Can Regulating Tobacco Get Smokers to Kick the Habit? : Health: FDA proposal would gradually cut cigarettes’ nicotine content. Critics say people will just light up more.

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Imagine a society in which cigarettes are so tasteless and unappealing that smokers can easily quit and teen-agers may try them but will never get hooked.

Unrealistic? Perhaps.

Nevertheless, such a scenario--or a version of it--is looming in the nation’s not-too-distant future.

In recent months, anti-smoking forces in the federal government--particularly the Food and Drug Administration, key members of Congress and the White House--quietly have been building a case for the regulation of cigarettes. FDA officials believe they already have the authority under the agency’s drug statutes to regulate cigarettes as drugs--or more precisely, as drug delivery systems--because of the addictive nature of nicotine.


Ultimately, the goal would be to help the nearly 50 million Americans already addicted to cigarettes kick their habit and to keep young people who experiment with tobacco from getting permanently hooked.

“The first premise would have to be to try to not make things too tough on smokers,” said Dr. Neal Benowitz, a professor of medicine at UC San Francisco who has studied the effects of nicotine on humans. “It shouldn’t be a punitive policy but one aimed at protecting minors. There is going to be some discomfort for smokers, but it’s worth it if it protects the next generation from getting addicted.”

To be sure, experts insist that any war against tobacco must be a multi-pronged approach--including the strict enforcement of existing laws against sales to minors and restrictions against smoking in public places, in addition to changing labeling and curbing advertising practices, particularly those aimed at the nation’s youth.

But the most dramatic--and intriguing--proposal so far is the idea of a forced change in the product itself: a carefully timed lowering--over the course of a decade or so--of the allowable levels of nicotine in cigarettes to enable smokers to wean themselves gradually from their addiction.

The concept raises some thorny questions: Will smokers consume more cigarettes to compensate for the decrease in nicotine? Will the cigarette industry find some other way--perhaps by adding some new substance to cigarettes--to maintain the demand? Will the changes turn law-abiding Americans into tobacco bootleggers, since full-strength cigarettes almost certainly will still be available outside this country?

Or will there come a time when Americans will look back with incredulity on a 20th-Century society in which cigarettes were freely available and smoked by millions?


“You never know for sure, because it’s never been done before,” Benowitz said. “But I believe it can be successful, if it’s real slow.”

The FDA is in a “fact-finding mode,” said Commissioner David A. Kessler, who is scheduled to give congressional testimony on the subject Tuesday. The agency is investigating both “the physiological aspects of nicotine and the extent to which manufacturers control or manipulate the nicotine content in cigarettes,” he said.

Industry officials repeatedly have denied that they deliberately increase nicotine levels in their products. However, they have acknowledged that nicotine concentrations can be adjusted through blending different tobaccos, and that their companies engage in this process.

If nicotine is addictive, as a growing body of scientific evidence indicates, then it could be classified as a drug under FDA statutes--which define a drug as “an article, except for food, intended to affect the structure and function of the body”--and it would be subject to agency regulation. The agency already regulates nicotine in all nicotine-containing products except cigarettes. Kessler refused to discuss the FDA’s regulatory options at this time but said a realistic approach must “involve reducing demand” for cigarettes. An all-out ban would never work, he contends, because “prohibition would only result in a black market.”

A former FDA official involved in the earliest discussions of cigarette regulation there predicts that one of two things will occur.

“The cigarette companies will try to cut a deal in which they lower their nicotine content and open up their plants, and we will see massive restructuring of how cigarettes are sold in this country,” he says. “Or the cigarette companies will have a flock of lawyers try to block the FDA at every turn, and it will go all the way up to the Supreme Court to decide whether FDA has jurisdiction over tobacco.”


He adds: “The agency is committed to this course now, which it has never been committed to before. The companies have vastly underestimated this, which has been a big mistake on their part.”

The FDA has been supported in its efforts by President Clinton and key members of Congress who regard themselves as foes of tobacco--including Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health, who is also pushing for legislative restrictions against smoking in public places. It is his committee that will hear Kessler’s testimony on Tuesday.

The agency also has the support of Reps. Richard J. Durbin (D-Ill.), Mike Synar (D-Okla.) and Ron Wyden (D-Ore.), all of whom are seeking measures to strengthen the FDA’s authority to regulate tobacco.

Walker Merryman, vice president of the pro-industry Tobacco Institute, calls litigation to block the FDA “a very strong possibility” and says he anticipates a long battle.

“If the FDA wants to push it, we’re not going to give in,” he says, adding: “You can’t have a federal agency designing a cigarette. That is a concept that boggles the mind.”

