Note: The revision of this Import Alert (IA) dated 08/23/2022 updates the reason for alert, guidance section, charge section and PAC code. Changes to the import alert are bracketed by asterisks (***). ***Antibiotics are used in the treatment of honey bee diseases. In the United States, the Food and Drug Administration (FDA) has approved tylosin, oxytetracycline, and lincomycin for therapeutic use in bees and established tolerances for the residues in honey at 500, 750*, and 750 parts per billion (ppb), respectively (*Sum of tetracycline residues). However, certain drug residues are a concern to human health. FDA has not approved the use of chloramphenicol, nitrofurans and/or fluoroquinolones as drugs to treat honey bees. Extra-label uses of chloramphenicol, nitrofuran and/or fluoroquinolone drugs are prohibited in food producing animals. Therefore, if they are used as drugs to treat honey bees, they are considered to be unsafe new animal drugs within the meaning of Section 512. If there are residues of these drugs in honey as a result of unapproved treatments of the bees, the honey is deemed to be adulterated under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (FFDCA).*** Furthermore, chloramphenicol, nitrofurans and/or fluoroquinolones are considered to be food additives if the intended use of these substances results in or may reasonably be expected to result in their becoming a component of food. Chloramphenicol, nitrofurans and/or fluoroquinolones are not generally recognized as safe for use in food, nor is there a food additive regulation authorizing their use in food. Consequently, residues of these drugs in foods are unsafe food additives within the meaning of Section 409 of the FFDCA and would render the food adulterated under section 402(a)(2)(C)(i).
All honey products (comb honey, strained honey, whipped honey, honey), Blended Syrups
The article is subject to refusal of admission pursuant Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409. [Adulteration, Section 402(a)(2)(C)(i)] OASIS charge code: UNSAFE ADD AND/OR The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a food that appears to bear or contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. [Adulteration, Section 402(a)(2)(C)(ii)] OASIS charge code: VETDRUGRES
Divisions may detain without physical examination all shipments of honey, honey products and ***blended syrups*** from the firms listed on the Red List of this Import Alert. ***Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). DIO will coordinate with CFSAN for concurrence.*** ***Release of Articles Subject to Detention without Physical Examination Under this Import Alert: In order to secure release of an individual shipment detained pursuant to this import alert, the importer should provide evidence which verifies the product does not contain non-permitted antibiotic residues. Such evidence may include a third-party laboratory analysis of samples. Products from firms on the import alert due to violative enrofloxacin or ciprofloxacin (fluoroquinolones) need to be analyzed for both enrofloxacin and ciprofloxacin with results reported as a sum. Such evidence 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 Laboratory Procedure-Private Laboratory Analytical Packages. Following receipt and review of private laboratory 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 a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FFDCA. For guidance on removal from detention without physical examination (DWPE), 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 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 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 08/23/2022 updates the reason for alert, guidance section, charge section and PAC code. Changes to the import alert are bracketed by asterisks (***). ***Antibiotics are used in the treatment of honey bee diseases. In the United States, the Food and Drug Administration (FDA) has approved tylosin, oxytetracycline, and lincomycin for therapeutic use in bees and established tolerances for the residues in honey at 500, 750*, and 750 parts per billion (ppb), respectively (*Sum of tetracycline residues). However, certain drug residues are a concern to human health. FDA has not approved the use of chloramphenicol, nitrofurans and/or fluoroquinolones as drugs to treat honey bees. Extra-label uses of chloramphenicol, nitrofuran and/or fluoroquinolone drugs are prohibited in food producing animals. Therefore, if they are used as drugs to treat honey bees, they are considered to be unsafe new animal drugs within the meaning of Section 512. If there are residues of these drugs in honey as a result of unapproved treatments of the bees, the honey is deemed to be adulterated under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (FFDCA).*** Furthermore, chloramphenicol, nitrofurans and/or fluoroquinolones are considered to be food additives if the intended use of these substances results in or may reasonably be expected to result in their becoming a component of food. Chloramphenicol, nitrofurans and/or fluoroquinolones are not generally recognized as safe for use in food, nor is there a food additive regulation authorizing their use in food. Consequently, residues of these drugs in foods are unsafe food additives within the meaning of Section 409 of the FFDCA and would render the food adulterated under section 402(a)(2)(C)(i).
Country-specific information is available in the full alert detail on the FDA website.
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