"ILLEGAL" Allegedly, FDA Detains Imported Elf Bar & Esco Bar Products from China and Korea

Shopify API - 23 May 2023

Vapeboss – Currently, the U.S. Food and Drug Administration (FDA) is facing pressure from anti-vaping organizations like Campaign for Tobacco-Free Kids to crack down on disposable vapes, including all flavored and synthetic nicotine-based vape products. Pressure also comes from Congress and from one of the major tobacco companies that also sells vaping products.

Disposable vapes like Elf Bar and Esco Bar became increasingly popular after early 2020, when the FDA announced priority enforcement against pod and cartridge-based vaping products sold in flavors other than tobacco and menthol. In the 2 years after the FDA changed its enforcement priorities, disposables captured 33% of the convenience store segment of the vape market.

In 2009, the FDA's drug office seized a shipment of e-cigarettes from China and ended up in court, which was ultimately won by the owner of NJOY. Shortly after that seizure was challenged, the FDA gained regulatory authority over tobacco products, and then in 2016 the agency asserted its own authority over vaping products by "deeming" them as tobacco.

Recently, the FDA stated that the Center for Tobacco Products (CTP) had determined that "this company may be importing/manufacturing/shipping new tobacco products (Elf Bar/Elfbar or EBDESIGN) without marketing authorization." Tobacco products that do not have pre-market authorization requirements are considered illegal for any Esco Bar sender.

Based on this, the FDA has ordered its import inspectors to detain shipments of Elf Bar and Esco Bar disposable vapes sent to U.S. ports from manufacturers and exporters in China and Korea. The products have been added to an "import red list" which allows for product detention at U.S. ports of entry without further physical inspection.

Packages identified as containing Elf Bar or Esco Bar products from red-listed shippers can be detained on the assumption that they are unauthorized tobacco products. It is up to the shipper or manufacturer to prove that the product is legal before it can be removed from the red list and released to continue to its destination in America.

This warning is based on the products in question being unauthorized for sale by the FDA, which technically makes them illegal ("adulterated and misbranded"), yet the FDA has so far allowed products with pending pre-market tobacco applications (PMTAs) to remain on the market undisturbed. The question is whether the FDA's "enforcement discretion" allows the agency to pick and choose two brands (out of thousands) with pending PMTAs for enforcement. The main distributor of Elf Bar said that Elf Bar and Esco Bar had already submitted PMTAs last year. The distributor said that "there is a possibility that the FDA will face lawsuits related to the import ban."

Source: Vaping360

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