David Kessler, former commissioner of the U.S. Food and Drug Administration, spent the better part of a decade helping uncover the tobacco industry’s dirtiest secrets. He recently told an audience of Rhode Island tobacco-control advocates that they must not let that information lie idle.
“Knowing is part of it,” said Kessler during his keynote speech at the Rhode Island Health Department’s 11th annual Tobacco Control Conference Nov. 15 at the Crown Plaza Hotel in Warwick. “But educating – doing something about what you know – is critical.”
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In his one-hour address to about 150 people, Kessler recounted how he and other FDA officials doggedly pursued evidence against the tobacco industry during his tenure from 1990 to 1997. The effort was part of Kessler’s primary goal: to win FDA clearance for the regulation of tobacco.
“The FDA regulates everything that touches the skin, everything that’s inhaled, everything that’s ingested – why not regulate tobacco?” Kessler asked.
But Kessler said the FDA couldn’t regulate tobacco because it didn’t meet the federal definition of a drug. Federal law defines a drug as any substance “intended to affect the structure or function of the body.”
Intent, Kessler explained, historically has been interpreted to mean the manufacturer’s intent. So the battle lines were drawn: Kessler and his FDA counterparts set out to unmask tobacco companies’ intent for smokers to become addicted to nicotine.
The FDA uncovered a string of internal documents and buried federal filings. Patent applications from the 1960s showed tobacco companies added nicotine to cigarette filter and wrappers, later adding organic acid to mask the nicotine’s harsh taste.
An informant told Kessler’s administration that while working at a tobacco company in the early 1980s, he helped conduct tests on lab rats showing that they self-administered nicotine over food and water. The informant’s mission was to find a substance as addictive or more so than nicotine.
In the mid-1990s, the FDA learned that Brown & Williamson concealed the use of imported tobacco from Brazil, which had been genetically modified to have more than double the amount of nicotine than conventional tobacco.
Other research during the 1990s uncovered an R.J. Reynolds internal document stating: “If our company is to survive and prosper over the long term, we must get our share of the youth market.” The memo was written in the early 1970s, Kessler said, shortly before the launch of the Joe Camel brand.
Still more FDA investigations during Kessler’s commissioner stint found documents quoting tobacco company executives fully admitting their awareness that tobacco is an addictive product and has all the characteristics of a drug.
“We are, then, in the business of selling nicotine, an addictive drug,” read a quote from the Brown & Williamson general counsel during the 1960s – buried for nearly three decades until the FDA dug it up under Kessler’s watch.
Kessler left the FDA after seven years – a far longer tenure than most FDA commissioners – and later became dean of the Yale University School of Medicine. His recently published book, “A Question of Intent,” chronicles the FDA’s probe of the tobacco industry.
Since Kessler’s departure, tobacco companies have admitted that nicotine is addictive, that cigarettes cause cancer and some tobacco executives even have called for federal regulation.
“I worked for most of a decade for (FDA regulation of the tobacco industry), and a funny thing happened along the way: The tobacco companies now want regulation,” Kessler said.
Although Kessler says he still favors regulation, he is guarded against the prospect of lending an air of social responsibility to the industry. As hard as the tobacco industry fought regulation, Kessler said, it always had one concern above all others: maintaining the social acceptability of cigarettes and smoking.
“It’s about changing the social image of smoking,” Kessler said. “How do you change public policy in this country? You’ve got to change public opinion.”
Robert Marshall, an assistant director at the state Department of Health and in attendance for Kessler’s speech, agreed that federal officials should weigh regulation of the tobacco industry carefully.
“I’d be very concerned about regulations, because every time we’ve taken a deal from the tobacco industry it’s worked in their favor,” he said. “Although I think we should regulate it, I’d be very careful how we begin that process.”
