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2026-10-25
To import dietary supplements into the United States, the manufacturing facility must be registered with the FDA, a US-based agent must be appointed, every shipment needs Prior Notice, labels must follow the Supplement Facts format, and any claims must stay within structure/function boundaries. Getting these five elements right puts you ahead of most first-time importers; missing any one of them can hold a shipment at port.
This is an overview for B2B buyers — regulations are amended and interpreted professionally, so engage a US regulatory consultant before your first commercial shipment. For the general framework of importing health food, see our import compliance basics, and for vetting the factory itself, our supplier evaluation checklist.
Under the Food Safety Modernization Act, the foreign manufacturer of the supplement must register its facility with the FDA before exporting. Registration is free, renewed biennially, and tied to a unique facility identifier. As the buyer, your first supplier question is simple: what is your FDA facility registration number, and when was it last renewed?
The foreign facility must designate a US agent — a person or company in the United States who acts as the FDA contact. Many factories maintain this through consultants; verify it is current, not lapsed.
Every food shipment, including supplements, requires Prior Notice filed with FDA before arrival, and entry data through customs. Shipments can be detained for missing or inconsistent notices. Practical hygiene: make sure the product name, manufacturer and facility registration details are identical across the commercial invoice, Prior Notice and label.
US supplement labels follow a specific format — the Supplement Facts panel — with defined elements: serving size, ingredients and amounts per serving, and a specific set of required disclaimers. Key points:
Structure/function claims (for example, "supports energy metabolism") are permitted with the disclaimer; disease claims ("treats fatigue disorders") are not. This boundary is where most import problems and enforcement letters originate. Keep every claim string in a documented list, reviewed by your compliance counsel.
| Mistake | Consequence |
|---|---|
| Using a drug-style claim on the label | Detention, warning letter risk |
| Panel formatted like an EU nutrition table | Relabelling at port or rejection |
| Facility registration lapsed | Shipment refusal |
| No FSVP clarity between trading parties | Compliance gap discovered during inspection |
Does the ginseng product need a New Dietary Ingredient (NDI) notification?
If the ingredient has a history of dietary use in the US market before October 1994, generally no new notification is needed; genuinely new extracts or concentrated new forms may trigger NDI questions. This is precisely the point for professional compliance review.
Can I import as "conventional food" instead of a supplement?
Sometimes — a ginseng tea beverage may be positioned as conventional food, which changes labelling entirely. Decide the regulatory category before designing packaging, not after.
Who is responsible if a shipment is detained — supplier or importer?
Legally, the US importer/distributor holds most obligations. Contractually, allocate detention costs and relabelling responsibility explicitly.
How long does the whole setup take?
With documents ready and a compliance consultant engaged: typically 3–6 weeks for facility/agent verification, label work and FSVP documentation, before the first shipment.
Is FDA registration a quality endorsement?
No. It is a legal requirement, not a certification of quality. Third-party certifications (GMP, ISO) and batch COAs are separate quality evidence.