May 23 update
Elf Bar manufacturer IMiracle issued a statement today regarding the FDA's import alert (excerpts are included below). The company did not make any comment about potential legal actions.
“IMiracle is disappointed by the U.S. Food and Drug Administration’s (FDA) decision to abruptly and arbitrarily add the company’s products to the FDA ‘import red list.’ IMiracle was given no notice regarding this decision and was provided no opportunity to address any FDA concerns before action was taken," said a company spokesperson.
“It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making."
“IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders,” the statement concluded.
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” that allows detention of the products at U.S. ports of entry without physical examination.
Packages identified as containing Elf Bar or Esco Bar products from the red-listed shippers can be detained on the assumption that they are unauthorized tobacco products. It is up to the shippers or manufacturers to prove that the products are legal before they can be removed from the red list and released to continue to their U.S. destinations. The import alert represents “current guidance to FDA field personnel.”
The alert lists Elf Bar under both its ELFBAR and EBDESIGN names, and specifies six Chinese shippers from which products can be detained, including Elf Bar owner IMiracle. The alert also lists one shipping address in the Republic of Korea, and one U.S. address. The document names six Chinese shippers of Esco Bar, and one U.S. address.
Under the “Notes” section for each Elf Bar shipper, the FDA says its Center for Tobacco Products (CTP) “has determined that this firm may be importing/manufacturing/shipping a new tobacco product (Elf Bar/Elfbar or EBDESIGN) without marketing authorization. Tobacco products that lack the premarket authorization requirements are considered adulterated.” For each Esco Bar shipper, the same language is used. Each red list entry is dated either May 15 or May 17.
The alerts were sent by the FDA Office of Import Operations, a division of the Office of Regulatory Affairs (ORA). But the impetus for the import crackdown came from the CTP.
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert,” says the FDA alert. “If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP). CTP concurrence is required to add a product to the Red List.”
The alert is based on the products in question being unauthorized for sale by the FDA, which technically makes them illegal (“adulterated and misbranded”)—but the FDA has so far allowed products with pending premarket tobacco applications (PMTAs) to remain on the market undisturbed. The question is whether FDA “enforcement discretion” allows the agency to pick two brands (out of thousands) with pending PMTAs to enforce against.
Vaping360 has been told by a major Elf Bar distributor that both Elf Bar and Esco Bar submitted PMTAs last year during the short window the FDA accepted PMTAs for products containing synthetic nicotine. That distributor said the FDA will likely face lawsuits challenging the import ban.
“Unless the Supreme Court or Congress steps in, the FDA will only double and triple down on its current whack-a-mole enforcement strategy,” Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Vaping360. “Arbitrarily selecting products to deem extra-forbidden is what a federal agency does when it has no competent long-term vision or plan.”
In 2009, the FDA drug office seized shipments of e-cigarettes from China, setting up a court battle eventually won by the owners of NJOY. Soon after those seizures were challenged, the FDA gained regulatory authority over tobacco products, and then in 2016 the agency granted itself authority over vaping products by “deeming” them to be tobacco.
The FDA has faced pressure by anti-vaping organizations like the Campaign for Tobacco-Free Kids to crack down on disposable vapes (and all flavored and synthetic nicotine-based vape products). But pressure has also come from Congress—and from one major tobacco company that also sells vaping products.
R.J. Reynolds—maker of Vuse vapes, including the extremely popular Vuse Alto—filed an FDA citizen petition in February, asking the agency to prioritize enforcement against “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products” in order to “better protect public health.” Soon after Reynolds’ petition, a House bill was introduced that would demand the FDA prioritize enforcement against disposables.
Why won’t the @FDA close a loophole that’s allowing disposable Chinese vapes to be marketed and sold to underage minors? CASE is demanding action right at their front door and all across Washington, DC. #vape
Read more here: https://t.co/4v50NFPrLe pic.twitter.com/sdSGxUBHDJ
— CASE (@CASE_forAmerica) March 17, 2023
Reynolds is also believed by many to be the funder of a weird anti-disposable campaign by a supposed consumer group called Consumer Action for a Strong Economy. The campaign includes social media posts and a signboard truck driving around the FDA’s Washington, D.C. offices. The truck bears messages berating the FDA for its inaction against flavored disposables “aimed at minors.”
Disposable vapes like Elf Bar and Esco Bar grew rapidly in popularity after early 2020, when the FDA announced prioritized enforcement against pod- and cartridge-based vaping products sold in flavors other than tobacco and menthol. During the two years after the FDA changed its enforcement priorities, disposables grabbed 33 percent of the convenience store segment of the vape market.