Food Importation FAQ

Key Regulatory Agencies Overseeing Food and Dietary Supplement Imports

FDA: The FDA regulates the majority of food imports into the USA, which includes Dairy, seafood, fruits, vegetables, packaged goods, and dietary supplements. 

USDA / APHIS: The USDA / APHIS regulates imported meat, poultry, and egg products into the United States. To import meat, poultry, or eggs into the U.S these products must originate from USDA/FSIS eligible foreign establishments. 

An eligible foreign establishment must have their country’s central competent authority (CCA) certified as meeting the requirements of the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) to be determined equivalent. For a list of eligible foreign establishments and the certified products, see the FSIS website. 

What is a Foreign Supplier Verification Program (FSVP)?

Under 21 CFR Part 1 Subpart L of the FDA’s Food Safety Modernization Act (FSMA), all importers of any goods intended for human consumption must be registered under the Foreign Supplier Verification Program (FSVP) and establish a system which controls and prevents potential hazards in imported goods. It is the responsibility of the importer to ensure only safe products are imported and distributed.

What Are the Key Roles and Responsibilities for Importing Food?

U.S. Food Agent: A U.S. Agent is a mandatory representative located in the U.S. designated by any foreign facility that manufactures, processes, packs, or stores food, beverages, or dietary supplements intended for consumption in the United States. Please note, a U.S. Agent is designated when the foreign manufacturer does not have personnel or an office in the U.S.

Customs Broker: A licensed trade expert who prepares entries, submits declarations to CBP, and calculates tariffs. Please note, they are not legally liable for customs or product compliance errors.

Importer of Record (IOR):  A legally designated entity or individual responsible for ensuring that goods imported into a country comply with all local laws, regulations, and customs requirements. The FSVP IOR is specifically responsible for ensuring imported goods comply with the FDA’s Food Safety Modernization Act (FSMA).

Qualified Individual:  The technical food safety expert who develops and executes food safety verification tasks and reviews documentation. In many cases, the Qualified Individual and FSVP IOR are the same individual or group. 

What Documents Do I Need to Request from Suppliers?

Documents you need to request for food imported from your foreign supplier:

• If applicable, a valid GFSI (Global Food Safety Initiative) certificate or third-party food safety audit certificate
  • Make sure it is not expired
• HACCP Plan (or Hazard Analysis) along with proof that the analysis was performed by a qualified individual
• Process flow 
• Proof of Food Safety training of qualified individual
• Product specifications, letters of guarantee, Certificates of Analysis, or Certificates of Conformance
• Allergen statements (if not included on product specifications)

Please note that this is a generic list, and depending on the type of product and supplier documentation you receive, there may be additional documents required. 

Documents you need to request for dietary supplements imported from your foreign supplier:

• If applicable, a valid GFSI (Global Food Safety Initiative) certificate or cGMP certificate
  • Make sure it is not expired
• HACCP Plan (or Hazard Analysis) along with proof that the analysis was performed by a qualified individual
• Process flow 
• Proof of Food Safety training of qualified individual
• Product specifications, letters of guarantee, Certificates of Analysis, or Certificates of Conformance
  • Purity, strength and composition of dietary supplements specifications along with contamination limits of the dietary supplement action achieved through lab testing
• Specifications for dietary supplement labels (label specifications) and packaging that may come in contact with dietary supplements (packaging specifications).

What is the Verification Process?

Once you receive documentation from suppliers, it is the FSVP IOR’s or Qualified Individual’s responsibility to verify that the product is safe and the foreign supplier is providing an FDA recognized safe product. A Hazard Analysis of the product must be conducted or reviewed by the Qualified Individual to evaluate the biological, chemical, and physical risks of each product being imported into the U.S. The analysis uses the foreign supplier documentation as evidence for the assessments.

Each foreign supplier’s manufacturing site must be reviewed based on documentation they provided, and a reassessment must be performed on all suppliers at least every three years regardless of status or changes to their programs.

What to do When Food Safety Findings are Made by Regulators?

Responding to food safety findings (Noncompliance Record (NRs), 483s, state level findings)

All responses should be in writing and include:

• A brief explanation of the situation
• Corrections made during inspections (if any)
• Corrective Actions (new forms, new programs, scheduled actions)
• Preventive Actions (new forms, new programs, scheduled actions)

Responding to Government Food Safety Warning Letters

• Very serious
• May lead to legal action if not addressed
• This may require involvement from a lawyer

For a detailed review of how to respond to 483 forms and Warning letters, view our blog post. 

Ending Regulatory Findings

• Agency will acknowledge receipt of responses
• Agency will not provide guidance or assessment of response
• Agency will notify if follow up action is required
• Agency will expect to see evidence of responses in follow up inspections

Please note, when reviewing regulatory findings for FSVP (483 forms or warning letters), the inspector may not follow-up until your establishment’s next inspection. 

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