FDA WARNING_LETTER - Midnight Vapors Corp. - February 01, 2024

On January 31, 2024, the FDA issued a Warning Letter to Daniel Hernandez and Francisco Nicanor of Midnight Vapors, following a review of their website, https://www.midnightvapors.com. The FDA determined that the company is offering for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that are considered "new tobacco products" and lack the required premarket authorization.

Specifically, the FDA identified the following products being sold without authorization: Elf Bar Ultra Disposable 5000 Puffs - Tropical Rainbow Blast, Funky Republic Disposable 7000 Puffs Ti7000 – Mango Kiss, and Lost Mary MO5000 Disposable 5000 Puffs – Ginger Beer. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order or exemption.

Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the lack of required premarket notification.