FDA bans aids to quit smoking Over-the-counter products found to be useless

June 03, 1993|By Marlene Cimons | Marlene Cimons,Los Angeles Times

WASHINGTON -- Over-the-counter smoking cessation products do not work and will be banned from the marketplace after Dec. 1, the Food and Drug Administration announced yesterday.

The prohibition will affect all pills, tablets, lozenges, and chewing gum tablets that do not require a prescription and that contain ingredients not proved useful in helping smokers quit. The products are sold under such brand names as Cigarrest, Bantron, Tabmint, Nikoban, Smoke-X and others.

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, and current supplies may be sold until they are exhausted, the FDA said.

"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," Dr. David A. Kessler, the FDA commissioner, said in a statement.

"However, to reduce smoking-related illnesses and deaths, smoking deterrents have to work. We hope such products will be developed in the future."

Currently, an estimated 43.5 million Americans continue to smoke, according to the U.S. Public Health Service. About 1 million people in this country quit every year, a number offset by the estimated 3,000 young people daily who take up the habit, the office said.

By 1990, more than 44 million Americans had stopped smoking cigarettes, nearly half of all living adults who ever smoked, according to the American Cancer Society.

The majority of people who stop smoking do so on their own without the use of formal smoking cessation methods, according to the Public Health Service.

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.

"We need to have products on the market that will help people stop smoking, but until we have the science to back up claims made by these products, Americans should not waste their money," Dr. Kessler said. "We hope this action will encourage new research into this area."

Silver acetate trials

The agency said several manufacturers have discussed the possibility of conducting clinical trials on two of the major ingredients in the products, lobeline sulfate and silver acetate, although past studies with these and other ingredients have not shown them to be effective in helping people quit or reduce their smoking, the FDA said.

These ingredients had been thought to simulate nicotine to help reduce the craving for cigarettes.

The agency based its decision to ban the products, in part, on these earlier studies that showed the ingredients were ineffective. Their safety is not in dispute.

"FDA believes that allowing ineffective products to stay on the market discourages research to find effective ones," the agency said in a statement. "The agency has informed companies that it is anxious to work with them to develop new products in this area."

The FDA said the manufacturer of Nicorette, Marion Merrell Dow Inc., has expressed interest in gaining approval to switch the nicotine-based gum to non-prescription status.

'Potential for addiction'

But the agency said it would first have "to consider carefully Nicorette's own potential for addiction, since it contains nicotine."

Ken Tanner, a spokesman for Advantage Life Products of Laguna Hills, Calif., which manufactures Cigarrest, said the product -- which comes in tablets, gum and lozenges -- is only "one small aspect" of the stop-smoking program marketed by the company.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.