(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:
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 recommendation for detention to CFSAN/OC/DE/DSLAB. Based on the Center's evaluation, a CMS 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 release of an individual shipment detained pursuant to this Import Alert, all relevant information supporting the request for release should be submitted to the appropriate FDA Division compliance office.
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 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 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 involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at email@example.com
Questions on policy, sample collection recommendations, or any other additional questions, 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)