The US is the most open of the major markets on paper — there is no pre-market approval for dietary supplements — and the one where that openness misleads people most often. Nothing is approved before entry, but a great deal is required, and the burden sits in places first-time exporters do not expect.
The central fact for a Korean supplier: most US obligations fall on your American importer, not on you. Your job is to make their compliance possible. Understanding what they need is what makes you an easy supplier to work with rather than a difficult one.
This page is general regulatory information, not legal advice.
Under DSHEA, dietary supplements do not require FDA approval before sale. There is no Blue Hat, no SGR, no product registration certificate. A compliant product can be on a US shelf in weeks.
What replaces approval is a system of registration, verification and post-market enforcement. FDA can inspect your Korean facility, can detain shipments, and maintains publicly accessible Import Alerts authorising detention of specific products or specific companies without physical examination. Getting onto an Import Alert is far worse than a slow approval elsewhere — it is public, it is hard to exit, and it affects every shipment.
The absence of pre-market approval is not the absence of scrutiny. It is scrutiny moved to the border and to the market.
Facilities that manufacture, package, label or hold dietary supplements — including foreign ones — must register with FDA as a food facility, selecting dietary supplements as the product category.
Two details that catch Korean exporters:
in the US who handles FDA communications on your behalf. It is not the same as your importer, though the importer can sometimes serve.
years. 2026 is a renewal year. A lapsed registration means shipments are refused entry — and this is a common avoidable failure, because nobody diarises it.
Foreign facilities are subject to the same dietary supplement cGMP requirements as domestic ones, and FDA may inspect your Korean plant.
Korean health functional food is already made under mandatory MFDS GMP, which puts you in a strong starting position — but Part 111 is a distinct standard with its own documentation expectations. Your Korean GMP certificate demonstrates capability; it does not demonstrate Part 111 conformance. If a US buyer asks how you meet Part 111, "we hold Korean GMP" is an incomplete answer.
See below. This is where most of the practical work sits.
The Foreign Supplier Verification Program obliges the US importer to verify that foreign suppliers meet US safety standards. The importer is the US owner or consignee of the food — if none exists, the US agent of the foreign owner, confirmed by signed consent. A Korean exporter cannot take this role.
Supplements get modified treatment, and knowing which sub-case applies saves argument:
requirements except hazard analysis, with verification focused on cGMP compliance.
specifications under Part 111: most standard FSVP requirements do not apply.
will manufacture the finished supplement, the modified requirements are lost entirely and full FSVP applies. This catches ingredient traders.
Practically, expect requests for:
Supplying these promptly and completely is the single most useful thing a Korean manufacturer can do for a US relationship. Importers carry the regulatory exposure; the supplier who makes their file easy keeps the business.
Two mechanics that trip up first shipments:
needs one, and their customs broker transmits it using the FSV entity role code in ACE. It is free from Dun & Bradstreet. Note this is separate from food facility registration — related but distinct obligations.
2–8 hours depending on transport mode. FSVP and Prior Notice are separate obligations for the same shipment. A valid Prior Notice does not indicate FSVP compliance and FSVP records do not substitute for Prior Notice. You need both, every time.
US labelling is prescriptive and differs from Korean labelling in structure, not just language:
Korean nutrition table
Claims. DSHEA permits structure/function claims ("supports immune function") without pre-approval, but they must be truthful, substantiated, and accompanied by the required disclaimer that the statement has not been evaluated by FDA and the product is not intended to diagnose, treat, cure or prevent any disease. Disease claims are prohibited outright.
Korean MFDS-approved wording does not transfer. It is often more conservative than US practice, which creates a specific risk: a US distributor may want to strengthen the copy. The substantiation obligation sits with whoever makes the claim, so agree in writing who is responsible for claim substantiation before launch.
Ingredients not marketed in the US before 15 October 1994 may require an NDI notification to FDA under section 413(a)(2) of the FD&C Act, submitted 75 days before marketing.
Most standard Korean formulations — vitamins, minerals, omega-3, lutein, milk thistle, probiotics, CoQ10 — are well established in the US and do not trigger this. Korean botanical extracts and individually approved functional ingredients (개별인정형) are the cases to check, since an ingredient with a Korean approval may have no US marketing history at all.
Check this early. An NDI question discovered after packaging is expensive.
Serious adverse events must be reported to FDA within 15 business days. The obligation falls on whoever is named on the label as manufacturer, packer or distributor. Make sure your agreement states who that is and who handles the reporting, because the label decides it and the label is usually designed by the marketing side without this in mind.
| Stage | Typical duration |
|---|---|
| FDA facility registration and US Agent appointment | 1–2 weeks |
| Importer's FSVP file preparation | 2–6 weeks, mostly waiting on supplier documents |
| Label development to US format | 2–4 weeks |
| NDI notification, if triggered | 75 days minimum, plus preparation |
| To first shipment, no NDI | 6–10 weeks |
Materially faster than any other market covered here — provided nothing triggers NDI and your documentation is ready.
The Korea–US Free Trade Agreement uses a knowledge-based certification system: no prescribed form, no government-stamped certificate. A written or electronic certification by the importer, exporter or producer with knowledge of the facts is sufficient, in English or Korean, signed and dated.
Do not reuse a certificate across agreements. A product qualifying under KORUS may not qualify under another FTA, and preference criteria codes differ between agreements.
healthcito.com compiles publicly available regulatory information. Reviewed 11 August 2026. This page is general information, not legal advice — confirm current requirements with FDA or a qualified regulatory consultant before acting. Supported by GNMLIFE, Inc.
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