FDA WARNING_LETTER - Jai Guruji LLC d/b/a Vape Marley - December 19, 2024

On December 18, 2024, the FDA issued a Warning Letter to Dhruv Goel regarding ENDS products sold on vapemarley.com. The FDA determined that products like "Apple Gummies – Tyson 2.0 HeavyWeight 7000 Disposables," "Blue Razz Tyson 2.0 HeavyWeight 7000 Disposables," and "Pink Bomb Funky Republic Ti7000 5% Nic Disposable Vape" are tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source as amended on March 15, 2022.

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 required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they 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 notice or information under section 905(j).

The FDA requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. Failure to comply may result in regulatory actions such as civil money penalties, seizure