Vapemoreinc.com, Inc. – FDA Warning Letter, Feb 28, 2024

The FDA issued a Warning Letter to Sunny Chawla regarding electronic nicotine delivery system (ENDS) products offered for sale on vapemoreinc.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The violation identified is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. Specific products cited include EBDesign (Formerly Elf Bar) Malibu Elf Bar BC5000, Funky Republic Fi3000 Disposable Vape – Tropical Delight, Hyde Edge RAVE Recharge 4000 Puffs – Peachy, Lost Mary MO5000 – Plum Rose Mint, and Lost Mary OS5000 Disposable 5% – Cherry Peach Lemonade. These products are deemed "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption.

Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification under section 905(j). The FDA requires a written response within 15