A brand owner with a US buyer lined up usually discovers this requirement late, and it stops the shipment rather than delaying it. Food arriving in the United States from a facility that is not registered with the FDA can be refused at the port.
D&O completed its own FSMA food facility registration recently, so this is written from having gone through it rather than from reading about it.
What is FDA food facility registration?
Under the US Food Safety Modernization Act (FSMA), any facility that manufactures, processes, packs or holds food for consumption in the United States must register with the FDA — including facilities outside the US. The facility receives a registration number, and shipments from an unregistered facility can be refused entry.
Two things it is not:
- It is not an approval. The FDA does not inspect and approve a facility as part of registration. Registration gives the FDA visibility of who is shipping food into the country. Claiming to be "FDA approved" on the strength of a registration is a misrepresentation.
- It is not a product registration. The facility is registered, not the individual product. Your product still has to comply with US labelling and ingredient rules on its own.
How is this different from MoCRA cosmetic registration?
Completely different law, different filing, different identifier. FSMA covers food facilities. MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — covers cosmetics facilities and product listings. A food factory registers under FSMA; a cosmetics factory registers under MoCRA.
This confusion is common inside manufacturing groups that make both. The two registrations are held by different entities, under different rules, and the numbers are not interchangeable:
| FSMA (food) | MoCRA (cosmetics) | |
|---|---|---|
| What is registered | Food facility | Cosmetics facility, plus product listings |
| Applies to | Food, beverage, supplements | Cosmetics and personal care |
| Identifier used | FDA food facility registration number | FDA Establishment Identifier (FEI), plus listing numbers |
| Renewal | Biennially, in even-numbered years | Per the MoCRA schedule |
If a supplier shows you a cosmetics registration as evidence for a food product, that is not the right document.
Does a foreign facility need a US agent?
Yes. A facility located outside the United States must designate a US agent for FDA communications as part of registration. The agent is the FDA's point of contact in the US for that facility.
In practice most foreign manufacturers use a registration service to act as agent and to submit the filing. D&O's registration was submitted through Liberty Management Group Ltd. as US agent.
The agent designation is not optional and it is not a formality — an unreachable agent can put the registration itself at risk.
What does the registration actually require?
The filing itself is straightforward. What takes time is assembling it:
- Facility name, address and contact details, matching your other documents
- Parent company details where applicable
- The US agent's details and their acceptance of the role
- Food product categories the facility handles
- An authorising individual at the facility
- A PIN and registration number issued on completion
Two practical notes from doing it: the address must match your other registrations exactly, and the product categories you list should cover what you actually intend to ship, because adding categories later means amending the registration.
What is D&O's registration?
D&O Nutraceutical Manufacturing Sdn. Bhd. holds a US FDA Food Facility Registration under FSMA, registration number 14791969014, as a foreign facility, registered through Liberty Management Group Ltd. as US agent.
For separate identity verification, D&O also holds a D-U-N-S® Number: 47-325-1431, issued by Dun & Bradstreet — commonly requested by US buyers, banks and procurement systems as a basic due-diligence check.
Registration is a filing requirement. It is not an FDA approval or endorsement of the facility or its products, and we state that plainly for the same reason we publish the number: a buyer can verify a number, and cannot verify a claim.
What does the brand owner still have to do?
The factory's registration covers the factory. Everything about the product is still yours: labelling to US requirements, ingredient compliance, allergen declaration, nutrition facts format, and any claims you make.
The items that most often stop a first US shipment:
- Nutrition Facts panel in the current US format — not the Malaysian format, and not a translation of it
- Allergen declaration to US requirements
- Ingredient names in the US common or usual name, which is not always the same as the Malaysian one
- Claims — structure/function claims have specific requirements, and disease claims are not permitted on food or supplements
- Prior Notice — a separate FDA submission required for each shipment, filed before arrival
- Supplier verification under FSVP, which is your US importer's obligation but will require documents from the factory
Does Halal certification matter for the US?
Not to the FDA — it is not a regulatory requirement there. It matters commercially, to the US Muslim consumer market and to retailers serving it, in the same way it does anywhere else. Treat it as a market access asset rather than a compliance step for this destination.
Frequently asked questions
Is FDA registration the same as FDA approval? No. The FDA does not approve food facilities. Registration is a filing that gives the FDA visibility of the facility. Any supplier claiming "FDA approved" for a food factory is misdescribing it.
How often does registration have to be renewed? Food facility registrations are renewed biennially, in even-numbered years, during a defined renewal window.
Can I export to the US using my manufacturer's registration? The facility registration must be held by the facility. As a brand owner you rely on your manufacturer holding it — and you still need Prior Notice for each shipment, plus a US importer meeting FSVP obligations.
Does my product need to be registered too? Food and most supplements do not require pre-market product registration with the FDA, but they must comply with labelling and ingredient rules, and certain new dietary ingredients have their own notification requirements.
Can D&O supply the registration certificate? Yes, on request, along with our Halal, GMP, HACCP, ISO 22000 and MeSTI certificates.