FDA WARNING_LETTER - Green Leaf Foods

The FDA Center for Tobacco Products issued a Warning Letter to Ather Ahmed regarding the website http://www.greenleafecigs.com, which sells electronic nicotine delivery systems (ENDS) and e-liquid products. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA determined that several Green Leaf ENDS and e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act because they were sold to a person younger than 18 years of age. Specifically, an underage individual purchased Green Leaf Disposable Pina Colada, Green Leaf Double Apple Cartomizer, and Green Leaf Tutti Frutti E-Liquid from the website. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to individuals under 18.

The letter requires immediate correction of these violations and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinued sales and a plan for maintaining compliance, must be submitted within 15 working days.