Cornered (17 page)

To regulate the industry's activities, Kessler would have to show that nicotine was indeed a “drug” in the accepted medical definition of the term; that it affects the structure and function of the body, that it is addictive, and that, despite their denials, the manufacturers “intended it to affect the structure or function of the body.” The key word was “intend.”

The 1976 amendment to the federal Food, Drug, and Cosmetic Act gave the FDA the power to regulate medical devices and Kessler's agency now argued that cigarettes were “drug delivery systems.” If the drug being delivered is deemed unsafe, it said, the agency can ban it. Since the FDA believed cigarettes were “plainly not safe,” Kessler could have announced a ban. In fact, Kessler knew that was what the tobacco industry would accuse him of planning. And they did charge him with “backdoor prohibition.” But it was, in fact, not Kessler's intention. As he said, to do that would present a public health problem; because since nicotine was an addictive substance, its sudden withdrawal would cause great discomfort to those so addicted. Prohibition of cigarettes was also a bad idea, he believed, just as silly as the efforts to ban alcohol had been at the beginning of the century; it would encourage a black market. In fact, in those early days, he was not clear exactly what restrictions he would impose.

*   *   *

B
EFORE
K
ESSLER ARRIVED
at the FDA, a young political activist named Jeff Nesbitt, who had joined the FDA as spokesman, had been badgering the staff about regulating tobacco. Nesbitt, then thirty-one, had worked for the muckraking journalist Jack Anderson and for Ralph Nader. Soon after he arrived he began asking the simple question, “If you're going to regulate consumer products, why leave this big gap?” When Kessler arrived, eighteen months later, Nesbitt's father, a heavy smoker, was dying of lung cancer, and he was more agitated than ever about tobacco. He had some talks with Kessler about it, and the new commissioner said he wanted to do something, but it had to wait until after he had attended to more pressing issues. In the spring of 1991, Nesbitt, then chief of staff, called a brainstorming meeting at the Rockville headquarters of the FDA. The topic was tobacco regulation.

About thirty people attended, representing all the agency's power centers—general counsel, the drug group, the food group, the policymaking and regulatory apparatus, plus all the deputy commissioners. They met in Kessler's conference room and quickly divided into two camps. Essentially, the old guard was against regulation of tobacco. They had heard the arguments before. The younger staff members were for it; so was the FDA's legal counsel, who said regulation of the industry was within the FDA's power.

The naysayers had several compelling arguments. First, any such move would entail a long, drawn-out legal process, fought every inch of the way by the tobacco companies, and the FDA did not have the resources for such a campaign. Second, Congress by its inaction had effectively told the FDA that the tobacco industry was untouchable; there would be no support from the Hill, especially in this era of deregulation. Third, before any offensive could be launched, more inside information about the industry's products was needed to satisfy the key provision in the law: that the companies “intended” to hook people with nicotine. A cache of “smoking-gun” documents would have to be found to ensure victory, but the agency had no authority to compel the companies to produce such data. The conclusion: to challenge the tobacco companies would be tilting at windmills.

On the other side, the FDA's legal counsel argued that it had always been theoretically possible to regulate the industry under the “intent” clause; thus congressional approval was actually moot. Nesbitt emphasized that the political climate had changed. He recalls telling the meeting that two things had changed. Few members of Congress wanted to stand up anymore to support a product that puts children on a path to early death. Second, there weren't nearly as many tobacco states as there used to be—essentially Virginia, North Carolina, and Kentucky. Congress would be more receptive. The tobacco lobby, like the National Rifle Association, was operating under different rules than in past eras.

