Import Alert 98-01
(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 # 98-01
Published Date: 03/13/2023
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Flavored Cigarettes, Including Cigarette Component Parts, Cigarette Tobacco, Roll-Your-Own Tobacco and Roll-Your-Own Tobacco Component Parts
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 03/13/2023 updates the guidance section including agency contacts. Changes to the import alert are bracketed by asterisks (***).
In June 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) provided FDA with authority to regulate tobacco products by amending the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) (FFDCA or the Act) and recognizing FDA 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.
Effective September 22, 2009, cigarettes or any of its component parts, including cigarette tobacco, and roll-your-own tobacco or any of its component parts that contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol), herbs, or spices, that is a characterizing flavor of the tobacco product or tobacco smoke are adulterated per section 902(5) of the Act. Products that appear to be adulterated are subject to refusal of admission under section 801(a)(3) of the Act.
Specifically, section 907(a)(1)(A) of the Act provides a tobacco product standard special rule for cigarettes or any of its component parts that states in part:
"…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."
The ban on characterizing flavors applies to all tobacco products that meet the definition of a cigarette in section 900(3) of the Act even if they are not labeled as cigarettes or are labeled as cigars or as some other product.
In June 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) provided FDA with authority to regulate tobacco products by amending the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) (FFDCA or the Act) and recognizing FDA 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.
Effective September 22, 2009, cigarettes or any of its component parts, including cigarette tobacco, and roll-your-own tobacco or any of its component parts that contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol), herbs, or spices, that is a characterizing flavor of the tobacco product or tobacco smoke are adulterated per section 902(5) of the Act. Products that appear to be adulterated are subject to refusal of admission under section 801(a)(3) of the Act.
Specifically, section 907(a)(1)(A) of the Act provides a tobacco product standard special rule for cigarettes or any of its component parts that states in part:
"…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."
The ban on characterizing flavors applies to all tobacco products that meet the definition of a cigarette in section 900(3) of the Act even if they are not labeled as cigarettes or are labeled as cigars or as some other product.
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).
***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 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 firm has resolved the conditions that gave rise to the appearance of the violation. Specifically, that either the product does not contain a characterizing flavor (other than tobacco or menthol) or the product is not a cigarette or component part of a cigarette. Additionally, it should be shown the tobacco product is legally marketed in accordance with the FD&C Act. 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 related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
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***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 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 firm has resolved the conditions that gave rise to the appearance of the violation. Specifically, that either the product does not contain a characterizing flavor (other than tobacco or menthol) or the product is not a cigarette or component part of a cigarette. Additionally, it should be shown the tobacco product is legally marketed in accordance with the FD&C Act. 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 related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
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Product Description:
Cigarettes, including Cigarette Component Parts, Cigarette Tobacco, Roll-Your-Own Tobacco, and Roll-Your-Own Tobacco Component Parts
Charge:
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907(a)(1)(A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke. [Adulteration: Section 902(5) of the FD&C Act].
OASIS charge code: TP FLAVOR
OASIS charge code: TP FLAVOR