FDA WARNING_LETTER - BloVape - January 29, 2021

The FDA issued a Warning Letter to Corey J. Stanbery regarding e-liquid products manufactured and sold via blovape.com. The FDA determined that products like "The Bakery" and "Melon Milk" are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These e-liquid products are subject to FDA jurisdiction (section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1) and require premarket authorization. The company failed to obtain the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or demonstrate substantial equivalence 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 corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.