FDA Could Take Stronger Enforcement Action Against Tobacco Retailers With Histories of Sales to Youth and Other Violations

09-18-2023 | OEI-01-20-00240 | Complete Report

KEY TAKEAWAYS

Over the 10 years ending in 2019, FDA inspected nearly three-quarters of tobacco retailers nationwide at least once. However, it could take stronger action against retailers with histories of noncompliance.

WHY WE DID THIS STUDY

Youth tobacco use in the United States remains a high public health concern. FDA's Tobacco Retailer Compliance Check Inspection Program is a critical part of our approach to prevent youth access to tobacco. Through that program, FDA inspects tobacco retailers to determine whether they are in violation of tobacco law or regulation. If FDA finds a violation, it may issue an advisory action, such as a warning letter, or an enforcement action, such as a civil money penalty. End of
Translation When FDA issues an enforcement action, it must consider mitigating factors including the nature, circumstances, extent, and gravity of the violation and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, and the degree of culpability.

HOW WE DID THIS STUDY

We analyzed data from FDA on retailer inspections; violations; and advisory and enforcement actions from 2010 through 2019. We also analyzed retailer inspection and violation histories for a random sample of retailers that were subject to enforcement actions. To determine whether FDA inspection, advisory, or enforcement actions varied by neighborhood socioeconomic characteristics, we compared FDA inspection data to the Area Deprivation Index. We also interviewed FDA officials about the agency's direction and management of the retailer compliance check inspection program.

WHAT WE FOUND

FDA conducted more than one million inspections from 2010 through 2019, by inspecting, at least once, 74 percent of tobacco retailers that were in business nationwide as of 2020. 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, we 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.

WHAT WE RECOMMEND

We recommend that FDA (1) give greater weight to retailers' past noncompliance when taking enforcement actions against retailers with histories of violations and (2) 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. FDA concurred with our second recommendation and neither concurred nor nonconcurred with our first recommendation. FDA described steps it would take toward implementing both recommendations.