The question comes down to this: If nicotine is a drug and cigarettes deliver nicotine to the human body, then aren't cigarettes a drug delivery device which should be subject to regulation by the government?
The FDA will argue that it not only has the right to oversee cigarettes, it has an obligation, given that 45 million Americans remain addicted to them, reports CBS News Correspondent Jim Stewart. Every health group in the country agrees.
"The real fact is that nicotine is a deadly, addictive drug," former FDA Commissioner Dr. David Kessler told CBS Early Show Anchor Bryant Gumbel. "It should be regulated as such by the FDA."
Kessler was the first to assert FDA jurisdiction over these products. He said the FDA rule would focus on reducing the number of young people who would start to smoke.
However, Kessler said the agency does not have to ban cigarettes under the law, even though they are known to be deadly.
"The FDA regulations will reduce the number of children and adolescents who become addicted," Kessler said. "The regulations are just common sense."
But the tobacco industry argues this isn't a debate over whether cigarettes are bad for a person's health.
"There is no safe cigarette," said Phillip Morris attorney Mark Berlind. "We would never pass a safe and effective test. We don't pretend to pass that. That's why we don't think it makes any sense to try to regulate cigarettes as a medical device."
Kessler said if Big Tobacco wins the case, "we will have generation after generation of young people continuing to be addicted to a deadly product."
Manufacturers point out the FDA chose not to regulate tobacco for 30 years and question the FDA's timing and their right to oversee cigarettes.
After all, it was Congress that passed regulations calling for warning labels on cigarettes Â— not the FDA. In the end, big tobacco argues, this is a court case about power and who should have it over tobacco Â— Congress or the FDA.
The FDA calls the case the most important public health and safety effort in the last 50 years. The Supreme Court promises an answer by June.