J.A.V.S Corp d/b/a Buitrago Cigars d/b/a Buitrago Vape Shop – FDA Warning Letter, Feb 1, 2024

On January 31, 2024, the FDA issued a Warning Letter to Martin Buitrago, Juan A Castillo Ventura, and Maximillian Lovera, regarding electronic nicotine delivery system (ENDS) products sold on buitragovapeshop.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

The letter states that "new tobacco products" require premarket authorization. The FDA found that Lost Mary Mo5000 Disposables Vapes Pineapple Apple Pear, Funky Republic Fi3000 Vape Disposables 5% 3000 Puffs Strawberry Peach Sakura, and Lava Plus Vape Disposables 5% 2000 Puffs Cherry Banana were offered for sale without the required marketing authorization. These products are considered "new tobacco products" as 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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil