Scroll Top
FOOD FACILITY

FDA REGISTRATION

For Companies in the United States and around the World

232
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

Afghanistan32
Albania96
Algeria57
Andorra3
Anguilla1
Antigua and Barbuda2
Argentina1,438
Armenia197
Aruba5
Australia1,474
Austria601
Azerbaijan22
Bahamas25
Bahrain15
Bangladesh146
Barbados27
Belarus37
Belgium640
Belize32
Benin12
Bermuda2
Bhutan2
Bolivia113
Bosnia and Herzegovina55
Botswana3
Brazil2,272
Brunei2
Bulgaria362
Burkina Faso6
Burma115
Burundi11
Cambodia39
Cameroon37
Canada5,680
Cape Verde0
Cayman Islands3
Chad4
Chile1,448
China9,764
Colombia1,565
Comoros6
Congo4
Congo (DRC)20
Costa Rica540
Cote d’Ivoire100
Croatia208
Curacao6
Cyprus68
Czechia227
Denmark282
Djibouti4
Dominica2
Dominican Republic453
East Timor0
Ecuador1098
Egypt388
El Salvador237
Estonia54
Eswatini10
Ethiopia252
Falkland Islands (Malvinas)5
Faroe Islands33
Fiji103
Finland94
France10,455
French Guiana2
French Polynesia16
Gambia6
Georgia239
Germany2,204
Ghana159
Greece1,237
Greenland47
Grenada38
Guadeloupe6
Guatemala652
Guinea19
Guinea-Bissau1
Guyana54
Haiti77
Honduras328
Hong Kong456
Hungary273
Iceland155
India4,217
Indonesia989
Iran22
Iraq55
Ireland308
Isle Of Man1
Israel558
Italy10,026
Jamaica212
Japan9,949
Jersey1
Jordan168
Kazakhstan26
Kenya176
Kiribati2
Korea0
Korea (south)3,939
Kosovo17
Kuwait7
Kyrgyzstan8
Laos9
Latvia99
Lebanon205
Lesotho3
Liberia13
Liechtenstein4
Lithuania137
Luxembourg22
Macau9
Macedonia0
Madagascar103
Malawi28
Malaysia591
Maldives13
Mali8
Malta5
Marshall Islands4
Martinique14
Mauritania5
Mauritius33
Mexico7,552
Micronesia2
Moldova88
Monaco9
Mongolia6
Montenegro7
Morocco333
Mozambique30
Myanmar0
Namibia15
Nepal91
Netherlands957
New Caledonia2
New Zealand1,162
Nicaragua247
Nigeria587
North Macedonia73
Northern Mariana Islands0
Norway388
Oman25
Pakistan371
Palau0
Panama173
Palestinian Territory0
Papua New Guinea43
Paraguay116
Peru1,150
Philippines675
Poland897
Portugal1049
Qatar4
Reunion23
Romania141
Russia1,061
Rwanda42
Saint Barthelemy1
Saint Helena, Ascension3
Saint Kitts and Nevis1
Saint Lucia27
Saint Vincent & Grenadines16
Samoa11
San Marino5
Sao Tome and Principe0
Saudi Arabia76
Senegal42
Serbia227
Seychelles8
Sierra Leone24
Singapore230
Sint Maarten1
Slovakia83
Slovenia176
Solomon Islands4
Somalia1
South Africa963
Spain4,611
Sri Lanka350
Sudan45
Suriname20
Swaziland0
Sweden171
Switzerland380
Syria77
Taiwan1,852
Tajikistan3
Tanzania100
Thailand1,355
Timor-Leste7
Togo31
Tonga9
Trinidad and Tobago89
Tunisia147
Turkey1,480
Turkmenistan1
Turks and Caicos Islands3
Uganda90
Ukraine527
United Arab Emirates214
United Kingdom1,707
U. S. Minor Outlying Islands0
Uruguay123
Uzbekistan45
Vanuatu15
Venezuela184
Viet Nam1,814
Virgin Islands11
West Bank17
Western Sahara1
Yemen42
Zambia16
Zimbabwe13
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.

QUESTIONS?

    Related Posts

    Leave a comment

    You must be logged in to post a comment.