FAQ Read the entire FDA rule here


Why is the FDA adding this requirement?
What are the major components of the Bioterrorism Act?
What is a facility?
Do we need a US agent?
What if the FDA changes the reporting requirements?
Do I have to remember to come back to your site periodically?
What are the penalties for not registering?
Why should I pay RLS to help me register?
What if I don`t understand what the FDA is asking for?
What are the terms and conditions for using this site?
What is your pricing structure?
What is our agreement if I choose you to be my US Agent?
Why is my certificate only valid for 60 days?
How can I view my registration on the FDA website?
 
Why is the FDA adding this requirement?
For the purposes of the Food Facility Registration System, the FDA defines a ‘‘facility’’ as any establishment, structure, or structures under one management at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.

What are the major components of the Bioterrorism Act?
  • The owner, operator, or agent in charge of a facility is responsible for submitting the registration form to FDA;
  • The registration form must include the name and address of each facility at which, and all trade names under which the registrant does business, the registrant conducts business. Foreign facilities also must include the name of the U.S. agent for the facility;
  • FDA also may require each facility to submit the general food or feed category of the food or feed manufactured, processed, packed, or held at the facility. FDA plans to require this;
  • Foreign facilities exporting food or feed to the United States are required to register unless the food undergoes further processing or packaging by another facility outside the United States;
  • Facilities excluded from the registration requirement are: farms, restaurants and other retail facilities, nonprofit food establishments in which food is prepared for or served directly to the consumer, and fishing vessels (except those engaged in processing as defined in the requlations);
  • FDA will notify the registrant when it has received the registration and assign a unique registration number to each registered facility. This number is not subject to public disclosure under the Freedom of Information Act;
  • FDA will encourage electronic registration; and
  • Registered facilities must notify FDA in a timely manner of any change to their registration information.
What is a facility?
For the purposes of the Food Facility Registration System, FDA defines a ‘‘facility’’ as any establishment, structure, or structures under one management at one general physical location which manufactures, processes, stores or receives food or feed. In the case of a mobile facility, traveling to multiple locations, that manufactures or processes, packs, or holds food or feed for consumption in the United States, the rules are the same.

Do we need a US agent?
Yes, the Bioterrorism Act specifically requires a US agent for foreign facilities – “Foreign facilities also must include in their registration the name of the U.S. agent for the facility.”

What if the FDA changes the reporting requirements?
Should the FDA change reporting requirements, RLS will contact you requesting the additional information. There is no need for you to try to stay “up-to-date” on the current status of the FDA’s requirements, we do it for you.

Do I have to remember to come back to your site periodically?
No. Just make sure you check your email. We will send you requests for more information if the FDA increases the reporting requirements. We will also check with you periodically to make sure the information you originally provided is still current.

What are the penalties for not registering?
Failure of either domestic or foreign facilities to register is considered a prohibited act. The United States can bring a civil action in Federal court to enjoin persons who commit a prohibited act and can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. Under the Bioterrorism Act, FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States.

Why should I pay RLS to help me register?
There are several reasons for using RLS to help register your facility. First, it is likely that the FDA will change the reporting requirements before the rule is finalized. By registering with us, you transfer the burden of staying current with FDA rules to us. We will check for new requirements and come to you if more information is needed. Secondly, many companies have multiple facilities. Non-reporting by just one of these facilities could cost your organization dearly. Our reporting system helps you keep tabs on which facilities are registered. Additionally we help guide you through the submission process by making sure you provide all information required by the FDA. Should you submit on paper, and leave a required element blank, it could take months for you to be notified by FDA that your submission was not accepted. This could mean that products coming from your facility may be recalled from the market! Finally, we maintain a record of your submission, thereby providing third-party verification of your submission.

What if I don`t understand what the FDA is asking for?
If you`re confused by any of the questions, you may contact us by phone or email. We are here to help.

What are the terms and conditions for using this site?
By entering the Registration & Licensing Systems, Inc. site for registration of your facility with FDA the submitter certifies that the information entered herein is accurate and that the submitter has authority to register on the owner`s behalf. You acknowledge that this information is of extreme importance in connection with the United State Government`s effort to confront bioterrorism threats. You agree to indemnify and hold Registration & Licensing Systems, Inc. and our officers, directors, agents and employees harmless from any claim or demand made by the United States Government or any third party due to or arising out your failure to submit accurate information.

What is your pricing structure?
The current pricing is $399 per facility per calendar year; subsequent Renewals are $150 per facility per calendar year and US Agent Fee is $250 per facility per calendar year.

What is our agreement if I choose you to be my US Agent?
You can view our Agent Agreement here.

Why is my certificate only valid for 60 days?
The Bioterrorism Act which directed the FDA to establish the Food Facility Registrations also requires that the FDA be notified of any changes that occur at a facility within 60 days. This usually means a change of email addresses or telephone numbers, the additional of a new line of food products, or the change of an emergency contact.

We took this into consideration when we designed our system. We send out an email notice every 60 days, two weeks before the expiration of the Certificate, asking for confirmation that all the important information in the registration is unchanged. The email also gives the client a chance to update any information. In either case, the client then gets a new Certificate valid for the next 60 days. This happens six times each year and guarantees that you are compliant with all FDA requirements.

How can I view my registration on the FDA website?
If you create an account on the FDA website, you can "associate" your registration with that account using the Registration Number and PIN Number that we sent you.

How can I view my registration on the FDA website?
"The simple online way to comply with regulatory requirements!"

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