Import Alert 98-02
(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 # 98-02
Published Date: 08/09/2023
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF REGULATED TOBACCO PRODUCTS WHOSE LABEL, LABELING, or ADVERTISING USES DESCRIPTORS OF LIGHT, MILD, or LOW
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 07/14/2021 updates the guidance, agency contacts, charge code language, and PAC. 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 recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products.
Effective July 22, 2010, tobacco product manufacturers, including importers of regulated tobacco products, may not introduce into domestic commerce any tobacco product for which the label, labeling, or advertising contains the descriptors light, mild, low or similar descriptors, irrespective of the date of manufacture, unless an FDA order is in effect under Section 911(g) of the FD&C Act with respect to such product (Section 911(b)(3) of the FD&C Act). Under Section 902(8) of the FD&C Act, a tobacco product shall be deemed to be adulterated if it is in violation of Section 911 of the FD&C Act.
In June 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) 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.
Effective July 22, 2010, tobacco product manufacturers, including importers of regulated tobacco products, may not introduce into domestic commerce any tobacco product for which the label, labeling, or advertising contains the descriptors light, mild, low or similar descriptors, irrespective of the date of manufacture, unless an FDA order is in effect under Section 911(g) of the FD&C Act with respect to such product (Section 911(b)(3) of the FD&C Act). Under Section 902(8) of the FD&C Act, a tobacco product shall be deemed to be adulterated if it is in violation of Section 911 of the FD&C Act.
Guidance:
Divisions may detain, without physical examination, the tobacco products identified on the Red List of this import alert.
Divisions may detain, without physical examination, smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that have or are described in the entry declarations as having label, labeling, or advertising containing the descriptors light, low, or mild unless an appropriate FDA order is in effect with respect to such product. Currently, there are no orders in effect for any products. The firms and products with an FDA order in effect will be listed in the Exception list of the import alert.
***Under the following circumstances submit labeling, photographs, and entry documents for detention concurrence to CTP for review:***
1.If Divisions encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that are sold or distributed for consumer use and that are declared or labeled with descriptors similar to light, mild, or low, or
2.If Divisions encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco components or parts that are sold or distributed for consumer use and that are declared or labeled with light, mild, low, or similar descriptors.
***Requests for reconditioning of regulated tobacco products detained under this Import Alert should be submitted to CTP for concurrence.***
***Recommendations for additions to the Red List of this Import Alert, should be forwarded to 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 a violation. 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 related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
Divisions may detain, without physical examination, smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that have or are described in the entry declarations as having label, labeling, or advertising containing the descriptors light, low, or mild unless an appropriate FDA order is in effect with respect to such product. Currently, there are no orders in effect for any products. The firms and products with an FDA order in effect will be listed in the Exception list of the import alert.
***Under the following circumstances submit labeling, photographs, and entry documents for detention concurrence to CTP for review:***
1.If Divisions encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco products that are sold or distributed for consumer use and that are declared or labeled with descriptors similar to light, mild, or low, or
2.If Divisions encounter imported smokeless tobacco, cigarettes, cigarette tobacco, or roll-your-own tobacco components or parts that are sold or distributed for consumer use and that are declared or labeled with light, mild, low, or similar descriptors.
***Requests for reconditioning of regulated tobacco products detained under this Import Alert should be submitted to CTP for concurrence.***
***Recommendations for additions to the Red List of this Import Alert, should be forwarded to 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 a violation. 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 related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
Product Description:
REGULATED TOBACCO PRODUCTS: CIGARETTES, CIGARETTE TOBACCO, ROLL-YOUR-OWN TOBACCO (RYO), SMOKELESS TOBACCO, TOBACCO PRODUCT COMPONENTS FOR CONSUMER USE
Charge:
***The 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 appears to be in violation of Section 911. [Adulteration: Section 902(8)]***
OASIS charge code: TP VIOL911
OASIS charge code: TP VIOL911