(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 Name:
Reason for Alert:
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the TCA, 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)).
Deemed products that meet the definition of a "new tobacco product" are subject to the premarket requirements in sections 910 and 905 of the FD&C Act.
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/or are misbranded under section 903(a)(6) of the FD&C Act because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. 387e(j)).
As used in this document, "ENDS" refers to electronic nicotine delivery systems that deliver aerosolized e-liquid when inhaled and includes components, and/or parts.
FDA has issued a Guidance for Industry (Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS)and Other Deemed Products on the Market Without Premarket Authorization) regarding how it intends to prioritize enforcement regarding the lack of premarket authorization for ENDS products.
Center concurrence is required prior to issuing a refusal under this Import Alert. Upon detention, Compliance Officers should create a CMS case in the MARCS CMS database and assign it to "CTP Division of Enforcement and Manufacturing." Submit the case to CTP/OCE as a "Center Review of Detained Shipment for Refusal."
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
If a firm would like to request removal of ENDS products from the Red List of this Import Alert, firms should provide information to FDA to adequately demonstrate that the ENDS product is not adulterated under section 902(6)(A) of the FD&C Act and/or misbranded under section 903(a)(6) of 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 information 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 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 via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at email@example.com.
Questions related to tobacco products may be directed to the Center for Tobacco Products, Office of Compliance at CTP-ComplianceImports@fda.hhs.gov.
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 FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that 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
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)