Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oakshire-trading-co-llc-564753-09212018
Timestamp: 2020-06-03 14:12:20
Document Index: 396480067

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

Oakshire Trading Co, LLC - 564753 - 09/21/2018 | FDA
Oakshire Trading Co, LLC - 564753 - 09/21/2018
Oakshire Trading Co, LLC MARCS-CMS 564753 — September 21, 2018
Samuel Benaim
Oakshire Trading Co, LLC
1561 N Gemini Place
Oakshire Trading Co., LLC
Attn: Samuel Benaim
sales@oaktradeco.com
michael@oaktradeco.com
Dear Samuel Benaim:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.oaktradeco.com and determined that the e-liquid 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 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 your Ben Jonson Snickelfritz e-liquid products are 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 https://www.oaktradeco.com revealed that you sold e-liquid products to a minor. Specifically, during our investigation of https://www.oaktradeco.com, a person younger than 18 years of age purchased Ben Jonson Snickelfritz e-liquid from your website. Additionally, you sent a complimentary Classified Keen e-liquid. 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 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 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)).
Please note your reference number, RW1800982, in your response and direct your response to the following address:
Oakshire Trading Co.
1661 N Raymond Ave, Ste 225
Anaheim, CA 92801-1186
Ben Jonson Juice, LLC
Igneous, LLC
richard@igneous.co
qnbpujsg8het@contactprivacy.email