Bring your food products to the U.S. market
Fresh, dried, canned, shelf-stable, retort, ready-to-eat and pouch products. We tell you what FDA requires for your product and help you meet it, from facility registration to the shipment.
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Food categories we support
Every category below leads to an assessment with your industry and product already selected.
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Fresh & processed fruits and vegetables
Whole, cut, frozen or processed produce.
Assess this product : Fresh & processed fruits and vegetables -
Dehydrated & dried foods
Dried fruit, vegetables, chiles, herbs and snacks.
Assess this product : Dehydrated & dried foods -
Canned foods
Low-acid canned and acidified foods in metal or glass.
Assess this product : Canned foods -
Shelf-stable foods
Sauces, salsas, jams, grains, snacks and bakery.
Assess this product : Shelf-stable foods -
Retort & pouch products
Flexible pouches and autoclave (retort) processes.
Assess this product : Retort & pouch products -
Ready-to-eat foods
Prepared foods that are eaten without further cooking.
Assess this product : Ready-to-eat foods -
Beverages & juices
Juices, nectars and shelf-stable drinks.
Assess this product : Beverages & juices -
Ingredients & other foods
Ingredients, spices and products that do not fit above.
Assess this product : Ingredients & other foods
How we can help
The requirements depend on the product and the process. These are the ones we handle most often for food exporters.
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Food facility registration and renewal
Registration of the facility that manufactures, processes, packs or holds the food, and its renewal.
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U.S. Agent
Required for foreign food facilities.
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Labeling
Nutrition Facts, ingredients, allergens, net quantity and claims under 21 CFR 101.
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GMP and preventive controls
Readiness for 21 CFR 117: current good manufacturing practice and food safety plans.
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Canned, acidified and retort processes
Support with FCE registration and process filing for low-acid canned and acidified foods (21 CFR 108, 113, 114).
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Prior Notice and import support
Prior Notice for each shipment and what your U.S. importer will ask you for.
Listing a category here does not mean FDA approval of any product. Registration and compliance are evaluated product by product.
Key FDA regulations for food
| Reference | Topic | Why it matters |
|---|---|---|
| 21 CFR 1, Subpart H | Food facility registration | Who must register and renew, and the U.S. Agent requirement. |
| 21 CFR 1, Subpart I | Prior Notice of imported food | Advance notice to FDA before each shipment arrives. |
| 21 CFR 101 | Food labeling | Nutrition Facts, ingredient list, allergens, claims. |
| 21 CFR 117 | cGMP and preventive controls | How the facility must operate and control hazards. |
| 21 CFR 108, 113, 114 | Low-acid canned and acidified foods | Establishment registration and process filing for canned, retort and acidified products. |
| 21 CFR 170 | Food additives | Whether each ingredient may be used in food for the U.S. |
Our process
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Regulatory assessment
We review your product, process and target market.
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Gap analysis
What is missing for the U.S., in order of priority.
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Compliance implementation
Registration, labels, documents and plant readiness.
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U.S. market readiness
Prior Notice and importer requirements before shipping.
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Ongoing support
Renewals, updates and questions within your scope.
Food export FAQs
Does my food facility need to register with FDA?
Facilities that manufacture, process, pack or hold food for consumption in the U.S. generally must register, with some exemptions such as farms. Foreign facilities also need a U.S. Agent. We confirm whether it applies to you.
How often is the registration renewed?
Food facility registrations are renewed every two years, between October 1 and December 31 of each even-numbered year.
Is registration the same as FDA approval?
No. Registration tells FDA who you are and where you operate. It does not mean FDA approves the facility or the products, which must still comply with the regulations.
What is Prior Notice?
An advance notice to FDA of each food shipment imported into the U.S., submitted before arrival with details of the product, manufacturer, shipper and importer.
Do canned or retort products have extra requirements?
Yes. Low-acid canned and acidified foods require FCE registration and process filing with FDA (21 CFR 108, 113 and 114), in addition to facility registration.
Not sure where your product fits?
Call or WhatsApp us with the product name and how it is packed. We will tell you which requirements apply.
Ready to take your food to the U.S.?
Tell us about the product and we will define the path with you.