Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes



More than 54 years after the landmark Surgeon General’s report on smoking and health, tobacco use – primarily cigarette smoking – remains the leading cause of preventable disease and death in the U.S., responsible for 480,000 premature deaths each year. Why? Because cigarettes are incredibly addictive.

Most adult smokers want to quit, and nearly half try to do so every year. But nicotine, which a cigarette efficiently delivers through the lungs and to the brain in less than 10 seconds, draws many people back despite their desire to stop.

While nicotine keeps smokers addicted, it’s the smoke and the 7,000 chemicals contained in it that causes the disease and death. That’s why a key element of our comprehensive plan to significantly reduce tobacco-related disease and death is recognizing that nicotine, while highly addictive, is delivered through products along a continuum of risk with combustible cigarettes at one end, and nicotine replacement therapy (NRT) products at the other. In particular, NRT products, which are designed to safely reduce withdrawal symptoms, including the nicotine craving associated with quitting smoking, are generally considered to double the likelihood of a successful quit attempt. Quitting smoking can lower a person’s chances of having lung disease, heart disease or getting certain types of cancer.

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