Food and Beverage

In the United States, the FDA regulates food exported to the United States through law to protect their citizens from food-borne hazards, and products that meet established standards require FDA approval and registration.

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  What is FDA's Food and Beverage Registration?

  Under the Public Health Safety and Bioterrorism Preparedness and Response Act (Bio-Terrorism Act), the FDA Food & Drug Administration (www.fda.gov) is a food regulatory agency that threatens the U.S. food supply and other food-related emergencies. Or have taken steps to protect the people from real terrorist attacks.

  • Medicines, foods, cosmetics, radiation equipment emission pre-inspection, imports / exports inspection
  • Compulsory approval and management of target products (food, pharmaceuticals, etc.) at the time of import customs clearance in the US market.
  • If you get disqualified during import clearance decision, Legal marketing in the United States is prohibited

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  FDA registration target items

  Food, cosmetics, medicines and medical devices (including accessories), veterinary drugs, animal feed, infant formula, food additives, low acid canned food, oxidized food (in the case of meat, poultry and processed meat products, the Ministry of Agriculture, Food Safety & Inspection Service (FSIS) inspects and regulates.)

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  Food and beverage FDA export flow chart

  • Factory registration (FFR)
  • Product ingredient review
  • Nutrition analysis and nutrition fact label creation
  • SID/FCE report in case of low acidity room temperature food
  • GACCP certification and related documents for seafood
  • In the case of health food, comply with US health food cGMP regulations
  • In the case of general food, the manufacturer shall comply with the Food for Human Use Regulation (PDCHF).
  • In the case of fresh agricultural products, comply with the Produce Safety Rule
  • USDA-related approval when a small amount of meat, eggs, and milk ingredients (2%) are included(In principle, Korean meat is prohibited for export to the United States.)
  • Whether the importer of the United States has DUNS# or FSVP (Overseas Supplier Verification System)

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  IGC’s Competency

  • IGC is contributing to the continuous development of customers by accurately evaluating the suitability of product certification through the technology and expertise accumulated over the years.
  • IGC has updated knowledge of a wide range of specific scope and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operations.

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  Related Services

  1. Food facility registration (FFR)

  Domestic and foreign facilities that manufacture, process, package, and store food and feed consumed in the United States must register as an FDA food facility. FDA food facility registration must be completed before any food can be manufactured, processed, packaged, or stored for distribution in the United States

  2. Foreign Supplier Verification Program (FSVP)

  FSVP is a program that requires importers to certify that a manufacturer's food is produced in accordance with the process of US food safety standards. Companies wishing to export food and beverages to the United States must appoint a United States agent to export food to the United States.

  3. FDA Health Supplement labeling

  Health supplements that are not pharmaceuticals do not need to go through the FDA pre-approval process. However, unlike in Korea, if the product is labeled with a phrase saying that it has a therapeutic effect, it may be treated as a drug, so it is necessary to pay close attention. We help you comply with Health supplements labeling regulations.

  4. US agent service

  Foreign companies wishing to sell food or beverages in the United States must go through the process through a United States agent. The US agent acts as an intermediary between the company and the FDA. IGC offers a wealth of experienced U.S. agent services

  5. FDA Food Labeling Review

  Food labeling must be strictly observed when exporting food to the United States. Those in the food manufacturing, food export, and distribution businesses considering entering the U.S. should check for new regulations and amendments to related laws and prepare food labeling.

  6. FCE & SID registration

  FCE & SID registration (food factory registration & process registration) is required if the product is acidic or low-acid food. According to FDA regulations, acidified foods and low-acid foods must be registered as a food factory and process registration before they can be exported to the United States. IGC helps you comply with FDA regulations through FCE & SID registration (food factory registration & process registration).

  7. FDA prior notification

  The United States has enacted the Bioterrorism Act to prevent terrorism using food. Accordingly, in the United States, it is mandatory for facilities in and outside the United States that manufacture/process, package, and store food consumed by humans and animals to be registered as FDA facilities. Until the time, the product may be detained at the port of entry or moved to a third place. Assist with FDA-defined pre-declared imported foods and assist with FDA pre-declaration and facility registration.