FDA loosens restrictions on nicotine replacement products

Mon Apr 1, 2013 3:25pm EDT

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.

Credit: Reuters/Jason Reed

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(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."

(Reporting By Toni Clarke in Washington; Editing by Sofina Mirza-Reid and Steve Orlofsky)

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Comments (1)
NRT Failure Rate Soars to 98.4%

New revelations confirm that Nicotine Replacement Therapy (NRT) has a documented long term failure rate of 98.4%.

PRLog (Press Release) – Apr 03, 2009 –
New revelations confirm that Nicotine Replacement Therapy (NRT) has a documented long term failure rate of 98.4%.

NRT is the Government’s recommended treatment for its smoking cessation programmes and is heavily funded by the tax-payer.

Pro-choice group Freedom2choose are alarmed at these revelations and the obvious waste of tax-payers’ funds. Colin Grainger, vice chairman of the group states, “NRT products are obviously unfit for the purpose for which they are sold. This is fraud, wrong and immoral.”

Freedom2choose have previously highlighted alternative ways to successfully quit smoking, including the Allen Carr method, with a documented success rate of 58% for those choosing to give up. The Allen Carr method even promises a money back guarantee to those that don’t successfully quit.

“More worryingly,” continues Colin Grainger “is the shock that the scientists who put the study together even work for the manufacturers of NRT. This clearly shows how the Big Pharmaceutical companies influence the outcome of studies.”

The revelations were originally made public by long-term anti-smoking campaigner Professor Michael Siegel who states “With a long-term smoking cessation percentage of only 1.6%, one can hardly call NRT treatment an “effective” intervention. In fact, the logical conclusion from this paper is that NRT was a dismal intervention.”

Apr 02, 2013 8:58am EDT  --  Report as abuse
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