FDA WARNING_LETTER - Smoking Vibes LLC d/b/a Smoking Vibes - July 31, 2024

On July 31, 2024, the FDA issued a Warning Letter to Tomer Korit and Natan Atrakzhi, associated with thesmokingvibes.com, for offering unapproved electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA's Center for Tobacco Products reviewed the website and determined that "Geek Bar Pulse 15000 Puffs Disposable Vape – Fcuking Fab" and "Geek Bar Pulse 15000 Puffs Disposable Vape – Frozen Pina Colada" are new tobacco products lacking required premarket authorization.

Under sections 201(rr) and 901(b) of the FD&C Act, ENDS products are considered tobacco products subject to FDA jurisdiction. The legislation signed on March 15, 2022, expanded the definition of "tobacco product" to include products with nicotine from any source. Since these products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization under section 910(c)(1)(A)(i), they are deemed 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