UPDATE 1-FDA loosens restrictions on nicotine replacement products

Mon Apr 1, 2013 3:21pm 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 said on Monday it 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.
    British drugmaker GlaxoSmithKline Plc, whose 
nicotine replacement products include Nicorette chewing gum and
the NicoDerm skin patch, commended the decision, saying it
believes "this is a positive step to help more smokers quit."
    The FDA said nicotine patches and gum were first approved
between 1984 and 1992, while nicotine lozenges and mini-lozenges
were approved between 2002 and 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."