Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sabagh-group-llc-dba-lighterusacom-573183-02262019
Timestamp: 2019-11-13 13:57:26
Document Index: 637267778

Matched Legal Cases: ['§ 1143', '§ 1143', '§ 1140', '§ 1100', '§ 1100', '§ 1100', '§ 387', 'art 1143', '§ 1143', '§ 1143', '§ 387', '§ 387', '§ 387', '§ 321', '§ 387', '§ 387']

The Sabagh Group LLC d/b/a LighterUSA.com - 573183 - 02/26/2019 | FDA
The Sabagh Group LLC d/b/a LighterUSA.com - 573183 - 02/26/2019
The Sabagh Group LLC d/b/a LighterUSA.com MARCS-CMS 573183 — February 26, 2019
For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution in the United States such product unless such tobacco product package bears the following required warning statement on the package label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical” (21 C.F.R. § 1143.3(a)). It also is unlawful for such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement (21 C.F.R. § 1143.3(b)). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to the FD&C Act under 21 C.F.R. § 1100.2, excluding components or parts not made or derived from tobacco. Before 21 C.F.R. § 1100.2 became effective, only cigarettes, smokeless tobacco, roll-your-own tobacco, and cigarette tobacco were subject to chapter IX of the FD&C Act. 21 C.F.R. § 1100.2 deems all other tobacco products, except accessories of such tobacco products, subject to chapter IX and its implementing regulations. The products cited in this violation are “covered tobacco products.” Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed in violation of regulations prescribed under section 906(d) of the FD&C Act, including those within 21 C.F.R. Part 1143. Because your website regarding e-liquid products does not include the required nicotine warning statement for these products, in violation of 21 C.F.R. § 1143.3(a) and/or 21 C.F.R. § 1143.3(b), your e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C.§ 387c(a)(7)(B)).
In addition, a tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular. A tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular. Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. Because your website regarding e-liquid products doesnot include the required nicotine warning statement for these products, your e-liquid products aremisbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) and/or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).