It is a matter of your time and staying aware of new registration regulations. The FDA estimates it can take a domestic food facility up to three hours to understand the requirements, properly complete the Registration Form and then obtain the Registration Number. A domestic medical device facility can spend twelve hours, and a domestic drug company can spend weeks in navigating FDA's electronic gateway. In addition, a domestic facility must first create its own account with the FDA before it can process a registration.
The simplified login and form-completion process of FDA Agents eliminates the need to waste all your time and allows a domestic facility to complete the process in as little as a few minutes. FDA Agents' nominal fee allows the domestic facility to save management time and concentrate on its core business. And a simple email to us and we can make any changes or amendments you might need, always for free. As one domestic client wrote us, "Thank you so much for getting this updated so quickly for us, Sandra! We appreciate it!" (Heidi B, Wisconsin)
Yes. You are still required to register if the law applies to your facility. In fact, without your very own FDA Registration Number, your products will not be allowed entry into the USA and makes you liable for civil and criminal liability. Your FDA Registration Number is required, and for foreign facilities and importers, on every shipment of the products into the USA under the "Prior Notice" program.
All domestic facilities are also required to register. Failure to register is a prohibited act under the law and subjects the domestic facility to prosecution and civil penalties.
Food/Beverages: 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"). Foreign manufacturers must also designate a U.S. Agent.
Medical Devices: Any company (both domestic and foreign), including initial distributors (importers), involved in putting medical devices in the USA commmercial marketplace must register their establishments with the FDA and must list their devices (importers do not have to list). In addition to registration, foreign establishments must also designate a U.S. Agent.
Drugs:Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Foreign establishments must also designate a U.S. Agent.
In addition, if the facility is located outside the United States, that facility is called a "foreign facility" and it must designate a U. S. FDA Agent. The U.S. FDA Agent can register the foreign facility.
Once registered, the facility will obtain an FDA Registration Number which must be given on every prior notice of a shipment of products into the United States.
In order to remain in compliance, every registration must be updated within sixty (60) days of any changes to the information previously submitted to the government. These include for example product changes and name or address changes.
Every new facility must register before its products can be placed into the nation's food supply. A facility ending its business with the United States must file a notice of cancellation.
A domestic facility may choose to use a professional U.S. Agent to handle the registration process, even though it is not required to appoint a U.S. Agent. It may want the services of a professional U.S. Agent for registration so that the domestic facility's registration gets handled, without losing the many hours needed to research and comply with this law. This permits the facility to focus on its central business and still be in compliance.
If you do not register and appoint a U.S. FDA Agent as required by the government of the United States, your product 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 and critical 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.
If your U.S. FDA Agent fails in any of these responsibilities to you, serious and grave consequences may result to your business, such as your products being refused entry into the United States. It is therefore critical that your U.S. FDA Agent be only in the business of serving as a U.S. FDA Agent.
In this way, your U.S. FDA Agent is always knowledgeable in the complicated and changing laws and regulations of the United States government. Your U.S. FDA Agent, paying attention to the requirements of this important responsibility, can provide immediate and proper attention to your facility.
Yes. Your U.S. FDA Agent must have the legal capabilities to fulfill its responsibilities to you, confidentially. The FDA issued a Statement dated November 21, 2003, concerning outbreaks of Hepatitis A in various U.S. States possibly associated with green onions coming in from certain Mexican food facilities. If your importer also served any of these facilities as their registered U.S. Agent, where do you think he will buy from in the future?
Your U.S. FDA Agent is required to be the communications intermediary between you and the United States government. Only a U.S. FDA Agent with responsibilities only to you and not otherwise involved in the import/export business can insure the confidentiality of your information.
Perhaps you have a niche market, or are seeking to exploit a niche market for your products. You cannot risk that a disclosure may be made, even inadvertently, or your trade secrets and confidential information used to your disadvantage, by an agent you selected who is in the same industry as you.
The federal government may send confidential information to you, transmitted by law through your U.S. FDA Agent. Or the federal government may want to ask questions of you about your products and suppliers, transmitted through your U.S. FDA Agent. Those questions and your answers, and even the fact that questions are asked, should stay secret and not be known by anyone who is in your same industry.
Your U.S. FDA Agent should be solely in the business of serving as U.S. FDA Agent so that you can know, as to this requirement, you have placed the responsibility in the hands of a professional company.
You already use other professionals to help your business: customs brokers, freight forwarders, logistics specialists. You do this because each is a specialist in that area; your U.S. FDA Agent is a specialist in this area of serving as your U.S. FDA Agent and registering your facility with the Food and Drug Administration.
The new 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 new 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. Read the Definitions
The threats posed by worldwide terrorism were made clear to the people of the United States on September 11, 2001. The federal government passed laws that required new systems for protecting the food supply of the country. By appointing your U.S. FDA Agent and your U.S. FDA Agent registering your facility, your facility can be immediately contacted in the event 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.
Your U.S. FDA Agent can register your facility with the United States Food and Drug Administration, as required under federal law.
