Korean food is having a moment in the US, and many founders want to ride that wave by importing snacks, sauces, drinks, and packaged meals. But before a single product reaches an American shelf, you must clear US regulatory requirements, and FDA food registration is at the center of that process. The US Food and Drug Administration oversees most food products sold in the country, and getting registration and labeling right is what separates a smooth launch from products held or refused at the border.
Who Regulates Food in the US
Most food products in the US are regulated by the FDA. There are exceptions: meat, poultry, and certain egg products fall under the US Department of Agriculture (USDA) instead. For the majority of K-food items, such as ramen, snacks, kimchi, sauces, teas, and packaged sweets, the FDA is the primary authority. Understanding which agency governs your product is the first step, because the rules and processes differ.
The FDA does not pre-approve most foods the way it approves drugs. Instead, it sets requirements that facilities and importers must meet, and it inspects and enforces at the border and in the market. This means the burden is on you to comply correctly, because there is no approval certificate that guarantees entry.
FDA Facility Registration
A core requirement is FDA food registration of the facility that manufactures, processes, packs, or holds food for consumption in the US. This applies to foreign facilities too. If your Korean manufacturer produces food destined for the US, that facility generally must be registered with the FDA. Registration is renewed on a recurring cycle, and facilities must keep their information current.
Foreign facilities are also required to designate a US Agent, a contact based in the US who serves as a liaison with the FDA and can respond on the facility behalf. Without a valid registration and US Agent, shipments can be delayed or refused. Because registration details and renewal timing are set by the FDA and can change, verify current requirements directly or with a specialist before you rely on any single step.
Prior Notice for Imports
Beyond facility registration, each shipment of imported food generally requires Prior Notice submitted to the FDA before the goods arrive. Prior Notice tells the FDA what is coming, from which facility, and where it is headed, allowing the agency to review incoming food. Missing or inaccurate Prior Notice is a frequent cause of shipments being held at the port.
In practice, your customs broker or import partner often handles Prior Notice and entry filings, but as the owner you should understand that the following pieces must line up: a registered facility, a designated US Agent, accurate Prior Notice, and compliant labeling. If any one is missing, the shipment can stall.
US Food Labeling Requirements
Labeling is where many K-food importers stumble, because a label that is perfectly legal in Korea is often not compliant in the US. FDA food labeling rules are specific, and labels must generally be in English. Key elements the FDA requires on most packaged foods include:
- Statement of identity: the common name of the food, prominently displayed.
- Net quantity of contents: the amount of product, shown in both US customary units and metric.
- Nutrition Facts panel: formatted according to current FDA rules, with serving sizes and required nutrients.
- Ingredient list: all ingredients listed in descending order by weight, using their common names.
- Allergen declaration: major food allergens must be clearly identified, which is critical for many Korean products containing soy, wheat, egg, fish, shellfish, tree nuts, peanuts, sesame, and milk.
- Name and address: of the manufacturer, packer, or distributor.
Nutrition Facts must follow the current US format, which differs from Korean labels in layout, serving-size rules, and required nutrients. Allergen labeling is taken very seriously in the US, so translating and reformatting your label properly is essential. Many importers work with a labeling specialist to produce a compliant US label rather than adapting the Korean one by guesswork.
Other Considerations for K-Food Importers
Depending on your product, additional rules may apply. Low-acid canned foods and acidified foods (which can include some fermented or pickled items) have extra process filing requirements designed to prevent foodborne illness. Products making health or nutrient-content claims face stricter scrutiny. Dietary supplements and certain beverages have their own categories. The Food Safety Modernization Act also introduced importer responsibilities, including verifying that foreign suppliers meet US safety standards.
A sensible sequence for launching K-food in the US looks like this:
- Confirm your product is FDA-regulated and identify its category.
- Ensure the manufacturing facility completes FDA food registration and designates a US Agent.
- Prepare a fully compliant English label, including Nutrition Facts and allergen statements.
- Set up Prior Notice and entry filing with a customs broker.
- Confirm any special category requirements, such as acidified or low-acid canned foods.
This article is general information and not legal or regulatory advice. FDA requirements are detailed and change over time, and product-specific rules vary, so consult a qualified regulatory professional before importing.
Frequently Asked Questions
Does the FDA approve my food before I can sell it?
For most foods, no. The FDA does not pre-approve ordinary food products. Instead it requires facility registration, Prior Notice for imports, and compliant labeling, and it enforces at the border and in the market. Compliance is your responsibility.
Do I need to translate my Korean label into English?
Yes. US food labels must generally be in English and follow FDA formatting for the Nutrition Facts panel, ingredient list, allergen declarations, and net quantity. A direct translation of a Korean label is usually not sufficient, so a compliant relabel is recommended.
What is a US Agent and do I need one?
A US Agent is a US-based contact that a foreign food facility must designate to communicate with the FDA. If your food is manufactured in Korea for sale in the US, the facility generally needs both FDA registration and a designated US Agent.
Bringing K-food to the US market is a huge opportunity, but the regulatory details can make or break your launch. If you want guidance on FDA registration, labeling, and import setup, book a free consultation with USdongsan and bring your products to America the right way.
