In May 2023, the FDA (Food and Drug Administration) ordered the nicotine vape products Elf Bar (EB Design) and Esco Bar , which are exported to the United States from China and South Korea, to be added to the "import red list" as unauthorized tobacco products and to be cracked down on at customs .
- Red List Registered Businesses
Exporters are also registered on this Red List , including six Chinese exporters, including IMiracle, the owner of Elf Bar (EB Design). Six Chinese exporters are also registered for Esco Bar. The FDA Center for Tobacco Products (CTP) stated that "these companies may be manufacturing and exporting Elf Bar (EB Design) without a marketing license " as the reason for the Red List registration.
- How exports are controlled
The FDA has a 2019 Red List of Tobacco Products , which is a non-profit organization that provides tobacco products to consumers and businesses in the U.S. and Canada. The Red List of Tobacco Products is a non-profit organization that provides tobacco products to consumers and businesses in the U.S. and Canada.
- The basis for and problems with the current regulations
The basis for this regulation is that "it is illegal because the FDA (Food and Drug Administration) has not approved its sale." However, in the past, the FDA has allowed tobacco products that are in the process of pre-market approval (PMTA) to be on the market . Therefore, the question is whether it is acceptable to unilaterally regulate only Elf Bar (EB Design) and Esco Bar among the products that have submitted pre-market approval to the FDA.
According to one Elf Bar (EB Design) distributor, both Elf Bar (EB Design) and Esco Bar were submitted for pre-market approval at the same time that the FDA approved pre-market approval for synthetic nicotine products , and the FDA said it was likely to be sued over the import restrictions (Vaping360).
"Unless the Supreme Court or Congress steps in, the FDA will continue to play a cat-and-mouse game with nicotine vape manufacturers," said Gregory Conley, director of the National Nicotine Vape Manufacturers Association. "It is cherry-picking who it regulates without taking the long-term view ."
- FDA Regulatory Background
Why is the FDA (Food and Drug Administration) regulating Elf Bar (EB Design)? It is because anti-tobacco groups, including tobacco control groups, Democratic politicians, and tobacco companies, are pressuring the FDA to regulate the most popular nicotine vape .
Source ( https://vaping360.com/vape-news/124161/fda-orders-elf-bar-and-esco-bar-imports-detained/ )
