EFF Marketing LTD d/b/a Cigara – FDA Warning Letter, Jul 23, 2019

On July 12, 2019, the FDA issued a Warning Letter to Rahad Miah regarding the sale of e-liquid products on the website https://www.mycigara.com. The FDA determined that e-liquid products, specifically Candy King Belts Strawberry with NICNIC Nicotine Shot, are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified was the sale of these e-liquid products 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 to individuals under 18.

The letter requires immediate corrective action for this and similar violations 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. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention and refusal of admission. A written response detailing corrective actions and a plan for maintaining compliance is required within