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  5. ARDT Sales, LLC d/b/a Zenith E-Juice - 580345 - 05/17/2019
  1. Warning Letters

WARNING LETTER

ARDT Sales, LLC d/b/a Zenith E-Juice MARCS-CMS 580345 —

Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901087
Product:
Tobacco
Recipient:
Recipient Name
Arlind Rexha
ARDT Sales, LLC d/b/a Zenith E-Juice

165 Locust Avenue
Staten Island, NY 10306
United States

arlind@zenithejuice.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Arlind Rexha:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://zenithejuice.com and determined that the e-liquid and smokeless 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 (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 and smokeless 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 the Orion on Ice e-liquid 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 a smokeless tobacco product, Zenith Chewing Tobacco Orion (Raspberry Lemonade), is misbranded under 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 smokeless tobacco products fails to include any health warning label statements for smokeless tobacco products.   

Sales to Minors Violation

FDA’s investigation of the website https://zenithejuice.com revealed that you sold an e-liquid product to a minor.  Specifically, during our investigation of https://zenithejuice.com, a person younger than 18 years of age purchased Orion on Ice e-liquid from your website.  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)).

Health Warning Statement Violation

Additionally, our review of the website https://zenithejuice.com also revealed that the following smokeless tobacco product that you offer for sale or distribution in the United States does not include the required health warning statements for smokeless tobacco products: Zenith Chewing Tobacco Orion (Raspberry Lemonade).  Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act) (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act, requires that advertisements for smokeless tobacco products bear one of the following health warning label statements:

     WARNING: This product can cause mouth cancer.
     WARNING: This product can cause gum disease and tooth loss.
     WARNING: This product is not a safe alternative to cigarettes.
     WARNING: Smokeless tobacco is addictive.

A tobacco product is misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) if its labeling is false or misleading in any particular.  In addition, a tobacco product is misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular.  Under section 201(n) of the FD&C Act (21 U.S.C. § 321(n)), in determining whether labeling and/or advertising is misleading, the agency considers, among other things, the failure to reveal material facts concerning the consequences that may result from the customary or usual use of the product. 

Because your website regarding smokeless tobacco products does not include the required health warning statements for smokeless tobacco products, your smokeless tobacco product is misbranded under 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)).

In addition, we note that you are required to follow all other applicable federal laws and regulations.  For example, section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402) requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco.  Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.

Conclusion and Requested Actions

The violations discussed in this letter do not necessarily constitute an exhaustive list.  You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. 

It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA’s implementing regulations.  Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.  Please note any adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.  You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

Please note your reference number, RW1901087, in your response and direct your response to the following address:

DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.   


Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement
Center for Tobacco Products


VIA UPS and Electronic Mail

cc:

ARDT Sales, LLC d/b/a Zenith E-Juice
Attn: Arlind Rexha
8314 5th Avenue
Brooklyn, NY  11209

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