Tobacco Regs The First Strike In A Long Legal Battle, Says UF Expert

August 28, 1996

GAINESVILLE — New federal tobacco regulations are just the first strike in what figures to be a long legal and political battle, says a University of Florida law professor who thinks the Food and Drug Administration’s new rule could face trouble in federal court.

Already four separate lawsuits are challenging the regulations, and any definitive ruling could be a year or more away.

But strongly voiced Constitutional objections could lead the North Carolina judge assigned to handle the lawsuits to grant a preliminary injunction against enforcement of the regulations pending a full resolution of the dispute, said Lars Noah, a professor at the UF College of Law, who has written an article to be published in the Alabama Law Review identifying several weaknesses in the regulations.

“Unless Clinton loses the election and the tobacco industry prevails, it’s going to be appealed,” Noah said. “Under a Dole administration, The Department of Justice might just concede defeat, and the FDA could do little about it.”

Should the industry win, a Clinton administration would appeal the case to the highest levels. But that would mean another several years in the courts.

“If the industry is unsuccessful, no matter what happens in the election, you can count on this being appealed very vigorously by the tobacco and advertising industries,” Noah said. “This is going to be tied up for quite a while in the federal courts.”

The most powerful argument that the tobacco industry has in challenging the regulations is one founded on the statutory limitations on the FDA’s authority, Noah said.

“The statute that the FDA implements and other statutes that Congress has enacted dealing with tobacco advertising and labeling suggest that the FDA does not have any authority to regulate tobacco products under any of its product category powers,” said Noah, noting instead that authority rests with the Federal Trade Commission.

In an unprecedented move, Noah said, the FDA is using a special type of restricted device categorization to achieve power over the advertising for tobacco products.

“In doing so, they take away from the Federal Trade Commission its existing authority to control the advertising of tobacco products, ” Noah said. “So the one agency that for the last 30 or so years clearly has had some authority over tobacco product advertising is now stripped of its pre-existing authority.”

The FDA’s argument that nicotine is a drug, but tobacco products are medical devices also could prove “very vulnerable to judicial challenge,” Noah said. The agency has never before made that sort of “counter-intuitive” definition or product categorization, he said.

“Every other drug-delivery system containing nicotine or some other chemically active substance, though it is technically a pre-filled drug delivery device, has been regulated by the FDA as a prescription drug,” Noah said. “Now they’re saying, Forget that. We’re going to change our approach to combination products and instead regulate the whole thing as a medical device.’”

The next step could be a more serious limitation on access such as making tobacco products available on a prescription-only basis, or adjusting nicotine levels in cigarettes so that only those cigarettes likely to reduce addictiveness or help reduce withdrawal symptoms would be allowed, Noah said.

“Assuming that this final rule survives judicial and legislative challenges, FDA could tomorrow ban all tobacco products,” Noah said. “It has already made the finding that nicotine is a drug, not withstanding the classification of tobacco products as medical devices.”