David A. Kessler was appointed chief of the Food and Drug Administration by the elder George Bush in 1990, and remained in that office until 1997, when he left to become dean of the Yale Medical School. While at the FDA he conducted crusades for nutritional labeling and against tobacco use that are the subject of this book. Mainly, this is a cloak-and-dagger tale about his pursuit of evidence against Big Tobacco, which would justify the regulation of cigarettes.
Kessler says, credibly enough, that he did not come to office determined to conduct this crusade. It was urged on him by a staff member, Jeffrey Nesbit, an associate commissioner for public affairs. Kessler found inspiration also among the agency's lawyers, particularly Catherine Lorraine. Disappointed that the FDA was not more aggressive, she responded to the Nesbit-Kessler overture on tobacco by say that "This is the most important thing we can do. If we take it up, I'm willing to spend the rest of my career working on it." Only veteran careerists, the line officials who regulated conventional drugs, were opposed, fearing a compromise of the agency's core mission, but Kessler's initiative did not depend on them. To carry it out, he created a task force of persons whom he either hired from outside or hand-picked from within the agency.
The catch was that FDA commissioners for years had insisted that the agency lacked statutory authority to regulate tobacco, and courts had agreed. How could the FDA execute a reversal? Initially, the answer came from two sources.
The first was Scott Ballin, chairman of the Committee on Smoking OR Health, an anti-tobacco consortium comprising the American Heart Association, American Lung Association, and American Cancer Society. "Ballin thought the appropriate federal laws to regulate tobacco might already by somewhere on the books," Kessler explains, "and for months he sat in his office studying them." Ballin noticed that all of the consumer protection laws passed in the '60s and '70s explicitly excluded tobacco. However, the FDA's statutory charter, much of it dating from 1938, contained no such provision. No doubt, this was because it would not have occurred to Congress or to the tobacco industry in 1938 that any such provision was necessary. Ballin saw the omission as on opportunity. If the FDA's law alone failed to prohibit tobacco regulation, then this absence of prohibition could be taken as permission.
It was not enough to find a lacuna in the law. It was necessary also to identify language that could be sued affirmatively to cover the case. Here the key was supplied by a lawyer in the agency's policy office, David Adams—"a freelance artist of the law," a colleague called him. Adams told Kessler that instead of regulating tobacco, the agency should regulate its active ingredient, nicotine. "Cigarette manufacturers can take the nicotine out, but they leave it in," Adams said. "That goes to the question of intent." That could bring nicotine within reach of the FDA statute, which authorizes the agency to regulate products that are intended by their manufacturer to affect the structure or function of the body. "The idea was powerful, as elegant as it was succinct, and I recognized it was a dramatic way to approach an old problem," Kessler writes. "From that moment on [it was the fall of 1992]…I began to focus on tobacco."
Publicly, his effort was launched in the spring of 1994 with a letter to Ballin and a major media event—hearings in the House of Representatives, presided over by Rep. Henry Waxman (D-Ca.), at which the tobacco executives swore that they believed nicotine was not addictive. Kessler was the lead witness at these hearings, which he opened with an attack on the industry's traditional defense that Americans had a right to smoke if they wanted to. Kessler's response was that it was a right not freely exercised because smokers are addicts.
In the following year, Kessler pursued twin objectives. One was to catch the industry in the act of purposely manipulating the nicotine content of cigarettes in order to addict smokers. A second was to win support from the Clinton White House. Whatever slim chance there had been of securing support from Congress vanished with the election of 1994, in which the Republicans chairman of the Subcommittee on Health and Environment of the Committee on Energy and Commerce, which was abolished. Rep. Tom Bliley (R-Va.), whose district included a big Philip Morris manufacturing plant, became chairman of the full committee.
