Vapezilla LLC – FDA Warning Letter, Dec 19, 2024

On December 18, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Ebrahim Talebi of Vapezilla.com, following a review of their website. The FDA determined that Vapezilla.com offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that 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 primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the products "Insta Puff Ronaldinho 10 15K Disposable Vape – Strawberry Kiwi" and "Chris Brown CB15K Disposable Vape – Cherry Lemon" were cited. These products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization or exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification.

Vapezilla.com is required to submit a written response within 15 working days, detailing actions taken to address the