FDA WARNING_LETTER - Tulumba Marketing

The FDA's Center for Tobacco Products reviewed the website http://www.tulumba.com and determined that it offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. The King Peach E-hookah ENDS product sold on the website is classified as a tobacco product under section 201(rr) of the FD&C Act.

The FDA found that the King Peach E-hookah ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including ENDS, to minors. The product is deemed a "covered tobacco product" under 21 C.F.R. § 1140.3.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act. 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. A written response detailing corrective actions, including dates of discontinued sales and a compliance plan, is required within 15 working days.