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“A Question of Intent” by David Kessler PublicAffairs, 492 pages, $27.50 A few weeks ago, a 10-person commission of experts appointed by former President Bill Clinton recommended that the U.S. Food and Drug Administration be given authority to regulate tobacco for health reasons. The report ended up on the desk of the new president, George W. Bush, who during his campaign said that Congress should give the FDA the powers necessary to discourage youngsters from using tobacco products. Although it sounds logical that the FDA should have authority over perhaps the most deadly product ever sold, it has never been so. The tobacco industry has pretty much escaped government regulation for all time. Until, that is, David Kessler, a Republican appointee in the administration of the elder George Bush, became FDA commissioner in 1990. Clinton kept Kessler, a physician and lawyer, as commissioner despite differing political affiliations. During his six years running the FDA, Kessler, now dean of the Yale University medical school, led the campaign to rein in the tobacco industry on public health grounds. His report of those six years, “A Question of Intent,” is one of the best federal government insider books ever published. Why? First, the topic is interesting. The battle between the tobacco industry and the FDA contains built-in drama. Furthermore, the portions of the book that discuss other FDA initiatives, such as honest food labeling, are gripping as well. Second, Kessler’s intelligence and humanity leap off the pages. He is never self-important and rarely deluded. Rather than rely solely on his memory — the norm in books of this type — Kessler did lots of reporting as he strove for accuracy and balance. Third, the writing is clear, jargon-free, and sometimes downright compelling. The book is a policy procedural that in places rises to the level of policy thriller. I read part of the book while traveling between my home in Missouri and New York City. As I reached the climax of Kessler’s battle with other parts of the government and with private industry to label food accurately in terms of nutrition, a flight attendant handed me a small package of snack mix. On the back, within a thin black border, was information titled “Nutrition Facts.” Eating the contents of the .45 ounce bag would mean consuming 60 calories, 30 from fat. I would receive 5 percent of my daily value of sodium, no iron, no calcium, no Vitamin A or C. Although a compulsive overeater, I put the package aside. If Kessler had never run the FDA, consumers might never have been able to make accurate determinations about nutrition, food product by food product. His book explains precisely how he and his FDA colleagues prevailed, losing out only to the restaurant industry, which won an exemption for meals served. The food labeling victory came before the FDA tobacco wars. Perhaps its most significant long-term impact on Kessler was to demonstrate that he could succeed by working inside the system, even when the odds looked bad. Turning seeming defeat into victory began when Congress approved the Nutrition Labeling and Education Act of 1990. The law required all food products to list amounts of fat, saturated fat, protein, sodium, carbohydrates, and fiber, and place those amounts in the context of a daily diet. The FDA had the task of developing regulations to translate the law into action. Kessler understood the importance of the assignment he inherited. As a doctor, he was acutely aware that diet accounts for the second-biggest cause of preventable death in the United States — after tobacco. He did not want to dictate behavior, because he understood that such an attempt would be hopeless. He did, however, hope to display accurate information so prominently that lots of consumers would be able to make educated choices. Where to begin? The law said nothing about how to present the information. “Somehow,” Kessler writes, “we had to find a way to fit added information on thousands of different types of food packages, from pasta to peanuts, on hard packs, clear packs, candy wrappers, boxes of Cheerios and cans of Coke.” Another challenge involved serving sizes. “It had been widespread industry practice,” Kessler says, “to minimize serving sizes so that they bore little relation to the amount people actually ate — for example, the calorie content of ‘light’ cheesecake was based on a serving size of half a slice. We were determined to close this loophole by requiring serving sizes to reflect the amount customarily consumed.” At that point in the book, Kessler does something he does well throughout — he introduces FDA regulators playing a key role in each decision, humanizing them so they become memorable individuals rather than faceless, interchangeable bureaucrats. Jerold “Jerry” Mande from the FDA policy office takes center stage in Kessler’s account of the food labeling controversy. Kessler’s humanization of Mande opens like this: “If it had not been for red M&Ms, Jerry might never have come to the FDA.” Intrigued? Kessler continues: In the 1970s, as an undergraduate at the University of Connecticut studying nutrition and biochemistry, Jerry read that the agency had banned a red dye that gave M&Ms and many other red foods their distinctive color. That set him thinking about regulatory priorities, and wondering why the FDA focused more on cancer-causing trace additives, such as the dye, than on the macro-nutrients that dominated daily diets and had a far greater impact on health. Mande and other FDA staff members began working on the regulations. They knew, however, that they would butt up against not only influential food producers, but also another government agency — the much larger U.S. Department of Agriculture, which regulates meat and meat products. Kessler hoped that one label could be applied to all packaged foods. “For too long, the two agencies had been divided by absurd territorial disputes,” Kessler says. “Pizza toppings was one example — cheese and tomatoes came under FDA labeling rules, but if pepperoni was added, the USDA took charge. It was time for the federal government to speak with one voice.” Finding one voice seemed unlikely. The USDA, influenced by the powerful meat industry, wanted the per-serving percentage of fat and other nutrients to be based on a daily intake of 2,350 calories. Kessler, supported by much of the less politically influential public health community, wanted 2,000 calories to be the standard. The turning point came from an unlikely source: a McDonald’s restaurant in New Jersey. Kessler was driving his children to a family vacation near the ocean when they clamored to stop for fast food. While his daughter and son ate Chicken McNuggets that day in August 1992, Kessler, himself consuming French fries, started reading the tray liner. “I was surprised to see that, against a background photograph of fresh vegetables, McDonald’s had set out its own case for a healthy, balanced diet. In small type at the bottom, I spotted this statement: ‘Based on nutritional guidelines by the National Research Council. Fat recommendation based on a total daily intake of 2000 calories.’ ” Kessler collected several tray liners to take to his office. Eventually, Kessler showed the tray liner to his political superior, Secretary of Health and Human Services Louis Sullivan. The next day, Sullivan attended a White House showdown with Agriculture Secretary Ed Madigan. With the meeting proceeding poorly from Sullivan’s standpoint, he produced the McDonald’s tray liner, commenting that if the dominant company in the fast-food industry supported a 2,000-calorie benchmark, why was the USDA acting in such an intransigent manner? “Madigan was taken completely by surprise,” Kessler writes. “The President [George Bush] sat staring at the liner for a minute or two, studying the detail.” Two days later, Bush ruled in favor of the FDA approach. Such controversies made it difficult for Kessler to focus on finding a way for a health-oriented government agency to regulate tobacco products. Just when a draining policy controversy like nutrition labeling would get resolved more or less, a life-and-death crisis needing Kessler’s immediate attention would arise. There are heart-stopping sections of the book explaining how the FDA tries to deal with deadly food poisoning outbreaks and homicidal product tampering. Near the beginning of the book, Kessler explains how, during his first month as commissioner, he had to make a snap decision on whether to pull Sudafed from store shelves in every city across the United States because of evidence, then inconclusive, that a few packages in an isolated geographic area had been filled with poison by a murderer. As Kessler explains, reluctance to order a national recall is not just about inconveniencing a politically connected manufacturer — in this case, Burroughs Wellcome — but also is about deciding whether a recall will incite a nationwide panic among the citizenry. After the third Sudafed poisoning report, Kessler decided he had to risk a panic. The national recall commenced. Eventually, law enforcers charged a man who had decided to murder his wife with a poisoned Sudafed, then placed other poisoned capsules in a variety of stores so the death would appear to be the result of anonymous product tampering. Kessler thought he had moved as expeditiously as the evidence warranted. But, he says, “The morning after the national recall, a reporter asked me why we had not moved sooner. I began to understand just what I was facing.” Most of the book, as the title and subtitle — “A Great American Battle with a Deadly Industry” — suggest, is devoted to facing down the tobacco industry. Much of that saga has been oft-told. But Kessler’s account is worth reading, partly because of the new details that do emerge, partly because he addresses so impressively seemingly abstract political, legal, and ethical issues within the context of the controversy. That controversy remains partially unresolved years after Kessler’s departure from the FDA, giving the book a timely rather than an outdated feel. Some passages mix anecdotes about the famous with policy-making insights. For example, Kessler and his wife, Paulette, are surprised to be invited to a Christmas party at the White House after he has been retained by President Clinton. After all, Kessler was a Republican appointee first. Furthermore, Southerner Clinton is getting heat from the tobacco industry about rumblings at the FDA. Attending the Christmas party is Kathleen Linehan, Washington lobbyist for tobacco giant Philip Morris. When Kessler and Linehan are introduced, Kessler finds her chilly. The answer to why Kessler and his wife are in attendance comes in the receiving line, as they meet Hillary Rodham Clinton. “I wanted you to come,” she tells Kessler warmly. “I put you on the list. I really admire what you are doing. It’s Orwellian to say that nicotine is not a drug.” Eventually, Kessler would be back at the White House, keeping the Clintons informed about the unprecedented foray into tobacco product regulation. Kessler never forgot Hillary Clinton’s support. Kessler has stayed on top of the issues he advanced as FDA commissioner. After he stepped aside, FDA regulation of tobacco entered the judicial system and eventually came before the U.S. Supreme Court, where the justices ruled 5-4 that the agency had exceeded its authority concerning the tobacco industry. It is now up to Congress to craft a law allowing the FDA to regulate tobacco products in ways likely to withstand court challenges. Kessler will be watching closely. As he says at the end of his book, the tobacco industry “cannot be left to peacefully reap billions of dollars in profits, totally unrepentant, and without thought to the pain caused in the process. For that remains its intent.” Steve Weinberg is an author in Columbia, Mo. He previously worked as a Washington correspondent for newspapers and magazines.

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