Food sold in the United States is required by law to comply with the Food and Drug Administration (FDA). The FDA is responsible to ensure food sold in the United States is safe, wholesome and properly labelled. This applies to foods produced domestically, as well as food from foreign countries.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) stipulated that the Food and Drug Administration (FDA) is the food regulatory agency of the Department of Health and Human Services, and are responsible to take steps to protect the public from any threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established the following regulations:

  • Food facilities must register with FDA, and

  • Importers must provide FDA advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at any time and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities to register with FDA and to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if 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, FDA may by order suspend the registration of a facility that:

  • Created, caused, or was otherwise responsible for such reasonable probability; or

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

Food Registration

The Bio-terrorism Act requires U.S FDA registration for domestic and foreign food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic or foreign food facility is required to register their facility with the U.S FDA.

Domestic facilities require FDA registration whether or not food from the facility enters interstate commerce. Foreign food facilities that manufacture/process, pack, or hold food would require U.S FDA registration (this is done through a U.S FDA Agent) unless food from that facility undergoes further processing (including packaging) by another foreign food facility before the food is exported to the U.S. However, if the subsequent foreign food facility performs only a minimal activity, such as putting on a label, both food facilities require U.S FDA registration. Acidified and low-acid food manufacturers require FDA food canning establishment (FCE) registration as well. All dietary supplement manufacturers also require U.S FDA registration.

Food Canning Establishment

All commercial acidified and low-acid canned food processors located in the United States and all processors in other countries who process acidified or low-acid canned food products for export to the United States must register with the FDA.

Processing plants must also submit process filing forms containing scheduled process information for each acidified and low-acid canned food produced, and must meet all other requirements of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labelling Act. Importers, wholesalers, distributors, brokers, etc. are excluded from the requirement to register.

What is acidified food?

“Acidified foods” are low-acid foods to which acid(s) or acid food(s) are added; they have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below .The definition of acidified foods provides that carbonated beverages and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of 21 CFR part 114 (21 CFR 114.3(b)).

What is Low-acid canned food?

A low-acid canned food has the following characteristics:

  • Equilibrium pH value greater than 4.6 and water activity greater than 0.85.

  • Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).

  • Receives a heat treatment for the purpose of achieving commercial sterility.

  • Normally stored and distributed under non-refrigerated conditions.

Food Labelling

Food labelling is required for all prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labelling for raw produce (fruits and vegetables) and fish is voluntary. Under FDA’s laws and regulations, FDA does not pre-approve labels for food products “labelling” is defined by the U.S. Federal Food, Drug and Cosmetic Act (FFDCA) as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

Agent Services

It is a FDA regulatory requirement that any foreign establishments which manufacture, process, pack, or hold food should identify a U.S FDA Agent at the time of FDA registration. In an emergency the FDA will contact the U.S FDA Agent and it will be considered as a FDA contact for the registered foreign establishment. U.S FDA Agent acts as the point of contact for US FDA to the registered foreign establishment.

Foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to have an FDA agent. The US FDA agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. FDA agent cannot use a post office box as an address. U.S. FDA agent must be available to answer the phone or have an employee available to answer the phone during normal business hours. The FDA agent acts as a communications link between US FDA and the food facility for both routine and emergency communications.

As your FDA Food Agent, Primary Solutions PLT will assist you in:

  • food facility Registration

  • Issuing prior notice to US FDA

  • Providing consultancy on food product labelling as required by FDA standards.

Prior Notice

FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is excluded from Prior Notice. FDA must electronically receive and confirm Prior Notice before a food shipment arrives at the first port in the United States (port of arrival). The deadline for submitting Prior Notice depends on the mode of transportation used for shipment.


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