FDA WARNING_LETTER - j-vapor llc - October 07, 2021

The FDA's Center for Tobacco Products reviewed northshorevapor.com and found that e-liquid products, specifically "Cereal Monster Frankn Berry 60mL" and "Icing on the Flake Strawberry 100mL," are manufactured and sold in the U.S. These products are deemed "tobacco products" under the FD&C Act (21 U.S.C. § 321(rr)) and are subject to FDA regulation (21 C.F.R. § 1100.1).

The key violation is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required 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)). Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required information under section 905(j) was not provided.

The firm is a registered manufacturer with over 4,300 products listed. A Premarket Tobacco Product Application (PMTA) (STN PM00012