The Health and Human Services (HHS) Inspector General (OIG) recently conducted a comprehensive analysis of the Food and Drug Administration’s (FDA) enforcement actions against tobacco retailers with a specific focus on youth-related violations. The report covers the period from 2010 to 2019 and provides insights into inspection rates, recommendations, and enforcement outcomes.
Key Findings:
Inspection Coverage:● From 2010 to 2019, the FDA inspected 74% of tobacco retailers nationwide.
● The FDA estimates that there are approximately 360,000 tobacco retailers across the country.
OIG Recommendations:● The OIG recommended that the FDA concentrate inspections on retailers with a history of failures, but the FDA chose not to respond to this suggestion.
Enforcement Measures:● Failed inspections result in consequences ranging from warning letters for first offenses to fines up to $12,795, accompanied by orders not to sell tobacco products.
Inspection Resources:● The FDA employs a combination of internal inspectors, state-contracted inspectors, and third-party contractors.
● The OIG suggested collaboration with the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for compliance inspections.
● The FDA agreed with the suggestion to work with the ATF for enforcement but did not express a stance on inspecting online retailers.
Follow-Up Inspections:● Over the period from 2010 to 2020, 74% of tobacco retailers were inspected, with 57% inspected more than once.
● On average, a retailer was inspected three times during the time period considered.
● The FDA conducts follow-up inspections for 88% of retailers who failed within a year of their initial inspection.
Regional Disparities:● The frequency of follow-up inspections varies significantly by state.
● States like California, Texas, Nevada, Alaska, New York, North Dakota, the Virgin Islands, and Puerto Rico show low rates of follow-up inspections.
● Specific states, such as Nevada and California, exhibit notable patterns:
● Nevada: Only 32% of retailers were inspected. A third-party inspector, unlicensed by the state, delayed inspections until 2018.
● California: Only 42% of retailers were inspected, attributed to budget issues.
● The FDA attributes the lack of reliable data on the Virgin Islands and Puerto Rico to the hurricanes of 2017. The FDA has recently contracted with a third party to get reliable data on the locations of tobacco retailers in the two regions.
Enforcement Data:
Violations Observed:● The FDA has issued 93,813 warning letters.
● 24,708 civil money penalties issued
■ Civil money penalties (CMPs) ranged from $320 to $12,795.
■ 80% of CMP violations resulted in fines of less than $584, with only 4% exceeding $10,000.
● 204 No tobacco sale orders were issued.
Payment Trends:● The Department of Justice can pursue retailers for failing to pay CMPs.
● Retailers with histories of violations paid in full for only 9% of CMPs received.
● Those with only one CMP paid in full at a rate of 60%.
● Retailers failed to pay nearly $18,000,000 in accumulated CMPs.
The HHS Inspector General’s report sheds light on the FDA’s enforcement actions against tobacco retailers, revealing disparities in inspection rates, follow-up procedures, and payment trends.