FDA WARNING_LETTER - r. melton enterprises llc - February 08, 2024

The FDA issued a Warning Letter to R. Melton Enterprises LLC d/b/a North Georgia Vapor on February 8, 2024, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption. This classification includes products with nicotine from any source, as amended by the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Peach" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires the company to submit a written response within 15 working