FDA WARNING_LETTER - JSST Enterprises LLC

The FDA's Center for Tobacco Products issued a Warning Letter to Thomas Albert Waller, operating Fog Minion, after reviewing the website http://www.fogminion.com. The review determined that e-liquid products, specifically "Fog Minion Bake Sale e-liquid," are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Fog Minion Bake Sale 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 retailers from selling covered tobacco products, including e-liquid, to individuals under 18.

The FDA requires immediate correction of this violation and similar issues, ensuring all tobacco products and related labeling/advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, is required within