Importance: The US Food and Drug Administration (FDA) is pursuing a low-nicotine product standard for cigarettes and other combusted tobacco. Very low nicotine content cigarettes (VLNCs) contain approximately 95% less nicotine than standard cigarettes. A key concern is that people who smoke may increase their smoking to compensate for the reduced nicotine levels, which would be a major unintended consequence of the regulation.

Question: If the US Food and Drug Administration (FDA) implements a low-nicotine product standard for cigarettes, will people who smoke increase their smoking behavior or smoke exposure?

Findings: In this systematic review and meta-analysis of 17 trials with 5500 adolescent and adult participants, no trials in the systematic review reported increases in the number of cigarettes smoked per day or exhaled breath carbon monoxide (CO) exposure among participants assigned to very low nicotine content cigarettes (VLNCs). In the meta-analysis, fewer than 1% of the participant population could be expected to increase cigarettes smoked per day, and 8% could be expected to increase CO exposure when smoking VLNCs.

Meaning: This study suggests that an FDA-mandated low-nicotine product standard for cigarettes is unlikely to result in widespread compensatory smoking.