FDA WARNING_LETTER - Vapors of Ohio Inc d/b/a Nostalgic Vapes - December 08, 2022

On December 8, 2022, the FDA issued a Warning Letter to Vapors of Ohio Inc d/b/a Nostalgic Vapes for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that the "FLVR SHOP E-LIQUID GLZD-DNT 6mg 120ml" e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under section 201(rr) of the FD&C Act, e-liquid products are considered tobacco products subject to FDA jurisdiction. The company failed to obtain a premarket authorization order under section 910(c)(1)(A)(i) or demonstrate an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties