Import Alert 54-18

Import Alert # 54-18

Published Date: 06/27/2025

Type: DWPE

DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN NEW DIETARY INGREDIENTS

Note: The revision of this Import Alert (IA) dated 09/08/2023 updates the guidance section including the contact information and PAC. Changes to the import alert are bracketed by asterisks (***).

This Import Alert (IA) has been developed for bulk dietary ingredients and dietary supplements that have been imported or offered for import into the United States that are or contain ingredients that FDA has determined to be adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(f)(1)(B)].

A "new dietary ingredient" (NDI) is defined as a dietary ingredient that was not marketed in the United States before October 15, 1994, (Section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Under section 402(f)(1)(B) of the FD&C Act [21 U.S.C. § 342(f)(1)(B)], a food shall be deemed to be adulterated if it is a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Based on FDA's review of the available information, the products listed in the Red List of this import alert are or contain one or more new dietary ingredients for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Therefore, the new dietary ingredients and dietary supplements labeled to contain the new dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)].

"Divisions may detain, without physical examination, the identified products from the firms on the Red List of this Import Alert."

*** The evidence to support recommendations for addition to the Red List of this Import Alert ( this can include an NDI alone or as an ingredient that appears on the Red List of this alert that is offered for import by a firm other than that which is listed on the Red List of this alert) will be evaluated by Human Foods Program (HFP) on a case-by-case basis. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO). ***

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

***In order to secure the release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence that the product is not or does not contain a new dietary ingredient, or all relevant information to demonstrate the safety of the new dietary ingredient such as a new dietary ingredient notification. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention.***

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

To remove a firm's product from the Red List, information should be provided to the Agency to demonstrate that the firm has resolved the conditions that gave rise to the appearance of the 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 information 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 DWPE under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov."

Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to OII/DIO at (301) 796-0356 or Imports@fda.hhs.gov.

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                          ***

New Dietary Ingredients

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. [Adulteration, Section 402(f)(1)(B)]

OASIS charge code: NDIDIETSP

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Desc: HIGENAMINE

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Desc: Sakae NAA