title: Addressing the evidence for FDA nicotine replacement therapy label changes: a policy statement of the Association for the Treatment of Tobacco use and Dependence and the Society for Research on Nicotine and Tobacco.
abstract: Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT; lisa.fucito@yale.edu.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Fucito
authors.affiliation: FDNY BHS Tobacco Treatment Program, New York, NY; IntelliQuit, Mahwah, NJ;
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Bars
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT;
authors.forename: Ariadna
authors.initials: A
authors.lastname: Forray
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT;
authors.forename: Alana M
authors.initials: AM
authors.lastname: Rojewski
authors.affiliation: Department of Psychology, University of Pittsburgh, Pittsburgh, PA;
authors.forename: Saul
authors.initials: S
authors.lastname: Shiffman
authors.affiliation: Addictions Division, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada;
authors.forename: Peter
authors.initials: P
authors.lastname: Selby
authors.affiliation: Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College, London, London, UK;
authors.forename: Robert
authors.initials: R
authors.lastname: West
authors.affiliation: Cancer Institute and Department of Public Health Sciences, Penn State University, College of Medicine, Hershey, PA;
authors.forename: Jonathan
authors.initials: J
authors.lastname: Foulds
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, CT;Yale Comprehensive Cancer Center, New Haven, CT; Smilow Cancer Hospital at Yale-New Haven, New Haven, CT.
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Toll
mesh_terms: D000279:Administration, Cutaneous; D017408:Guidelines as Topic; D006291:Health Policy; D009538:Nicotine / Q000008:administration & dosage*; D004366:Nonprescription Drugs; D016032:Randomized Controlled Trials as Topic; D012907:Smoking / Q000188:drug therapy; D016540:Smoking Cessation / Q000379:methods*; D061485:Tobacco Use Cessation Devices / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004366:Nonprescription Drugs; D009538:Nicotine