FAQ

All foreign and domestic Food, Beverage, Dietary Supplement companies whose products are marketed in the USA must have their company registered and their products listed with the FDA. All foreign companies additionally must have a designated US Agent. If this is not done, the shipments will not only be denied entry into the USA but domestic and foreign companies will be subject to criminal and civil penalties.

Yes. You are required to register if the law applies to your facility or products before your products enter the USA marketplace. Unless you have your own unique US FDA Registration account and number, your products will not be allowed entry into the USA and you will be liable for civil and criminal penalties. All domestic facilities are also required to register with the FDA. Failure to register is a prohibited act under the law and subjects the domestic facility to prosecution and civil penalties. Domestic facilities importing any products that are required by law to be registered with the FDA must have their own unique US FDA Registration account and number or the shipment will be denied entry, even if the foreign company is already registered.

Food/Beverages/Dietary Supplements: Every owner, operator or person in charge of a facility that manufactures, processes, packs or holds food or beverages for human or animal consumption in the United States must register that facility with the United States government’s Food and Drug Administration (“FDA”) and list the products. Foreign manufacturers must also designate a U.S. Agent.

If you do not register and appoint a US Agent as required by the government of the United States, your shipment will not be allowed into the United States. Your product will be held at the port of entry, and you will be fully responsible for arranging and paying for all storage, transportation and posting of bond. If you do not register and appoint a U.S. FDA Agent as required by the government of the United States, you will have committed a prohibited act. The federal government can bring criminal actions in federal court to prosecute, and the federal government can prevent you from ever again exporting to the United States. If you are a domestic facility and do not register, you too will have committed a prohibited act. The federal government can bring both civil and criminal charges against you.

The United States Food and Drug Administration has placed significant responsibilities on your U. S. FDA Agent. Firstly, if you are a foreign facility, you are required by law to appoint a U.S. FDA Agent. Your U.S. FDA Agent will administer the registration of your facility with the federal government. Your U.S. FDA Agent is deemed the emergency contact with the FDA, unless you choose to name another. Your U.S. FDA Agent is required under federal regulations to assist the Food and Drug Administration in communication with your facility. Your U.S. FDA Agent will transmit your responses to questions from the United States government which you are required to answer, concerning your products that are imported into the United States. Your U.S. FDA Agent will communicate with you in scheduling inspections that may be required by the United States Food and Drug Administration. Your U.S. FDA Agent will be required to receive information or documents from the United States Food and Drug Administration and send the information or documents to you.

The term and requirement for a “U.S. Agent” is very specific in the new regulations and does not refer to any agent you might already have for customs or other import purposes. It is a term referring to a person/company with very different duties and responsibilities. It is the FDA’s contact in cases of emergency or possible terrorist threat. By designating your U.S. FDA Agent and by your U.S. FDA Agent registering your facility, The United States government can immediately contact your facility via your U.S. FDA Agent or directly in the event that the United States government learns of potential problems. In addition, your U.S. FDA Agent will act as a required link between your facility and the federal government.

No. Upon registration, your food or beverage facility will be given an FDA Registration Number. This Registration Number must be given on every prior notice of every single shipment of your facility’s products into the United States. In addition, the laws and regulations of the United States government require the owner, operator or person in charge to update a registration within sixty (60) calendar days of any change to the information previously submitted. Changes include for example product changes or name and address changes. US FDA requires bi-annual registration renewal compliance for Food, Beverage and Dietary Supplement companies. US Agent compliance renewal is required annually under Standard Terms.

Go to the “FDA Registration” page on our site, complete the registration application. It takes about ten-twenty minutes. Registration is completed within one to two days. If for example your shipment is held in Customs until you are registered, rush service is available without extra charge.

Your company and products must comply with the registration requirement BEFORE your shipments reach the USA Port of Entry. The US FDA requires registration any time before your products enter or are in the US marketplace.

A “Facility” is an establishment, structure or structures at one general physical location, that manufactures, processes, packs or holds food or beverage for consumption in the United States. If your business is conducted out of more than one location, your U.S. Agent must obtain a registration number for each separate location.

Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, food and feed ingredients and additives, infant formula, live food animals, bakery goods, snack foods, candy, and canned foods. “Food” also means the substances that migrate into food from food packaging and other articles that may contact food. As well as beverages, including alcoholic beverages and bottled water. This includes pet food and the components or products that go into making food.

 “Holding” means the storage of food. Examples include warehouses, cold storage facilities, storage silos, grain elevators and liquid storage tanks

“Packing” means placing, putting, or repacking food into different containers without making any change to the form of the food.

“Manufacturing”/ ”Processing” means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples include cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling or packaging.