Your registration must be in the English language. Your registration application must be thoroughly and properly completed, or the application for registration will be denied.
The government strongly advises that registration be done through the Internet. This way you will instantly receive your facility's registration number, which will be necessary for all your products to enter the United States.
Your U.S. FDA Agent will administer this for you so that you will be in compliance with federal law.
There may be facilities that will try to register by mail, although the United States government is not recommending it. In this case, the time period between a facility obtaining the application, completing it, mailing it to the United States government, the government checking it over and mailing the response back to the facility can be weeks and perhaps months. Your products will not be allowed entry into the United States until you have received the registration number. If there is any incompleteness in your application, the entire process starts all over again. Taking such serious risks to your business is not advisable.
The federal regulations require that foreign facilities must have a U.S. FDA Agent if they want to continue to export products into the United States. Your U.S. FDA Agent, whose primary business is the administration and coordination of your registration process and ongoing updating to the government, is the most efficient and safest way to proceed.
No. Upon registration, your 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.
Every new facility must register before its products can be placed into the nation's food supply. A facility ending its business with the United States must file a notice of cancellation. Filing the notice of cancellation is important to insure that there will be no problems in this regard should the facility re-start its business with the United States.
Your U.S. FDA Agent should administer and coordinate your compliance with this requirement. Once you advise your U.S. FDA Agent of the details of any changes, your U.S. FDA Agent will electronically submit the updated information to the Food and Drug Administration. Your U.S. FDA Agent will advise you of the submittal, and your facility will be in compliance.
If you are the owner, operator or person in charge of either a domestic facility (a facility in the United States) or a foreign facility (a facility not in the United States), and your facility manufactures, processes, packs or holds food, medical devices or drugs for the USA marketplace, your facility must register.
A foreign facility's U.S. Agent can register the facility.
"Facility" means any establishment, structure or structures at one general physical location, that manufactures, processes, packs or holds food 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.
"Food" also means beverages, including alcoholic beverages and bottled water.
"Food" also means 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.
"Manufacturing" (also "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.
"Packing" means placing, putting, or repacking food into different containers without making any change to the form of the food.
Your company and products must comply with the registrations BEFORE your shipments reach the USA Port of Entry. The FDA permits registration any time. The U.S. Agent can coordinate that time-critical application with you.
Your U.S. FDA Agent should be focused on the business of being a U.S. FDA Agent. Your U.S. FDA Agent must have the legal capabilities to fulfill its responsibilties to you.
The laws and regulations in this area change constantly. A professional U.S.FDA Agent focuses on those law and regulations and make sure you stay in full compliance with the law.
The requirements imposed on the U.S. FDA Agent mean that there should not be any potential conflicts of interest by, for example, being an importer, a distributor, a broker or any association.
The federal government may send confidential information to you through the U.S.FDA Agent. Or the federal government may send questions to you, transmitted through your U.S. FDA Agent, about your products or your suppliers. Your answers will be transmitted through your U.S. FDA Agent, and your answers are and should stay secret.
Your U.S. FDA Agent is required to be the communication intermediary between you and the United States Government. Only a U.S. FDA Agent with responsibilities only to you and not otherwise involved in the import business can insure the confidentiality of your information.
This is not information you want in the hands of your distributor, your importer, your broker or an association composed of your direct competitors, who could use the information to their advantage or the advantage of some other client of theirs. Even the knowledge by them that questions are being asked could by hurtful to your business.
FDA Agents' registration, listing and US Agent fee is a flat-fee, and includes at no extra charge registration processing, product listings, amendments whenever needed and US Agent services. Click "Fees" page in the Menu above for exact fees. All FDA Agents' fees are a simple, flat-fee, with all services and Certificate included.
As a professional in your business, you work diligently on behalf of all your many clients or members. You stay aware of all the laws, regulations and trends that affect your business. You realize that it takes only one small change in one regulation to adversely affect your clients' and members' businesses.
Professionals focus on one core business activity and use other professionals to handle related functions. If you are a broker, you use a freight forwarder; if you are an importer, you use a customs broker. Similarly, use of a professional company to serve as your U.S. FDA Agent, an agent whose function is to serve as a required communications link between your clients and members and the U.S. Food and Drug Administration, helps insure the full compliance with the new regulations.
You can help your clients and members by referring them to a professional firm with the background and expertise to register your clients and members with the FDA, as required under the new regulations, and that will serve as U.S. FDA Agent to your foreign clients and members.
A professional company serving as your U.S. FDA Agent focuses on complete awareness of the changing laws and regulations with respect to the registration of foreign facilities. This is critical, as should there be any failure to comply, your clients' or members' products will be denied entry into the United States.
Establishing a relationship of trust and confidence between you, your clients or members, and the U.S. FDA Agent helps everyone. You can know that your clients or members are in compliance with the new regulations; you can know that communications between the Food and Drug Administration and your clients and members are handled expeditiously and professionally. You can know that all such communications are treated confidentially and will not be disclosed to others or used for any wrongful purpose.