Cigarette Smoking & Health Impact
Cigarette smoking remains the leading preventable cause of illness and death in the United States, with one in eight adults smoking. Most smokers are aware of health risks but struggle to quit due to nicotine dependence. In 2018, 55% of smokers attempted to quit, but only 7.5% succeeded.
FDA Regulation & Cessation Products
The FDA has authority over tobacco and nicotine products, with oversight divided between the Center for Tobacco Products (CTP) and the Center for Drug Evaluation and Research (CDER). The CDER oversees drug safety and efficacy, including tobacco-cessation medications. Currently, only three types of FDA-approved drugs (NRT, bupropion, and varenicline) are available for smoking cessation, with no substantial advances in the past 17 years.
Encouraging Innovation & Expanding Treatments
The FDA can encourage innovation in smoking cessation therapies by adjusting risk-benefit analysis, evaluating new therapies against the current situation, providing incentives for innovation, and fostering communication with companies. CDER could also consider "fast track" designation and accelerated approval pathways for smoking-cessation products. By promoting effective smoking-cessation aids, the FDA could make a significant contribution to public health.
Mello, M. M., & Bonnie, R. J. (2023). Encouraging development of smoking-cessation treatments: A case for FDA action. New England Journal of Medicine, 388(18), 1731-1733.