Op-ed: Tips for dealing with US CBP and FDA seafood law enforcement: FDA import alerts

From shrimp etouffee to lobster thermidor and Thai fish cakes to Singapore chili crab and your everyday tuna, salmon, and squid, most of the seafood being eaten in the U.S. is imported. 

Unfortunately, there is a health risk associated with imported seafood compared to other imported food products. Hence, seafood is much more highly regulated by the federal government, especially by U.S. Customs and Border Protection (CBP), the U.S. Food and Drug Administration (FDA), and NOAA Fisheries. Legally, all imported seafood is monitored under the Food Safety and Modernization Act (FSMA), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), the Lacey Act, and the FDA’s Hazard Analysis and Critical Control Points (HACCP) requirements.

In recent years, there has been greater emphasis by CBP and FDA to ensure the seafood brought into the United States adheres with U.S. laws. In 2022, there was a record amount of imported seafood inspected by the FDA, there were a record number of FDA import alerts on imported seafood, CBP issued the first-ever withhold-release orders on shipments of seafood that arrived in the United States, and we had a record number of investigations, penalties, and seizures of seafood products related to illegal, unreported, and unregulated (IUU) fishing. And even more enforcement actions are expected in 2023.

Foreign seafood suppliers, international transportation companies, and U.S. importers of seafood can protect themselves by learning about how to prevent issues with U.S. authorities, and how to respond to any detention of imported seafood, refusal from entry, or seizure, penalty, or investigation.

All imported food must be declared to both CBP and FDA prior to arrival in the United States. The data in those required advanced declarations are screened electronically and then, depending upon such factors as description of product, country of origin, name of supplier, tariff classification number, etc. the shipment is selected for a physical examination. There are three primary reasons for CBP and FDA to select, detain, and refuse imported seafood. The first of this three-part series investigates what happens if a foreign supplier is on an FDA import alert.

On 25 January, 2023, the FDA issued Import Alert 16-124, which was titled "Detention Without Physical Examination of Aquaculture Seafood Products due to Unapproved Drugs.” As background, the FDA wrote:

Aquaculture production is vulnerable to diseases and changing environmental conditions. The use of veterinary drugs in animal production is necessary to treat and control diseases; however, this use may result in the residues found in products for human consumption. The use of unapproved drugs and the misuse of FDA approved new animal drugs in aquaculture species is a concern. These uses may increase due to limited availability of treatment options, specifically for new emerging diseases. Veterinary drugs can also be administered to improve the production, e.g., to enhance feed efficiency and rate of weight gain. Residues of animal drugs, the parent compound, or its metabolite, in food may cause acute or chronic effects. As this industry grows, the use of unapproved new animal drugs and the misuse of approved new animal drugs in seafood raised through aquaculture also grows. The use of unapproved new animal drugs will have an impact on the safety of aquaculture products for consumers.

The FDA issued this import alert because it found on seafood from specifically identified companies from all over the world the presence of unapproved drugs for these seafood products. The seafood is considered “adulterated” and would not be allowed to enter the United States. The FDA Import Notice would state, for example:

Maoming Yuantian Aquatic Refrigeration Company

Date Published : 04/10/2018

Xiangshan Shenchong , Industrial Zone , Gaozhou, Guangdong CHINA

16 X - - 06 Tilapia, Aquaculture Harvested Fishery/Seafood Products

Date Published: 04/10/2018

Desc: Tilapia; Frozen Fillets

Problems: SULFADIAZINE

In order to secure release of an individual shipment subject to Detention Without Physical Evaluation (DWPE) under an import alert, the owner, consignee and/or other responsible party for the affected seafood would have to provide evidence which demonstrates that the product does not bear or contain unapproved drugs. Such evidence could include private laboratory analysis of a representative sample of the detained product. Importers should provide analytical results for the specific parent drug and its metabolite(s) identified on the firm's listing on the Red List of a specific import alert.

In order to permanently remove a foreign seafood supplier’s name and product from the FDA Import Alert Red List, information should be provided to the FDA to adequately demonstrate that the company has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the FDA will have confidence that future shipments will be in compliance with federal law. For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a company through its designated U.S. lawyer would like to file a Petition for Removal from DWPE under a specific FDA import alert, all relevant information should be forwarded to the following address:

U.S. Food and Drug Administration

Division of Import Operations

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857

Or via email to: [email protected]

The type of documentation to submit to the FDA depends upon the reason it was placed on the import alert list. Supporting evidence can vary by violation and import alert. Supporting evidence may include, but is not limited to:

• Third-party laboratory analyses
• Manufacturing or processing records
• FDA establishment inspections
• Proof of registration and/or listing
• Proof of certification by a foreign government or certified body
• Evidence that labeling violations have been corrected
• Evidence that the product is in compliance

After filing dozens of these requests over the last 25 years, the most-effective practice that results in the FDA granting a Petition for Removal from Import Alert is to provide the following:

1. Cover letter to FDA identifying the client company on the import alert list, the import alert number;
2. Letter of authorization from the company to me with my name, my law firm name and address, and my mobile phone number and email address, specifically authorizing me to file the Petition for Removal from FDA import alert;
3. The list of at least five entry numbers for which the product was cleared by the FDA; and
4. The supporting evidence that the company’s product should be removed from the FDA Import Alert;

Within 24 hours, the FDA will issue by email an automatic acknowledgement of the petition, and assign a case number. Moreover, an FDA contact person with name, phone number, and email address will be provided for any further contact. FDA has come a long way such that it is now routine for petitions to be decided by the FDA within 30 days. A successful petitioner, or its legal counsel, will receive a letter by email from the FDA stating that the petition was granted, and the company on the FDA import alert will be removed effective immediately.

Peter Quinter is the head of the U.S. customs and international trade team at West Palm Beach, Florida, U.S.A.-based law firm Gunster.