Import Alert 98-04

(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 # 98-04
Published Date: 02/13/2023
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Certain Regulated Tobacco Products Found to be Not Substantially Equivalent

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 02/13/2023 updates the reason for alert, guidance section including agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***).

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 tobacco products.

According to the FD&C Act, a new tobacco product is any product that was not commercially marketed in the United States as of February 15, 2007. This includes tobacco products that were modified and sold or distributed after February 15, 2007. To legally market a new FDA-regulated tobacco product in the United States, generally FDA must first issue a written order permitting the sale of a new tobacco product under one of three pathways: a substantial equivalence report, an exemption from substantial equivalence request or a premarket tobacco application.

Under the substantial equivalence pathway, a new tobacco product may continue to be sold or distributed if:

1) the tobacco product was sold or distributed after February 15, 2007 but before March 22, 2011; and
2) a Substantial Equivalence (SE) Report was submitted by March 22, 2011,

unless FDA issues an order that the new product is "not substantially equivalent" (NSE) to the predicate product that the applicant identified in their submission.

FDA has issued NSE orders for tobacco products sold or distributed in the US, and in some instances being imported into US commerce. Immediately upon issuance of the NSE order, those tobacco products become misbranded under section 903(a)(6) and adulterated under section 902(6)(A)of the FD&C Act and are subject to refusal of admission.

FDA has posted a list of Misbranded and Adulterated Tobacco Products due to "Not Substantially Equivalent" (NSE) Order at *** https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/marketed-tobacco-products-receive-nse ***

Guidance:

***Divisions may detain without physical examination tobacco products found to be not substantially equivalent as listed on the Red List of this Import Alert.

If divisions encounter shipments of products identified on the Red List, the articles are subject to refusal of admission, using OASIS charge codes TP NO PMTA and TP NO SE.

Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). DIO will coordinate with the Center for Tobacco Products (CTP) for concurrence.

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 demonstrate that the tobacco product is legally marketed in accordance with the FD&C Act. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for 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, be 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 related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.

                                                                                                                                                               

REFERENCE:

Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products | FDA
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions | FDA
Market and Distribute a Tobacco Product | FDA
Section 905 of the Federal Food, Drug, and Cosmetic Act - Annual Registration | FDA ***

Product Description:

***Tobacco Products Found to be Not Substantially Equivalent. See Red List.***

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) FD&C Act]

OASIS Charge Code: TP NO PMTA

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 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) FD&C Act]

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)


INDIA


C.H. Graphics
Date Published : 02/21/2014
71 Satkar Society No 2jyoti Park Society , Gujarat, INDIA
98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Red Cone
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Menthol Cone
Notes: ***The listed cigarette product is considered to be not substantially equivalent. Product Code Builder Description(s); 98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Red
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Menthol
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***


PHILIPPINES


Pacific Stanford Manufacturing Corporation
Date Published : 10/07/2015
# 2 Villa Carmen Subdivision , Pampanga, PHILIPPINES
98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/07/2015

Desc: North Cigarettes
Notes: ***The listed cigarette product, including all sub-brands, is considered to be not substantially equivalent. Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

98 B B A 01 Cigarettes, Flavored (Menthol), For Consumer Use
Date Published: 11/18/2015

Desc: North Cigarettes
Notes: ***The listed cigarette product; including all sub-brands; is considered to be not substantially equivalent.Product Code Builder Description(s); 98BAA01-Cigarettes; Unflavored; For Consumer Use; Cigarettes98BBA01- Cigarettes; Flavored (Menthol); For Consumer Use; Cigarettes98BCA01- Cigarettes; Flavored (Other); For Consumer Use; Cigarettes***

98 B C A 01 Cigarettes, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: North Cigarettes
Notes: ***The listed cigarette product; including all sub-brands; is considered to be not substantially equivalent. Product Code Builder Description(s); 98BAA01-Cigarettes; Unflavored; For Consumer Use; Cigarettes 98BBA01- Cigarettes; Flavored (Menthol); For Consumer Use; Cigarettes 98BCA01- Cigarettes; Flavored (Other); For Consumer Use; Cigarettes***


UNITED STATES


Eagle River Importers Inc
Date Published : 10/07/2015
8161 Ardrey Kell Rd , Suite 102 , Charlotte, NC 28277-5717 UNITED STATES
98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/07/2015

Desc: North Cigarettes
Notes: The listed cigarette product, including all sub-brands, is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01- Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

98 B B A 01 Cigarettes, Flavored (Menthol), For Consumer Use
Date Published: 10/28/2015

Desc: North Cigarettes
Notes: The listed cigarette product, including all sub-brands, is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01- Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

98 B C A 01 Cigarettes, Flavored (Other), For Consumer Use
Date Published: 10/28/2015

Desc: North Cigarettes
Notes: The listed cigarette product, including all sub-brands, is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01- Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

Jash International, Inc
Date Published : 02/21/2014
105 Prairie Lake Rd Ste A , East Dundee, IL 60118-9133 UNITED STATES
98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Red Cone
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Menthol
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Menthol Cone
Notes: ***The listed cigarette product is considered to be not substantially equivalent. Product Code Builder Description(s); 98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

98 B C A 09 Kreteks, Flavored (Other), For Consumer Use
Date Published: 11/18/2015

Desc: Sutra Bidis Red
Notes: ***The listed cigarette product is considered to be not substantially equivalent.Product Code Builder Description(s);98BCA09- Cigarettes; Flavored (Other); For Consumer Use; Bidis; Thin***

Lit Distributor, Inc.
Date Published : 10/07/2015
11652 Collins Creek Dr , Jacksonville, FL 32258-1108 UNITED STATES
98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Dark Green 100's Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Light Blue 100's Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Light Green 100's Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Light Green King Size Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Dark Green King Size Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Blue 100's Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Red 100's Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Red King Size Box
Notes: The listed cigarette product is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Blue King Size Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B A A 01 Cigarettes, Unflavored, For Consumer Use
Date Published: 10/15/2015

Desc: New Light Blue King Size Box
Notes: The listed cigarette products are considered to be not substantially equivalent. ***Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes***

98 B B A 01 Cigarettes, Flavored (Menthol), For Consumer Use
Date Published: 10/15/2015

Desc: New Red King Size Box
Notes: The listed cigarette product is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***

98 B C A 01 Cigarettes, Flavored (Other), For Consumer Use
Date Published: 10/15/2015

Desc: New Red King Size Box
Notes: The listed cigarette product is considered to be not substantially equivalent. *** Product Code Builder Description(s): 98BAA01-Cigarettes, Unflavored, For Consumer Use, Cigarettes 98BBA01- Cigarettes, Flavored (Menthol), For Consumer Use, Cigarettes 98BCA01- Cigarettes, Flavored (Other), For Consumer Use, Cigarettes***