U.S. FDA Registration & Labeling Compliance Assistance

U.S. FDA Facility Registration for Food, Beverage and Dietary Supplements 

According to the United States Food and Drug Administration FDA, all facilities that manufacture, process, pack and store food, beverage and dietary supplements that are marketed in the U.S. must register with FDA. In order to be registered, companies that are based outside the U.S. must have a U.S. agent assigned that will be FDA's primary point of contact on behalf of a foreign company. 

Related 2022 Update: FDA is requiring food facilities to obtain DUNS number prior to registration.  

Importance of U.S. FDA Agent

The U.S. agent may be called upon to speak with FDA in regards to the registered facility. This can be a time-sensitive matter. Hence it is crucial that the U.S. agent understands the FDA regulations and is able to advise the foreign company on FDA requirements that must be followed. Furthermore, having an independent U.S. Agent will prevent a potential conflict of interest that can appear when assigning a business partner as U.S. Agent.

FDA Listing Inc. provides FDA food facility registration and can act as U.S. Agent to Non-US companies that are already in the market or intending to enter the U.S. market. If you are already FDA registered and have a FDA registration number click here to renew your registration.

FDA Registration Certificate

After the registration is complete a registered facility will be allocated a 11 digit FDA registration number from FDA. The FDA registration number will identify your firm with FDA as well as assist you in the custom clearance process. U.S. FDA does not issue any certificate however, as a third party firm, FDA Listing Inc. will provide you with a certificate of FDA registration (see the sample here) that can be used as FDA registration confirmation. The FDA registration certificate is good for one year and copy of the FDA registration certificate can be used as a proof of registration before U.S. custom, importers, distributers and other commercial outlets. If you are already registered and need to order a certificate of FDA registration please click here.

Shipment's Prior Notice with FDA:

U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).