OFW’s Customs and Trade team regularly assists food importers with import compliance and enforcement matters. Importers of human foods should be familiar with the importation process and requirements prior to importation. Otherwise, the product and importer could be subject to U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) enforcements, such as refusals, import alert listings, seizures, injunctions, and criminal prosecution as well as penalties or liquidated damages claims. In an effort to help the trade community avoid costly enforcement actions, our team is sharing a general overview of the process a food importer should follow to ensure a smooth import process.
How do CBP and FDA target food imports?
All human food products offered for entry into the U.S., including items for personal use, must be declared to CBP. CBP refers all FDA-regulated products to FDA for review. All imported shipments of food are reviewed by FDA and must comply with the same standards as domestic products. FDA uses its PREDICT System, a risk-based analytics tool, to electronically screen all regulated shipments imported or offered for import during the entry review process. FDA and CBP also use CBP’s Automated Commercial Environment (ACE), the system through which the trade community reports imports and exports, and the CBP determines admissibility. ACE further enhances targeting by allowing FDA and CBP to share information. These systems are used to improve import screening and targeting to prevent entry of adulterated, misbranded, or otherwise violative goods and expedite the entry of non-violative goods. PREDICT uses automated data mining, pattern discovery, and automated queries of FDA databases to determine the potential risk of a shipment. It takes into consideration the inherent risk of a product and information about the previous history of importers, manufacturers, and shippers.
For an importer and its supply chain to best prepare for a smooth entry and clearance process and avoid being targeted by automatic systems, it must understand FDA’s jurisdiction over human food, the importance of knowing its product, supply chain, and specific requirements as well as the common reasons for delays at the time of importation and the risks involved in importing non-compliant human foods.
Human foods subject to FDA jurisdiction
FDA regulates all foods and food ingredients imported in retail and bulk form or for further processing, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture (USDA).
Know your product, how it is regulated, and the risk of enforcement for non-compliance.
For an importer to know what requirements must be complied with it must know its product formulation and manufacturing process because FDA regulations may vary based on the ingredients and marketing claims. This is crucial for importers to understand as they engage with their overseas suppliers, which are a source of knowledge for ensuring proper compliance.
The following highlights general FDA food requirements that when not complied with will likely lead to enforcement at the time of entry or post-entry during FDA inspections.
Food Facility Registrations
Importers must confirm its overseas suppliers that process, package, or hold food comply with Food facility registration requirements pursuant to the Bioterrorism Act. This is a top cause for an FDA detention. We recommend requesting evidence of the registration (printout of the actual FDA registration, and not a third-party-generated certificate) from the supplier before importing to confirm the registration is active.
Food Safety Standards
There are requirements under the Food Safety Modernization Action (FSMA) that if not complied with during importations can subject a firm to future violations during facility inspections, particularly those related to the Foreign Supplier Verification Program (FSVP) where compliance is imposed on the FSVP Importer. There have been approximately 246 FDA warning letters issued to firms for violations of FSVP; 27 were issued in 2023 alone.
For importers of Seafood and Juices, a Hazard Analysis Critical Control Point (HACCP) is a crucial written plan that when developed and implemented correctly, will reduce the substantial risk of enforcement at the border. Often FDA will not only screen documentation transmitted, but it will sample and test seafood products for decomposition which is evidence of improper commercial handling. This risk will not only likely result in a shipment refusal, but recommendation by the FDA Compliance Officer to the Division of Import Operations for the product, manufacturer/supplier/importer, to be added to an Import Alert. This type of enforcement impacts an entire supply chain as future imports will be automatically held and subject to physical inspection until evidence establishes that the shipment overcame the reason for the alert.
We recommend cross-checking import alerts for all products and suppliers prior to importation because failure to do so is another top reason for an FDA detention.
Nutrition and labeling
FDA requires human food labels to be uniform in format. FDA does not provide a human food label review or approval process; therefore, the duty to ensure a product label is compliant is imposed on importers. When importing a human food product there is an inherent high risk of enforcement because an FDA officer at the border is more likely to review a product label to confirm compliance when compared to domestic products. FDA will likely request a label from the importer for review when there are risks flagged by FDA’s PREDICT System or if the product is sampled and tested at the Port of Entry. Typical label violations include the use of non-English labels, incorrect or missing statement of identity, no allergens statement or list of ingredients, missing or incorrect format for “Nutrition Facts”, undeclared or uncertified color additives, and undeclared food additives.
These issues are more likely to occur when importers rely on compliance to be performed by their suppliers without understanding that non-compliance liability strictly falls on the importer of record from a CBP and FDA perspective. This means that regardless of the contractual obligation negotiated by the parties, an importer cannot contract out its responsibility to ensure the imported products comply with federal regulations.
Prior Notice
Before the food shipment arrives in the U.S., importers must submit prior notice to the FDA through the Prior Notice System Interface (PNSI). This notice should include details about the food, its origin, and the importer.
Due Diligence
Conduct a thorough search of your suppliers and entities in your supply chain and recent enforcement actions to avoid similar actions being taken against your firm. Be aware of any FDA Import Alerts. Perform a risk assessment by reviewing FDA Warning Letters issued to similar companies and for similar products as well as recent recalls.
CBP requirements for food importation
Under CBP regulations, an importer of record (IOR) is required to use reasonable care in making entry of a good into the U.S. The IOR must exercise reasonable care by 1) filing such information as is necessary to enable CBP to determine whether the merchandise may be released from CBP custody; and 2) submitting to CBP the declared value, classification, country of origin, and rate of duty and such other documentation or information as is necessary to enable CBP to properly assess duties, collect accurate statistics, and determine whether any other applicable requirement of the law is met. This includes, for example, compliance with requirements enforced or administered by FDA. Importers should be aware that, unlike FDA, CBP has the ability to impose substantial monetary penalties for failure to exercise reasonable care when declaring, for example, the correct classification or value of an imported product at entry.
Becoming an IOR requires engaging a U.S. Customshouse Broker, registering with CBP as an IOR via CBP Form 5106, and obtaining a Customs continuous bond from a surety. A first-time food importer should read CBP’s Importing into the United States A Guide for Commercial Importers to understand the complexity of customs issues. Food importers have recordkeeping requirements under FDA and CBP regulations; again, CBP has the ability to impose substantial penalties for failure to comply with these recordkeeping requirements.
Our team assists IORs in determining the correct tariff classification of their merchandise to CBP, as well as country of origin determinations, valuation assessments (especially when dealing with related parties), implementing compliance plans, determining Free Trade Agreement eligibility, and responding to CBP enforcement actions such as Request for Information (CBP 28) or Notice of Actions (CBP 29), Notice of Detention or Seizure Notice, and pre-penalty/penalty proceedings. Requesting a binding ruling from CBP can help importers demonstrate their use of reasonable care and reduce the risk of an enforcement action.
Please note that this is a general guideline, and specific requirements can vary depending on the type of food, its source, and other factors. It’s crucial to consult with the FDA and CBP or seek assistance from experienced legal professionals to ensure compliance with all import regulations.
If you would like further information or assistance, please contact Jessica Rifkin (jrifkin@ofwlaw.com), Tom O’Donnell (todonnell@ofwlaw.com) Lara Austrins (laustrins@ofwlaw.com) or Denise Calle (dcalle@ofwlaw.com).
