FDA WARNING_LETTER - Inter-Continental Trading USA, Inc. d/b/a E-Luminate E-Cig LLC - August 20, 2019

On August 20, 2019, the FDA issued a Warning Letter to Shrujal Patel regarding the website https://www.eluminateecig.com, which offers electronic nicotine delivery systems (ENDS) and e-liquid products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA determined that several ENDS and e-liquid products advertised on the website are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act. The primary violation is the failure to include the required nicotine warning statement on the website's advertising for products such as E-Luminate Soft Tip Disposable E-Cigarette – Gold, E-Luminate Tutti Fruity E-Liquid, and others.

According to 21 C.F.R. § 1143.3(b), advertising for covered tobacco products must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." The absence of this statement renders the products misbranded. Additionally, the products are misbranded because the advertising is considered false or misleading due to the omission of material facts regarding the consequences of product use, as per sections 903(a)(1) and 9