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FDA's Approach to Overseeing Online Tobacco Retailers Needs Improvement


This review raises questions about the effectiveness of FDA's efforts to prevent youth access to tobacco products online. In the first 10 years of its oversight, FDA's actions toward online tobacco retailers were limited to warning letters and its oversight has had poor transparency.


Youth tobacco use in the United States remains of high concern. Because online tobacco sales happen without buyers interacting with sellers face to face, these sales present a potentially easy way for minors to buy tobacco products without having their ages verified. The Food and Drug Administration (FDA) regulates the manufacturing, distribution, and marketing of tobacco products. As part of multiple efforts to this end, FDA conducts investigations of online tobacco retailers to determine whether they are in violation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). If a retailer violates the Tobacco Control Act, FDA may impose an advisory action—such as a warning letter—or an enforcement action. This study assesses FDA's efforts to oversee online tobacco retailers' compliance with the Tobacco Control Act.


We analyzed annual summary data from FDA from 2010 through 2020 to determine the extent of FDA's advisory and enforcement actions and to identify trends in FDA's oversight of online retailers. We also interviewed FDA officials and collected written responses from FDA to understand the following: how the online investigations program operates, FDA's challenges in implementing the program, and FDA's actions to address these challenges. Finally, we reviewed FDA's public website to gather information on FDA's oversight of online tobacco retailers.


From 2010 through 2020, for the 16,000 online tobacco websites that FDA's contractor flagged for review, FDA issued warning letters to 899 websites but took no enforcement actions. Although FDA can verify compliance immediately following warning letters, it is unclear to what extent FDA conducted additional oversight of these online tobacco retailers at later dates and found subsequent violations that could result in FDA taking enforcement actions.

FDA faces challenges—many unique to the online environment—to taking action against online tobacco retailers that violate the Tobacco Control Act. For example, websites may correct violations or "disappear" before FDA can issue an enforcement action. Adding to these challenges is the fact that FDA has not taken certain steps that could help it address gaps in its ability to oversee online tobacco retailers. For example, FDA has not completed rulemaking on non-face-to-face (e.g., online) tobacco sales, nor has it worked with the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)—part of the Department of Justice—to potentially obtain information on online tobacco retailers, beyond that which is already obtained by FDA. Finally, FDA provides limited transparency into its oversight, limiting the public's ability to hold it accountable for preventing youth access to tobacco online.


We recommend that FDA (1) collaborate with ATF on oversight of online tobacco retailers; (2) complete its rulemaking on non-face-to-face sales of tobacco products, as required by the Tobacco Control Act; (3) collect data to support process and outcome measures for its oversight of online tobacco retailers; and (4) publish information and performance data on its oversight of online tobacco retailers. FDA concurred with our first and fourth recommendations and neither concurred nor nonconcurred with our second and third recommendations.