Under the FDA food law known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 food facility registration is required to certain food facilities as well as providing FDA advanced notice of shipments carrying imported foods. Under the food laws domestic and food facilities that manufacture, process, pack or hold food for human or animal consumption must provide a FDA registration.
Foreign FDA registration is required in specific instances depending on what process of manufacturing is occurring in the particular facility. There are situations where the “primary” facility must register and there are situations where both the primary and secondary facilities must register.
Foods that are included and result in the requirement of food facility registration include dietary supplements, beverages, infant formulas, fruits and vegetables, dairy products, raw agricultural commodities, bakery goods, and many more. There are also a few exclusions as to what foods require FDA registration.
Foreign facilities must designate a US agent, who maintains a location in the US and is physically present in the US.
The purpose of the facility registration requirement is to provide FDA with the location and source of potential bioterrorism incident or an outbreak of food-borne illness as well as allow FDA to quickly notify any facilities that may be affected.
Failure to register is prohibited under US regulations. The federal government may bring a civil action, or it may bring a criminal action to prosecute persons who are responsible for the commission of a prohibited act. Furthermore, a foreign facility that fails to register will not be able to pass US Customs. The food product will be detained by FDA or Customs and Border Protection Services.
The repercussions of failing to register are widespread and can have a direct impact on your company's ability to conduct business. Be sure your facility is registered before going to market.