
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, June 3, 1993                   TAG: 9306030204
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-1   EDITION: METRO 
SOURCE: Los Angeles Times
DATELINE: WASHINGTON                                LENGTH: Medium

FDA ORDERS QUIT-SMOKING PRODUCT BAN

Over-the-counter products marketed to help smokers quit do not work and will be banned after Dec. 1, the Food and Drug Administration announced Wednesday.

The prohibition will affect all pills, tablets, lozenges and chewing gum tablets that do not require a prescription and that contain ingredients not proven useful in helping smokers quit. The products include Cigarrest, Bantron, Tabmint, Nikoban and Smoke-X.

The action does not affect the nicotine patch or nicotine gum, which are available only by prescription.

The Dec. 1 ban will apply only to new shipments. Supplies may be sold until they run out.

"Smoking is one of the nation's leading public health risks, and we favor any safe and effective method for helping people kick the habit," said FDA Commissioner David Kessler. "However, to reduce smoking-related illnesses and deaths, smoking deterrents have to work. We hope such products will be developed in the future."

Several manufacturers have discussed conducting clinical trials on two of the products' ingredients, lobeline sulfate and silver acetate, although past studies with these and others ingredients have not shown them to help people quit or reduce their smoking, the FDA said. The ban is based on these studies' findings.

The FDA said Marion Merrell Dow Inc., which makes Nicorette, a prescription chewing gum, has expressed interest in gaining agency approval to sell the product without prescription.

An estimated 43.5 million Americans smoke, according to the Public Health Service. About 1 million quit every year, a number offset by the estimated 3,000 young people daily who take up the habit, it said.

The majority of people who stop smoking do so on their own without using formal smoking-cessation methods, the Public Health Service said.

Smoking is almost universally regarded by the public health community as the most preventable cause of death, killing more than 400,000 Americans annually and 2.5 million people worldwide.

by CNB