Import Alert 16-136

Import Alert # 16-136

Published Date: 08/28/2026

Type: DWPE

Detention without Physical Examination of Aquacultured Shrimp and Prawn Products in all Market Forms from Peninsular Malaysia Due to the Presence of Unapproved Animal Drugs or Unsafe Food Additives

Note: The revision of this Import Alert (IA) dated 08/28/2026 updates the reason for alert, guidance section including agency contacts, charge code language, and countries section. Changes to the import alert are bracketed by asterisks (***).

***The extensive commercialization and high consumption of aquacultured seafood products continue to rise worldwide. Aquacultured seafood has become the fastest-growing sector of the world’s food economy, accounting for more than half of all global seafood production. Approximately 90% of the seafood consumed in the U.S. is imported from foreign countries, and over 40% of that imported seafood originates from aquaculture operations. Malaysia remains one of the key suppliers of shrimp and prawns to the U.S. market (NOAA National Marine Fisheries Service).

Aquaculture, also known as fish and shellfish farming, refers to the breeding, rearing and harvesting of aquatic food animals under environmentally controlled conditions with some form of intervention designed to enhance production, such as regular stocking, feeding, prevention and treatment of diseases, protection from predators, etc.

As the aquaculture industry continues to expand, concerns regarding the use of unapproved animal drugs and unsafe chemicals, and the misuse of approved animal drugs during aquaculture production has increased significantly. The existing scientific evidence demonstrates that the administration of pharmacologically active compounds during the various aquaculture life-cycle stages can result in the presence of residues in the edible portion of the finished seafood products. The consumption of these products may have an adverse impact on human health. A public health concern exists regarding prolonged exposure to nitrofurans and chloramphenicol, broad-spectrum antimicrobial drugs used in food-producing animals. Residues of these drugs in food products may present a potential health risk to consumers. These compounds are known to have carcinogenic and genotoxic properties. Also, the introduction of these residues into the food supply can contribute to the development and spreading of antimicrobial-resistant (AMR) bacterial strains. These resistant pathogens may be transferred to and cause infections in humans, compromising the effectiveness of critical antimicrobial treatments vital to human medicine.(see 21 C.F.R. 510.110(c)). Based on a robust body of scientific evidence, the FDA has determined that the detection of parent compounds or metabolite marker residues of nitrofurans and chloramphenicol in shrimp is directly linked to the administration of these prohibited veterinary drugs during the aquaculture production stages (i.e., hatcheries, farms).

Nitrofurans and chloramphenicol are classified as drugs under Section 201(g)(1) of the FD&C Act when intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of aquacultured shrimp or prawns. Because they are not generally recognized as safe and effective for these purposes, they are considered "new animal drugs" under Section 201(v)(1). Pursuant to Section 512(a)(1), the use or intended use of a new animal drug requires an approved new animal drug application, conditional approval, or index listing. The FDA has not approved any of these applications for the use of nitrofurans or chloramphenicol in shrimp or prawns. Therefore, these substances are considered to be unsafe new animal drugs within the meaning of section 512(a)(1). Consequently, the presence of these parent drugs or their metabolite conversion products in processed shrimp or prawns renders the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA has determined that using nitrofurans or chloramphenicol at any life stage of an animal results in residues in the final edible products. Because these substances are not generally recognized as safe for human consumption, any residues not classified as "new animal drugs" are deemed food additives under Section 201(s) of the FD&C Act.
Under Section 409, food additives are considered unsafe unless the FDA has issued a specific regulation or exemption authorizing their safe use. No such regulations or exemptions exist for nitrofurans or chloramphenicol in food-producing animals. Because these residues present clear human food safety risks, they are classified as unsafe food additives. Consequently, the presence of nitrofuran or chloramphenicol residues in food, including shrimp and prawns, renders the product adulterated under Section 402(a)(2)(C)(i) of the FD&C Act and subjects it to regulatory action.***

From October 1, 2014, through September 30, 2015, FDA detected a significant increase in the presence of nitrofurans and chloramphenicol residues in shrimp products imported from Peninsular Malaysia. During that period, FDA sampled and tested 138 shrimp shipments from Peninsular Malaysia. Of those collected, forty-five samples (32%) tested positive for the presence of nitrofuran residues (residues of furazolidone metabolite AOZ) and/ or chloramphenicol residues. The concentrations of nitrofuran residues detected in shrimp ranged from 1.0 ppb to 23 ppb, and the concentrations of chloramphenicol residues in shrimp ranged from 0.3 ppb to 6.8 ppb.

