(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:
Substitution of another fat for the fat in cow's milk or any addition of a nitrogen source to cow's milk in milk-based products without reflecting this information on the label results in products that are not as they are presented and that are adulterated and misbranded.
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner or consignee of the affected goods should provide:
1. Results of a third-party laboratory analysis, of a representative sample of the lot, which verifies that the product does not contain a source of substitute milk fat or milk protein.
2. Documentation supplied in English which identifies ingredients in the product, to include product formulation and product labeling (for example; process or batch records from the manufacturer, and the actual product labeling or a facsimile of the product labeling).
Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's website for Private Laboratory Testing and FDA's ORA Lab Manual, volume III, section 7 https://www.fda.gov/media/73540/download.
Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***
***Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):
In order to add a firm's product to the Green List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. This can include written preventive controls, monitoring records, and if the condition is pre-existing, a root cause analysis identifying the source or potential sources of contamination. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).
Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third-party laboratory analysis of a representative sample of the lot verifying that products do not contain filth.
For further guidance on removal from detention without physical examination (DWPE), refer to FDA's 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, 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 science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at firstname.lastname@example.org
Questions or issues on human food policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov ***
OASIS charge code - FALSE
"The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be adulterated as defined in sections 402(b)(2) of the FD&CA. It appears that a substance has been substituted wholly or in part for one or more of the articles ingredients. [Adulteration, Section 402(b)(2)]."
OASIS charge code - SUBSTITUTE
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)