FDA WARNING_LETTER - V3Beyond, Inc. d/b/a Beyond Vape - August 27, 2024

The FDA issued a Warning Letter to Kazutoshi Takimoto and Naritoshi Takimoto of Beyond Vape on August 16, 2024, after reviewing their website, beyondvape.com. The FDA determined that the company offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, specifically "EB Design TE6000 Disposable Vape 6000 Puffs – Kiwi Passionfruit Guava" and "EB Design TE6000 Disposable Vape 6000 Puffs – Pineapple Mango Orange," which are considered "new tobacco products."

These products are deemed 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 (21 U.S.C. § 387j(c)(1)(A)(i)). Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act