Cautions and warnings on the US OTC label for nicotine replacement: what's a doctor to do?

Addict Behav. 2011 Apr;36(4):327-32. doi: 10.1016/j.addbeh.2010.12.003. Epub 2010 Dec 10.


Background: FDA-approved labeling for over-the-counter (OTC) nicotine replacement therapy (NRT) limits duration of use to a relatively short period of time (10-12 weeks) and explicitly advises against NRT use while smoking or with additional forms of NRT.

Objective: To consider and summarize evidence accumulated since the OTC label was created regarding the safety and efficacy of longer-term and concomitant use to provide recommendations regarding these uses.

Method: Literature searches were conducted on Medline, journal websites, and Internet search engines, with findings reviewed by six smoking cessation researchers.

Results: Persistent (i.e., long-term) use of NRT does not appear harmful and self-selected persistent use is primarily driven by concerns about relapse to smoking, not addiction. Similarly, continued use of NRT and tobacco during a lapse or relapse and combination NRT treatment do not appear harmful and appear to enhance efficacy.

Conclusions: Persistent users of NRT should be counseled to reduce and stop NRT only when they are not concerned about relapsing to smoking. Use of NRT with return to smoking during a lapse or relapse should not be automatically discontinued. Combination NRT therapy should be considered for all smokers, especially those who are unable to quit smoking using a single form of NRT.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Chewing Gum
  • Drug Therapy, Combination
  • Humans
  • Nicotinic Agonists / administration & dosage*
  • Nonprescription Drugs / administration & dosage*
  • Self Medication / adverse effects*
  • Smoking Cessation / methods*
  • Time Factors
  • Treatment Outcome
  • United States


  • Chewing Gum
  • Nicotinic Agonists
  • Nonprescription Drugs