FDA WARNING_LETTER - Master Sales LLC d/b/a NU Tobacco - July 09, 2019

The FDA's Center for Tobacco Products reviewed Master Sales LLC d/b/a Nu Tobacco's website, nutobacco.com, and determined that their waterpipe tobacco products are subject to FDA jurisdiction. The company was issued a Warning Letter for two primary violations.

Firstly, Nu Tobacco's "NU California Dream" waterpipe tobacco was found to be misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). A complimentary "NU Pineapple" waterpipe tobacco was also sent to the minor.

Secondly, several waterpipe tobacco products advertised on the website, including "NU Blue Guava," "NU Blueberry," and "NU Grape," were deemed misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act. This is because their labeling and/or advertising failed to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3. The absence of this material fact also renders the products misbranded due to misleading labeling/advertising.

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