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FOOD FACILITY

FDA REGISTRATION

For Companies in the United States and around the World

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FOOD FACILITY REGISTRATION

The United States imports food, feeds, and beverages worth more than $199 billion.

Before you consider exporting cocoa beans, cocoa powder, cocoa butter, cocoa nibs, cocoa liquor, chocolate, coffee, tea, wine, beer, champagne, soft drink, vegetable oil, spice, rice, cheese, sugar, nuts and any other food products, you must first register your facility or establishment with the U.S. Food and Drug Administration (FDA).

When the FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the FDA may by order suspend the registration of a facility that:

▪ Created, caused, or was otherwise responsible for such reasonable probability.

▪ Knew of, or had reason to know of, such reasonable probability, and packed, received, or held such food.

FOOD FACILITY DEFINED

Food Facilities include:

▪ Manufacturer, Processor.
▪ Warehouse, Holding Facility.
▪ Packer, Repacker.
▪ Labeler, Relabeler.
▪ Contract Sterilizer.
▪ Salvage Operator.
▪ Animal Food Manufacturer, Processor.
▪ Trading Company.
▪ Dietary Supplements Manufacturer, Processor, Exporter, Importer.

Establishments that meet the definition of a primary production farm, secondary activities farm, retail food establishment, restaurant, or nonprofit food establishment, are not required to register.

Farm mixed-type facilities, must register.

U.S. AGENT REQUIREMENT

Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is required to appoint one, such as ITB HOLDINGS LLC, as part of the registration process.

What a U.S. Agent is not?

  • Commercial Agent
  • Customs Broker
  • Initial Importer
  • Importer of Record
  • FSVP Importer
FDA U.S. Agent
FDA REGISTERED FOREIGN FOOD COMPANIES

Registered Facilities as of January 9, 2023

Domestic (U.S.) registrations: 84,494

Foreign registrations: 198,232

Total: 282,726

Here is the list of Foreign Registered Facilities by Country:

Country

Total

Afghanistan 32
Albania 96
Algeria 57
Andorra 3
Anguilla 1
Antigua and Barbuda 2
Argentina 1,438
Armenia 197
Aruba 5
Australia 1,474
Austria 601
Azerbaijan 22
Bahamas 25
Bahrain 15
Bangladesh 146
Barbados 27
Belarus 37
Belgium 640
Belize 32
Benin 12
Bermuda 2
Bhutan 2
Bolivia 113
Bosnia and Herzegovina 55
Botswana 3
Brazil 2,272
Brunei 2
Bulgaria 362
Burkina Faso 6
Burma 115
Burundi 11
Cambodia 39
Cameroon 37
Canada 5,680
Cape Verde 0
Cayman Islands 3
Chad 4
Chile 1,448
China 9,764
Colombia 1,565
Comoros 6
Congo 4
Congo (DRC) 20
Costa Rica 540
Cote d’Ivoire 100
Croatia 208
Curacao 6
Cyprus 68
Czechia 227
Denmark 282
Djibouti 4
Dominica 2
Dominican Republic 453
East Timor 0
Ecuador 1098
Egypt 388
El Salvador 237
Estonia 54
Eswatini 10
Ethiopia 252
Falkland Islands (Malvinas) 5
Faroe Islands 33
Fiji 103
Finland 94
France 10,455
French Guiana 2
French Polynesia 16
Gambia 6
Georgia 239
Germany 2,204
Ghana 159
Greece 1,237
Greenland 47
Grenada 38
Guadeloupe 6
Guatemala 652
Guinea 19
Guinea-Bissau 1
Guyana 54
Haiti 77
Honduras 328
Hong Kong 456
Hungary 273
Iceland 155
India 4,217
Indonesia 989
Iran 22
Iraq 55
Ireland 308
Isle Of Man 1
Israel 558
Italy 10,026
Jamaica 212
Japan 9,949
Jersey 1
Jordan 168
Kazakhstan 26
Kenya 176
Kiribati 2
Korea 0
Korea (south) 3,939
Kosovo 17
Kuwait 7
Kyrgyzstan 8
Laos 9
Latvia 99
Lebanon 205
Lesotho 3
Liberia 13
Liechtenstein 4
Lithuania 137
Luxembourg 22
Macau 9
Macedonia 0
Madagascar 103
Malawi 28
Malaysia 591
Maldives 13
Mali 8
Malta 5
Marshall Islands 4
Martinique 14
Mauritania 5
Mauritius 33
Mexico 7,552
Micronesia 2
Moldova 88
Monaco 9
Mongolia 6
Montenegro 7
Morocco 333
Mozambique 30
Myanmar 0
Namibia 15
Nepal 91
Netherlands 957
New Caledonia 2
New Zealand 1,162
Nicaragua 247
Nigeria 587
North Macedonia 73
Northern Mariana Islands 0
Norway 388
Oman 25
Pakistan 371
Palau 0
Panama 173
Palestinian Territory 0
Papua New Guinea 43
Paraguay 116
Peru 1,150
Philippines 675
Poland 897
Portugal 1049
Qatar 4
Reunion 23
Romania 141
Russia 1,061
Rwanda 42
Saint Barthelemy 1
Saint Helena, Ascension 3
Saint Kitts and Nevis 1
Saint Lucia 27
Saint Vincent & Grenadines 16
Samoa 11
San Marino 5
Sao Tome and Principe 0
Saudi Arabia 76
Senegal 42
Serbia 227
Seychelles 8
Sierra Leone 24
Singapore 230
Sint Maarten 1
Slovakia 83
Slovenia 176
Solomon Islands 4
Somalia 1
South Africa 963
Spain 4,611
Sri Lanka 350
Sudan 45
Suriname 20
Swaziland 0
Sweden 171
Switzerland 380
Syria 77
Taiwan 1,852
Tajikistan 3
Tanzania 100
Thailand 1,355
Timor-Leste 7
Togo 31
Tonga 9
Trinidad and Tobago 89
Tunisia 147
Turkey 1,480
Turkmenistan 1
Turks and Caicos Islands 3
Uganda 90
Ukraine 527
United Arab Emirates 214
United Kingdom 1,707
U. S. Minor Outlying Islands 0
Uruguay 123
Uzbekistan 45
Vanuatu 15
Venezuela 184
Viet Nam 1,814
Virgin Islands 11
West Bank 17
Western Sahara 1
Yemen 42
Zambia 16
Zimbabwe 13
FDA & CANADIAN FOOD INSPECTION AGENCY (CFIA)

Canada’s three largest cities, Toronto, Montreal and Vancouver account for 75% of national economic activity and population. Approximately 90% of Canadians live within 100 miles of the U.S. border.

Nearly $130 million in food and agricultural products cross the U.S-Canada border every day.

The United States-Mexico-Canada agreement (USMCA) entered into force on July 1st, 2020.

However, Canadian food companies must register with the United States Food and Drug Administration (U.S. FDA).

Furthermore, Canadian food businesses that export products which are under the scope of the Food Safety Systems Recognition Arrangement (FSSRA), require a licence issued by the Canadian Food Inspection Agency (CFIA).

Ready to join businesses around the world?
You could click on the link below for additional information.

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