FDA WARNING_LETTER - MV Store, Inc. d/b/a myvaporstore - June 22, 2023

The FDA issued a Warning Letter to Heman Yu of MyVaporStore.com on June 7, 2023, for offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products without required marketing authorization. The FDA's review of MyVaporStore.com found ENDS products advertised as containing non-tobacco nicotine, which are considered "tobacco products" under the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

Specifically, the products "Elf Bar BC5000 Disposable Vape – Gumi," "Elf Bar BC5000 Disposable Vape – Honeydew Pineapple Orange," and "Elf Bar BC5000 Disposable Vape – Strawberry Pina Colada" are cited as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for compliance. Failure to comply