Nicotine should be regulated as a drug, FDA says


WASHINGTON -- The Food and Drug Administration has concluded for the first time that nicotine is a drug that should be regulated, and it has proposed limited, initial steps for regulating tobacco products, according to officials.

But in a sign of the delicacy of the issue -- and of the opposition in the Republican Congress to new restraints on smoking -- the agency is not using the authority it has to act on its own. Instead, it has thrown the issue to President Clinton, by submitting proposed regulations to the White House.

The proposals themselves are modest, involving only new limits on tobacco advertising and measures to curtail sales to young people.

"There have been some preliminary discussions on the issue of protecting children from tobacco," White House spokesman Michael D. McCurry said yesterday.

"It's at a very preliminary stage, and there are not any concrete recommendations to the president," Mr. McCurry said.

The FDA and its commissioner, Dr. David A. Kessler, refused to comment on the proposals, which have not been publicly announced. The proposed regulations were described yesterday by administration officials on the condition that they not be identified.

Current tobacco regulation is limited primarily to a ban on television advertising and the requirement that warning labels be printed on packages, approved by Congress and administered by the Federal Trade Commission. However, if the FDA gains the authority to regulate tobacco, it would be on the basis that nicotine is an addictive drug -- a basis that would give the agency authority far beyond requiring warning labels.

The companies and their allies in Congress are expected to oppose any new regulation.

Rep. Richard M. Burr, a freshman Republican from Winston-Salem, N.C., in the heart of tobacco country, said yesterday:

"As long as tobacco is a legal product in the United States and Congress decides not to change that status, then the Agriculture Department and any other federal agency should treat it as a legal commodity."

Among the proposals sent to the White House is a ban on vending machine sales, one of the chief sources for the unsupervised purchase of cigarettes by children.

Another proposal is to restrict industry access to advertising aimed at the "youth market," such as magazines with primary readership under age 18.

In the past, such restrictions have been challenged on First Amendment grounds.

Copyright © 2020, The Baltimore Sun, a Baltimore Sun Media Group publication | Place an Ad