The FDA has issued a directive to its import inspectors, instructing them to detain shipments of Elf Bar and Esco Bar disposable vapes from manufacturers and exporters in China and Korea that are being sent to U.S. ports. These products have been placed on an “import red list,” which allows their detention at U.S. ports without undergoing physical examination.
Shipments containing Elf Bar or Esco Bar products from the shippers listed on the red list are subject to detention based on the assumption that they are unapproved tobacco products.
The shippers or manufacturers must provide proof that the products are legal before they can be removed from the red list and released for delivery to their U.S. destinations. This import alert represents the “current guidance to FDA field personnel.”
The alert identifies Elf Bar, both under its ELFBAR and EBDESIGN names, and lists six Chinese shippers, including Elf Bar owner IMiracle, from which products can be detained. It also mentions one shipping address in the Republic of Korea and one in the U.S. The document names six Chinese shippers of Esco Bar and one U.S. address.
For each Elf Bar and Esco Bar shipper, the FDA notes that its Center for Tobacco Products (CTP) has determined that these firms may be importing, manufacturing, or shipping new tobacco products (Elf Bar/Elfbar or EBDESIGN) without the necessary marketing authorization. Such tobacco products that lack the required premarket authorization are considered adulterated. Each entry on the red list is dated either May 15 or May 17.
Although the products in question are technically illegal (“adulterated and misbranded”) due to lacking FDA authorization for sale, the FDA has previously allowed products with pending premarket tobacco applications (PMTAs) to remain on the market undisturbed. It remains to be seen whether the FDA’s “enforcement discretion” permits the agency to selectively enforce against two brands, out of the many with pending PMTAs.
A major distributor of Elf Bar has stated that both Elf Bar and Esco Bar submitted PMTAs last year during the limited period when the FDA accepted PMTAs for products containing synthetic nicotine. The distributor believes that the import ban imposed by the FDA will likely face legal challenges through lawsuits.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, expressed concerns about the FDA’s enforcement strategy, stating that it lacks a competent long-term vision or plan. He believes that unless the Supreme Court or Congress intervene, the FDA will persist in its current approach.
In 2009, the FDA seized shipments of e-cigarettes from China through its drug office, leading to a court battle ultimately won by NJOY’s owners. Following those seizures, the FDA gained regulatory authority over tobacco products and, in 2016, extended its authority to vaping products by deeming them to be tobacco.
The FDA has been under pressure from anti-vaping organizations like the Campaign for Tobacco-Free Kids to crack down on disposable vapes, flavored products, and those containing synthetic nicotine. In February, R.J. Reynolds filed an FDA citizen petition urging the agency to prioritize enforcement against “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products” to safeguard public health. Subsequently, a House bill was introduced to demand the FDA’s focus on enforcing against disposables.