FDA Moving to Declare Nicotine a Drug

TOBACCO July 1994

The Food and Drug Administration is conducting research to determine whether nicotine is an addictive drug. (Phillip J. Hilts, "Stiffer Regulations Could Avert Cigarette Ban, F.D.A. Head Says", New York Times, 6/29/94, A1). If results show that it is, then nicotine could be banned. F.D.A. Commissioner, David A. Kessler, says that he wants to avoid a ban on cigarettes that tobacco companies have said he is seeking, and which Federal law may force him to order. Representative Henry A. Waxman, (D-CA), chairman of the House Energy and Commerce Subcommittee on Health and the Environment and an opponent of smoking is also against a ban on nicotine. Leaders on all sides of the tobacco issue agree that they may be able to find common ground on some type of regulatory scheme. Nevertheless, if the F.D.A. concludes that nicotine is an addictive drug, then Federal law requires a finding that the drug is safe -- which almost certainly will not happen -- in order for the agency to approve its use.

To avoid the stricter regulation that could be brought about under the Federal Food, Drug and Cosmetic Act, Dr. Kessler suggests that Congress, the agency, and the industry could develop compromise legislation that would create an alternative to prohibition. All sides agree that the object should not be to destroy the tobacco industry and force the country's 45 million smokers to get their cigarettes on the black market.

Instead, many feel that regulation should focus on prevention such as helping deter teen-agers from starting to smoke, and making it easier for smokers to quit.

One possibility is to regulate the amount of tar and nicotine in cigarettes as the Europeans are in the process of doing. An even more drastic approach would be to gradually lower the levels of nicotine in cigarettes until they are no longer addictive. However, Dr. Kessler said he was not convinced that this approach would be effective. "We don't want to create a black market. But we need to discuss it."

Other possibilities include banning vending machines; restricting advertisements such as those that use cartoon characters which are said to influence children, and restricting sales to state run stores, in much the same way as some states restrict the sale of alcohol.