Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: WEDNESDAY, August 3, 1994 TAG: 9408040022
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: Associated Press
DATELINE: SILVER SPRING, MD. LENGTH: Medium
Food and Drug Administration Commissioner David Kessler welcomed the vote as an important piece of the evidence he is compiling to show that his agency should regulate nicotine as a drug.
``We keep hearing from the tobacco industry that smoking is free choice. What is the free choice of an addictive product?'' Kessler told reporters after the 91/2-hour advisory committee meeting. He refused to say when he would act on the issue, however.
For the FDA to legally regulate nicotine, it must prove that the chemical affects the ``structure and function'' of the body. Kessler has maintained since February that he believes this is the case, but Tuesday's advisory committee meeting was the first official move to confirm that.
The FDA usually agrees with advisory committee decisions.
The nine-member panel said there is no doubt that nicotine in the amount now sold in cigarettes hooks smokers, but it could not determine if there is a level at which nicotine would be safe.
Some scientists on Tuesday urged the FDA to restrict nicotine levels in cigarettes to such a low level that people could smoke 20 in one day and still not absorb more than 5 milligrams of the chemical, which they deemed the addictive threshold.
Committee members said the level that is addictive could vary from smoker to smoker, just as the level that causes alcoholism varies from drinker to drinker.
``I don't hear any evidence that lets me answer the question clearly,'' said Alice Young, a psychology professor at Wayne State University in Detroit.
Cigarette makers argued that smoking is no more addictive than caffeine, and that lowering nicotine to the level critics want effectively would ban cigarettes.
``If Dr. Kessler wants people to try to quit smoking he ought to tell them to try because they can quit, and not characterize them as addicts doomed to fail if they try to quit,'' said Philip Morris Vice President Steven Parrish.
The FDA considered Tuesday's meeting so critical that Kessler personally questioned witness after witness.
``How difficult is it for the regular user of nicotine in cigarettes to quit?'' he asked a Tufts University scientist who agrees with cigarette makers that nicotine is not addictive.
``It's hard to lose weight, it's hard to change behavior,'' Dr. Domenic Ciraulo responded. He said he had stopped a pack-a-day habit without professional help.
At issue is the very definition of addiction. Once, scientists insisted that an addictive substance had to cause intoxication or euphoria, as opiates do. The standards set by the American Psychiatric Association no longer include that requirement.
Its new definition includes substances that can cause withdrawal symptoms, are hard for people to quit despite significant physical problems caused by the drug and to which people build a tolerance.
by CNB