The FDA has issued another 14 warning letters to online retailers who continue to market and sell unauthorized vape products to consumers in the United States. This brings the total number of warning letters issued to vape retailers to more than 550, many within the last six months.
A further 670 warning letters have already been issued to manufacturers, importers, and distributors for illegally selling or distributing unauthorized new tobacco products, including e-cigarettes.
The unauthorized vape brands identified in the letters include Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary. While not an exhaustive list of the violating devices, the FDA is always keen to take action against retailers of these brands in particular. As with almost all FDA announcements about this type of enforcement action, the federal agency points to the results of the 2023 National Youth Tobacco Survey that highlight the popularity of Elf Bar and Esco Bars among the youth of America.
The number of warning letters landing in retailers’ mailboxes has grown significantly over the past year. In just the last few months, the FDA has:
- Issued warning letters to three online retailers for selling unauthorized ZYN nicotine pouches. (April 4, 2024)
- Issued warning letters to 61 brick-and-mortar retailers for selling unauthorized e-cigarette products, including Elf Bar and Lava. (March 26, 2024)
- Issued warning letters to five online retailers for selling unauthorized e-cigarette products, including Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze, and Cali Bars. (Feb. 28, 2024)
- Issued warning letters to 14 online retailers for selling and marketing unauthorized disposable tobacco products, including Elf Bar/EB Design and Lava Plus e-cigarette products. (Feb. 1, 2024)
- Issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. (Dec. 20, 2023)
What Do Warning Letters Mean for Retailers?
Warning letters are generally the first action the FDA takes against retailers identified to be selling unauthorized e-cigarette products. The letters include details of the FD&C Act sections that pertain to the suspected violations, along with a list of products that do not have FDA marketing authorization orders.
The retailers then have 15 days to respond, in writing, to either provide evidence that refutes the violation or prove the offending products have been removed from sale. Failure to address the FD&C Act violations stated in these letters could lead to the FDA seeking Civil Money Penalties (CMPs) of $20,000 per retailer.
In some cases, continuing to violate the laws around the sale of unauthorized e-cigarettes can lead to more direct action, including seizure. Only one day before these warnings were issued, 45,000 illegal disposables worth $700,00 were seized from a distributor warehouse in California.
Which Online Retailers Have Been Warned?
As the FDA publicly publishes details of every warning letter sent to retailers, anyone can check which online vape stores are involved in this latest round of enforcement action. The 14 warned vape retailers include:
- Vape Star USA
- Vape4Less
- VapeNico
- HighFi Vape
- JuiceFly
- PuffSee
- Podlix Vape
- SmokCity
The action these retailers have taken or plan to take to correct the violations is currently unknown, and the FDA warning letter database states: “Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.”
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