Import Alert 98-03
(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 # 98-03
Published Date: 11/02/2023
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF SMOKELESS TOBACCO PRODUCTS WITHOUT REQUIRED WARNING LABEL
Reason for Alert:
NOTE: The revision of this Import Alert, dated 03/09/2023, updates the guidance section on addition to and removal from DWPE (red list), the product description section, current Agency contact information, charge section, and PAF/ PAC codes. Changes are bracketed by asterisks (***).
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.
As of July 22, 2010 manufacturers cannot distribute any smokeless tobacco product unless its packaging complies with the warning requirements in accordance with the Food Drug and Cosmetic Act (FD&C Act) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 USC 4402.
Under section 3 of CSTHEA, the package of a smokeless tobacco product for sale or distribution in the United States must bear one of the following warning labels:
"WARNING: This product can cause mouth cancer."
'"WARNING: This product can cause gum disease and tooth loss."
"WARNING: This product is not a safe alternative to cigarettes"
"WARNING: Smokeless tobacco is addictive."
Under 903(a)(8)(B)(i) of the FD& C Act, a tobacco product distributed or offered for sale in any state is misbranded unless the manufacturer, packer or distributor includes on the package label a brief statement of the relevant warnings. A misbranded tobacco product is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
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.
As of July 22, 2010 manufacturers cannot distribute any smokeless tobacco product unless its packaging complies with the warning requirements in accordance with the Food Drug and Cosmetic Act (FD&C Act) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), 15 USC 4402.
Under section 3 of CSTHEA, the package of a smokeless tobacco product for sale or distribution in the United States must bear one of the following warning labels:
"WARNING: This product can cause mouth cancer."
'"WARNING: This product can cause gum disease and tooth loss."
"WARNING: This product is not a safe alternative to cigarettes"
"WARNING: Smokeless tobacco is addictive."
Under 903(a)(8)(B)(i) of the FD& C Act, a tobacco product distributed or offered for sale in any state is misbranded unless the manufacturer, packer or distributor includes on the package label a brief statement of the relevant warnings. A misbranded tobacco product is subject to refusal of admission under Section 801(a)(3) of the FD&C Act.
Guidance:
***Divisions may detain, without physical examination, smokeless tobacco products identified on the Red List of this Import Alert.
If the product does not meet the definition of smokeless tobacco, then this import alert does not apply. If it is unclear from the labeling and other documents whether the product is a smokeless tobacco product, consult with the Division of Import Operations (DIO) for guidance.
REFERENCE:
https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements
Recommendations for additions to the Red List of this Import Alert, should be forwarded to DIO. DIO will coordinate with the Center for Tobacco Products (CTP) for concurrence.
Requests for reconditioning of regulated smokeless tobacco products detained under this Import Alert should be submitted to 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 that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. 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.
***
If the product does not meet the definition of smokeless tobacco, then this import alert does not apply. If it is unclear from the labeling and other documents whether the product is a smokeless tobacco product, consult with the Division of Import Operations (DIO) for guidance.
REFERENCE:
https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements
Recommendations for additions to the Red List of this Import Alert, should be forwarded to DIO. DIO will coordinate with the Center for Tobacco Products (CTP) for concurrence.
Requests for reconditioning of regulated smokeless tobacco products detained under this Import Alert should be submitted to 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 that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. 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.
***
Product Description:
***Smokeless tobacco products. The industry code and product class for smokeless tobacco products is 98C.***
Charge:
***This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e. one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act.) [Misbranding, Section 903(a)(8)(B)(i)]
OASIS charge code: TPNOWRNLBL***
OASIS charge code: TPNOWRNLBL***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
PORTUGAL
Fabrica Tabaco Estrela
Date Published : 10/09/2015
Apartado 166
, Ponta Delgada,
Ilha de Sao Miguel PORTUGAL
98 C C A 04 Snuff, Dry, Flavored (Other), For Consumer Use
Date Published: 10/09/2015
Desc: Snuff
Notes: Problem(s);
Product label does not bear any smokeless tobacco warning statements