Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-leaf-534410-07312017
Timestamp: 2019-09-23 00:56:40
Document Index: 239215825

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

Green Leaf - 534410 - 07/31/2017 | FDA
Green Leaf - 534410 - 07/31/2017
Green Leaf MARCS-CMS 534410 — July 31, 2017
Black Dragon Enterprises LLC
d/b/a Green Leaf
Attn:Ather Ahmed
2680 Chandler Avenue
sales@greenleafecigs.com
Dear Ather Ahmed:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website FD&C Act http://www.greenleafecigs.com and determined that the electronic nicotine delivery system (ENDS) and e-liquid products listed there are offered for sale or distribution to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act () (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (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 thatseveral of your ENDS and e-liquid productsare misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)) because you sold these products to a person younger than 18 years of age.
FDA’s investigation of the website http://www.greenleafecigs.com revealed that you sold ENDS and e-liquid productsto a minor. Specifically, during our investigation of http://www.greenleafecigs.com, a person younger than 18 years of age purchased Green Leaf Disposable Pina Colada, Green Leaf Double Apple Cartomizer, and Green Leaf Tutti Frutti E-Liquid from the website. No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco, and dissolvable tobacco products, as well as 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 productscited 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 1140. Because these products are sold or distributed to persons younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), these 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,RW1700746, in your response and direct your response to the following address: