How to Get FDA Registration (the "FDA Certificate")
FDA registration is the process by which a manufacturer shipping food, cosmetics, dietary supplements or pet food to the U.S. registers its facility in the FDA system and appoints a US Agent. Export Partners is an Amazon SPN verified team that handles this registration, the US Agent role, label review and, where needed, the USDA permit on behalf of manufacturers. Same-day response, fixed-price quote and one point of contact throughout the process.
FDAUSDA · APHISMoCRAFCE / SIDCBP Customs
What does "FDA certificate" actually mean?
The terms people search for most are "FDA certificate" or "FDA approval". Technically, the FDA does not issue a certificate and does not approve food, cosmetic or supplement products one by one. The FDA registers the facility that manufactures or stores the product and assigns it a registration number. The "FDA certificate" that U.S. customs and buyers ask for is this facility registration number and its active record in the system.
Completing FDA registration means completing these three steps:
- Facility registration (Food Facility Registration): registration of the manufacturing, packing or storage facility in the FDA system, with a registration number.
- US Agent (U.S. representative): the required U.S.-based representative through whom the FDA communicates with the facility. Registration cannot be completed without this appointment.
- Compliant label: registration alone does not put the product on a U.S. shelf; if the label does not meet FDA rules, the product may be held at the port of entry.
For cosmetics the process has a different name: under MoCRA, in effect since 2023, cosmetic facility registration and product listing became mandatory. For animal-origin products, USDA comes into play alongside the FDA. Each is covered under its own heading below.
Who needs it?
Every manufacturer, packer and warehouse shipping products to the U.S. that falls into one of the groups below. The only case where it is not required is not shipping to the U.S. at all; selling through Amazon FBA also counts as exporting.
Food
Dietary supplements
Cosmetics
Pet food and animal-origin products
How is FDA registration done in four steps?
Product and facility classification
Collecting documents
Registration and US Agent appointment
Label review and shipment preparation
How long does it take, and which documents are needed?
| Step | Duration | What we need from you |
|---|---|---|
| Facility registration and US Agent | Same day | Facility details, authorized contact |
| D-U-N-S number (if you don't have one) | Usually 1-2 weeks | Company documents |
| Label review | 2-5 business days | Current label file, formulation |
| FCE and SID (canned foods) | 2-4 weeks | Process information |
| USDA VS permit (animal-origin) | Varies by product, several weeks | Veterinary certificate from the country of origin |
| MoCRA cosmetic registration | A few days | Product list, INCI ingredients |
Timelines depend on how fast the FDA and USDA systems are moving at the time; the figures above are typical, not guaranteed.
How is the fee determined?
The price depends on three things: how many facilities will be registered, whether the product group requires additional registrations (FCE and SID for canned foods, USDA for animal-origin products, MoCRA for cosmetics) and the scope of the label review. We have a fixed package price for a single facility and a single product group, and we send the quote the same day. Payment can be made in USD.
FDA registration lookup: is your registration active?
The FDA does not publish food facility registrations in a public list; lookups are done from the facility owner's own account or with the registration number and PIN. An "FDA certificate lookup" usually means three checks: do you have a registration number, is the registration active, and who is listed as US Agent. Send us your registration number and we will check the status the same day and report back in writing; for expired or suspended registrations, we also explain how to reactivate them.
Registration renewal: the 2026 cycle
FDA food facility registration is renewed every two years, in even-numbered years. The 2026 renewal period opens on October 1 and closes on December 31. A registration that is not renewed is considered invalid at year end, and products may be held at U.S. entry. We track our clients' renewal calendar, send a reminder when the period opens and handle the renewal. Details: FDA registration renewal.
Services delivered alongside registration: labels, USDA, canned foods, cosmetics, Amazon, customs
Label review
USDA APHIS permit
Canned foods: FCE and SID
Cosmetics: MoCRA
FDA for Amazon
FDA renewal
Customs and logistics
FDA registration fee and 2026 service prices
The fee for FDA food facility registration and U.S. Agent service is 650 USD, or 550 USD when purchased together with a second service. The prices below are service fees valid as of September 25, 2026.
The package price applies when at least two services are purchased together. Each service can also be purchased on its own.
| Service | Single Service | Package Price |
|---|---|---|
| FDA Food Facility Registration and U.S. Agent | 650 $ | 550 $ |
| Label and Ingredient Compliance Review | 400 $ | 350 $ |
| FDA Cosmetic Facility Registration and U.S. Agent | 550 $ | 525 $ |
| FDA Cosmetic Product Listing | 175 $ | 150 $ |
| USDA VS Permit | 1.250 $ | 1.100 $ |
| Customs Bond (annual) | 1.150 $ | 1.075 $ |
| Customs Registration | 200 $ | 175 $ |
| FCE Registration | 550 $ | 525 $ |
| SID Registration | 200 $ | 150 $ |
- FDA Cosmetic Product Listing is per product; it adds a new product to an existing MoCRA product listing.
- USDA VS Permit covers up to 5 products; each additional product notification is $75.
- Customs Bond renews annually and covers unlimited entries for 12 months.
- The amounts in the table are service fees; government fees (such as the USDA VS Permit fee) are passed through separately at cost.
Why Export Partners?
US Agent service
Everything under one roof
Freight and U.S. customs procedures
Compliance for Amazon sales
Joining our supplier portfolio
Simple invoicing, one dedicated contact
FDA Registration or FDA Approval? What Each Product Group Needs
In searches, FDA certificate, FDA registration and FDA approval are often used as if they meant the same thing, but they are three different things. FDA registration means the facility that ships products to the U.S. registers itself in the FDA’s system. It does not certify product quality; it makes the facility traceable. FDA approval is a separate process that applies only to products such as new drugs and certain high-risk medical devices, where test and clinical data are reviewed. The FDA does not grant approval for food or cosmetics; what is required is registration. The FDA also does not issue a printed certificate. Documents provided by service companies are informational letters confirming that a registration exists; what counts is the active registration in the FDA system.