Nesbitt had a good argument. Ever since the ski resorts of Aspen and Vail pioneered smoking bans in restaurants in 1985, there had been a steady campaign to limit smoking in restaurants, offices, airplanes, and in public places. Hundreds of cities had smoking restrictions. The Environmental Protection Agency was working on studies that would declare secondhand smoke a carcinogen. Despite the arrival of the Gingrichites, support for the tobacco companies in Congress was eroding. Health-conscious Americans were turning away from cigarettes. Consumption had fallen 1 to 2 percent annually since 1982. But teenage smoking was on the rise. The latest drive of the antismoking forces had begun focusing on how the tobacco companies aimed their marketing strategies at youngsters. Members of Congress, Democrat and Republican, would support a move that cut back youth smoking. At the end of the meeting that day, Kessler was cautious, but he told the group it was a policy worth looking into. A task force, including his brightest lawyers, was formed. For a few months before he left to become former vice president Dan Quayle's communications director, Nesbitt was the team's agitator. Even after he left he continued to badger his former boss about tobacco.

Kessler likes to tell the story of how he led his troops into battle. “I walked into the Library of Congress, sat down at the computer and typed in the word ‘nicotine,'” he told CBS's
60 Minutes
long after the event. Up came hundreds of studies funded by the tobacco companies, putting the lie to the industry's claim that nicotine plays an incidental role in smoking and is in cigarettes for “taste.” “Why fund those studies if you're not interested in nicotine?” was the question Kessler asked CBS correspondent Lesley Stahl. Of course, a trip to the library was not necessary for the commissioner of the FDA; he could have called any number of nicotine experts in person. But the self-confessed “science jock” wanted to take command of the operation. It also made a good story to have the FDA commissioner doing his own research in the library. Kessler was “media savvy.”

Kessler's team became interested in the way tobacco companies control the levels of nicotine in cigarettes. Between 1957 and 1987, the average tar and nicotine yield of American cigarettes had fallen dramatically from 34 mg to 13 mg for tar, and from 2 mg to 0.9 mg for nicotine. The lowest nicotine brands on the market contained 0.6 mg, but no one was selling a nicotine-free cigarette. Philip Morris had spent $300 million developing one and christened it “Next,” but it was a flop in test marketing and only confirmed what they already suspected: people won't smoke cigarettes that don't contain nicotine.

The data showed, while tar levels in cigarettes had dropped over the last decade, nicotine levels had not fallen proportionately. This was odd because it was known that the chemical process of reducing tar also reduced nicotine. It appeared that the companies were boosting nicotine levels in some fashion. The FDA analyzed three varieties of one cigarette brand, high, medium, and low tar. The lowest tar had the highest concentration of nicotine. The question was, How does the industry do this?

In March 1994, Kessler provided some possible answers to the Waxman Subcommittee on Health and the Environment. The young commissioner put on quite a show. Using a series of charts, he described numerous patents the FDA had unearthed showing the ability of the industry to control nicotine levels in cigarettes. Eight patents described adding nicotine to the tobacco rod, five to the filters and wrappers. Kessler conceded that patents can only describe an invention and do not indicate it has been used, but the wording of the patents suggested there was “intent” to use nicotine to change bodily functions. One talked about “maintaining the nicotine content at a sufficiently high level to provide the desired physiological activity, taste and odor.” Others spoke of “maintenance of the proper amount of nicotine,” and “the release in controlled amounts of nicotine,” and “manipulation of nicotine.”

“The public may think of cigarettes as no more than blended tobacco rolled in a paper,” Kessler said, “but they are more than that. Some of today's cigarettes may in fact qualify as high technology nicotine delivery systems.” Kessler referred to a 1972 Philip Morris research memo that had been discovered during the Rose Cipollone case. The memo said, “Think of the cigarette pack as a storage container for a day's supply of nicotine. Think of the cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle for nicotine. Smoke is beyond question the most optimized vehicle of nicotine and the cigarette the most optimized dispenser of smoke.”

Showing how deeply the FDA had dug into the files and the cigarette manufacturing process, Kessler also demonstrated how the levels of tar and nicotine on the warning labels on a cigarette pack may be very different from what the smoker actually receives. The Federal Trade Commission tests cigarettes with a smoking machine that puffs at a level representing how a human would smoke, and the contents are measured when the cigarettes are finished. Kessler argued that the advertised “low-yield” cigarette was “in many ways a myth.”

