NEWS
06/02/1993

<TITLE>FDA Announces that No Over-The-Counter Smoking Deterrent Works</TITLE>








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<PRE>

P93-22                            Food and Drug Administration
FOR IMMEDIATE RELEASE             Mike Shaffer (301) 443-3285


   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
nonprescription 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 nonprescription 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.   
                             -MORE-


                       Page 2, P93-22, OTC Smoking Deterrents 

   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 nonprescription 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 it 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.
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</PRE>





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