Import Alert 98-06

Import Alert # 98-06

Published Date: 01/03/2025

Type: DWPE

"Detention Without Physical Examination of New Tobacco Products, Other Than ENDS, Without Required Marketing Authorization"

Note: The revision of this Import Alert (IA) dated 12/20/2024 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.***

***Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP). Upon detention, divisions should follow OIO’s pre-established admissibility processes.

Note: Electronic nicotine delivery systems or ENDS products previously listed in this Red List are now subject to the 98-07 Import Alert.***

***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 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 information on removal from detention without physical examination, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and or it representative 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:

Importalerts2@fda.hhs.gov

All requests for removal from DWPE will be forwarded by OII/DIO to CTP for evaluation.

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.

                                                                                                                                                         

New tobacco products, ***other than ENDS,*** that do not have the required FDA marketing authorization.

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

Desc: NOIS Brand All smokeless tobacco and nicotine delivery products for consumer use

Desc: Velo smokeless tobacco and nicotine delivery products

Desc: "Lyft Cool Air" Nicotine Pouch products

Desc: Velo smokeless tobacco and nicotine delivery products

Desc: Velo smokeless tobacco and nicotine delivery products

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: Klint smokeless tobacco and nicotine delivery products

Notes:                                                                                                                                                                                                                          

Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE

Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE

Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE

Desc: SKRUF SUPERWHITE or SKRUF SUPER WHITE