Cosco International, Inc. MARCS-CMS 609714 — August 26, 2020

WARNING LETTER

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• Delivery Method: VIA UPS and Electronic Mail
• Product: Tobacco

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• Recipient: Mr. Peter M. Hoffman; CEO; Cosco International, Inc.; 1633 Sands Place SE; Marietta, GA 30067; United States; peter@coscous.com

• Issuing Office: Center for Tobacco Products; United States

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WARNING LETTER

August 26, 2020

Dear Mr. Hoffman:

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed your submissions to the FDA and our inspection records, and determined that Cosco International, Inc. manufactures and distributes e-liquid products for commercial distribution in the United States, and that the e-liquid products 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)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including e-liquid products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)) and 21 C.F.R. § 1100.1.

Please be aware that, effective August 8, 2016, FDA deemed additional products meeting the definition of a tobacco product, except accessories to these newly deemed products, to be subject to regulation under the Act. These products include, but are not limited to, electronic nicotine delivery systems (including ecigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685.

New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded

The FD&C Act requires “new tobacco products” to have premarket authorization. A “new tobacco product” is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. § 387j(a)). Generally, 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) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. § 387e(j)) and 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) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. § 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. § 387e(j)(3)).

FDA has determined that you manufacture and distribute to customers in the United States the following eliquid products without a marketing authorization order: Infuze Salts Tan Lines - Baja Ice, Infuze Salts Basilisk - Iced Dragon Fruit, and Infuze Salts Labyrinth - Shortbread Cookie.

The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act. In addition, they are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act. 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 Without Required Ingredient Listing Submissions Are Misbranded

FDA has determined that you have not provided an ingredient listing to FDA as required by section 904(a)(1) of the FD&C Act (21 U.S.C. § 387d(a)(1)). Section 904(a)(1) requires each tobacco product manufacturer or importer, or agents thereof to provide “a listing of all ingredients, including tobacco, substances, compounds, and additives that are… added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and sub-brand.”

Because you have not provided FDA with an ingredient listing, FDA has determined that your products listed below, which Cosco International, Inc. manufactures and offers for sale and/or distribution to customers in the United States, are misbranded under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. § 387c(a)(10)(A)) because you failed to comply with requirements prescribed under section 904 of the FD&C Act (21 U.S.C. § 387d). The introduction into interstate commerce of any tobacco product that is misbranded is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). In addition, the failure to provide any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. § 331(q)(1)(B)).

 

#	NAME OF TOBACCO PRODUCT	#	NAME OF TOBACCO PRODUCT
1	Empyrean Cirrus	25	Infuze Rings of Saturn – Watermelon Slushie
2	Empyrean Cumulus	26	Infuze Ruby – Patriotic Popsicle
3	Empyrean Stratus	27	Infuze Smooth Monkey – Banana Nut Bread
4	House Blends Arctic Leaf – Cool Mint	28	Infuze Spectrum – Gummy Candy
5	House Blends Brew – Cappuccino Italiano	29	Infuze Stotch – Caramel Butterscotch
6	House Blends Frost – Fresh Menthol	30	Infuze Sublime – Fruit Twist
7	House Blends Heisenberg – Blue Energy Drink	31	Infuze Sublime Ice – Fruit Twist
8	House Blends Jam – Candied Grape	32	Infuze Tan Lines – Baja Ice
9	House Blends Juice Box – Strawberry Kiwi Splash	33	Infuze Veneto – Almond Macaroon
10	House Blends Steaming James – Coconut Hazelnut Tobacco	34	Infuze Salts Basilisk – Iced Dragon Fruit
11	House Blends Strawberry Fields – Full Bodied Strawberry	35	Infuze Salts Bohemian Raspberry – Blue Raspberry
12	House Blends Talladega – All American Tobacco	36	Infuze Salts Hollow – Vanilla Hazelnut
13	Infuze ATL – Strawberry Banana	37	Infuze Salts Labyrinth – Shortbread Cookie
14	Infuze Basilisk – Dragon Fruit Pomegranate	38	Infuze Salts Rings of Saturn – Iced Watermelon Slushie
15	Infuze Bohemian Raspberry – Blue Raspberry	39	Infuze Salts Serum – Berry Lemonade
16	Infuze Bohemian Raspberry Ice - Blue Raspberry	40	Infuze Salts Strawberry Fields – Strawberry Strange
17	Infuze Blue Widow – Blueberry Doughnut	41	Infuze Salts Sublime – Fruit Twist
18	Infuze Castaway – Tropical Fruit	42	Infuze Salts Tan Lines – Baja Ice
18	Infuze Elementary – Berry Crunch Cereal	43	Top Shelf Bliss
20	Infuze Forbidden Fruit – Fresh Apple	44	Top Shelf Hollow
21	Infuze Fuzz – Orange Peach	45	Top Shelf Labyrinth
22	Infuze Hooch – Watermelon Cactus	46	Top Shelf Nectar
23	Infuze Lava Shark – Frosted Island Drink	47	Top Shelf Rapture
24	Infuze Northern Lights – Candy Cane	48	Top Shelf Serum

Conclusion and Requested Actions

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones 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 comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to address any violations of the type described above may result in FDA’s taking regulatory action. These actions may include, but are not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute “written notice” for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that any adulterated and/or 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 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, ER2000063, 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