Combining a prosecutor's zeal with a scientist's curiosity, Kessler directed his team of lawyers and criminal detectives in a far-flung pursuit of tobacco's miscreants. They visited the major manufacturing plants. To avoid arousing suspicion at the tobacco archives of North Carolina State University in Raleigh, they dispatched a student intern dressed in blue jeans and carrying a backpack. They went down back roads in Wilson, North Carolina and Cynthiana, Kentucky, in search of farmers who had grown "Y-1," a nicotine rich experimental tobacco. With an interest in the industry's early advertising practices, they hunted through the papers of John Hill of Hill & Knowlton, the advertising agency, in the Wisconsin Historical Society.
FDA investigators also benefited from a rising flood of inside information from whistleblowers, document thefts, and legal discovery. Although in order to sustain the narrative and create suspense Kessler makes the quest sound uncertain and difficult, the fact is that in a relatively short time they were awash in useable evidence. They hit one jackpot after another as industry filers were opened. Of course industry officials knew that nicotine was the active ingredient in cigarettes—everybody knew it—and after evidence developed that cigarettes cause cancer, a central objective of the industry had been to remove cancer-causing agents while sustaining levels of nicotine high enough to satisfy smokers. Kessler's project was to make this strategy sound like a crime instead of a rational response to the moral ambiguity of cigarette manufacture.
Kessler took his evidence to higher levels of the executive branch in search of support. His first stop was the Department of Health and Human Services. Secretary Donna Shalala was enthusiastic, except for reservations about breaking the link between tobacco and sports sponsorships. As a former chancellor of the University of Wisconsin, Shalala knew the thrill of athletic competition. After Wisconsin's football team qualified for the Rose Bowl in 1994, she offered to share her "cheesehead" paraphernalia with Kessler, who declined. Not a fun-lover, Kessler recounts taking his young son to a minor league baseball game and plunging into the study of opinion poll data on tobacco as the first pitch passed over home plate.
Shalala's subordinates in HHS, with whom FDA officials regularly met, were much less receptive. They saw the FDA staff as "stubborn advocates," Kessler says, and thought him "mesmerized" by tobacco. It was not that they questioned his claim to have regulatory authority even in the absence of a clear grant from Congress. It was rather the substance of the proposed regulations, which, for example, contained strict prohibitions on advertising, and would have set the legal age limit for tobacco purchases at 19 when every state legislature had set it at 18.
The department's assistant secretary for legislation, Jerry D. Klepner, who would have to defend the FDA before Congress, was enraged. "Are you people crazy?" he asked. He "pushed his chair away from the table, his breathing rapid and hard. He walked to the window, struggling to control his fury, and then walked back to the edge of the able. He looked directly at [Kessler] and said, 'I feel f[---]d.'" As this passage suggests, Kessler does not hesitate to recount the effect that his extreme willfulness had on other officials, though in what spirit he does this I could not decide. Kessler is meticulous, and this maybe the unvarnished truth-telling of a scientist. Or it may be the pride of a man who wants us to know how courageous and persistent he was in the face of opposition.
Unfazed by the reservations in HHS, Kessler writes that "Whether the Department was with me or not, I was going to move the issue forward. I decided we should quietly establish our own channels to the White House. It was a risk to circumvent the Department, and I did not want to offend my overseers, but I needed support from other quarters."
Within the White House, Kessler found several allies, beginning with Hillary Rodham Clinton, who put his name on the guest list for the White House Christmas party in 1994. The president, however, was understandably preoccupied with electoral politics. He remarked that the Democrats had lost the congressional election because of two issues—tobacco and gun control. Defeated Southern Democrats had told him that trying to increase the tobacco excise tax to fund health care reform had cost enough votes to be decisive in their races. Kessler's outspoken wife reassured the president that he had done the right thing, and Kessler quickly planted an idea: "we can do this, if we focus on kids." President Clinton decided to embrace youth smoking as an issue, persuaded that it would not be fatal to him in the South and might even help him in such populous states as New York and California, which harbored strong anti-smoking movements.
