Import Alert 98-01
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(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: 11/08/2012
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF FLAVORED CIGARETTES OR THEIR COMPONENT PARTS
Reason for Alert:
The Family Smoking Prevention and Tobacco Control Act provides FDA with authority to regulate tobacco products by recognizing FDA as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products.
Effective September 22, 2009, cigarettes 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 considered adulterated under the FD&C Act. Specifically, Section 907(a)(1)(A) of the FD&C Act provides a tobacco product standard special rule for cigarettes 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
Effective September 22, 2009, a cigarette or any of its component parts that fails to comply with the special rule established under Section 907 of the FD&C Act is deemed adulterated under Section 902 of the FD&C Act. A cigarette or any of its component parts that appears to be adulterated is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
Effective September 22, 2009, cigarettes 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 considered adulterated under the FD&C Act. Specifically, Section 907(a)(1)(A) of the FD&C Act provides a tobacco product standard special rule for cigarettes 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
Effective September 22, 2009, a cigarette or any of its component parts that fails to comply with the special rule established under Section 907 of the FD&C Act is deemed adulterated under Section 902 of the FD&C Act. A cigarette or any of its component parts that appears to be adulterated is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
Guidance:
Districts may detain, without physical examination, the cigarettes or their component parts identified on the Red List of this Import Alert.
Districts may also detain cigarettes that are described in the entry declarations or labeled as having a characterizing flavor (other than tobacco or menthol).
Districts should obtain concurrence from CTP before detaining component parts of cigarettes (e.g., the tobacco, filter, or paper) that are described in the entry declarations or labeled as having a characterizing flavor (other than tobacco or menthol). Submit labeling, photographs, and entry documents to Division of Import Operations (DIO).
Field offices should consult with DIO if they have questions regarding the application of Sections 907(a)(1)(A) or 902(5) of the FD&C Act to a particular product.
The Yellow List of this Import Alert is a listing of importers that have imported or offered for import one or more shipments of cigarettes or their component parts that have been refused admission pursuant to Section 801(a)(3) of the FD&C Act in that the product appeared to contain a prohibited flavor that caused it to appear to be adulterated within the meaning of Section 902(5) of the FD&C Act. Increased surveillance of cigarettes or their component parts imported by these firms is indicated.
In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide evidence to verify either:
1. The product does not contain a characterizing flavor (other than tobacco or menthol,); or
2. The product is not a cigarette or component part of a cigarette.
If the importer provides evidence to verify that the product does not contain a characterizing flavor, the product may appear to be misbranded (e.g., if its labeling is false and misleading because it makes the representation that the product contains a flavor as a characterizing flavor). For this reason, the field office should consult with Center for Tobacco Products if the importer provides such evidence.
If an importer wishes to request removal from the Yellow List of this Import Alert, information should be provided to FDA to adequately demonstrate that the importer is no longer importing or offering for import cigarettes or their component parts that appear to be adulterated within the meaning of Section 902(5).
Requests for removal from DWPE should be directed to FDA's Division of Import Operations at:
Food and Drug Administration
Division of Import Operations (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.
Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
REFERENCE:
http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/ucm183228.htm
Currently no tobacco products are subject to DWPE under this Import Alert
Districts may also detain cigarettes that are described in the entry declarations or labeled as having a characterizing flavor (other than tobacco or menthol).
Districts should obtain concurrence from CTP before detaining component parts of cigarettes (e.g., the tobacco, filter, or paper) that are described in the entry declarations or labeled as having a characterizing flavor (other than tobacco or menthol). Submit labeling, photographs, and entry documents to Division of Import Operations (DIO).
Field offices should consult with DIO if they have questions regarding the application of Sections 907(a)(1)(A) or 902(5) of the FD&C Act to a particular product.
The Yellow List of this Import Alert is a listing of importers that have imported or offered for import one or more shipments of cigarettes or their component parts that have been refused admission pursuant to Section 801(a)(3) of the FD&C Act in that the product appeared to contain a prohibited flavor that caused it to appear to be adulterated within the meaning of Section 902(5) of the FD&C Act. Increased surveillance of cigarettes or their component parts imported by these firms is indicated.
In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide evidence to verify either:
1. The product does not contain a characterizing flavor (other than tobacco or menthol,); or
2. The product is not a cigarette or component part of a cigarette.
If the importer provides evidence to verify that the product does not contain a characterizing flavor, the product may appear to be misbranded (e.g., if its labeling is false and misleading because it makes the representation that the product contains a flavor as a characterizing flavor). For this reason, the field office should consult with Center for Tobacco Products if the importer provides such evidence.
If an importer wishes to request removal from the Yellow List of this Import Alert, information should be provided to FDA to adequately demonstrate that the importer is no longer importing or offering for import cigarettes or their component parts that appear to be adulterated within the meaning of Section 902(5).
Requests for removal from DWPE should be directed to FDA's Division of Import Operations at:
Food and Drug Administration
Division of Import Operations (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-5992.
Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
REFERENCE:
http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/ucm183228.htm
Currently no tobacco products are subject to DWPE under this Import Alert
Product Description:
Cigarettes or any of their component parts
Charge:
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) 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 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
Pac Code: 98R800
OASIS CHARGE
CODE: TP FLAVOR
Pac Code: 98R800
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