Import Alert 98-07
(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 # 98-07
Published Date: 01/06/2025
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Electronic Nicotine Delivery Systems (ENDS) Lacking Premarket Authorization"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 12/23/2024 updates the guidance section and agency contacts. Changes to the import alert are bracketed by asterisks (***).
***The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires premarket review for any "new tobacco product," which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).
New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act. FDA has not adopted a broad policy of enforcement discretion regarding ENDS that are being marketed without the required marketing authorization. For more information about advisory and enforcement actions for unauthorized ENDS products, please visit https://www.fda.gov/tobacco-products/compliance-enforcement-training/advisory-and-enforcement-actions-against-industry-unauthorized-tobacco-products.
As used in this document, "ENDS" refers to electronic nicotine delivery systems that deliver aerosolized e-liquid when inhaled and includes components and parts.***
***The Federal Food, Drug, and Cosmetic Act (FD&C Act) generally requires premarket review for any "new tobacco product," which means any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. 387j(a)). A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) FDA issues an order finding the product to be exempt from the requirements of substantial equivalence and the required submission is made under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)).
New tobacco products that do not have the required FDA marketing authorization are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act. FDA has not adopted a broad policy of enforcement discretion regarding ENDS that are being marketed without the required marketing authorization. For more information about advisory and enforcement actions for unauthorized ENDS products, please visit https://www.fda.gov/tobacco-products/compliance-enforcement-training/advisory-and-enforcement-actions-against-industry-unauthorized-tobacco-products.
As used in this document, "ENDS" refers to electronic nicotine delivery systems that deliver aerosolized e-liquid when inhaled and includes components and parts.***
Guidance:
***Divisions may detain without physical examination ENDS that do not have the required marketing authorization. Submit the case to CTP/OCE as a "Center Review of Detained Shipment for Refusal." ENDS products that have FDA marketing authorization are listed at both: https://www.accessdata.fda.gov/scripts/searchtobacco and https://digitalmedia.hhs.gov/tobacco/print_materials/CTP-250?locale=en.***
Questions or issues involving import operations should be addressed to ***OII/DIO*** (301) 796-0356 or Imports@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.
Questions or issues involving import operations should be addressed to ***OII/DIO*** (301) 796-0356 or Imports@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:
ENDS (electronic nicotine delivery systems that deliver aerosolized e-liquid when inhaled and includes components and parts).
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 appears to be adulterated under section 902(6)(A) of the FD&C Act in that it appears 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)]
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 appears to be misbranded under section 903(a)(6) of the FD&C Act in that it appears a notice or other information respecting it was not provided as required by section 905(j). [Misbranded, Section 903(a)(6)]
OASIS charge code: TP NO SE
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 appears to be misbranded under section 903(a)(6) of the FD&C Act in that it appears a notice or other information respecting it was not provided as required by section 905(j). [Misbranded, Section 903(a)(6)]
OASIS charge code: TP NO SE
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(98 - - - --) Tobacco Products