This study assesses the impact of the 1993 NIH Revitalization Act on the inclusion and subgroup analysis of women and minorities in trials of FDA-approved smoking cessation pharmacotherapy. Female representation, while commensurate with population levels, declined significantly for trials that began recruitment after 1993(M = 47.2% vs. M = 53.9%), and fewer than half reported analyses by gender. Minorities continued to be under-represented in later trials; however, significant improvement in representation (M = 16.1% vs. M = 10%) and analysis by race occurred. Industry-sponsored studies had lower minority representation than NIH funded studies. Recommendations are offered to improve subgroup analyses and minority inclusion.