Note: The revision of this Import Alert (IA) dated 11/27/2024 updates the reason for alert and guidance section including the agency contacts. Changes to the import alert are bracketed by asterisks (***). ***Nitrofurans are a class of synthetic antibiotics, very effective against a wide range of bacteria including Gram- positive and Gram- negative bacteria and protozoa. Nitrofurans can be used for treatment for a variety of infections in both humans and animals. The nitrofuran class of drugs include furazolidone, furaltadone, nitrofurantoin, nitrofurazone (also known as nitrofural or furacilin) and nifursol. Nitrofuran parent drugs are rapidly absorbed and metabolized after administration and ingestion to form corresponding tissue bound metabolites. These metabolites have a relatively long half-life and cannot be further metabolized, resulting in higher concentrations remaining in the body. There is clear scientific evidence that the use of these drugs during the various stages of aquaculture production can result in the presence of residues in the edible portion of the aquaculture products. *** The tissue-bound residues of nitrofurans are very stable and do not degrade to a significant extent upon common food preparation techniques like cooking, baking, grilling, and microwaving. Studies have shown that residues of nitrofurans ingested by consumption of contaminated product are bioavailable. When consumed, nitrofuran residues are absorbed by the consumer's body and again form tissue-bound residues. Since the ***compounds are considered to be carcinogenic and genotoxic, consumption over time (chronic consumption) of product contaminated with nitrofurans may have an adverse impact on human health.*** ***In the past FDA has withdrawn several approved nitrofuran products for food-producing animals due to concerns regarding their carcinogenicity and genotoxicity. For example, nitrofurazone, one of the nitrofurans, has been shown to produce mammary tumors in rats and ovarian tumors in mice. Additionally, some people may be hypersensitive to this product. Nitrofurazone containing products are required to have a warning statement to alert hypersensitive individuals. Nitrofurans are on the list of drugs prohibited from extra-label use in food animals. A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug (21 U.S.C. � 321(v)).FDA has not approved a new animal drug application (NADA) for use of nitrofurans in aquaculture, nor is there a conditional approval or index listing in effect for this class of drugs. Therefore, nitrofurans used in aquaculture are considered to be unsafe new animal drugs within the meaning of section 512(a)(1), and the presence of these drugs or their conversion products in processed seafood adulterates the products under section 402(a)(2)(C)(ii) of the FD&C Act. *** There are very few approved animal uses of nitrofurans in the U.S. The approved products are for topical dosage forms approved for non-food producing animals only, i.e., cats, dogs and horses. FDA issued an order in February, 2002 prohibiting the extra-label use of topical nitrofuran animal and human drugs in food-producing animals,*** including seafood.*** This order was based on evidence that extra-label use of topical nitrofuran drugs in food-producing animals may result in the presence of residues in the animal tissue.
All Seafood
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it 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 AND "The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to bear or contain a food additive, namely, nitrofurans, that is unsafe within the meaning of section 409. [Adulteration, Section 402(a)(2)(C)(i)]" OASIS Charge code - NITROFURAN
Divisions may detain without physical examination, the products from the firms identified in the Red List to this alert. Product entries testing positive for the presence of nitrofurans should be refused entry under the charges described below. ***Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO and the Human Foods Program (HFP) will evaluate regulatory packages 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 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 nitrofurans. Such evidence could include private laboratory analysis of a representative sample (s) collected from the affected article. 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. 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 DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to request 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/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 OII/Office of Regulatory Testing and Surveillance at 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 11/27/2024 updates the reason for alert and guidance section including the agency contacts. Changes to the import alert are bracketed by asterisks (***). ***Nitrofurans are a class of synthetic antibiotics, very effective against a wide range of bacteria including Gram- positive and Gram- negative bacteria and protozoa. Nitrofurans can be used for treatment for a variety of infections in both humans and animals. The nitrofuran class of drugs include furazolidone, furaltadone, nitrofurantoin, nitrofurazone (also known as nitrofural or furacilin) and nifursol. Nitrofuran parent drugs are rapidly absorbed and metabolized after administration and ingestion to form corresponding tissue bound metabolites. These metabolites have a relatively long half-life and cannot be further metabolized, resulting in higher concentrations remaining in the body. There is clear scientific evidence that the use of these drugs during the various stages of aquaculture production can result in the presence of residues in the edible portion of the aquaculture products. *** The tissue-bound residues of nitrofurans are very stable and do not degrade to a significant extent upon common food preparation techniques like cooking, baking, grilling, and microwaving. Studies have shown that residues of nitrofurans ingested by consumption of contaminated product are bioavailable. When consumed, nitrofuran residues are absorbed by the consumer's body and again form tissue-bound residues. Since the ***compounds are considered to be carcinogenic and genotoxic, consumption over time (chronic consumption) of product contaminated with nitrofurans may have an adverse impact on human health.*** ***In the past FDA has withdrawn several approved nitrofuran products for food-producing animals due to concerns regarding their carcinogenicity and genotoxicity. For example, nitrofurazone, one of the nitrofurans, has been shown to produce mammary tumors in rats and ovarian tumors in mice. Additionally, some people may be hypersensitive to this product. Nitrofurazone containing products are required to have a warning statement to alert hypersensitive individuals. Nitrofurans are on the list of drugs prohibited from extra-label use in food animals. A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug (21 U.S.C. � 321(v)).FDA has not approved a new animal drug application (NADA) for use of nitrofurans in aquaculture, nor is there a conditional approval or index listing in effect for this class of drugs. Therefore, nitrofurans used in aquaculture are considered to be unsafe new animal drugs within the meaning of section 512(a)(1), and the presence of these drugs or their conversion products in processed seafood adulterates the products under section 402(a)(2)(C)(ii) of the FD&C Act. *** There are very few approved animal uses of nitrofurans in the U.S. The approved products are for topical dosage forms approved for non-food producing animals only, i.e., cats, dogs and horses. FDA issued an order in February, 2002 prohibiting the extra-label use of topical nitrofuran animal and human drugs in food-producing animals,*** including seafood.*** This order was based on evidence that extra-label use of topical nitrofuran drugs in food-producing animals may result in the presence of residues in the animal tissue.
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