Note: The revision of this Import Alert (IA) dated 09/14/2023 updates the guidance section. Changes to the import alert are bracketed by asterisks (***). On September 6, 1991, Baltimore District was informed by the Maryland Department of Health of an outbreak of cholera. Three individuals became ill and were found to be infected with toxigenic Vibrio cholerae O1, biotype El Tor, serotype Ogawa. The product implicated in this outbreak was a dessert made with coconut milk. A number of different products were collected by Baltimore district as a result of a follow-up investigation; laboratory analysis of a sample of fresh frozen coconut milk identified the presence of toxigenic V. Cholerae O1, serotype Ogawa. The product was also found to contain Salmonella. In 2008, a sample of shredded coconut manufactured in India, was collected, and analyzed and found to contain Listeria monocytogenes, Type 4.
All fresh, frozen and dried products containing coconut milk or coconut meat. NOTE: This does not include thermally processed canned products
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Vibrio cholerae, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code: VIBRIO and/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code: SALMONELLA and/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Listeria monocytogenes, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code: LISTERIA
Divisions may detain, without physical examination, all shipments of the specified coconut product(s) from the firms listed in the Red List below due to the presence of microbiological contamination, using the appropriate charges as noted. Recommendations for additions to the Red List of this import alert, that are due to findings of Salmonella, should be forwarded directly to the Division of Import Operations (DIO). Additions to the Red List of this import alert as a result of Listeria monocytogenes or Vibrio cholerae findings will require a review by both DIO and the Center. If other strains of Vibrio are encountered, these findings will be reviewed on a case-by-case basis by the Center. Release of Articles Subject to Detention Without Physical Examination under This Import Alert: *** In order to secure release of an individual shipment subject to detention without physical examination 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 the presence of microbiological contamination. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. ***Beginning 12/02/2025, Listeria 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*** Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further 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): In order to remove a firm's product from the Red List, 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. 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 (i.e., the Act). For guidance 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 sent via email to: Importalerts2@fda.hhs.gov. Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@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 the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 09/14/2023 updates the guidance section. Changes to the import alert are bracketed by asterisks (***). On September 6, 1991, Baltimore District was informed by the Maryland Department of Health of an outbreak of cholera. Three individuals became ill and were found to be infected with toxigenic Vibrio cholerae O1, biotype El Tor, serotype Ogawa. The product implicated in this outbreak was a dessert made with coconut milk. A number of different products were collected by Baltimore district as a result of a follow-up investigation; laboratory analysis of a sample of fresh frozen coconut milk identified the presence of toxigenic V. Cholerae O1, serotype Ogawa. The product was also found to contain Salmonella. In 2008, a sample of shredded coconut manufactured in India, was collected, and analyzed and found to contain Listeria monocytogenes, Type 4.
Country-specific information is available in the full alert detail on the FDA website.
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