Frequently asked questions
Straight answers to the questions we hear most from food businesses preparing for the U.S.
Does FDA approve my food?
Generally, no. FDA does not approve food products before they are marketed, and it does not approve individual food labels. Certain ingredients, such as food additives, require FDA review. Labels must be truthful and not misleading. No one — including us — can make your food "FDA approved."
Will I receive an FDA registration certificate?
No. FDA does not issue certificates of registration, and FDA does not recognize certificates issued by private businesses. What FDA issues is a registration number. We do not issue any registration certificate either.
Does FDA charge a registration fee?
No. FDA does not charge a fee for food facility registration. Fees on this website are for our administrative support services only.
Do I have to use a service like yours?
No. Facilities may register directly with FDA and are not required to use a third party. Businesses use services like ours for help with preparation, language, U.S. Agent service, and Nutrition Facts.
What is a U.S. Agent?
A U.S. Agent is a U.S.-based point of contact that acts as a communications link between FDA and a foreign food facility. Foreign facilities must designate one to register. A U.S. Agent is not an FDA representative, and U.S. Agent service is not FDA approval or certification.
Why hasn't my registration number been issued yet?
For foreign facilities, FDA verifies that the designated U.S. Agent has agreed to serve before confirming registration and issuing a registration number. Accurate facility name and address information helps this step go smoothly.
What is a DUNS number and why is it needed?
A DUNS number is a unique identifier issued by Dun & Bradstreet. FDA requires a Unique Facility Identifier (UFI) for food facility registration and recognizes the DUNS number as acceptable. The name and address registered with the DUNS number should match your facility information.
How often must registration be renewed?
Registration must be renewed every other year, during the renewal period from October 1 to December 31 of each even-numbered year. Registrations not renewed by the deadline are considered expired.
We're a trading company. Do we need to register?
Traders and brokers that do not manufacture, process, pack, or hold food are generally not required to register. However, the facility that does may need to. We can help you confirm your supplier facility's status.
Is the Nutrition Facts information you prepare guaranteed to be compliant?
We prepare Nutrition Facts information based on the information you provide. Final labeling requirements may vary depending on the product, serving size, formulation, applicable FDA requirements, and other regulatory considerations. FDA does not pre-approve labels.
Is my product exempt from Nutrition Facts?
Some exemptions exist. For example, FDA's small business (low-volume) exemption applies when a firm has fewer than an average of 100 full-time equivalent employees and sells fewer than 100,000 units of the product in the U.S. in a 12-month period. A notice must be filed with FDA every year, and the exemption is not available if the label or advertising makes nutrition claims. Eligibility depends on your business and product — please confirm with FDA or ask us to review your situation.
Still have questions?
Tell us about your product and we'll help you identify the next step.