2/8/23 - Report Highlights Holes in FDA's Enforcement of Online Sales of E-Cigarettes and Other Tobacco Products | the Health and Human Services Office of the Inspector General ("OIG") recently raised questions about the effectiveness of the Food and Drug Administration's (FDA) efforts to prevent youth access to tobacco products online.

In a December 7, 2022 report, the Health and Human Services Office of the Inspector General ("OIG") recently raised questions about the effectiveness of the Food and Drug Administration's (FDA) efforts to prevent youth access to tobacco products online. The OIG is an oversight division of a federal agency aimed at preventing inefficient or unlawful operations. In this audit, the OIG concluded that the FDA's approach to overseeing online tobacco retailers is lacking.

Internet sales of commercial tobacco products to underaged individuals significantly undermine efforts to protect public health. Laws preventing the sale of tobacco products to youth and young adults play an essential role in averting a lifetime of addiction and tobacco-caused disease. Internet retailers, however, often fail to implement necessary controls to avoid illegally selling tobacco products to young people. For more about this issue, see the Public Health Law Center's Online Sales of E-Cigarettes and Other Tobacco Products. The FDA is supposed to conduct investigations of online tobacco retailers to determine whether they are in violation of the Family Smoking Prevention and Tobacco Control Act. If a retailer violates the Tobacco Control Act, the FDA may issue a warning letter or impose monetary penalties. In an extensive audit reviewing the last ten years of data, the OIG took a close look at what, if anything, the FDA is doing about online sales, and found areas of significant concern.

Highlights from Inspector General’s Report

The OIG found that in the first 10 years of its oversight, the FDA's actions toward online tobacco retailers were limited to warning letters and that its oversight has had poor transparency. The OIG analyzed annual data from 2010 through 2020 to determine the extent of the FDA's advisory and enforcement actions and to identify trends in the FDA's oversight of online retailers. It also interviewed FDA officials and collected written responses from the FDA to understand (1) how the online investigations program operates, (2) the FDA's challenges in implementing the program, and (3) the FDA's actions to address these challenges.

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

The OIG noted that the FDA faces challenges unique to the online environment. For example, websites may correct violations or disappear before the FDA can issue an enforcement action. In addition, the FDA has not taken certain steps that it should. That is, the FDA has not completed rulemaking to effectively regulate online tobacco sales. Nor has it worked with the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) to potentially obtain information about online tobacco retailers. The OIG concluded:

FDA provides limited transparency into its oversight, limiting the public's ability to hold it accountable for preventing youth access to tobacco online.

Recommendations

The OIG recommends that the FDA (1) collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives in overseeing 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. For its part, the FDA concurred with the first and fourth recommendations and declined to accept or reject the second and third recommendations.

What Does This Mean for Public Health?

State, Tribal, and local governments should not wait for the federal government to act. Through licensing and related regulations, your community can address the sale of e-cigarettes and all other commercial tobacco products in the retail environment. The Public Health Law Center's Toolkit for the Online Sales of Commercial Tobacco Products provides an overview of federal and Minnesota law regarding online and other delivery sales of commercial tobacco products, including the rationale for prohibiting delivery sales. For more information, technical assistance, or policy options on how your community can act, please contact our Center.

Willow Anderson, Staff Attorney
February 7, 2023