1.4 Million Disposable Vapes Seized by FDA May Have Been Counterfeits

In the latest skirmish in the FDA’s war on disposable vapes, the agency has teamed up with customs inspectors to intercept 41 shipments of products intended for store shelves around the United States. The agency says it seized 1.4 million devices worth $18 million at retail.

The products were seized by a team of FDA and U.S. Customs and Border Protection (CBP) employees at Los Angeles International Airport in what the FDA described as a “three-day joint operation.”

But according to an industry insider involved with the import of some of the brands the FDA intercepted, many of the seized disposable vapes are likely counterfeit products.

Did the FDA seize counterfeit vapes?

According to an FDA press release, the seized shipments included Elf Bar disposables, as well as Lost Mary, Funky Republic, RELX Pod and IPLAY Max products. There were other brands seized, but the Elf/EB, Funky Republic and RELX products accounted for a large portion of the total, according to an FDA source who did not wish to be named.

But, according to Vaping360’s industry source, Elf Bar-branded disposables haven’t been exported to the United States by Elf Bar parent company IMiracle since February 2023, when the company became embroiled in a trademark dispute. At that time, IMiracle began using the EBDESIGN name on Elf Bar products sold in the U.S.—and later added the EBCREATE brand. None of the seized shipments were destined for U.S. Elf Bar distributors authorized by IMiracle, the source told Vaping360.

The Funky Republic brand is also no longer used by the legitimate manufacturer, according to our industry source.

Additionally, Chinese vape market leader RELX does no business in the U.S. According to industry sources, any RELX product sold here should automatically be considered a counterfeit. (The company does legally sell products in Canada.)

While the FDA press release doesn’t specifically say the products seized were legitimate Elf Bar/EB, Funky Republic and RELX devices that were shipped from those manufacturers’ factories, it implies that the named manufacturers are responsible for the shipments. The FDA apparently did not attempt to verify the legitimacy of the seized products before announcing the airport operation, and makes no mention in its press release that the products could be counterfeit. The unnamed FDA employee did concede that some of the 41 shipments seized by the agency may have contained counterfeit products.

In effect, the FDA may have unintentionally done legitimate disposable vape manufacturers and importers a huge favor. Counterfeit disposable vapes are a major problem for the industry: not only do they compete for sales with legitimate products in retail outlets, but they're often made with substandard materials and shoddy workmanship, damaging the reputations of the actual manufacturers. Disposable manufacturers go to great lengths to educate consumers how to distinguish legitimate and counterfeit vapes.

Months of investigation to stop less than 1% of sales

The FDA says the FDA-CBP team “worked for months to review shipping invoices, identify potentially violative incoming shipments, and complete other investigative work that led to this successful operation.”

In August 2022, Chicago market research form IRI estimated the U.S. disposable vape business had already exceeded $2 billion in annual convenience store and gas station sales. Even assuming zero market growth since last year—and excluding online and vape shop sales—the FDA seizures would account for less than one percent of annual sales, or about a three-day supply of the popular vapes.

“The FDA is committed to continuing to stem the flow of illegal e-cigarettes into the United States,” said FDA Commissioner Robert Califf. “Unscrupulous companies try everything they can to bring unauthorized, youth-appealing tobacco products into the country. The FDA will remain vigilant, and together with our federal partners, stop these imports before they make it into the hands of our nation’s youth.”

Other recent FDA disposable vape actions

The announcement of the airport seizures came one day after the FDA announced it had issued warning letters to 11 online retailers for selling unauthorized disposable vapes.

The agency cited the online businesses for selling various combinations of the Lost Mary, Funky Republic/Funky Lands, Elf Bar/EBDESIGN, Kangvape, Cali, and Breeze brands, according to an FDA press release.

Warning letter recipients have 15 working days to reply to the FDA, describing what corrective actions they’ve taken or disputing the agency’s allegations. Those who don’t remove the products from the market or reply to the FDA may face additional FDA sanctions.

The FDA has sent hundreds of warning letters to disposable vape sellers in the last year. It has also ordered FDA import inspectors to detain shipments of Elf Bar and Esco Bar products, and sought civil money penalties for some repeat retail violators.

Last week the FDA announced it would seek civil money penalties against 25 brick-and-mortar and online retailers for repeat sales of unauthorized vapes. The FDA complaints seek the single-violation maximum of $19,192 from each retailer.

Businesses charged with violations punishable by civil money penalties can pay the full amount immediately, reach a settlement agreement with the FDA, ask for an extension to answer the complaint, or answer with a request for a hearing. They have 30 days to respond or risk a default order imposing the full penalty.