Over-the-counter availability of nicotine replacement therapy and smoking cessation

Nicotine Tob Res. 2005 Aug;7(4):547-55. doi: 10.1080/14622200500185975.


In 1996, the FDA approved over-the-counter (OTC) availability of nicotine gum and two brands of nicotine skin patches. Little is known about how this reclassification has influenced the effectiveness and use of nicotine replacement therapy (NRT) and whether it has been a public health benefit. Data for the present study came from a prospective cohort study of 1,639 adult smokers surveyed by telephone in 1993, as part of the National Cancer Institute's Community Intervention Trial for Smoking Cessation (COMMIT), and resurveyed in 2001. NRT-assisted quit rates, NRT use rates, and the characteristics of NRT users were calculated before and after the 1996 OTC reclassification. Also calculated was the percentage of NRT users who quit by year. Results are presented for patch and gum separately and combined. OTC NRT use rates were lower for Hispanics and higher for those with no desire to quit at baseline. The quit rate decreased for patch-assisted quit attempts after OTC reclassification (22.5% to 18.5%, p = .05), but it did not change for gum-assisted quit attempts (11.9% to 10.5%, p = .54). NRT use rates increased for both patch and gum by about 60% following reclassification. A greater percentage of gum users had quit in the post-OTC period than in the pre-OTC period (9.7% vs. 14.6%, p = .05). Long-term quit rates in patch users were similar in both periods. Insurance coverage of NRT and concurrent attendance in a stop smoking clinic decreased for both patch- and gum-assisted attempts in the post-OTC period. The results suggest that OTC reclassification may have contributed to the increased use of NRT, compared with the pre-OTC period, whereas the efficacy for quitting decreased slightly for those using nicotine patch and remained about the same for those using the gum.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Cohort Studies
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Health Promotion / statistics & numerical data*
  • Humans
  • Male
  • Middle Aged
  • Nicotine / supply & distribution
  • Nicotine / therapeutic use*
  • Nonprescription Drugs / supply & distribution*
  • Nonprescription Drugs / therapeutic use
  • Prospective Studies
  • Smoking / drug therapy*
  • Smoking Cessation / methods
  • Smoking Cessation / statistics & numerical data*
  • Smoking Prevention
  • Surveys and Questionnaires
  • Time Factors
  • United States


  • Nonprescription Drugs
  • Nicotine