Nicotine replacement therapy makes it easier to quit smoking by providing a therapeutically safe fix of the chemical that makes cigarettes addictive in the first place. In the 25+ years since nicotine-laced patches, gum and lozenges became available, they have amassed a remarkable safety record. In fact thousands of people—and perhaps many more than that–have used NRT products for decades with few or no untoward effects (other than a notably thinned-out wallet).
As a result, the FDA may soon relax the warning label verbiage affixed to NRT products. Currently, the FDA recommends that such products should be used for no longer than 12-weeks. The recommendation under consideration is that NRTs can be used for prolonged periods—perhaps indefinitely.
“There really doesn’t appear to be any great harm” with the use of NRT over long periods of time, said K. Michael Cummings, chair of the department of health behavior at the Roswell Park Cancer Institute in an interview. “You’re better off chewing gum or wearing a patch than smoking.”
Public health advocates like Cummings have petitioned the FDA for years to relax its recommendations. They received a boost from a 2009 law which empowered the FDA for the first time to regulate tobacco products. A provision in the law tasks the agency to consider relaxing the warning labels on NRT products.
Labels on NRT products advise users to taper-off on their consumption of the products over a 12-week period. These recommendations have stood since the FDA first approved nicotine gum in 1984. They were established to be consistent with the duration of NRT product utilization during clinical trials that were designed to test their efficacy, rather than scientific data regarding health risks associated with long-term NRT use.
There is no evidence that nicotine is carcinogenic in its own right, at least in humans. It may however increase cardiovascular risk because it causes mild tachycardia and mild elevations in blood pressure.
If the FDA does relax its warnings, it will have followed a precedent set by the British Royal College of Physicians, which concluded 4 years ago that “medicinal nicotine is a very safe drug,” and “there are no grounds to suspect appreciable long-term adverse effects on health.” Regulatory authorities in the UK, Japan, Germany and Canada have already approved NRT product use periods between 6 and 12 months.
Glaxo markets the industry-leading product, the Nicorette brand of gum, patches and lozenges. It collects a lion’s share of an $800 million US market for NRT products. Pfizer and Novartis also play in the space.