FDA Will Ban Over-Counter Smoking Aids
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 Wednesday.
The prohibition will affect all pills, tablets, lozenges and chewing gum that do not require a prescription and that contain ingredients not proven 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 under FDA approval.
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,” FDA Commissioner David A. Kessler said.
An estimated 43.5 million Americans continue to smoke, the U.S. Public Health Service’s office on smoking says. About 1 million individuals in this country quit every year, a number that is 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, accounting for nearly half of all living adults who ever smoked, the American Cancer Society says.
The FDA 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 of 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 the effects of nicotine to help reduce the craving for cigarettes.
The agency based its decision to ban the products in part on the earlier studies that showed the ingredients were ineffective. Their safety is not in dispute.
Ken Tanner, a spokesman for Advantage Life Products of Laguna Hills, 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.
“Ours is a stop-smoking clinic for your home,” he said, adding that the program includes a cassette tape, booklet and other educational materials to help the consumer quit. “It takes you through an entire course, including keeping a diary and making a list of the triggers that make you smoke. The (lobeline sulfate) is one small aspect of the entire program. It is supposed to be used in conjunction with behavior modification. If not, it isn’t effective.”
Tanner said that his firm probably will modify its program to conform to FDA regulations by eliminating use of the products. Also, he said, the company might seek to find a new non-prescription product that is effective.
“We’ve been researching alternatives to lobeline sulfate for several years,” he said.
Several prescription products already have been approved as smoking cessation aids, among them the nicotine patch and prescription chewing gum containing nicotine, the major addictive ingredient in cigarettes.
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