FDA Issues Warnings Regarding Unapproved E-cigarettes Gaining Popularity Among Youth

The FDA has taken steps to address the growing use of e-cigarettes among young people. On September 14, 2023, the FDA sent warning letters to 15 online retailers and three manufacturers/distributors. This was the result of the sale and distribution of unauthorized e-cigarette products. Notably, one retailer was selling them to minors. The warning letters were directed at a range of trendy e-cigarette products known to appeal to young consumers. These include disposable products under brand names such as Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech.

E-cigarette smoking

Data-Powered Approach to Spot Emerging Risks

The FDA’s identification of these youth-attractive e-cigarette products was driven by swift surveillance and data-driven investigations. This approach involved analyzing retail sales data, emerging data from youth surveys, and other sources to identify the growing popularity of these products. This comprehensive analysis enabled the FDA to gain a deep understanding of the evolving landscape of e-cigarette usage among young individuals.

Consequently, the FDA focused its investigations on the entire supply chain, from manufacturers to distributors to retailers, deploying a multi-faceted strategy to combat the proliferation of these appealing yet potentially harmful products. By harnessing the power of data, the FDA aims to stay one step ahead of emerging threats to public health.

Boosting Compliance and Enforcement Efforts

Brian King, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products, stressed the importance of agile surveillance tools in addressing evolving threats in the e-cigarette landscape, especially those affecting young people. These tools are crucial for proactively identifying threats and safeguarding public health.

The companies that received warning letters were found to be selling or distributing e-cigarette products in the United States without FDA authorization. This action violates the Federal Food, Drug, and Cosmetic Act. These companies have 15 working days to respond with corrective actions and plans to prevent future violations.

Continued FDA Efforts to Protect Youth

These recent warning letters are part of the FDA’s ongoing efforts to combat youth-oriented tobacco products throughout the supply chain. Typically, most recipients of warning letters take corrective actions. Failure to do so may lead to further FDA actions, such as injunctions, seizures, or civil penalties. Over the past year, the FDA has taken its first steps toward issuing injunctions and civil penalties against e-cigarette manufacturers. Additionally, it issued a warning letter to a distributor for distributing illegal e-cigarettes. Since January 2023, the agency has imposed civil penalties on 29 manufacturers for the illegal sale of e-cigarettes.

Looking Ahead

To strengthen its compliance and enforcement endeavors, the FDA is expanding its surveillance capabilities to swiftly identify and respond to emerging products that pose public health risks. In June, the FDA collaborated with the National Institutes of Health (NIH) to allocate funding for the Center for Rapid Surveillance of Tobacco (CRST). CRST aims to support the FDA and the research community by rapidly detecting and reporting information about changes in the tobacco product marketplace and tobacco use patterns. CRST will complement the FDA’s array of time-sensitive data sources, offering potentially actionable information more quickly than traditional data collection methods.

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