FDA WARNING_LETTER - Sweis Global LLC - November 16, 2023

The FDA issued a Warning Letter to Sweis Global LLC on November 16, 2023, following a review of inspection records. The FDA determined that Sweis Global LLC manufactures and distributes hookah tobacco products, which are considered tobacco products under the FD&C Act. The letter highlights that certain tobacco products, including hookah tobacco, require premarket authorization to be legally marketed in the U.S., especially "new tobacco products" not commercially marketed as of February 15, 2007.

The primary violation identified is the marketing of "FML PURE TOBACCO 250 g (Green Label)" without the required marketing authorization order. This product is deemed a new tobacco product because it was not commercially marketed by the February 15, 2007, predicate date. Consequently, the product is cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The introduction or delivery of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) and 301(p) of the FD&C Act. Sweis Global LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales