When a US health food importer evaluates Korean organic green tea powder for sourcing, their first legal task is verifying you as a foreign supplier under FDA's Foreign Supplier Verification Program. Getting that verification done — plus clearing every shipment through prior notice — takes five specific documents from your side. This guide lists what to prepare and why each one matters, so your first US shipment moves without delays at the port.
What Your US Buyer Must Verify Before Clearing Customs
Under the FDA's Foreign Supplier Verification Programs rule (21 CFR Part 1, Subpart L), the US importer is the party legally responsible for confirming that foreign suppliers produce food meeting US safety standards. That responsibility falls on them, not on you — but the documentation comes from your facility. Without the right paperwork in place, your buyer's customs broker cannot complete the FSVP entry, and your shipment cannot clear the port.
The five items below make up what a US importer's FSVP file needs from the Korean supplier side, before the first container ships.
5 documents your US buyer's FSVP file requires from you
- ✓ FDA food facility registration number (active status)Foreign facility registers under 21 CFR Part 1, Subpart H — no fee, renew biennially Oct-Dec even years
- ✓ US agent designation on file with FDARequired for all foreign food facilities; agent must reside or maintain a US business address
- ✓ Written food safety plan under 21 CFR Part 117Hazard analysis, preventive controls, monitoring, corrective actions, and verification records
- ✓ FSVP evidence package — audit reports and test recordsYour buyer uses this documentation to meet their legal supplier-verification obligation under FSVP
- ✓ MAFRA-accredited organic certificate + NOP Import CertificateBoth required per shipment to label and market the product as 'organic' in the US
Document 1 — FDA Food Facility Registration and US Agent
Any facility that manufactures, processes, packs, or holds food for US consumption must register with FDA — and that rule covers foreign facilities. The authority comes from Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), implemented in 21 CFR Part 1, Subpart H. For a Korean green tea powder operation, your processing or packing site must hold a current FDA registration number before any product ships to the US.
Two points make this more manageable than it sounds. First, the FDA charges no fee to register a food facility. Second, you must renew — registrations must be updated every two years, during October 1 through December 31 of each even-numbered year. An expired registration has the same effect as no registration at all: your shipment can be stopped at the port. Build a biennial reminder into your compliance calendar now, before your first renewal window passes.
Foreign facilities cannot register without a US agent. The FDA requires every foreign food facility to designate a US agent — a person or company that lives or maintains a business address in the United States and is physically present there. The agent receives FDA communications on your behalf and serves as the agency's direct point of contact for your facility. If your company has no US office, identifying a qualified US agent is the first practical step toward completing registration.
Document 2 — Written Food Safety Plan Under 21 CFR Part 117
Registering your facility tells FDA you exist. A food safety plan tells FDA — and your US buyer — how you control hazards in the product. The FSMA Preventive Controls for Human Food rule (21 CFR Part 117) requires covered facilities, including foreign facilities that must register under Section 415, to maintain a written plan covering hazard analysis, preventive controls, monitoring, corrective actions, and verification.
If you already hold HACCP certification, that documentation gives you a strong base. The difference is structure: 21 CFR Part 117 uses its own format and terminology, and your US buyer's FSVP agent will compare your records against that framework when they review your supplier file. Mapping your existing HACCP documentation to the Part 117 structure in advance — ideally with help from a consultant familiar with US requirements — reduces back-and-forth during buyer onboarding and positions you as a supplier they can approve quickly.
Document 3 — FSVP Evidence Package
Your US buyer is legally required to verify that you produce safe food. The evidence they gather goes into their FSVP file, which FDA can inspect at any time. From your side, that file typically needs your active FDA registration number and registration status, a copy or structured summary of your food safety plan and hazard analysis, any third-party audit reports or finished-product test results that show your controls are working, and your current HACCP and quality certifications.
How often your buyer must update their FSVP records depends on the risk level they assign to your product and their evaluation of your performance over time. Keeping your audit records current and your certifications unexpired means they can refresh their file on schedule without contacting you for emergency documents right before a shipment date.
One identifier the US importer needs at entry: the FDA requires the FSVP importer to provide a DUNS (Data Universal Numbering System) number as their unique facility identifier when clearing customs. It is the only identifier FDA currently accepts for this purpose, and it is available free of charge. That number belongs to your US buyer, not to you, but confirming they have one on file before the first entry saves a last-minute delay at the port.