ENDNOTES:

1. "Shrimp" and "prawns" are common names (not scientific names) and are often used interchangeably by importers.

2. FDA has prohibited food production uses of chloramphenicol in animals since 1984. See 49 Fed. Reg. 20915 (May 17, 1984). FDA withdrew new animal drug applications for nitrofurans (furazolidone and nitrofurazone) in 1991 based on its finding that these drugs were no longer shown to be safe under the conditions of use for which they were approved. 56 Fed. Reg. 41902 (Aug. 23, 1991). There are very few approved animal uses of nitrofurans in the U.S. ***Product approvals are restricted to topical formulations designated solely*** for non-food producing animals only, i.e., cats, dogs and horses. Both chloramphenicol and nitrofurans are prohibited from extra-label use in food producing animals, including seafood. See 21 C.F.R. 530.41(a)(1), (7)-(8).

3. Section 201(s) of the FD&C Act defines "food additive" as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food . . . if such substance is not generally recognized . . . as safe under the conditions of its intended use."

4. Chloramphenicol residues may cause serious human blood disorders, including aplastic anemia, and other serious toxic effects. In the context of a new animal drug application withdrawal, the Director of the Center for Veterinary Medicine concluded that "use of chloramphenicol in food-producing animals causes a risk to human health" and that "[a]ny such risk is unacceptable." See 50 Fed. Reg. 20759 (July 1, 1985).

Divisions may detain without physical examination, all shipments of aquacultured shrimp and/or prawns from processors from Peninsular Malaysia, except for shipments from the firms identified on the Green List to this alert. Peninsular Malaysia consists of the eleven states and two federal territories located on the Malay Peninsula. This alert covers all market forms of shrimp and prawns to include raw frozen, cooked, breaded, cakes, balls, etc. The processing method does not impact the concentration of drug residues.

***Peninsular Malaysia includes:
Eleven States: Johor, Kedah, Kelantan, Malacca (Melaka), Negeri Sembilan, Pahang, Penang (Pulau Pinang), Perak, Perlis, Selangor, and Terengganu.

Two Federal Territories: Kuala Lumpur and Putrajaya.***

To facilitate stream-lined entry review of shipments from firms not located in the region of Peninsular Malaysia importers may provide documentation (i.e., invoices, bills of lading) declaring the source farm(s). If the importer is unable to provide source farm documentation, FDA may detain the product as appearing to be sourced from Peninsular Malaysia.

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 import 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 any nitrofuran or chloramphenicol residues. Such evidence may include private laboratory analysis of a representative sample(s).

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. 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(ADD TO GREEN LIST):

In order to facilitate and expedite a review of the processor's request for removal from DWPE under this import alert, FDA recommends that the processor submits information to allow FDA to adequately assess whether the processor(s) has appropriate controls and processes in place to ensure future shrimp and/or prawns from the processor will not bear or contain nitrofuran or chloramphenicol residues or their conversion products and will be in compliance with the FD&C Act.

In addition to FDA's review of documentation submitted requesting removal from DWPE, FDA, either solely or in conjunction with the relevant Malaysian regulatory authority, may conduct on-site inspections of the processor and/or the processor's Malaysian supplier(s) (including aquaculture farms and processors preceding the shipper), where applicable, prior to rendering a decision to place the processor and processor's products on the Green List. For further guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

***If a firm and/or a representative thereof would like to be added to the Green List of this Import Alert, all relevant information supporting the request should be sent via email to:
Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be evaluated by DIO and referred to the Human Foods Program (HFP) Imports Enforcement Branch for review. ***

***Questions or issues involving import operations should be addressed to OII/OIO 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

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Aquacultured shrimp and prawns products.


This alert covers all market forms of shrimp and prawns, raw frozen, cooked, breaded, cakes, balls, etc. The processing method does not impact the concentration of drug residues.

***”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

OR

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of Section 409." [Adulteration, 402(a)(2)(C)(i)]

OASIS charge code - UNSAFE ADD