HTXW LLC d/b/a FOMO Culture – FDA Warning Letter, Jul 31, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Tanveer Sunesara, Parthkumar Patel, and Shehzad Hussain Agharia, associated with the website https://www.thefomoculture.com, on July 31, 2024. The letter states that the website offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, specifically "Geek Bar Pulse 15000 Puffs – Frozen Strawberry" and "Geek Bar Pulse 15000 Puffs – Fcuking Fab."

These products are considered "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source. The FDA determined that these ENDS products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905