Import Alert 09-01

Import Alert # 09-01

Published Date: 02/04/2022

Type: DWPE

Detention Without Physical Examination of Milk-Based Products That Are Adulterated or Misbranded Due to Substitution

A study of fluid milk conducted by the Food Safety and Standards Authority of India suggests that some milk-based products, imported from India, may have alternative fat and nitrogen sources substituted for a portion of the cow's milk ingredient in the food. FDA analyses conducted on shipments of ghee and butter from two different manufacturers in India during July, 2012 found that the products had a substitute fat source not derived from cow's milk.

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.

Districts may detain, without physical examination, the specified products from the firms identified on the Red List of this alert.

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.

AND

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 oraorsprivatelabimportalerts@fda.hhs.gov

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 ***

See Red List

"The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be misbranded as defined in sections 403(a)(1) of the FD&CA. The articles labeling appears to be false and misleading in any particular. [Misbranding, Section 403(a)(1)]."
OASIS charge code - FALSE

AND

"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

Desc: Amul Pure Ghee