The US Food and Drug Administration (FDA) has mandated that varenicline carry a black box warning (the agency's strongest safety warning) on its labelling highlighting the increased risk of suicidal ideation and depression in patients prescribed varenicline based on spontaneous reports to the FDA Adverse Events Reporting (FDA AERS) database. These warnings are meant to indicate causal effects of pharmaceuticals. However, there is an increasing number of experimental and observational studies that suggest there is little difference in risk of adverse neuropsychiatric effects of varenicline compared to nicotine replacement products. On October 16th 2014, the FDA will hold a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to: