Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nor-scot-trading-limited-587076-07172019
Timestamp: 2020-07-04 06:56:17
Document Index: 779460078

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

Nor-Scot Trading Limited - 587076 - 07/17/2019 | FDA
Nor-Scot Trading Limited - 587076 - 07/17/2019
Nor-Scot Trading Limited MARCS-CMS 587076 — July 17, 2019
Nor-Scot Trading Limited
info@nor-scot.com
Dear William Stewart:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.nor-scot.com and determined that the electronic nicotine delivery system (ENDS) products and e-liquid products listed there are advertised and offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including ENDS and e-liquids, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several ENDS and e-liquid products advertised and offered for sale or distribution on your website are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) and 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)) because your website regarding ENDS and e-liquid products fails to include the required nicotine warning statement for these ENDS and e-liquid products.
Our review of the website http://www.nor-scot.com revealed that the labeling and/or advertising for several ENDS and e-liquid products that you advertise and offer for sale or distribution in the United States does not include the required nicotine warning statement, for example: Nor-Scot (e-Cig) – Simplicity White, Nor Scot (e-Cigar) – Ignite, E Liquid 50ML – Red Bull, E Liquid 30ML – Chocolate, and E Liquid 10ML – Apple. Under 21 C.F.R. § 1143.3, labeling and advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as ENDS and e-liquid products, must bear the following warning statement:
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 ENDS and 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 ENDS and 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 ENDS and e-liquid products does not include the required nicotine warning statement for these products, your ENDS and e-liquid products are misbranded 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)).
Please note your reference number, RW1901136, in your response and direct your response to the following address: