FDA facility registration: what buyers should know

US FDA food facility registration is a mandatory filing for any facility that manufactures, processes, packs or holds food that will be consumed in the United States, including facilities outside the country. It has to be renewed every two years, and it is not a certification, an approval or an inspection by the FDA. This article is for buyers and importers who want to read that registration correctly when it appears in a Vietnamese supplier's documents.

What facility registration is

The requirement dates from US food security legislation passed in 2002 and was tightened by the Food Safety Modernization Act, known as FSMA. The idea is simple: the FDA wants to know where food entering the United States is made, so that it can trace the source if something goes wrong. A facility files its name, address, the categories of food it handles and its activities through the FDA's online system. There is no fee.

For a facility outside the United States there is one more requirement: a US agent, a person or company located in the United States that the FDA can contact when needed. This is usually a paid service, and it is a detail worth asking about.

Where registration differs from approval

This is the most common misunderstanding, among sellers and buyers alike. FDA facility registration does not mean:

• That the FDA has inspected the facility. Registration is a declaration, not an audit.
• That the FDA has approved the product. The FDA does not approve ordinary foods before sale.
• That the product meets any particular safety standard. Compliance remains the responsibility of the facility and the importer.
• That anyone may print FDA approved or an FDA logo on the pack. The FDA prohibits using registration to suggest approval.

In short, registration is a condition for getting food in, not evidence that the food is good. A food safety management certificate such as ISO 22000 is a different matter, assessed by an independent certification body.

The renewal cycle and what travels with it

Under the current rules, registration must be renewed every two years, in a window at the end of even-numbered years. A facility that misses renewal is treated as unregistered, and its shipments can be held at the port. Buyers should check this periodically, not only once at contract signing. We recommend reading the dates and procedure on the FDA's official website, because rules change.

Two other obligations travel with registration and are easily forgotten:

• Prior Notice for every shipment: the exporter or its agent must notify the FDA in advance of each consignment of food about to arrive.
• The Foreign Supplier Verification Program, known as FSVP: the US importer is responsible for verifying that its foreign suppliers produce food safely. In practice the buyer will need records from us, and we have to be ready to provide them.

What a buyer should check

The FDA does not publish a public list of registered facilities, so a buyer has to ask the supplier directly. Four things worth asking for:

• Confirmation that the registration is current, with the date of the latest renewal.
• Whether the facility name and address on the registration match the place where the food is actually made. For a brand made at a partner facility, the registration must belong to that facility, not to the brand owner.
• The US agent details.
• How the supplier describes the registration in its documents. Anyone writing FDA approved has misunderstood it, or is choosing to.

At Color of Vietnam, our partner facilities hold US FDA food facility registration. We write exactly that in the documents we send buyers: the registration belongs to the manufacturing facility, together with its current status. We do not write FDA approved anywhere, and if a buyer asked us to for the sake of easier selling we would decline. We also say plainly that we are preparing for export and have not announced any market yet.

FDA labelling: the work that remains after registration

Registration covers the facility. The product is covered by the label. Food sold in the United States needs an English label with a Nutrition Facts panel in the FDA format, an ingredient list, an allergen declaration following the US list of major allergens, net quantity in both US customary and metric units, and the name and address of the responsible party. For nut bars and snacks, the allergen section, covering cashews, peanuts, milk, soy and wheat among others, needs a careful review.

This work should start early, because a US label is usually a separate print run, and who pays for it is a question to settle before the first order.

If you are a US importer, or you are building an FSVP file and need records from a Vietnamese supplier, get in touch. We will send a copy of the manufacturing facility's registration, the related certificates and samples.