The FDA has issued 14 new warning letters to online vape retailers and distributors, almost all for sales of unauthorized disposable vapes. The actions follow the agency’s recent blueprint of seeking enforcement targets by searching online for obscure sellers linked to search keywords like “Elf Bar” and “Lava disposable.”
The FDA also warned longtime Chinese manufacturer Kangertech for wholesale offerings of a vape pen and replacement coils that are practically fossils in the fast-moving vape market. The items cited in the warning letter were listed as “Kanger TOP EVOD Kit, Kanger T2 Replacement Coil – 5PK, Kanger SOCC Replacement Coil – 5PK – 2.2OHMS.” The EVOD is a low-wattage vape pen based on the early eGo-style devices used with clearomizers.
“The youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations,” said the FDA press release. “Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped FDA to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.”
But even the anti-vaping zealots at the Center for Tobacco Products couldn’t mistake the Kanger TOP EVOD for a “youth-appealing” product. If there is still a demand for this product at all, it is almost certainly from vapers who began using the it years ago and have depended on it ever since.
Aside from picking product names to search for, the only “nimble tools” employed in the FDA’s “rapid surveillance” and “data-driven” enforcement approach are computers with Google search capability. The agency targets products it already knows have not been authorized, and searches for sellers that have not been cited before (to maximize the chance they’ll be frightened into compliance).
Today’s warning letters—aside from Kangertech’s—went to online sellers offering disposables made by Bang (cited in one warning letter), Cali Bar (six letters), Elf Bar/EBDESIGN (eight letters), and Lava (seven letters). Some warning letters included more than one of these brands. There is no mystery which search terms the data-driven FDA investigators used to find the scofflaws cited today.
Unfortunately for the FDA, manufacturers will simply change the product names—or even the brand names—and keep supplying retailers eager to sell the popular disposables that now dominate the convenience store vape market. But the FDA is largely ignoring brick-and-mortar stores, because enforcing against them requires too much time, money and effort.
Warning letter recipients are given 15 working days to reply, describing the corrective actions they’ve taken or disputing the agency’s allegations. Those who don’t comply with the warning may face additional FDA sanctions—although that almost never happens.