Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-smoke-llc-533250-07282017
Timestamp: 2019-08-18 01:47:39
Document Index: 122570109

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

Royal Smoke LLC - 533250 - 07/28/2017 | FDA
Royal Smoke LLC - 533250 - 07/28/2017
Royal Smoke LLC MARCS-CMS 533250 — Jul 28, 2017
Royal Smoke LLC
Royal Smoke, LLC
Attn: Mohammad Tahir Javed
2710 South 11th Street
Beaumont, TX 77701-7601
info@royalsmoke.com
info@starcoimpex.com
jennifer@starcoimpex.com
Dear Mohammad Tahir Javed:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website http://www.royalsmoke.com and determined that the electronic nicotine delivery systems (ENDS) 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 (FD&C 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, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined thatyour Royal Smoke Cotton Candy E-Hookah and Royal Smoke Egyptian Gold E-Hookah ENDS 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 productsto persons younger than 18 years of age.
Sales to Minors Violations
FDA’s investigation of the website http://www.royalsmoke.com revealed that you sold ENDS products to minors. Specifically, during our investigation of http://www.royalsmoke.com, persons younger than 18 years of age purchased Royal Smoke Cotton Candy E-Hookah and Royal Smoke Egyptian Gold E-Hookah 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 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 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, RW1700742, in your response and direct your response to the following address:
3675 Roberts St.