The U.S. Food and Drug Administration could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations, according to a report published by the Office of Inspector General (OIG) of the Department of Health and Human Services.
The authors analyzed the extent and nature of the FDA’s inspections of, and enforcement actions against, vendors occurring over nearly a decade through the agency’s tobacco retailer compliance check inspection program.
The OIG found the FDA conducted more than 1 million inspections from 2010 through 2019, by inspecting, at least once, 74 percent of tobacco retailers that were in business nationwide as of 2020. The FDA almost always returned to inspect retailers where it found violations within 12 months. In some States, inspection activities were correlated with neighborhoods’ socioeconomic conditions, raising questions about how FDA and its contractors select retailers to inspect.
Overall, FDA’s actions against retailers that violated tobacco laws and regulations were in accord with its policies.
However, retailers with histories of violations were often not subject to the strongest enforcement actions. FDA collected the full amount for only 9 percent of the civil money penalties (CMPs) it issued to retailers with histories of violations compared to 60 percent of CMPs it issued to retailers with fewer violations. Also, retailers in our sample that could have been subject to a no-tobacco-sale order usually did not receive one.
However, the OIG did not determine the extent to which FDA’s consideration of mitigating factors or actions by Administrative Law Judges played a role in these outcomes.
In its report, the OIG recommends that FDA give greater weight to retailers’ past noncompliance when taking enforcement actions against retailers with histories of violations, and determine whether variation in inspection activity on the basis of neighborhoods’ socioeconomic status is appropriate and the extent to which it is meeting FDA’s objective for protecting vulnerable populations.