FDA Food Registration Process
FDA registration is a legal requirement for all food, beverage, and dietary supplement companies under the US Bioterrorism Act of 2002. It is designed to ensure that such facilities selling products in the USA are known to FDA.
Global Import Agent offers a low-cost FDA Registration Service which is designed to ensure that facilities are correctly registered with FDA. This helps avoid problems with customs clearance due to incorrect registration. We achieve this goal by:
- Correctly identifying which food facilities in the supply chain need to register
- Gathering the relevant information to ensure that we can complete the registration
- Issuing a Certificate of Registration to the client
- Keeping the FDA Registration up to date as and when required
Registering with FDA includes an obligation to submit to facility inspection by FDA so that the product safety and bioterrorism requirements defined in US law can be assessed for compliance. By registering with FDA, you must agree that FDA may visit and inspect your facility and agree to make any changes required to your processes, or product, if FDA require it. Otherwise, FDA may suspend a facility registration and prevent export of products from that facility to the USA.
Who Needs to Register with FDA?
The FDA states that:
“Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDA.”
The purpose of this is to help FDA to:
- Determine the location and source of a potential bioterrorism incident,
- Determine the location and source of an outbreak of food-borne illness; and
- Quickly notify facilities and other affected parties.
This rule applies to both US based facilities and facilities operating outside the USA who export their products to the USA.
If FDA determines that product(s) manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may suspend the registration of a facility that:
- Created, caused, or was otherwise responsible for such reasonable probability; or
- Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
Registration Agent:
As part of the FDA Registration process, there is an option to enter the details of an appointed Agent to represent you on behalf of the FDA. In addition, you may also be required to have an FSVP (Foreign Supplier Verification Program) in place. Global Import Agent can act as your Registration Agent and as your FSVP Agent.
Appointing an FSVP Agent means that the FSVP Agent takes on the legal responsibility for the compliance of the overseas facility.
Who Must Register with FDA?
In many cases there may be more than one facility involved in producing a food, beverage, or dietary supplement product. For example, a processor may process in bulk and send to a packer who then packs and labels the product with their brand or the brand of a third-party brand owner. It is important to understand who needs to register with FDA in these cases. This is explained by FDA guidance below:
| Situation | Who must Register with FDA |
|---|---|
| 1. A foreign facility that manufactures, processes, packs, or holds the food sends it to another foreign facility for further manufacturing/processing (including packaging) before the food is exported to the U.S. | Only the second foreign facility is required to register with respect to that food. |
| 2. The second foreign facility performs only a minimal activity, such as putting on a label | Both facilities must register |
| 3. Any foreign facility packs or holds food after the last foreign manufacturer/processor of the food | The foreign packer or holder must also register (in addition to the last foreign manufacturer/ processor). |
| 4. A wholesaler in a foreign Country who buys products and sells them in the USA. | The warehouse must register and in addition each of the manufacturers of the products also need to be registered (it is important to know this before selling products). |
About Global Import Agent:
Global Import Agent is a team of industry leading FDA compliance import experts who understand how to help our clients get safe, high quality, profitable food products to market in the USA. Our team is a unique combination of food safety, legal, import and FDA compliance experts who can help companies overcome compliance barriers to trade, reducing regulatory risks and unexpected costs. At the heart of our operation, we have invested heavily in cloud technology to streamline and automate the documentation and assessment processes to ensure that compliance does not need to be a barrier to trade.
If our services are of interest, please get in touch using the contact form on this page to arrange a short call to discuss your situation.