FDA WARNING_LETTER - Smooth Vapes, Inc. - February 26, 2021

On February 26, 2021, the FDA issued a Warning Letter to Angela Goodman of Smooth Vapes, located at 1406 S. Walton Blvd, Suite 15, Bentonville, AR 72712. The letter states that a review of the website http://smooth-vapes.com revealed the manufacture and sale of e-liquid products, specifically "Smooth Vapes Amaretto Sour" and "Smooth Vapes Almond Butter," to U.S. customers.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they are derived from tobacco, intended for human consumption, and were not commercially marketed in the U.S. as of February 15, 2007. The FDA determined that these products 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)) and are not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due