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  5. Importing Human Foods
  1. Importing FDA Regulated Products

Importing Human Foods

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Overview

This page provides an overview of human foods and the requirements that FDA verifies/enforces at the time they are imported into the United States. For information on importing animal food and feeds visit our animal and veterinary products page.

The Center for Food Safety and Applied Nutrition (CFSAN) is the FDA center responsible for overseeing the human food program. Visit the Food webpage for more information.

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Prior Notice requirements for importation

FDA must receive notification before food is offered for import into the United States. The purpose of prior notice is to enable FDA to target inspections or examinations of the imported food at U.S. ports of entry more effectively, and to determine whether there is any credible information that the imported food shipment presents a threat or serious risk to public health.

For more information visit the prior notice of imported foods page.

What food requirements are verified at the time of importation?

Imported foods must be pure, wholesome, safe to eat, produced under sanitary conditions, and contain informative and truthful labeling in English. FDA does not certify, license, or otherwise approve individual food importers, products, labels, or shipments prior to importation.

At the time of importation, FDA will verify compliance with the following requirements for foods as applicable:

Additionally,

  • FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert. For example, Import Alert 99-08, Detention Without Physical Examination Of Processed Foods for Pesticides lists processed foods subject to DWPE due to illegal pesticide chemical residues.

For more information visit our Importing Food Products into the United States page.

How does FDA verify compliance with food requirements?

FDA entry reviewers are trained to verify compliance with applicable product requirements using the information provided to FDA in the importer’s entry transmission such as:

These entry declarations are compared to information in FDA’s internal data systems. FDA uses the internal data systems to verify registration, LACF/AF process filing, when required, or other product requirements and to determine if the firm/product is subject to DWPE. If the information submitted matches, then compliance is verified; if the information submitted does not match, FDA may gather additional information or may detain the product.

The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDAs internal data systems.

Note: Submitting inaccurate or incomplete information may delay the review of your entry.

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Food Facility Registration

Most facilities that manufacture, process, pack, receive or hold food must register with FDA every two years. This includes most foreign manufacturers and some importers. There are a few exceptions from the registration requirements. Please click here for more information on registering your food facility.

How does FDA verify food facility registration?

FDA will verify the registration for those firms requiring food facility registration. FDA will compare the submitted information to FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.

Can I obtain registration information for a food facility?

No, food facility registration is confidential and not available publicly. You will need to contact the firm to inquire about their FDA registration status.

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Seafood and Juice HACCP Regulations

FDA’s multifaceted and risk-informed seafood and juice safety programs rely on various measures of compliance with its seafood and juice Hazard Analysis and Critical Control Points (HACCP) regulations. Food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution, and consumption of the finished product. FDA conducts inspections to ensure importers are compliant with the requirements of import seafood and juice HACCP.

For more information on importing seafood visit the following pages:

For more information on importing juice visit the Juice HACCP page.

Low Acid Canned Foods/Acidified Foods (LACF/AF)

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA.  Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes.  However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

What LACF/AF requirements does FDA verify at the time of importation?

FDA verifies commercial processors engaged in the manufacture, processing, or packing of acidified foods (AF) or low-acid canned Foods (LACF) are registered and have a process on file for each product they import. For more information visit the registration and process filing page for LACF/AF.

How does FDA verify LACF/AF requirements?

FDA verifies that the declared manufacturer or processor is registered with FDA under the Food Canning Establishment Registration and has filed a process with the FDA by comparing the submitted information to FDA’s internal data systems.

If the information submitted matches FDA’s data systems, then compliance is verified; if the information does not match, FDA may request and/or collect additional information or may detain the product. If a firm lacks the required registration and listing, the product will be subject to refusal.

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Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, enables FDA to better protect public health by strengthening the food safety system. It gives FDA new tools and authorities to ensure imported foods (for humans and animals) meet the same safety standards as foods produced in the U.S.

Visit our FSMA page for more information.

Foreign Supplier Verification Program (FSVP)

One of the new key import authorities for foods under FSMA is importer accountability. For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final. For more information on FSVP and the key requirements visit our FSVP page.

To determine if you are subject to FSVP review the Am I Subject to FSVP? guide. Visit the compliance dates for the final rule on FSVP page for information on implementation timeline.

Voluntary Qualified Importer Program (VQIP)

VQIP is a voluntary, fee-based program that allows importers to receive expedited review and importation of foods into the United States if they apply, and then achieve and maintain, a high level of control over the safety and security of their supply chains. Participating importers can import their products to the United States with greater speed and predictability, avoiding unexpected delays at the point of entry. 

For more information visit the VQIP page.

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Food labeling

Food offered for import into the United States must comply with the FDA’s laws and regulations on food labeling. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, and drinks. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. All labeling and packaging must be informative and truthful, with the labeling information in English (or in the predominant language of a U.S. territory where the language is one other than English, such as Spanish in Puerto Rico). View the Food Labeling & Nutrition page for specific food labeling requirements and recently published guidance.

Dietary Supplements are a special category of products that fall under the general umbrella of foods, which have separate labeling requirements. For more information visit the Dietary Supplements page.

How does the FDA verify labeling compliance at the time of importation?

FDA routinely conducts field examinations and collects samples of food imported into the U.S. to ensure it complies with labeling requirements.

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Affirmation of Compliance codes for foods

Affirmation of Compliance codes (A of C) are three letter codes that can be provided at the time of import to facilitate the FDA review. The FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Providing the correct A of C codes reduces the likelihood that your shipment will be held for further FDA entry review during the FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.

For information on foods A of C codes as well as descriptions and examples of the food affirmation of compliance codes refer to the “Affirmation Of Compliance References” on the affirmation of compliance codes page.

Ingredients and packaging

The FDA regulates the safety of substances added to food.  We also regulate how most food is processed, packaged, and labeled.  This includes food additives and food contact substances.  For more information visit our Ingredients and Packaging webpage. 

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