The answer to how to get an FDA certificate depends on the product group:
- Food and dietary supplements: facility registration, a D-U-N-S number and a US Agent in the U.S. Registration is renewed in even-numbered years between October 1 and December 31, and a Prior Notice is also filed for each shipment.
- Canned and acidified foods: in addition to facility registration, FCE registration and an SID (process filing) for each product.
- Cosmetics: facility registration and product listing under MoCRA; products must also meet labeling rules.
- Products with animal-origin ingredients: in addition to FDA registration, often a USDA APHIS permit.
- Drugs and medical devices: a separate registration and product listing regime, with an annual FDA fee for devices; a different process from food and cosmetic registration.
Why isn’t FDA certificate lookup public?
Medical device and drug registrations can be searched in the FDA’s public databases. Food facility registrations, however, are not published in a public list for security reasons; verifying a food facility’s registration requires the facility registration number and PIN. That is why, when you do an FDA certificate lookup, the most reliable approach is to ask the company for its registration number and have the US Agent confirm that the registration is active.
Frequently asked questions
What people mean by “FDA certificate” is the facility registration and its registration number. The facility details and authorized contact are entered into the FDA system, a US Agent is assigned, and the registration number is issued the same day. If you work with us, you only need to send the documents.
Only through the FDA’s own registration system; no agency in your country issues it. Facilities outside the U.S. register through a US Agent. Export Partners LLC takes on this role.
There is no public list; lookup is done from the facility account with the registration number and PIN. Send us your registration number and we will tell you the same day whether it is active.
Facility registration and US Agent assignment take one day. If you have no D-U-N-S number, allow 1-2 weeks; FCE and SID for canned foods take 2-4 weeks, and a USDA permit takes several weeks depending on the product.
There is no public list of FDA-registered manufacturers; the registration details are held by the facility itself. If you want to verify a supplier’s registration, you can ask for its registration number and have it confirmed through the US Agent; we also carry out this check.
Yes, in even-numbered years. The 2026 renewal period runs from October 1 to December 31; a registration not renewed on time is considered invalid.
FDA food facility registration with U.S. Agent service is 650 USD, or 550 USD when combined with a second service. Label and ingredient compliance review is 400 USD, and cosmetic facility registration is 550 USD. The current list is in the price table above; there is no separate government fee paid to the FDA for registration.
When at least two services are purchased together. For example, if facility registration and label review are ordered together, both are billed at the package price. A single service can also be ordered, in which case the single-service price in the table applies.
The FDA does not issue an “approval” for food and cosmetic products; what is required is facility registration. Food from an unregistered foreign facility may be held at U.S. customs, and a Prior Notice is also required for each shipment. It is safer to confirm that the registration is active before shipping.
FDA premarket approval applies to products such as new drugs, certain medical devices and food additives. Food, dietary supplements and cosmetics are not approved; the manufacturing facility is registered with the FDA (for cosmetics, facility registration and product listing under MoCRA). We recommend not using the term “FDA approved” for these products.
Yes. For food facility registration, the FDA requires the facility’s unique facility identifier (UFI), and the D-U-N-S number is used for this. Dun & Bradstreet issues D-U-N-S numbers free of charge; the company name and address on the number must match the FDA registration exactly. For companies without a number, we handle the application, which usually takes 1-2 weeks.
Every food facility outside the U.S. must designate a representative based in the U.S. (US Agent) to handle communication with the FDA. During registration, the FDA sends this representative a confirmation e-mail, and the registration is not completed until the representative confirms. The US Agent is also the FDA’s first point of contact in emergencies and official correspondence. Export Partners LLC takes on this role through its office in Texas.
The facility’s legal name and full address, D-U-N-S number, contact details of the facility owner and the emergency contact, US Agent details, and the categories of products manufactured or packed at the facility. The details should match the D-U-N-S record; if the name or address differs, the registration may be rejected.
No. The FDA does not issue a printed certificate for registration; what is official is the active registration and registration number in the FDA system. Documents sold as an “FDA certificate” are informational letters prepared by the companies that handle the registration. The registration document we provide is likewise an informational document showing the registration number, facility details and the term of the US Agent service.
Yes. Under MoCRA (Modernization of Cosmetics Regulation Act), facilities shipping cosmetics to the U.S. must register with the FDA and list their products. There is no FDA approval for cosmetics either; in addition to registration and product listing, compliance with labeling and ingredient rules is required.
First, check whether the product is subject to approval at all. For drugs and certain medical devices, approval can be searched by product name in the FDA’s public databases. Food, dietary supplements and cosmetics are not approved, so the term “FDA approved” is misleading; for these products, what to check is the manufacturer’s active FDA facility registration, which is verified with the registration number and PIN.
We can also offer this as a package
FDA registration can be ordered on its own. If label compliance and importer registration at customs are also needed, everything is handled in one package, on one timeline, with one point of contact.
Free introductory callU.S. and Canada customsService packagesService catalog 2026
All of our FDA, USDA, MoCRA and customs services in a single file.
Get a quote
Tell us your product and target market; we reply the same day with a quote covering the process, timeline and price.
- Same-day quote, fixed price
- FDA registration and US Agent in one package
- Labeling, USDA and customs from one team
Contact us
E-mail: info@exportpartnersllc.com
U.S.: +1 210 756 2033
Export Partners LLC, 5835 Callaghan Rd, Ste 204-0501, San Antonio, TX 78228, USA