The U.S. Food and Drug Administration (FDA) may take stronger enforcement action against tobacco retailers involved in selling tobacco to youth and other violations, according to a report released by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. action.
The authors analyze the extent and nature of supplier inspections conducted by the FDA through the agency's Tobacco Retailer Compliance Inspection Program over nearly a decade, as well as the enforcement actions taken against suppliers.
The inspector general found that from 2010 to 2019, the FDA conducted more than 1 million inspections. As of 2020, 74% of operating retailers nationwide have been inspected at least once. The FDA will almost always inspect a retailer within 12 months of discovering a violation. In some states, inspection activity is tied to a community's socioeconomic conditions, which raises questions about how FDA and its contractors select retailers for inspections.
Overall, FDA's actions against retailers that violate tobacco laws and regulations are consistent with its policies.
However, retailers with a history of non-compliance often do not receive the harshest enforcement actions. The FDA collected only 9% of the civil monetary penalty (CMP) from retailers with a history of violations, compared with 60% of the CMP from retailers with fewer violations. Furthermore, in our sample, retailers who might have been subject to orders for smoke-free sales often did not receive the orders.
However, the inspector general did not determine how much of a role FDA's consideration of mitigating factors or the administrative law judge's actions played in these findings.
In the report, the inspector general recommends that FDA give greater weight to a retailer's past violations when taking enforcement actions against retailers with a history of violations and to determine whether changes in inspection activities are appropriate based on the socioeconomic status of the community, and The extent to which it is consistent with FDA's goal of protecting vulnerable populations.