(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:
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)].
For an entry that is determined to contain a NDI, alone or as an ingredient, that appears on the Red List of this import alert but has been manufactured or offered for import by a firm other than that which is listed on the Red List of this import alert, divisions may forward a detention recommendation case to the Center for Food Safety and Applied Nutrition/Division of Enforcement/Dietary Supplements and Labeling Assessment Branch (CFSAN/DE/DSLAB). Based on the Center's evaluation, a case for addition to the Red List of this alert may be forwarded to DIO by the Division's Compliance Branch.***
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 forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO at 301-796-0356 or FDAImportsInquiry@fda.hhs.gov
***Questions or issues with regard to human food, including dietary supplements and dietary ingredients, on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Dietary Supplements and Labeling Assessment Branch at CFSANEnforcement@fda.hhs.gov
OASIS charge code: NDIDIETSP
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)