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OTC SMOKING DETERRENTS

 WASHINGTON, June 2 /PRNewswire/ -- The Food and Drug Administration has concluded that no over-the-counter smoking deterrent product on the market today has been shown to be effective in helping people quit or reduce smoking. New shipments of these non-prescription products will be prohibited after Dec. 1.
 Products that will be affected include pills, tablets, lozenges and chewing gum-type products sold under various names such as Cigarrest, Bantron, Tabmint, Nikoban and others. They may continue to be sold until supplies are exhausted.
 "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 A. Kessler, M.D. "However, to reduce smoking-related illnesses and deaths, smoking deterrents have to work."
 Several manufacturers of the non-prescription products have discussed with FDA the possibility of conducting clinical trials on lobeline sulfate and silver acetate -- two ingredients in products now on the market. Past studies with these and other ingredients have not proven their effectiveness in helping people stop or reduce their smoking, FDA reported.
 Several prescription products are approved as smoking cessation aids. Marion Merrell Dow Inc., which manufactures Nicorette, a prescription chewing gum drug for this purpose, has expressed interest in gaining FDA approval for switching the product to non-prescription status, which would allow its use without the supervision of a physician. Before allowing a switch, the agency would need to consider carefully Nicorette's own potential for addiction, since in contains nicotine.
 FDA, which is a U.S. Public Health Service agency within HHS, believes that allowing ineffective products to stay on the market discourages research to find effective ones. The agency has informed companies that it is anxious to work with them to develop new products in this area.
 The announcement was published as a final rule in the Federal Register June 1.
 -0- 6/2/93
 /NOTE: TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Mike Shaffer of the Food and Drug Administration, 301-443-3285 or, after hours, 301-831-9364/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

TW -- DC029 -- 4533 06/02/93 14:31 EDT
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Publication:PR Newswire
Date:Jun 2, 1993
Words:358
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