Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/master-sales-llc-dba-nu-tobacco-580063-04262019
Timestamp: 2019-09-18 03:03:09
Document Index: 612111971

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

Master Sales LLC d/b/a NU Tobacco - 580063 - 04/26/2019 | FDA
Master Sales LLC d/b/a NU Tobacco - 580063 - 04/26/2019
Master Sales LLC d/b/a NU Tobacco MARCS-CMS 580063 — April 26, 2019
Master Sales LLC d/b/a NU Tobacco
16780 Oakmont Avenue
Attn: Raed Haidar
Dear Raed Haidar:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.nutobacco.com and determined that the waterpipe tobacco products listed there are manufactured 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 waterpipe tobacco, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that your NU California Dream waterpipe tobacco is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold this product to a person younger than 18 years of age. FDA has also determined that several waterpipe tobacco 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 waterpipe tobacco products fails to include the required nicotine warning statement for these waterpipe tobacco products.
FDA’s investigation of the website https://www.nutobacco.com revealed that you sold waterpipe tobacco products to a minor. Specifically, during our investigation of https://www.nutobacco.com, a person younger than 18 years of age purchased NU California Dream waterpipe tobacco from the website. Additionally, you sent a complimentary NU Pineapple waterpipe tobacco. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as electronic nicotine delivery system (ENDS) products that contain any tobacco derivative, to a person younger than 18 years of age under 21 C.F.R. § 1140.14(b). Under 21 C.F.R. § 1140.3, a “covered tobacco product” is defined as any tobacco product deemed to be subject to chapter IX of the FD&C Act by 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 product cited in this violation is a “covered tobacco product.” 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 1140. Because this product is sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), this product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Additionally, our review of the website, https://www.nutobacco.com, revealed that the labeling and/or advertising for several waterpipe tobacco products that you manufacture, advertise, and offer for sale or distribution in the United States do not include the required nicotine warning statement, for example: NU Blue Guava, NU Blue Orange, NU Blueberry, NU Blueberry Mint, NU California Dream, NU Coconut, NU Cool Lemon, NU Fresh Guava, NU Fruit Cocktail, and NU Grape. 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 waterpipe tobacco 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 waterpipe tobacco 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 waterpipe tobacco products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).
Please note your reference number, RW1901073, in your response and direct your response to the following address:
rahaidar@gmail.com