FDA Fails in Enforcement: Report

The U.S. Food and Drug Administration has failed to follow through after issuing warning letters to online tobacco products and vapor product sellers, according to a report by the Health and Human Services Office of the Inspector General (OIG).

Between 2010 and 2020, the FDA issued warning letters to 899 online retailers but “took no enforcement actions,” according to the report.

The FDA enforcement schedule, as of March 2022, calls for the following actions: first violation—warning letter; second violation within a 12-month period—fine of up to $320; third violation within a 24-month period—fine of up to $638; fourth violation within a 24-month period—fine of up to $2,559; fifth violation within a 36-month period—fine of up to $6,398; sixth violation within a 48-month period—fine of up to $12,794; and five or more repeated violations within 36 months—no-tobacco-sale order of 30 calendar days or six months or permanent.

The OIG report criticizes the FDA’s lack of transparency, which it says makes it hard to track the FDA’s performance. The report suggests that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives on oversight of online tobacco retailers; complete its rulemaking on non-face-to-face sales of tobacco products as required by the Tobacco Control Act; collect data to support process and outcome measures for its oversight of online tobacco retailers; and publish information and performance data on its oversight of online tobacco retailers.

In a response, the FDA did not dispute a lack of enforcement actions and agreed with the first and fourth suggestions, stating it is in the process of making those changes. The organization was noncommittal regarding the other two suggestions.

The OIG report is separate from the Reagan-Udall Foundation review of the FDA’s Center for Tobacco Products.