Food Facility Registration - USFDA Compliance

Animal Food and Feed Canned Food Dietary Supplements Enregistrement FDA FDA Compliance FDA Detention FDA Inspections FDA Labels FDA Prior Notice FDA Registratie FDA Registration FDA Registration Renewal FDA Registrierung FDA Service Fees Food Foreign Supplier Verification Programs U.S. Agent March 31, 2023

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 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).