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
Open accessAbstract
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.
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NRT licensing is being changed to allow its use for harm reduction purposes among ex-smokers.
“NRT licensing is also being changed to allow its use for harm reduction purposes among ex-smokers.71”
From Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study (2015) · cites this paper as [71]
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- Authors
- Fucito, L. M., Bars, M. P., Forray, A., Rojewski, A. M., Shiffman, S., Selby, P., West, R., Foulds, J., Toll, B. A., & Writing Committee for the SRNT Policy and Treatment Networks
- Affiliations
- Yale University (US)
- New York City Fire Department (US)
- University of Pittsburgh (US)
- Centre for Addiction and Mental Health (CA)
- University College London (GB)
- Pennsylvania State University (US)
- Yale Cancer Center (US)
- Venue
- Nicotine & Tobacco Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-06-11
- Volume
- 16
- Issue
- 7
- Pages
- 909-914
- ISSN
- 1462-2203 (ISSN-L)
- 1469-994X
- PMC
- PMC6281057
- OpenAlex
- W2091559396
- Cited by
- 34
- References
- 49
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 3 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 7 · 2015: 8 · 2014: 3
- FWCI
- 4.21
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Nicotine & Tobacco Research (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Cancer Research UK (14135)
- Medical Research Council (MR/K023195/1)
- Economic and Social Research Council (ES/G007489/1)
- National Institute on Alcohol Abuse and Alcoholism (K23AA020000)
- National Institute on Drug Abuse (P50DA036107)
- National Cancer Institute (P50CA196530)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nicotinic Acetylcholine Receptors Study
- Keywords
- nicotine replacement therapy, smoking cessation, nicotine patch, nicotine lozenges, smoking reduction, relapse prevention, over-the-counter nicotine products
- MeSH terms
- Administration, Cutaneous, Nonprescription Drugs, Health Policy, Nicotine, Smoking, United States, United States Food and Drug Administration, Randomized Controlled Trials as Topic, Smoking Cessation, Guidelines as Topic, Tobacco Use Cessation Devices
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