FDA WARNING_LETTER - Mac Vapes LLC d/b/a Oishi Jusu - September 03, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Mac Vapes LLC d/b/a Oishi Jusu after reviewing their website, http://www.oishijusu.com, and determining that their e-liquid products are tobacco products subject to FDA jurisdiction. The primary violation identified was that "The Ronins" e-liquid product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This misbranding stems from the product's labeling failing to display the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," in the manner mandated by 21 C.F.R. § 1143.3. Specifically, the warning was not conspicuous, prominent, or did not occupy at least 30 percent of each of the principal display panels. The FDA requires immediate correction of this and similar violations to ensure compliance with the FD&C Act. Mac Vapes LLC must submit a written response within 15 working days detailing their corrective actions, including dates of discontinuing violative activities and their plan for sustained compliance. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.