He and other industry officials maintain that cigarettes are not addictive and that “most of the kids who experiment with cigarettes don’t end up being smokers.”


Nevertheless, Dr. Jack Henningfield, chief of the clinical pharmacology research branch of the National Institute on Drug Abuse, points out that most adult smokers began smoking as teen-agers. He also notes that approximately one-third or more of smokers try to quit every year and “only about 7% make it.”

Moreover, he added, the 40 million Americans who have successfully stopped smoking represent “only 2.5% per year since 1964, which is really a lousy rate of spontaneous recovery.”

Addiction experts say the only logical strategy that would help current smokers quit and protect future smokers from addiction is to reduce the dependence on nicotine by lessening or eliminating it in cigarettes.

Cigarettes now on the market have five to six times the nicotine levels necessary to create and sustain an addiction, experts say.

The amount of nicotine in cigarettes has remained virtually the same for more than 30 years, according to Henningfield. In 1952, the percentage of nicotine in cigarettes was about 1.5% to 1.8%. Currently, the range is 1.5% to 2.5%, he says. Each cigarette, regardless of whether it is a “light” or regular version, contains from 7 to 9 milligrams of nicotine, he says.

The average smoker takes in a milligram or more of nicotine per cigarette, for a total of approximately 25 milligrams a day, according to Henningfield.


A smoker begins to suffer withdrawal when the accustomed level of nicotine drops below half, he says. For example, if a smoker is used to getting 40 milligrams of nicotine a day, he or she will begin to experience withdrawal when the level reaches 20 milligrams or less, he says.

Cutting nicotine levels by a small percentage over a long period of time “will give smokers the opportunity to learn to modify their taste and learn to smoke cigarettes with less nicotine,” Benowitz says. “People may find cigarettes not satisfying anymore, and will just stop.”

But some critics of this approach argue that smokers will only compensate by smoking more cigarettes.

“When we made light cigarettes, smokers just smoked more of them,” says Dr. Robert DuPont, the first director of the National Institute on Drug Abuse who now heads the Institute for Behavior and Health, a nonprofit research organization. “Smokers will smoke whatever it takes to get to the blood nicotine levels they need. The people who tell you that you can solve it this way are wrong. It won’t work.”

Any inclination by smokers to compensate for lower nicotine levels by smoking more cigarettes could indeed prove troublesome. Although the addiction to cigarettes stems from nicotine, the health dangers come from inhaling the smoke produced by burning the tobacco.

“The tobacco leaf is extremely toxic when burned,” Henningfield says. “You can clean up the natural product a little bit, but you still have a highly toxic product. It’s like the difference between falling out of a 10-story building instead of a 12-story building.


“The only way you get a huge gain, if you need to keep some people on nicotine, is by taking away the tobacco,” he adds. “Using nicotine in a non-tobacco product is infinitely safer than smoking a cigarette. Also, smoking brings out the worst in nicotine by giving you high, spiking doses that go directly to the left side of the heart, into the brain, and, if you’re pregnant, to the fetus.”

Experts acknowledge that there could be a short-term compensatory increase in smoking, or that smokers could puff their cigarettes more intensively. “But whether it will persist in the long term is unclear,” Benowitz says. “There is some evidence that people will be smoking the same number of cigarettes that they smoked before, or will adjust to the lower levels of nicotine. That’s why gradual weaning is imperative.”

The FDA is studying the limits to which it can reduce access without stimulating a black market. Currently, there are restrictions on numerous substances--alcohol and prescription drugs, for example--which have not resulted in the development of a black market. Agency officials already have rejected the idea of a ban for that reason.

“If you suddenly cut yields, then the black market likelihood would be great,” Benowitz says. “But if it’s pretty slow--a decade and a half--and if you go down by 10% a year, that gives people time. And they would never notice it much. Also, a black market would not be necessary for kids because they are not smoking in the beginning for nicotine, but more for social reasons. (Now) they learn to smoke for nicotine over time.”

Thus, a gradual tapering over years would give existing smokers enough time to adjust, and nicotine in cigarettes eventually would reach a level where it would be difficult to initiate addiction, particularly among first-time smokers, experts believe.

“A lot of kids experiment with cigarettes, but the difference (with a low or no nicotine cigarette) would be that four or five years down the road, if they decided not to be a renegade, they could stop,” Henningfield says. “They would be able to do it.”


Kessler, the father of two young children, calls this one of his major motivations--to keep today’s youngsters from becoming tomorrow’s smokers.

“If we can prevent the vast majority of teen-agers who smoke a few cigarettes from becoming addicted for life, then it will be an enormous public health achievement,” he says.