Import Alert 98-05
(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 # 98-05
Published Date: 12/01/2023
Type: DWPE
Import Alert Name:
"DETENTION WITHOUT PHYSICAL EXAMINATION OF REGULATED TOBACCO PRODUCTS FOR NON PAYMENT OF USER FEE"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 12/1/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***).
Section 919(a) of the FD&C Act requires FDA to, in accordance with section 919, "assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to" Chapter IX of the FD&C Act. Under section 902(4) of the FD&C Act, a tobacco product is deemed adulterated if the manufacturer or the importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee. A tobacco product that is, or appears to be, adulterated is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
Section 919(a) of the FD&C Act requires FDA to, in accordance with section 919, "assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to" Chapter IX of the FD&C Act. Under section 902(4) of the FD&C Act, a tobacco product is deemed adulterated if the manufacturer or the importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee. A tobacco product that is, or appears to be, adulterated is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
Guidance:
Divisions may detain without physical examination, tobacco products from importers who failed to pay a user fee as listed on the Red List of this Import Alert.
If Division offices encounter shipments of products identified on the Red List, the articles are subject to refusal of admission using the OASIS charge code TP USERFEE. Any recommendation to add a firm/product to DWPE will be evaluated by DIO and CTP.
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):***
If a firm would like to request removal from the Red List of this import alert, information should be provided to FDA demonstrating that the importer has paid or does not owe the user fee. The Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) will work with FDA's Office of Financial Management to determine the firm's current user fee status. OCE's Division of Enforcement and Manufacturing (DEM) should be contacted by ORA prior to importation of any regulated tobacco products by the subject firm to confirm the status of the importer's user fee account by emailing CTP-ComplianceImports@fda.hhs.gov whenever the subject firm contends that they should no longer be on the Red List of this Import Alert. ***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 via email to: Importalerts2@fda.hhs.gov
DIO will forward requests for removal to the Center for Tobacco Products Division of Enforcement and Manufacturing.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions related to tobacco products policy and any other additional questions may be directed to Center for Tobacco Products, Office of Compliance at CTP-complianceImports@fda.hhs.gov
*** ***
If Division offices encounter shipments of products identified on the Red List, the articles are subject to refusal of admission using the OASIS charge code TP USERFEE. Any recommendation to add a firm/product to DWPE will be evaluated by DIO and CTP.
***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):***
If a firm would like to request removal from the Red List of this import alert, information should be provided to FDA demonstrating that the importer has paid or does not owe the user fee. The Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) will work with FDA's Office of Financial Management to determine the firm's current user fee status. OCE's Division of Enforcement and Manufacturing (DEM) should be contacted by ORA prior to importation of any regulated tobacco products by the subject firm to confirm the status of the importer's user fee account by emailing CTP-ComplianceImports@fda.hhs.gov whenever the subject firm contends that they should no longer be on the Red List of this Import Alert. ***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 via email to: Importalerts2@fda.hhs.gov
DIO will forward requests for removal to the Center for Tobacco Products Division of Enforcement and Manufacturing.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions related to tobacco products policy and any other additional questions may be directed to Center for Tobacco Products, Office of Compliance at CTP-complianceImports@fda.hhs.gov
*** ***
Product Description:
Tobacco products subject to importer user fees.
Charge:
This article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that the tobacco product appears to be adulterated under Section 902(4) because the importer of the tobacco product failed to pay a user fee assessed to such importer pursuant to Section 919 by the date specified in Section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of the fee. [Adulteration, Section 902(4)]
OASIS Charge Code – TP USERFEE
OASIS Charge Code – TP USERFEE
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
UNITED STATES
A & T Tobacco Imports, Inc
Date Published : 08/25/2021
105/A Prairie Lake Road
, East Dundee,
IL 60118 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 08/25/2021
Desc: Tobacco Products
CALIFA IMPORTS INC
Date Published : 07/19/2023
3900 W Alameda Ave Fl 12
, Burbank,
CA 91505-4316 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 07/19/2023
Desc: Tobacco Products
Notes: Company has an additional location:
Califa Imports, Inc.
7533 4th Place
Downey, CA 90241 US
CALIFA IMPORTS INC
Date Published : 07/19/2023
5800 S Eastern Ave Ste 500
, Commerce,
CA 90040-4033 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 07/19/2023
Desc: Tobacco Products
Notes: Company has an additional location:
Califa Imports, Inc.
