The usual answer, Kessler said, was that the FDA couldn't take on the industry because it was too powerful in Congress. But, he said, "nobody said the agency didn't have the legal authority."
After a five-year study, the FDA decided that tobacco did come within the agency's regulatory reach, as an item -- in the words of the federal Food, Drug and Cosmetic Act -- "intended to affect the structure or function of the body."
Major revelations of internal industry documents filled in the "intent," Kessler said. Those files, he said, showed the companies to be acknowledging that tobacco was a pharmaceutical, aimed at creating and maintaining addiction.
"Once we saw that they knew nicotine was a drug, it was not credible for FDA not to act," Kessler said. "Once you recognize nicotine is an addictive drug and it's children and adolescents who are addicted, the industry's argument about freedom and adult choice began to unravel."
But for the moment, the agency does not have the power it formally claimed in 1996: A federal appeals court ruled last year that Congress has given the agency no power to regulate tobacco.
If tobacco did come under the federal law, the appeals court said, the FDA would have to ban tobacco products altogether. The law requires that any drug on the market has to be safe and effective, and the FDA itself has found that cigarettes and chewing tobacco cannot be made safe and effective, the appeals court said.
That is exactly the argument the industry is making to the Supreme Court, to counter the Clinton administration's claim that the FDA can regulate tobacco without banning it altogether.
The tobacco companies, in what sometimes seems to be a denunciation of their products, concede openly that cigarettes and chewing tobacco cannot be made safe and effective within the meaning of federal drug law.
"Always before," an industry representative said last week, "FDA has followed a bright line: Either a drug is safe, or it can't be on the market." If the FDA is allowed to regulate, said the representative, who asked not to be named, it could only do so on the basis of safety and effectiveness. "That is a standard we cannot meet," so tobacco would have to be banned, he suggested.
He added that the tobacco companies "have a duty -- morally and under the law -- to reduce the risks of our product." But he declined to say how that duty could be enforced by anyone outside the industry.