Kessler's campaign reached a successful conclusion within the executive branch in August 1995. President Clinton held a televised press conference at which he endorsed the FDA's proposed regulations. Surrounded by children, Clinton the moralist said: "When Joe Camel tells our children that smoking is cool, when billboards tell teens that smoking will lead to true romance, when Virginia Slims tell adolescents that cigarettes will make them thin and glamorous, then our children need our wisdom, our guidance, and our experience."
Throughout the investigation, which took his agents into homes, offices, tobacco fields, and factories, Kessler expected Congress to instruct that funds not be spent for the purpose. Congress's failure to take command contrasts sharply with its behavior in the mid-1960s when the Federal Trade Commission got out front in regard to tobacco regulation. The FTC was quickly reined in.
Members from the tobacco states did protest. Sen. Mitch McConnell (R-Ky.) secured signatures from 120 members of the House and 32 members of the Senate on a letter objecting to the FDA's reach into tobacco regulation. The chairmen of the House Agriculture Committee, first Rep. Charlie Rose (D-N.C.) and then Thomas Ewing (R-Ill.), his successor, asked Kessler to supply documents relating to the investigation, and when he refused, they asked the General Accounting Office (GAO) to investigate the FDA. The agency refused also to cooperate with the GAO. Kessler writes, "Document requests are an appropriate part of oversight, but this request bothered me because I was sure the tobacco companies were behind it." Rose and Ewing backed down rather than issue subpoenas.
In the event, not only did Congress fail to with old funds from Kessler's investigation, it acceded to appropriations with which the FDA in 1997 created its own anti-tobacco regulatory regime. This entailed signing contracts with state governments under which they used under-age youths to conduct "sting" operations against tobacco retailers and imposed civil fines on those who sold cigarettes illegally. By the beginning of 2000, the extra-legislative FDA regulatory regime had collected more than $800,000 in civil penalties and was gearing up to expand.
What one makes of this story will depend very much on how one views American constitutionalism and the use of government power. To those who think that government should do whatever it takes to protect citizens from the menace of tobacco, Kessler is a hero. To those who honor the precepts of individual freedom and responsibility, government by law, separation of powers, and agency accountability to the legislature, this is a deeply disturbing story. Consider the abuses: the FDA's ability to read the law as it wished, finding permission in its silences; Kessler's decision to set up his own outfit of criminal investigators because he did not want to have to rely on the FBI; his sending a team of his gun-toting cops into homes, offices, and tobacco fields without congressional sanction; engaging underage youths in sting operations, likewise without legislative sanction; ignoring questions from Congress and Congress's lawful agent, the General Accounting Office, because an agency head concluded that they were acting on behalf of a special interest (a rationale that would enable virtually any agency head to ignore virtually any congressional request); and generally its doing whatever Congress lacked the political will to prohibit.
In the end, the Supreme Court narrowly ruled the agency's actions impermissible because they were not authorized by law, though four members, following Justice Stephen Breyer, were prepared to read the FDA's statute to authorize whatever protected the public health. "The decision that could have saved hundreds of thousands of lives had been lost by a single vote," Kessler writes. "The split was not defined by a judgment on the industry's intent, or by the question of whether nicotine was a drug. I have to believe that attitudes toward government regulation determined the vote."
This was undoubtedly true, especially if one expands "government regulation" to encompass "legislative delegation." It is a revealing comment. In Kessler's eyes, the lawfulness of his agency's doing what he wanted it to do was not the central issue. Or even a very important one. A specialist in public health, he could see the issue only as one of nicotine addiction and industry wrongdoing. He felt no compunction to weigh the competing norms of constitutional principle. Though usually well-educated, curious, analytical, and scientifically engaged, he is almost never reflective. He turns so only at the very end of the book, when he reflects, not on his own actions, but those of the lawyers who were the principal framers of the industry's strategy of deception. This sets him to worrying about the legal profession, which he is surely right to do. It's as if he had never thought previously about that profession's ethics and obligations.
Anyone who wants to reflect on the condition of our legal system and the ethics of practitioners of the law will find a great deal to ponder in the tobacco war. Both sides of it.