US: Retailers fined for illegally selling Elfbar puffs

The U.S. Food and Drug Administration (FDA) announced that it has filed 20 civil monetary penalty (CMP) complaints against retailers for the unauthorized sale of Elfbar brand puffs. The agency said it has already sent each retailer a warning letter asking them to stop selling the products. Including these new complaints, the FDA has filed more than 100 complaints against retailers for the illegal sale of ElfBar[1].

The FDA has the authority to file civil charges and seek monetary penalties for violations of the Federal Food, Drug, and Cosmetic Act and for tobacco and nicotine products. This is particularly true when new tobacco and nicotine products do not have the required marketing authorization. Despite warnings from the agency, retailers continued to sell the brand. The agency is now seeking the maximum penalty amount, $20,678 per retailer in violation.

Products not authorized for sale

The FDA is responsible for ensuring that new tobacco and nicotine products undergo prior approval, along with the testing of certain health standards, before they are marketed. If a product does not meet a particular standard, the agency issues an order denying the marketing application. It is therefore illegal to market a new tobacco product in the United States without this prior FDA marketing approval. In May 2023, the agency asked customs to block imports of ElfBar from China into the United States, but the brand managed to circumvent the ban by simply renaming its products, which remain widely available in convenience stores and vape shops.

For Brian King, director of the FDA's Center for Tobacco Products, " The persistence of retailers in failing to comply with the law is inexcusable and sanctions must be taken. ".

Currently, $20,678 is the maximum civil penalty that FDA can seek from each retailer per violation. Retailers can pay the penalty, enter into a settlement agreement based on extenuating circumstances, request additional time to respond to the complaint, or respond and request a hearing. Retailers that fail to take action within 30 days of receiving a complaint may be subject to an order for payment requiring payment of the penalty in full.

According to the 2023 National Youth Tobacco and Other Nicotine Use Survey, Elf Bar is the most widely used brand among youth vaping users in the United States. Among middle and high school students who reported using e-cigarettes in the past 30 days, more than half reported using Elf Bar products in that time.

FDA's Fight Against Unapproved Products

Since 2021, the FDA has denied approval for thousands of vaping products because, according to the agency, it had not been established that they offered a benefit to adults (particularly in helping smokers quit smoking) that outweighed the risks posed to younger people. For example, more than 50,000 flavored vaping products, including Elfbar puffs, which were particularly popular with teenagers because they included flavors such as apple crumble, Coca-Cola, and cinnamon cereal, were denied approval.

In a recent statement, the FDA said it is committed to identifying and preventing the sale of unauthorized tobacco and nicotine products, and taking compliance and enforcement action where appropriate.

Keywords: United States, FDA, Elfbar, puff, vaping

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[1] Press release, FDA Files Complaints Seeking Maximum Fines Against 20 More Retailers for Selling Unauthorized Elf Bar E-Cigarettes, FDA, published February 26, 2024, accessed March 4, 2024