Health-related quality-of-life (HRQOL) claims in drug advertisements and HRQOL advertisements' compliance with FDA regulations were studied. HRQOL advertisements from three medical journals from the years 1984, 1988, and 1992 were analyzed. Information was collected on the drug products and classes for which HRQOL claims were made and (1) whether the claims were explicit or implied, (2) how the products were claimed to affect HRQOL, and (3) whether claims related to overall well-being, a specific physiological aspect, or functional ability. For 1992 only, the compliance of HRQOL advertisements with FDA regulations was assessed. Ninety-four HRQOL advertisements were identified: 27 for 1984, 41 for 1988, and 26 for 1992. The drug classes for which HRQOL advertisements were most commonly used were diuretics (1984), nonsteroidal anti-inflammatory drugs (all three years), antianginals (1984 and 1988), antihypertensives (1988 and 1992), and anti-depressants (1992). Almost all the advertisements contained a claim (usually implicit) related to a specific physiological aspect of HRQOL, and claims concerning physical functioning outnumbered other function-related claims. In 1992, 42% of the HRQOL advertisements appeared out of compliance with at least one FDA regulation. In 1984, 1988, and 1992, HRQOL claims in prescription drug advertisements in three medical journals were mainly implicit and related mainly to specific physiological aspects of HRQOL. Over 40% of the HRQOL advertisements reviewed for compliance with FDA regulations for prescription drug advertising appeared not to comply.