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Do FDA labels gum up the works for stop-smoking products?

Smoking kills. So does smokeless tobacco, which Baseball Hall of Famer Tony Gwynn blamed for the oral cancer that ended his life this week, at age 54. 

Nicotine replacement products—like patches, gum, and lozenges—are a safe and effective way for people to quit.

Why, then, does the US Food and Drug Administration have labeling requirements for nicotine replacement therapy (NRT) that “may undermine its positive public health impact”?

That question arises from a recent article by researchers at Yale and elsewhere.

Under the current labeling system, “Smokers are advised to start NRT only when they stop smoking (i.e., on their ‘quit date’), to only use one NRT product at a time, to refrain from using NRT if they resume smoking, and to stop NRT within 3 months, regardless of their progress,” write the authors, led by Lisa Fucito, assistant professor of psychiatry at the Yale School of Medicine.

“This creates the impression that NRT is only safe and/or effective when used under these conditions,” they continue. But “research evidence conflicts with this notion.”

The authors “applaud” recent FDA moves to let manufactuers modify their labels. But, they argue, the agency needs to go further to make it clear just how safe and effective the products are.

For example, combining a long-acting nicotine product, like a patch, with a quicker-acting method such as gum is “highly efficacious,” they say. Likewise, starting nicotine replacement before quitting is safe and can make it easier to stop smoking. What’s more, people should know that nicotine replacement is safe for up to six months if they need it, the authors write.

Cigarettes are the nation’s leading preventable cause of illness and death. Better nicotine replacement labeling, the authors predict, could “enable more smokers to successfully quit smoking.”


The Yale Alumni Magazine is published by Yale Alumni Publications Inc., an alumni-based nonprofit that is not run by Yale University. Its content does not necessarily reflect the views of the university administration.

Filed under smoking, School of Medicine, Lisa Fucito, nicotine replacement


  • Joe Gitchell, BK '92
    Joe Gitchell, BK '92, 12:14am June 19 2014 | Ico flag Flag as inappropriate

    This is a thoughtful story on an important issue. Thank you.

    Disclosure: my employer, PinneyAssociates, provides consulting services to GlaxoSmithKline Consumer Healthcare, the marketer of Nicorette and NicoDermCQ.

  • Michael J. McFadden
    Michael J. McFadden, 8:47am June 19 2014 | Ico flag Flag as inappropriate

    "people should know that nicotine replacement is safe for up to six months if they need it,"

    Can someone cite the research that supports this? It's hard to understand why something would be "safe" for six months, but "not safe" for 9 or 12 or 18 months. What parameters were used to set the 6 month safety limit?

    - MJM

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