FDA Fails to Enforce Warnings to Online Tobacco Retailers

The US Food and Drug Administration (FDA) failed to enforce warnings issued to online vendors of tobacco and vapor products, as reported by a document from the Office of the Inspector General for Health and Human Services.

A report states that between 2010 and 2020, the FDA sent warning letters to 899 online retailers, but "did not take any enforcement action".

As of March 2022, the FDA enforcement schedule requires the following actions for violations: first offense- warning letter; second offense within 12 months- maximum fine of $320; third offense within 24 months- maximum fine of $638; fourth offense within 24 months- fine of up to $2,559; fifth offense within 36 months- maximum fine of $6,398; sixth offense within 48 months- maximum fine of $12,794; five or more repeated violations within 36 months- 30 calendar day, six-month, or permanent smoking ban.

The OIG report has criticized the FDA for lacking transparency, which makes tracking the agency's performance difficult. The report recommends that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms, and Explosives to monitor online tobacco retailers. It also suggests that the agency comply with the Tobacco Control Act by creating regulations for non-face-to-face tobacco sales, collect data to support its process for monitoring online tobacco retailers, and disclose information and performance data pertaining to its monitoring of online tobacco retailers.

In their response, the FDA did not object to the lack of enforcement action and agreed with the first and fourth recommendations, stating that they are in the process of making these changes. The organization did not comment on the other two recommendations.

The OIG report is independent of the Reagan-Udall Foundation's review of the FDA's Center for Tobacco Products.