The U.S. Department of Health and Human Services’ Office of the Inspector General (OIG) has conducted a review of the Food and Drug Administration’s regulation and enforcement of tobacco sales by online tobacco sellers. The department published the report, FDA’s Approach to the Overseeing of Online Tobacco Retailers Needs Improvement, in December.
The report raises questions about the effectiveness of the FDA’s efforts to prevent youth access to tobacco products from online sources and determined that the agency’s efforts need improvement. These questions arose because 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.
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which authorized the FDA to regulate tobacco products in the United States. The Tobacco Control Act authorized FDA to inspect and investigate the activities of manufacturers, importers and retailers to assess their compliance with age and marketing restrictions on tobacco sales. Among other things, the Tobacco Control Act also required FDA to issue rules on the sale and marketing of tobacco products that do not occur through a face-to-face transaction at a retailer-based or physical location.
The Tobacco Control Act required these rules specifically to prevent non-face-to-face sales to minors and to protect them from the associated promotion and marketing. To monitor compliance with the Tobacco Control Act, the FDA conducts surveillance of the promoting, advertising and labeling of tobacco products. To identify websites for surveillance, the FDA uses information from multiple sources, mostly a contractor using technology to flag specified criteria. It also uses its public complaint portal allowing for tips about potential violations.
When the FDA’s investigation identifies a potential violation, the FDA must establish additional information to support an action against a retailer. The FDA must confirm that there is a violation; confirm FDA’s jurisdiction over the product in question; identify the online retailer’s owner or most responsible party; and determine whether the product was entered into interstate commerce.
The FDA has the authority to take advisory and enforcement actions when it determines that a retailer has violated the Tobacco Control Act. Advisory actions include warning letters. A warning letter represents the FDA’s attempt to bring a retailer into compliance and establish prior notice. Enforcement actions include civil money penalties (CMPs) and no-tobacco-sale orders (NTSOs). In certain cases, the FDA may pursue other enforcement actions including criminal prosecution, seizing tobacco products, or an injunction. The penalties for violating the Tobacco Control Act increase with subsequent violations. Generally, the FDA issues a warning letter the first time it finds a retailer in violation.
As the FDA’s authorities over tobacco have evolved, its enforcement has followed suit. For example, after the Tobacco Control Act came into effect in 2009, the FDA focused on violations of the ban on flavored cigarettes and sales, marketing and advertising. By 2013, the FDA had additional guidance on the sale of tobacco to minors, and its enforcement to prevent underage sales increased up to the onset of the COVID-19 pandemic, when COVID restrictions no longer allowed minors and FDA staff be together to attempt undercover buys. In 2020, new FDA guidance prioritized ENDS that were lacking marketing authorizations.
Among the 16,511 online websites flagged for meeting certain criteria, the OIG report found that the FDA issued warning letters to only 899 of them. The FDA reported that after issuing warning letters to online retailers, it provides feedback on corrective actions proposed by firms. The challenges around the volume, volatility, and transparency of online retailers make it difficult for the FDA to initiate an advisory or enforcement action against retailers that violate the Tobacco Control Act.
The limitless capacity of the internet to host retailers means that the sheer volume of websites that the FDA must survey is likely in the tens of thousands. This surveillance is further complicated by the evolving ways in which youth access the internet, such as through social media and by technology-driven changes in retailing, such as home delivery apps.
Once the FDA begins an investigation, it faces challenges with transparency and volatility that may prevent it from establishing the investigative facts needed to take action against a retailer. For example, a retailer who receives a warning letter could easily hide its identity or launch new websites where it commits the same violations, thereby skirting progressive enforcement action. Furthermore, the online retailer may choose not to work with the FDA to become compliant or, as an FDA official reported, it may just “disappear.”
The OIG report offered four recommendations to improve the FDA’s investigations and reach their goal—that the FDA:
- Collaborate with the Bureau of Alcohol, Tobacco and Firearms (ATF) on oversight of online tobacco retailers. The FDA concurred with this recommendation and plans to explore developing a Memorandum of Understanding with ATF.
- Complete its rulemaking on non-face-to-face sales of tobacco products, as required by the Tobacco Control Act. Rather than concur with this recommendation, the FDA affirmed its commitment to issuing rules to implement the Tobacco Control Act and stated that other laws and requirements—including those enforced by States or other jurisdictions—may achieve the same ends as a rule on non-face-to-face tobacco sales.
- Collect data to support the process and outcome measures for its oversight of online tobacco retailers. In its response, FDA expressed concerns that sharing information about ongoing investigations of online tobacco retailers may jeopardize investigations, thus enabling bad actors to evade FDA oversight.
- Publish information and performance data on its oversight of online tobacco retailers. The FDA concurred with this recommendation and stated that it would create a webpage dedicated to online tobacco retailer surveillance, including information about compliance and enforcement efforts.
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.
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