FDA WARNING_LETTER - CMM Capital, LLC d/b/a ETX Vape - January 15, 2021

On January 15, 2021, the FDA issued a Warning Letter to Clayton Musselman regarding e-liquid products manufactured and sold via etxvape.com. The FDA determined that products like "Mango Tango by Elite eJuice" and "RazzMelon by Elite eJuice" 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 products are subject to FDA jurisdiction (21 U.S.C. § 387a(b) and 21 C.F.R. § 1100.1) and require premarket authorization. The identified e-liquids lack the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and are not exempt. Consequently, these products are deemed 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).

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