Cigarette manufacturers put tiny, microscopic air holes in a band around the filters so that when the machine smokes the cigarette, additional air is drawn into the smoke mixture and dilutes it. Smokers, however, learn to get a bigger nicotine content in a puff by covering up the holes, either with their lips or their fingers. Studies had shown between 30 and 60 percent of people who smoke low-yield cigarettes cover up the holes, and some don't even know they are doing it. The cigarette makers also allow the smoker to increase nicotine levels, above the FTC-tested level by extending the paper that covers the filter—the so-called overwrap—down the cigarette rod. The FTC smoking machine is programmed to stop smoking when the rod is burned down to three millimeters before the overwrap. But in some cigarettes there is still more tobacco covered by the overwrap. Waxman and Wyden were suitably impressed and thanked Kessler for his excellent job. Kessler promised to come back when he had found out more.

The puzzle his team now faced was to find out precisely how nicotine levels were being manipulated. The basic tool for controlling the level of nicotine is “blending” tobacco leaves of different nicotine content. The FDA team started looking at experimental tobacco plants that produce leaves with higher levels of nicotine. They searched libraries for company patents and found out about the “blending” techniques. Kessler was lucky to have two scientists who had worked for the industry to help him. One had worked for Philip Morris and knew about that company's research on the addictiveness of nicotine. The other had been research director for Brown & Williamson. Both men had signed confidentiality agreements with their respective companies, and had to be careful about what they said, but Kessler enjoyed this cloak and dagger aspect of his work. In the end, a little air of mystery could only add to the drama and publicity value of his crusade. But at that time it was necessary to keep security tight and he gave his industry sources codenames: “Cigarette” and “Research.”

The next time he appeared before Congress, in July, Kessler knew he had at least one answer to how the companies manipulated the nicotine levels. It was Yl. His secret source was “Research.”

In the spring of 1994, the FDA asked for a meeting with Brown & Williamson officials at the company's research offices in Macon, Georgia. During the meeting, FDA lawyers asked about plant breeding techniques to increase nicotine levels and, according to the FDA's version, B&W said it was just not an issue because there was an agreement among U.S. cigarette companies that set limits on the nicotine yield of tobacco plants grown in the United States.

Back at FDA headquarters a few days later, an anonymous caller advised Kessler's investigators to check American Tobacco Company patents worldwide. So far, they had only checked U.S. domestic patents in Washington. The reason was the FDA's tight budget; it cost more to look up international patents. Now they tapped into the international database. Four days later, FDA librarian Carol Knoth turned up a Brown & Williamson patent that looked interesting, but it was a Brazilian patent in Portuguese. The key phrase was
“Variedade de fumo geneticamente estavel e planta de fumo … nicotiana … 6% ou maior.”

Even to someone who didn't speak Portuguese, which Knoth did not, it seemed that this plant produced levels of nicotine at 6 percent or greater of the total weight—and that was twice the normal levels of 2.5 to 3.5 percent. In fact the translation read, “The nicotine content of the leaf of this variety is usually higher than approximately 6 percent by weight … which is significantly higher than any normal variety of tobacco grown commercially.” Kessler's team went into high gear. Listed as the three inventors of the new variety were Phillip Fisher, Hubert Hardison, and Janis Bravo. The FDA found Hubert Hardison working for a Brown & Williamson affiliate company named Export Leaf in North Carolina. Hardison confirmed his role in the creation of Y1 and put the FDA in touch with a former Department of Agriculture research botanist, James Chaplin.

Chaplin had been the director of the department's experimental station in Oxford, North Carolina, only an hour by car from Lloyd Jones's farm. There was nothing secret about Chaplin's work. In 1977, he had written about the industry's possible need for a higher nicotine tobacco plant in a trade publication,
World Tobacco.
Among other things, he said, “Manufacturers have means of reducing tars, but most of the methods reduce nicotine and other constituents at the same time. Therefore, it may be desirable to develop levels [that are constant] or to develop levels higher in nicotine so that when the tar and nicotine are reduced there will still be enough nicotine left to satisfy the smoker.” Chaplin talked about crossbreeding commercial varieties of the common tobacco plant—
Nicotiana tabacum
—with
Nicotiana rusticana,
a wild variety high in nicotine but not used commercially.