FDA WARNING_LETTER - JP & SN Enterprises Inc. d/b/a eCigs International - May 18, 2021

On May 7, 2021, the FDA's Center for Tobacco Products issued a Warning Letter to John Poole regarding e-liquid products manufactured and sold via ecigsinternational.com. The FDA determined that "Zen Juice Icey Smurf Village" and "Zen Juice Smurfette" e-liquid products are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A). Additionally, they are misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 4,500 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, or injunction. The firm must submit a written response within 15 working days detailing corrective actions