduce risk, and the Institute of Medicine is confident enough to assert that reduction of risk “…might eventually bring a smoker to a risk equal to some lower level of lifetime exposure to conventional products.” Long before that goal is reached, a 50% reduction of smoke doses and risks is technically achievable possibly within 5 years, for a potential annual saving of some 250,000 lives in the US alone.

Congress now faces clear and unavoidable responsibilities. Prohibition may still be tempting, but it would simply prolong ineffective policies, besides fanning an uncontrollable black market. Remember Al Capone? Instead, a lasting solution requires trusting scientific truths, and a sober reassessment of the factual dangers of tobacco, of the social agencies of citizen smokers, and of the realities of free markets in a free society.

Will the legislation be enacted along statesmanship lines, or will it continue to be thwarted by intransigent prohibitionists and by contrasting industrial interests? The health of 40 million American smokers hangs in the balance, just as that of some 1 in 3 adults worldwide who smoke, and whose fate traditionally has trailed in the wake of US legislation. After many false starts, the prevention of millions of premature deaths finally is the central issue of legislation, and must not be denied by utopian or greedy expectations, disregarding the sure opportunities that reality offers.