7533 4th Place
Downey, CA 90241 US
CANO TABACCO, INC
Date Published : 06/06/2019
7351 NW 7th St
, Miami,
FL 33126-2926 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 06/06/2019
Desc: Tobacco Products
CHICAGO INDUSTRIES GROUP, INC
Date Published : 08/25/2021
105 Prairie Lake Rd Ste A
, East Dundee,
IL 60118-9133 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 08/25/2021
Desc: Tobacco Products
DK DISTRIBUTORS INC
Date Published : 03/21/2020
2191 Ebenezer Rd , Ste #36877
, Rock Hill,
SC 29732-0148 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/21/2020
Desc: Tobacco Products
DK DISTRIBUTORS, INC.
Date Published : 03/21/2020
1404 E Las Olas Blvd # 2300
, Fort Lauderdale,
FL 33301-2336 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/21/2020
Desc: Tobacco Products
Dk Distributors, Inc.
Date Published : 11/04/2014
757 SE 17th St Ste 869
, Fort Lauderdale,
FL 33316-2960 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 11/04/2014
Desc: All tobacco products
FLORIDA IMPORT EXPORT SERVICES
Date Published : 11/26/2019
425 Ne 22nd St
, Miami,
FL 33137-5148 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 11/26/2019
Desc: All Tobacco Products
Gsm Services Llc
Date Published : 07/17/2023
7533 4th Pl
, Downey,
CA 90241-3225 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 07/17/2023
Desc: Tobacco Products
JAY SHREE HANUMAN (JSH) INC
Date Published : 03/14/2022
2615 Capital Cir NE
, Tallahassee,
FL 32308-4105 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/14/2022
Desc: All tobacco products
Jash International, Inc
Date Published : 08/25/2021
105 Prairie Lake Rd Ste A
, East Dundee,
IL 60118-9133 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 08/25/2021
Desc: Tobacco Products
LA TOBACCO CORP
Date Published : 06/06/2019
9722 NW 131st St
, Hialeah,
FL 33018-1857 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 06/06/2019
Desc: Tobacco Products
LA TOBACCO CORP
Date Published : 03/30/2020
1393 W 30th St
, Hialeah,
FL 33012-4853 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/30/2020
Desc: Tobacco Products
LPR TOBACCO IMPORTS INC
Date Published : 10/04/2019
10661 N Kendall Dr Suit
, Miami,
FL 33176-8709 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 10/04/2019
Desc: All Tobacco Products
LPR TOBACCO IMPORTS INC
Date Published : 03/26/2020
1551 N Powerline Rd
, Pompano Beach,
FL 33069-1620 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/26/2020
Desc: Tobacco Products
Lit Distributor, Inc.
Date Published : 11/04/2014
11652 Collins Creek Dr
, Jacksonville,
FL 32258-1108 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 11/04/2014
Desc: All tobacco products
RAO TOBACCO IMPORTS
Date Published : 10/03/2019
7885 NW 165th Ter
, Miami Lakes,
FL 33016-3485 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 10/03/2019
Desc: All Tobacco Products
RAO TOBACCO IMPORTS
Date Published : 03/21/2020
10401 SW 26th St
, Miami,
FL 33165-2540 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 03/21/2020
Desc: Tobacco Products
SOUTH FLORIDA IMPORT & EXPORT
Date Published : 04/18/2023
8001 Sw 26th St
, Miami,
FL 33155-2530 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 04/18/2023
Desc: Tobacco Products
SOUTH FLORIDA IMPORT & EXPORT CORP
Date Published : 04/18/2023
6765 Sw 39th St
, Miami,
FL 33155-3730 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 04/18/2023
Desc: Tobacco Products
SPECIALTY TOBACCO, INC
Date Published : 06/06/2019
18915 Castle Pl
, Cerritos,
CA 90703-8063 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 06/06/2019
Desc: Tobacco Products
Specialty Tobacco Inc
Date Published : 02/05/2020
14670 Firestone Blvd Ste 412
, La Mirada,
CA 90638-5922 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 02/05/2020
Desc: Tobacco Products
ZA IMPORTS, INC.
Date Published : 01/18/2022
11241 W Atlantic Blvd Apt F-103
, Coral Springs,
FL 33071-5145 UNITED STATES
98 - - - -- Tobacco Products
Date Published: 01/18/2022
Desc: Tobacco Products