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WARNING LETTER

Hookah Imports Inc MARCS-CMS 584666 — Aug 08, 2019

Hookah Imports Inc - 584666 - 08/08/2019


Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco

Recipient:
Recipient Name
Rawi M. Issa
Recipient Title
Chief Executive Officer
Hookah Imports Inc

2105 South Hardy Drive, Suite 9
Tempe, AZ 85282
United States

Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


VIA UPS and Electronic Mail

Reference #: ER1900025

 

AUG 8, 2019

 

Rawi M. Issa

Chief Executive Officer  

Hookah Imports, Inc.

2105 South Hardy Drive, Suite 9

Tempe, AZ  85282

cityhookah@gmail.com

hookahimports@hotmail.com    

info@rortobacco.com  

 

 

WARNING LETTER

 

Dear Mr. Issa:

 

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA, our inspection records, and your website, https://www.rortobacco.com, and determined that Hookah Imports, Inc. manufactures and distributes hookah tobacco products for commercial distribution in the United States, and that the hookah tobacco products are manufactured, advertised, 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 hookah tobacco products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

 

New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded

 

FDA has determined that you manufacture, sell, and distribute to customers in the United States the following ROR Tobacco hookah tobacco products without a marketing authorization order:

 

ROR Tobacco Blueberry Spice

ROR Tobacco Chai Latte

ROR Tobacco Cinnamon

ROR Tobacco Double Apple

ROR Tobacco Duo Maloney

ROR Tobacco Grape Mint

ROR Tobacco Gummint

ROR Tobacco Hedonism

ROR Tobacco Ice Blue Mint

ROR Tobacco Lemon Meringue

ROR Tobacco Lemon Mint

ROR Tobacco Mint Avalanche

ROR Tobacco Minty Choco Glacier ROR Tobacco Mintylicious ROR Tobacco Moonshine
ROR Tobacco Orange ROR Tobacco Orangina Fizz ROR Tobacco Pineapple
ROR Tobacco Raspberry Lemonade ROR Tobacco Ruby Red ROR Tobacco Sckittles Crush
ROR Tobacco Sexy Senorita ROR Tobacco Slush ROR Tobacco Strawberry
ROR Tobacco Toot ROR Tobacco Vanilla ROR Tobacco Watermelon
ROR Tobacco White Peach ROR Tobacco Yummy Gummy  


The FD&C Act generally requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)).  A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and you make the required submission under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)).  All deemed products that meet the definition of a “new tobacco product,” including hookah tobacco, are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.  

 

FDA has determined that the ROR Tobacco hookah tobacco products listed in the table above were not commercially marketed in the United States as of February 15, 2007.

 

The ROR Tobacco hookah tobacco products listed in the table above are required to have premarket review and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act.  Therefore, they are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)).  In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)).  The introduction into interstate commerce of any tobacco product that is adulterated or misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)).  Additionally, to the extent that a report was required under section 905(j) of the FD&C Act, the failure to provide such report is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. § 331(p)).

 

Tobacco Products Sold to Minors Are Misbranded

                                                                                                                                    

FDA’s investigation of the website https://www.rortobacco.com revealed that you sold hookah tobacco products to a minor.  Specifically, during FDA’s investigation of https://www.rortobacco.com, a person younger than 18 years of age purchased the following hookah tobacco products from your website: 

 

ROR Tobacco Blueberry Spice

ROR Tobacco Double Apple

ROR Tobacco Grape Mint

ROR Tobacco Hedonism

ROR Tobacco Ice Blue Mint

ROR Tobacco Lemon Mint

ROR Tobacco Strawberry

ROR Tobacco Toot

ROR Tobacco Watermelon

ROR Tobacco White Peach

 

 


No retailer may sell covered tobacco products, including e-liquid, cigar, pipe tobacco, waterpipe tobacco (also referred to as “hookah 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 the hookah tobacco products listed in the table above were sold or distributed to a person younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b), they are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

Hookah Tobacco Products with Labeling and/or Advertising that Fails to Include the Required Nicotine Warning Statement are Misbranded

 

FDA’s review of the website https://www.rortobacco.com revealed that the labeling and/or advertising for the following hookah tobacco products that you manufacture, package, import, distribute, or retail in the United States does not include the required nicotine warning statement:  

 

ROR Tobacco Blueberry Spice

ROR Tobacco Double Apple

ROR Tobacco Grape Mint

ROR Tobacco Hedonism

ROR Tobacco Ice Blue Mint

ROR Tobacco Lemon Mint

ROR Tobacco Strawberry

ROR Tobacco Toot

ROR Tobacco Watermelon

ROR Tobacco White Peach

 

 

 

Under 21 C.F.R. § 1143.3(b), advertising for cigarette tobacco, roll-your-own tobacco, and covered tobacco products (other than cigars), such as hookah tobacco products, must bear the following warning statement:

 

WARNING:  This product contains nicotine.  Nicotine is an addictive chemical.

 

For cigarette tobacco, roll-your-own tobacco, and covered tobacco products other than cigars, it is unlawful for a 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 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 hookah tobacco products does not include the required nicotine warning statement for the hookah tobacco products listed in the table above, in violation of 21 C.F.R. § 1143.3(b), your hookah tobacco products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

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 does not include the required nicotine warning statement for these hookah tobacco products, your hookah tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).

 

Hookah Tobacco Products with Labeling that Fails to Include the Required Nicotine Warning Statement in the Required Manner are Misbranded

 

In addition, FDA’s review of the labeling for the hookah tobacco products listed in the table above revealed that the labeling for these products that you manufacture, package, sell, offer to sell, distribute, or import for sale or distribution does not display the required nicotine warning statement, in the manner required by 21 C.F.R. § 1143.3(a). Specifically, the labeling for the hookah tobacco products listed in the table above does not display the required nicotine warning statement in a conspicuous and prominent place on the two principal display panels of the package and in a warning area that comprises at least 30 percent of each of the principal display panels.  (21 C.F.R. § 1143.3(a)).

 

As described above, 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 the labeling for these hookah tobacco products does not display the required nicotine warning statement for these products, in the manner required by 21 C.F.R. § 1143.3, in violation of 21 C.F.R. § 1143.3(a), your hookah tobacco products are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

 

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 your website, on any other websites (including e-commerce, social networking, or search engine websites), and in any other media in which you advertise 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 that 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 your tobacco products and your plan for maintaining compliance with the FD&C Act.  If you do not believe that your tobacco 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, ER1900025, in your response and direct your response to the following address:

 

DEM-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 Lillian Ortega at (240) 402-9041 or Lillian.Ortega@fda.hhs.gov.  

 

 

Sincerely,
/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products