May 30, 2024
The U.S. Food and Drug Administration (FDA) has announced its intent to impose civil money penalties (CMPs) on nine brick-and-mortar retailers and one online retailer for continuing to sell the unauthorized Elf Bar e-cigarettes. This action follows previous warning letters issued to these retailers, which they failed to heed, resulting in continued violations.
Background and Violations
Elf Bar, a popular e-cigarette brand among youth, has been the subject of regulatory scrutiny due to its appeal to minors. According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among middle and high school students. Remarkably, 56.7% of youth e-cigarette users reported current use of Elf Bar, with about one-third (31.1%) naming it as their “usual” brand.
The FDA’s decision to seek CMPs of $20,678 per retailer is part of a broader effort to enforce compliance with tobacco regulations. This move is consistent with penalties imposed on other retailers earlier this year, including actions taken in February and April.
Enforcement Actions and Retailer Responsibilities
Retailers found in violation have several options: they can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Failure to take action within 30 days of receiving a complaint can result in a default order imposing the full penalty.
The FDA’s approach underscores its commitment to curbing youth access to unauthorized tobacco products. To date, the FDA has authorized only 23 tobacco-flavored e-cigarette products and devices for lawful marketing and sale in the U.S. This limited authorization is aimed at reducing the availability of flavored e-cigarettes that appeal to younger demographics.
Legal and Public Health Implications
The FDA’s actions highlight the ongoing tension between regulatory agencies and the e-cigarette industry. Retailers argue that compliance with ever-changing regulations is challenging and costly. However, from a public health perspective, stringent enforcement is essential to protect youth from nicotine addiction and other health risks associated with e-cigarette use.
On May 30, FDA announced it is seeking civil money penalties (CMPs) from nine brick and mortar retailers and one online retailer for the sale of Elf Bar, a popular youth-appealing e-cigarette brand. FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a CMP of $20,678 from each retailer.
According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among middle and high school students who reported using e-cigarettes in the past 30 days, with 56.7% of youth e-cigarette users reporting current use of Elf Bar and about one-third (31.1%) reporting it was their “usual” brand.
The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including February and April of this year. The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S. Further information on tobacco products that may be legally marketed in the United States is available in FDA’s new Searchable Tobacco Products Database.
