FDA Fines Retailers Selling Unauthorized Elf Bar

FDA Fines Retailers Unauthorized Elf Bar

The Food and Drug Administration (FDA) has announced that it is seeking civil money penalties (CMPs) from 10 retailers for selling unauthorized Elf Bar e-cigarettes. The agency’s decision comes after the retailers failed to correct violations highlighted in previous warning letters, as discovered during follow-up inspections.

Elf Bar’s Popularity Among Youth Raises Concerns

The FDA’s action is driven by concerns over the growing popularity of Elf Bar e-cigarettes among middle and high school students. According to the 2023 National Youth Tobacco Survey, Elf Bar was identified as one of the most commonly used brands among students who reported using e-cigarettes in the past 30 days. This alarming trend has prompted the agency to take a firm stance against retailers selling these unauthorized products.

Penalties and Compliance Measures

Each of the 10 retailers faces a potential CMP of $20,678, consistent with similar penalties sought against other retailers selling unauthorized Elf Bar products in recent months. The retailers have several options in response to the FDA’s complaint, including paying the penalty, entering into a settlement agreement, requesting an extension to respond, or requesting a hearing. Failure to take action within 30 days of receiving the complaint may result in a default order imposing the full penalty amount.

Authorized E-Cigarette Products in the U.S.

The FDA emphasizes that to date, only 23 tobacco-flavored e-cigarette products and devices have been authorized for lawful marketing and sale in the United States. Retailers and consumers can access information on legally marketed tobacco products through the FDA’s new Searchable Tobacco Products Database.

As the agency continues its efforts to regulate the e-cigarette market and protect public health, particularly that of youth, it remains crucial for retailers to adhere to FDA guidelines and refrain from selling unauthorized products. The FDA’s ongoing commitment to enforcing compliance measures serves as a reminder of the importance of responsible marketing and sales practices within the e-cigarette industry.

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Follow-Up Inspections Lead FDA to Seek Fines Against 10 More Retailers for Selling Unauthorized Elf Bar E-Cigarettes

Matthew Ma