FDA loosens restrictions on nicotine replacement products

Mon Apr 1, 2013 11:16am EDT

April 1 (Reuters) - The U.S. Food and Drug Administration is
relaxing its restrictions on the use of over-the-counter
nicotine patches, gum and lozenges.
    Currently, consumers are instructed to stop smoking when
they begin using a nicotine replacement product and to stop
using it after 12 weeks.
    The FDA plans to remove both these restrictions in response
to claims by critics that they may cause some smokers to abandon
attempts to quit if they have a cigarette while on a replacement
therapy.
    Allowing people to stay on a nicotine replacement for longer
than 12 weeks may increase their chance of quitting, they say.
    The FDA said nicotine patches and gum were first approved
between 1984 and 1992, while nicotine lozenges and mini-lozenges
were approved in 2002-2009.
    After reviewing published literature, the agency said it has
determined that the concomitant use of cigarettes and other
nicotine-containing products "does not raise significant safety
concerns."
    

 (Reporting By Toni Clarke in Washington; editing by Sofina
Mirza-Reid)
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