FDA WARNING_LETTER - E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar - March 01, 2022

On March 1, 2022, the FDA issued a Warning Letter to E-CIG USA INC dba Hutchinson Tobacco and Cigar, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that the company's e-liquid products, specifically "ECIG USA N.Y. Cheesecake 6mg/ml 15ml e-liquid," are tobacco products subject to FDA jurisdiction under the FD&C Act.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The "ECIG USA N.Y. Cheesecake" product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or 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 required notice or information was provided.

The FDA cited sections 301(k) and 301(p) of the FD&C Act for prohibited acts related to adulterated/misbranded products and failure to provide required reports. The company is a registered manufacturer with over 70 listed products. The FDA prioritizes enforcement against products without pending applications or those with Marketing Denial Orders.

The letter requires a written response within 15 working days detailing corrective actions,