Document 4 — Prior Notice for Every Shipment
Prior notice timing: minimum lead times before arrival
Know your window — late or early filing holds the shipment
Ocean vessel: 8 hours minimum before arrival. Air freight: 4 hours. Land by rail: 4 hours. Land by road (truck): 2 hours. International mail: before mailing. Upper limit: no more than 15 calendar days early via PNSI, or 30 calendar days via CBP ABI/ACE/ITDS. (Source: FDA, 21 CFR Part 1, Subpart I)
FDA facility registration covers your facility and stays valid between renewals. Prior notice is different — it must be filed for every individual shipment before that shipment arrives at a US port. The requirement comes from Section 801(m) of the FD&C Act, implemented in 21 CFR Part 1, Subpart I. Notice goes through FDA's Prior Notice System Interface (PNSI) or US Customs and Border Protection's Automated Commercial Environment (ACE/ABI).
Your customs broker typically handles the actual filing, but your job is making sure they receive accurate shipment data in time. Late prior notice — meaning notice that does not get FDA confirmation before the arrival window closes — can hold the entire shipment at the port. There is also an upper limit: notice cannot be filed more than 15 calendar days before the expected arrival date through PNSI, or more than 30 calendar days through CBP's ABI/ACE/ITDS. Filing too early creates the same problem as filing too late. Most Korean green tea powder moves by ocean container, so the 8-hour-before-arrival window is the standard planning target for each shipment.
Document 5 — Korean Organic Certificate and NOP Import Certificate
If the product will carry the word "organic" on a US label, two organic documents must accompany every shipment. The US and South Korea have had an organic equivalence arrangement under the USDA National Organic Program since July 1, 2014, according to the USDA Agricultural Marketing Service (AMS). Under that arrangement, a full separate USDA organic certification process is generally not required for qualifying Korean certified products.
The arrangement has conditions. The USDA AMS states that the product must be certified by a certification body accredited by Korea's Ministry of Agriculture, Food and Rural Affairs (MAFRA), must contain 95% or more organic content — "Made With Organic" products are not covered by the arrangement — and must travel with an NOP Import Certificate generated in USDA's Organic Integrity Database. Products meeting these conditions may display the USDA organic seal and the Korean organic food label on US packaging.
For 100% Korean organic green tea powder, the 95% organic content requirement is met. The practical step is confirming that your MAFRA-accredited certifier generates an NOP Import Certificate for each shipment through the Organic Integrity Database — not just once when the commercial relationship begins, but for every individual consignment that will carry the organic label in the US.
Frequently Asked Questions About US Import Requirements for Korean Green Tea Powder
Does my Korean factory register with FDA, or does the US importer handle registration?
The Korean factory registers. Per the FDA, any facility that manufactures, processes, packs, or holds food for US consumption must register as a foreign food facility under Section 415 of the FD&C Act (21 CFR Part 1, Subpart H). The factory must also name a US-resident agent to complete the registration process. FDA charges no fee to register.
My US buyer is asking for a DUNS number. Do I need to provide one?
The DUNS number belongs to the US importer, not the Korean exporter. The FDA requires the FSVP importer to use a DUNS number as their unique facility identifier at US Customs entry — it is the only identifier FDA currently accepts for this purpose, and it is available at no cost. Your buyer's compliance or logistics team handles obtaining it; you do not need to supply one yourself.
What is the prior notice deadline for an ocean shipment of green tea powder to the US?
For arrival by water, FDA requires prior notice to be submitted and confirmed no fewer than 8 hours before the shipment arrives at the US port. Filing more than 15 calendar days early through PNSI — or more than 30 calendar days early through CBP's ABI/ACE/ITDS — is also not permitted. Your customs broker sets the actual filing time; make sure they have accurate arrival data with enough lead time to meet the window.
Does our Korean organic certificate cover the US organic label requirement?
Under the US-Korea organic equivalence arrangement, which took effect July 1, 2014, qualifying Korean organic certification is recognized in the US, so a full separate USDA certification process is often not required. The product must be certified by a MAFRA-accredited body, must contain 95% or more organic content, and must travel with an NOP Import Certificate from USDA's Organic Integrity Database. "Made With Organic" products are not covered by the arrangement.
Are FDA compliance and USDA organic certification the same process?
They are two separate tracks. FDA rules — facility registration, food safety plan, FSVP, and prior notice — determine whether a shipment may enter the US at all. USDA National Organic Program rules govern only whether the label may say "organic." Both tracks must be cleared to import and market the product as organic in the United States.
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Ready to source Korean organic green tea powder from a supplier with HACCP certification and MAFRA-accredited organic credentials? Submit your sourcing requirements through our export desk at exportservice.cloud/inquiry — we connect buyers with verified Korean manufacturers for their target volume and market.
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