FDA WARNING_LETTER - Samba Premium Tobacco, Inc. - January 07, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Sasha Josef Friwat and Samar Itani on December 20, 2019, following a review of their website, https://www.sambatobacco.com. The FDA determined that waterpipe tobacco products advertised and sold on the website are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation is the failure to include the required nicotine warning statement in the advertising for several waterpipe tobacco products, such as "Banana Daiquiri" and "Candy." Under 21 C.F.R. § 1143.3(b), advertising for covered tobacco products, including waterpipe tobacco, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded because they violate regulations prescribed under section 906(d) of the FD&C Act (21 C.F.R. Part 1143) and because the advertising is considered misleading by failing to reveal material facts about the product's consequences.

The letter mandates immediate corrective actions, including discontinuing violative labeling, advertising, sale, and distribution. The company must submit a written response within 15 working days detailing their corrective actions and compliance plan