"Detention Without Physical Examination of Cheese Due to Microbiological Contamination"

Reason for Alert

NOTE: The revision of this Import Alert (IA), dated 05/29/2026, updates the alert to reflect changes pertaining to Staphylococcus aureus violations enforced under Import Alert #99-43. This includes changes to the Reason For Alert, Guidance, Agency Contacts, Product Description and Charge sections. Changes are bracketed by asterisks (***). ***Since the implementation of this import alert in 1996, the Agency continues to sample and analyze imported cheese for microbiological contamination of Salmonella, Listeria monocytogenes (L. monocytogenes), enterotoxigenic Escherichia coli (E. coli), enterohemorrhagic E. coli and/or staphylococcal enterotoxin. NOTE: This import alert does not apply to soft and soft ripened cheese from France found to contain Listeria monocytogenes (L. monocytogenes), which are covered under IA #12-03, "Detention Without Physical Examination of Imported Soft Cheese and Soft Ripened Cheese from France." It also does not apply to imported cheeses found to contain Staphylococcus aureus, which are covered under IA #99-43,"Detention Without Physical Examination of Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions."***

Product Description

***All cheese and cheese products (See exceptions in the Reason for Alert.)***

Charge

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]. Contains: OASIS CHARGE CODE(s): POISONOUS ***

Guidance

***Divisions may detain without physical examination, the specified cheese and cheese product(s) from the firms identified on the Red List of this alert. The Red List of this alert includes cheese and cheese product(s) found to be violative due to the presence of Salmonella, Listeria monocytogenes (L. monocytogenes), enterotoxigenic Escherichia coli (E. coli), enterohemorrhagic E. coli and/or staphylococcal enterotoxin. When cheese and cheese products are found positive for enterotoxigenic Escherichia coli (E. coli) and/or enterohemorrhagic E. coli, recommendations for addition to the Red List of this IA may be submitted to the Division of Import Operations (DIO). The evidence to support recommendations for addition to the Red List of this IA will be evaluated by the Human Foods Program (HFP) on a case-by-case basis.*** ***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: In order to secure release of an individual shipment subject to DWPE under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain microbiological contamination. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. Beginning December 02,2025 for analyte group Listeria, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical 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 (REMOVE FROM RED LIST): To remove a firm�s product from the Red List, the firm should provide information that adequately demonstrates it has resolved the conditions that gave rise to the appearance of a violation. This information is necessary for the Agency to have confidence that future shipments or entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (the Act). For additional guidance on removal from detention without physical examination, refer to FDA�s Regulatory Procedures Manual (RPM), Chapter 9-8, �Detention Without Physical Examination (DWPE).� Examples of such documentation that may be provided to assist FDA review may include: a. Documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented; and/or b. Documentation showing that a minimum of five (5) non-violative samples, each collected from a separate and distinct lot/shipment, analyzed by third-party laboratory as further verification that the products do not contain microbial pathogens and that corrective actions have been adequately implemented.*** If a firm and/or a representative thereof would like to submit a 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, contact OII, Division of Import Operations (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 HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov

Affected Countries (1)