IOC Marketing, LLC d/b/a eCig Source – FDA Warning Letter, Oct 13, 2023

The FDA issued a Warning Letter to IOC Marketing, LLC d/b/a eCig Source on October 12, 2023, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "KRAKEN eCig Source Signature Series 1.8% 30mL" and "KRAKEN eCig Source Signature Series 0.6% 30mL," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they 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 failure to provide required information under section 905(j).

The FDA states that marketing these products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is required to submit a written response within