Ex-FDA Chief Calls for Dismantling the Tobacco Industry

Dr. David Kessler, architect of the Clinton administration’s crusade to regulate cigarettes, says the only way to control the nation’s addiction is to dismantle the tobacco industry in a way that allows it to continue to produce cigarettes--but not a profit.

Writing in a new book, Kessler, a physician, predicts that escalating court judgments over the coming decade could force tobacco companies to function almost like public utilities--to provide a product to those who need it but not be allowed to make money from it or promote it.

“Every cigarette sold increases their liability. Tobacco is no longer an asset,” said Kessler, a former commissioner of the Food and Drug Administration who now is dean of the Yale University Medical School.

“This isn’t about regulations or Supreme Court decisions,” he said in an interview. “The fact is this is an industry that can’t continue to operate the way it’s now operating.”

He recommends that tobacco companies be spun off from their parent corporations to become tightly regulated quasi-private entities.

Cigarettes should continue to be available to already addicted smokers, he writes. However, they should be sold in brown paper wrappers with only a brand name and a warning label--and not allowed to be sold to children or adolescents. Sales revenues should be used only to underwrite manufacturing and distribution costs, with the rest going into a fund created to pay liability claims and to fund medical research and programs to counter youth smoking.

With no profit motive or political clout, smokers would dwindle and “it would be the end of the industry as we know it,” Kessler writes.

Book Chronicles FDA’s Inquiry

His book, “A Question of Intent: A Great American Battle With a Deadly Industry,” to be released Tuesday by PublicAffairs, a member of the Perseus Books Group, details the FDA’s tobacco investigation in detective-story fashion. It also offers rare personal glimpses into the evolving policy that led President Clinton to declare smoking a “pediatric disease” and to put his full weight behind the first-ever attempt to regulate cigarettes.

When the FDA began its inquiry, Kessler said, he never intended to dismantle the industry. But now he sees no other way to end the smoking problem in this country.

“Although nicotine and cigarettes have to remain available, you can’t ethically and morally continue to allow companies to make a profit,” he said.

Kessler was first appointed by President George Bush and did not meet Clinton, who chose to keep him on, until a 1994 Christmas party at the White House.

In the receiving line, First Lady Hillary Rodham Clinton told Kessler how he came to be invited to the very small party: “I wanted you to come. I put you on the list. I really admire what you are doing. It’s Orwellian to say that nicotine is not a drug.”

The president, however, seemed uneasy about taking on the powerful tobacco industry. He told Kessler that he blamed Democratic positions on tobacco and gun control for the Republicans’ takeover of the House that November.

Clinton was immediately taken to task by Kessler’s wife, Paulette. A lawyer, she lectured him: “What was your choice? You had to take those stands.”

Clearly surprised, Clinton responded: “Of course, those were the right stands to take. We just should have explained our positions better so that people would have understood them.”

Taking advantage of his opportunity, Kessler writes that he told Clinton: “You know, there’s a way we can do this, if we focus on kids.” The president “was beginning to move away,” Kessler writes, “but he turned back and gave a small nod.”

Later, Clinton supported a full-scale assault on the industry and focused his rhetoric on the industry’s marketing of cigarettes to children.

Kessler also credits Vice President Al Gore for gaining Clinton’s support. Gore was intensely interested in the issue because his older sister, Nancy, a smoker, had died of lung cancer.

Kessler, who headed the FDA from 1990 to 1997, also had to be convinced that it was possible to take on the tobacco industry, he writes.

After Kessler learned that tobacco companies could manipulate the amount of nicotine in cigarettes and was convinced that nicotine was addictive, he concluded that the concept of regulating nicotine as a drug was plausible.

The FDA’s two-year investigation involved poring over thousands of internal industry documents and holding numerous clandestine meetings with nervous secret informants given such code names as “Deep Cough.” What emerged was a clear picture “of the industry managing the social climate for tobacco over the last 50 years and scheming to defraud the American people,” Kessler said. “There was a script.”

The agency compiled evidence to support its case that nicotine is an addictive drug and that cigarettes are “drug delivery devices,” subject to FDA regulation. The administration put forth a series of tough regulations forbidding sales of cigarettes to minors and severely curbing advertising and promotion of tobacco products.

Agency Thwarted by Supreme Court

Last March, however, the Supreme Court, in a 5-4 decision, struck down the agency’s proposals, saying that Congress never intended the FDA to regulate tobacco as a drug.

But the industry’s troubles are far from over. Numerous lawsuits are pending, and juries appear increasingly willing to punish cigarette makers for marketing addictive products and denying their negative health effects.

As a result, Kessler said, the industry today is far less resistant to government regulation, probably because “its survival is at stake.”

Philip Morris Cos., in fact, has said that “tough and sensible FDA regulation of the industry is needed and should focus on such things as preventing kids from smoking.”