FDA WARNING_LETTER - Bowser Trading Corporation d/b/a High Seas E Liquid Trading Company - October 22, 2019

The FDA issued a Warning Letter to Shawn and James Bowser of High Seas E Liquid on July 12, 2019, following a review of their website, https://www.highseaseliquid.com. The FDA determined that their e-liquid products are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of iScream Maple Bacon Sundae e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors.

The letter requires immediate corrective action for this violation and similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinuation of violative sales and a plan for maintaining compliance, is required within 15 working days. The reference number for the response is RW1901126