Note: The revision of this Import Alert (IA) dated 09/19/2024 updates the name of the alert, reason for alert, guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). This alert will be expanded to include all seafood. Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.). Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia. Since these adverse reactions are idiosyncratic and are not dose related, a safe level of exposure to chloramphenicol ***has yet to be determined.*** Chloramphenicol is suspected to be a carcinogen and potentially affect the reproductive system in humans.
***All Seafood***
***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health." [Adulteration, Section 402(a)(1)]*** OASIS charge code: POIS CHLOR AND ***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348." [Adulteration, Section 402(a)(2)(c)(i)]*** OASIS charge code: CHLORAMP
Divisions may detain without physical examination (DWPE), the products from the firms identified in the Red List to this Alert. Release of Articles Subject to Detention Without Physical Examination under This Import alert: ***In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain Chloramphenicol. Such evidence could include Private Laboratory analysis of a representative sample(s) collected from the affected article. 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, further information regarding private laboratory analyses is found in FDA's Laboratory Procedure-Private Laboratory Analytical Packages. Third party laboratories may use any methods that are found acceptable to FDA. 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 that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs 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 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 09/19/2024 updates the name of the alert, reason for alert, guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). This alert will be expanded to include all seafood. Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.). Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia. Since these adverse reactions are idiosyncratic and are not dose related, a safe level of exposure to chloramphenicol ***has yet to be determined.*** Chloramphenicol is suspected to be a carcinogen and potentially affect the reproductive system in humans.
Country-specific information is available in the full alert detail on the FDA website.
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