FDA WARNING_LETTER - Texas Smoke Accessories/Luxury Lites - September 24, 2019

On September 24, 2019, the FDA issued a Warning Letter to Hasan Waqar regarding the website https://www.luxurylites.com, which advertises and sells electronic nicotine delivery systems (ENDS) and e-liquid products. The FDA determined these products are tobacco products under the FD&C Act.

The primary violation identified is that several ENDS and e-liquid products, including Luxury Lites Menthol E-Juice, Luxury Lites Paan Masala E-Juice, and SaltNic Disposable E-Cigarette – Juicy Mango, are misbranded. This misbranding occurs because their labeling and/or advertising on the website fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b).

Consequently, the products are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B), § 387c(a)(1), and/or § 387c(a)(7)(A)). The FDA considers the failure to reveal material facts, such as the addictive nature of