FDA WARNING_LETTER - Nor-Scot Trading Limited - July 23, 2019

On July 17, 2019, the FDA issued a Warning Letter to William Stewart of Nor-Scot, based on a review of their website, http://www.nor-scot.com. The FDA determined that Nor-Scot's electronic nicotine delivery system (ENDS) and e-liquid products, advertised and sold to U.S. customers, are misbranded tobacco products.

The primary violation cited is the failure to include the required nicotine warning statement on the labeling and/or advertising for several products, including "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." This violates 21 U.S.C. § 387c(a)(7)(B) and 21 C.F.R. § 1143.3(a) and/or (b), which mandate the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

Additionally, the absence of this material fact renders the products misbranded under 21 U.S.C. § 387c(a)(1) and/or § 387c(a)(7)(A) because their labeling and/or advertising is false