Import Alert 98-06

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 98-06
Published Date: 05/28/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization"

Reason for Alert:

In June 2009, the Family Smoking Prevention and Tobacco Control Act provided FDA with authority to regulate tobacco products by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Deeming rule, which published in the Federal Register on May 10, 2016, and took effect on August 8, 2016, extended FDA's authority to deemed tobacco products such as electronic cigarettes, cigars, hookah tobacco, and pipe tobacco, as well as their components and parts, but not their accessories.

The Federal Food, Drug, and Cosmetic Act (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 the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).

Deemed products that meet the definition of a "new tobacco product" are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.

New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act, and 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 (21 U.S.C. 387e(j)).

Guidance:

Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP). CTP concurrence is required to add a product to the Red List.

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or sent via email to: Importalerts2@fda.hhs.gov

All requests for removal from DWPE will be forwarded by DIO to CTP for evaluation.

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to Office of Import Systems Management/Division of Systems Solutions/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.

Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.

Product Description:

New tobacco products that do not have the required FDA marketing authorization

Charge:

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act. [Adulteration, Section 902(6)(A)]

OASIS charge code - TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).[Misbranding, Section 903(a)(6)]

OASIS charge code - TP NO SE

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


UNITED STATES


Eonsmoke, LLC
Date Published : 05/28/2020
1500 Main Ave Ste 2 , Clifton, NJ 07011-2120 UNITED STATES
98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Peach Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Pineapple Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Blue v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Blue Raspberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Mango Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Pink Lemonade Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Green Apple Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Pomegranate Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Blueberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Mint Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Strawberry Banana Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Sour Gummy Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Blue Raspberry Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Cubano Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Black v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Cucumber Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: 4X Peach Madness Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: 4X Kiwi Strawberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Silver Shiny v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Citrus Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Purple v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Sweet Grape Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Peach Rings Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Kiwi Strawberry Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Red v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Rainbow Chrome v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Pink v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Kiwi Strawberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Green v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: 4X Blue Raspberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Strawberry Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Cubano Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Berry Gelato Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Watermelon Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Mango Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Fresh Mint Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: 4X Ripe Mango Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Gold v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Lush Ice Disposable
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: ST!K Lush Ice Disposable Device
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 01 E-Cigarette
Date Published: 05/28/2020

Desc: Eonsmoke Pod Device Gold Chrome v2.0
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 02 E-Cigarette, Kit
Date Published: 05/28/2020

Desc: Vape Blue Chrome (Color)
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 02 E-Cigarette, Kit
Date Published: 05/28/2020

Desc: I Vape Aqua Unicorn (Color)
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 02 E-Cigarette, Kit
Date Published: 05/28/2020

Desc: I Vape Purple Unicorn (Color)
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 02 E-Cigarette, Kit
Date Published: 05/28/2020

Desc: I Vape Red (Color)
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 L - - 02 E-Cigarette, Kit
Date Published: 05/28/2020

Desc: I Vape Black (Color)
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Blue Raspberry Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Cotton Candy Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Mint Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Watermelon Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Candy Apple/Apple Honey Dew Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Mango Pineapple Sorbet Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Gummy Bear Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Donut Cream Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Raspberry Ice Lemonade Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 01 E-Liquid
Date Published: 05/28/2020

Desc: Cereal Killer Salt Nicotine E-Liquid
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Empty Pod
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Menthol
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Kiwi Strawberry
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Cool Mint
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Caffe Late
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Raspberry Mint Lemonade
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Green Apple
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Grape
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Mango Pineapple Guava
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Pineapple
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Multipack
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Citrus
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Peach Madness
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Sour Gummy
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Mango
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Watermelon
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Tobacco
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Silky Strawberry
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Frost
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Multipack
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Grape
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Wrangler
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Sour Berry Belts
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Blueberry
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Blue Blackberry
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: 4X Blue Raspberry
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Lush Ice
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Lush Ice Pods Pack
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.

98 M - - 07 Ends Cartridge
Date Published: 05/28/2020

Desc: Eonsmoke Pods Pink Lemonade
Notes: The product in this listing is subject to DWPE when Eonsmoke LLC is declared as the Importer and/or Consignee.