FDA Seeks Civil Penalties for 10 Retailers Selling Unauthorized ELFBAR

Regulations by 2FIRSTS.ai
May.31.2024
FDA Seeks Civil Penalties for 10 Retailers Selling Unauthorized ELFBAR
The FDA seeks civil fines against 10 retailers for selling unauthorized "ELFBAR" e-cigarette brand popular among teens, facing $20,678 penalties.

According to the official website of the U.S. Food and Drug Administration (FDA) on May 30th, the FDA will seek civil monetary penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling the popular e-cigarette brand "ELFBAR" targeted at teenagers.

 

The FDA had previously issued warning letters to these retailers, cautioning them against selling unauthorized tobacco products. However, a subsequent investigation found that these retailers had failed to correct these violations. Therefore, the FDA is now seeking to impose civil penalties of $20,678 on each retailer.

 

According to the 2023 National Youth Tobacco Survey, "ELFBAR" is the most commonly used brand of e-cigarettes among middle and high school students in the past 30 days, with 56.7% of teenage e-cigarette users currently using it, and about one-third (31.1%) of them considering "ELFBAR" as their "go-to" brand.

 

The FDA is seeking a civil penalty of $20,678 for each retailer, consistent with similar fines sought against retailers who have sold the unauthorized product in recent months. Retailers have the option to pay the fine, reach a settlement agreement, request an extension to respond, or request a hearing. If the retailer does not take action within 30 days of receiving the complaint, they may face a default order to pay the full penalty.

 

So far, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products currently available for legal sale and distribution in the United States, and specific information can be found in the searchable tobacco product database published by the FDA.

 

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