FDA WARNING_LETTER - The Sabagh Group LLC d/b/a LighterUSA.com - March 04, 2019

The FDA issued a Warning Letter to The Sabagh Group LLC d/b/a Lighterusa.com following a review of their website, lighterusa.com, which offers e-liquid products for sale in the United States. The FDA determined these e-liquids are classified as "tobacco products" under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation identified is the consistent failure of the website's labeling and/or advertising for numerous e-liquid products to include the federally mandated nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission constitutes a violation of 21 C.F.R. § 1143.3(a) for packaging and/or 21 C.F.R. § 1143.3(b) for advertising. Consequently, the e-liquid products are deemed misbranded under multiple sections of the FD&C Act, specifically 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A). Misbranding under 903(a)(1) and 903(a)(7)(A) is attributed to the failure to reveal material facts concerning the product's use. The FDA requires immediate corrective action, including discontinuing the violative labeling, advertising, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and refusal of admission for imported products.