WASHINGTON — Ultimately, when the battle over federal regulation of cigarettes is decided, it may all come down to intent.
What are the intentions of the tobacco industry when it controls nicotine levels in cigarettes? To keep smokers hooked, as the government believes? Or to maintain taste and flavor, as the companies insist?
The final interpretation likely will determine whether the Food and Drug Administration has the power to regulate cigarettes--more precisely, nicotine in cigarettes--as it does drugs.
No one challenges the fact that the tobacco industry controls and manipulates nicotine levels.
"The whole dispute is about \o7 why \f7 they do it," said Matthew Myers, an attorney for the anti-smoking Coalition on Smoking OR Health.
"Sure the companies adjust tar and nicotine levels," said Tobacco Institute spokesman Walker Merryman. "They have to, in order to produce a consistent product."
Federal law defines a drug as a substance intended to diagnose, treat, cure or prevent disease.
In 1938, when Congress amended the 32-year-old food and drug law, it added language to enable the agency to regulate other items, such as weight loss products, as drugs. Thus, a drug also is defined as a substance, other than food, "intended to affect the structure or any function of the body."
Nicotine is considered a drug--and regulated by the FDA--when it is used in patches, gum and other prescription products that are designed--\o7 intended--\f7 to help individuals stop smoking. But it has never been regulated in cigarettes.
Many experts agree that nicotine does have pharmacologic, or drug-like, affects. But they disagree over how addictive it is. In 1988, Surgeon General C. Everett Koop declared nicotine to be as addictive as cocaine and heroin. Tobacco industry officials insist it is not addictive at all.
"There is no question that nicotine affects your brain and your brain chemistry," said a senior FDA official. "But the manufacturer has to \o7 intend \f7 to affect the structure and function."
"If the industry could present a persuasive case that nicotine is only about taste, then the FDA would have a hard time showing that they intended for it to affect the body," said Myers, whose coalition is made up of the American Heart Assn., American Lung Assn. and American Cancer Society.
"What has changed is the ever-mounting evidence of the industry's complete understanding of the extent to which nicotine affects the body and our knowledge of the industry's technical ability to carefully control the level of nicotine."
But one lawyer knowledgeable in food and drug law, who declined to be identified because his firm represents tobacco interests, said the FDA is using the industry's knowledge that nicotine is present in cigarettes as a hook "to slide into" the question of intent.
He also pointed out that the industry began making cigarettes long before it knew about nicotine and its effect on the body.
"If you continue to be aware that something is there, it becomes difficult to say you bear no responsibility for it," he acknowledged. Nevertheless, "the tobacco companies say, 'Yes, we have more knowledge now that nicotine is present, and that it was always present. But you're telling us that, way back in 1922, we intended this? Even though we didn't know about it?'
All of the internal industry research documents that have been made public--either through leaks to the media or from Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce panel on health--tend to support the FDA's position that the industry is not adjusting nicotine levels for taste.
They show the companies' own research, memos and other papers preoccupied with the pharmacologic effects of nicotine--not with its relationship to taste or flavor.
"We never expected . . . to have evidence of intent," says the senior FDA official. "If you control and manipulate nicotine levels, that's an indicator of intent. That's why we focused on control and manipulation. What has happened here . . . is that documents from the industry go directly to the issue of intent, which is much more direct evidence."
FDA officials believe the agency already has jurisdiction over cigarettes through the provisions in the law. But many observers predict the FDA almost certainly will be thwarted or delayed by legal challenges filed by the industry and others if and when it attempts to act. Some say the agency's best chance to regulate cigarettes is for Congress to amend the law spelling out such specific power.
"The FDA is a bureaucratic entity, and I believe it is incapable of doing anything on this within (FDA Commissioner) David (A.) Kessler's lifetime, even if he outlasts some of the old-timers," said one lawyer familiar with food and drug law. "But it does not mean that the FDA will not cause things to happen, or cause Congress to get interested."
But, noting that the momentum against tobacco has been building, he added: "Will they issue a ruling that ultimately will be put into effect? It could take years. And the court proceedings will take additional years. And by the time the process moves toward culmination, the circumstances might have changed in such a way that the FDA's original approach might not even seem worth doing."