The United States regulates dietary supplements as a category of food, not as medicines, which surprises brand owners used to a stricter licensing model. That does not mean the rules are light — the Japanese factory, the ingredients and the label all have to clear specific FDA requirements before a shipment can legally enter the country.
This guide covers how DSHEA frames a supplement, what a Japanese manufacturing facility must do to register with the FDA, when a New Dietary Ingredient notification applies, what Supplement Facts labelling requires, and how structure/function claims work with their mandatory disclaimer.
💬 Planning to bring a Japan-made supplement into the US market? We prepare the manufacturing side against FDA requirements from the start. See Japan-made supplement OEM.
How DSHEA classifies a supplement
Under the Dietary Supplement Health and Education Act of 1994, a dietary supplement is regulated as a special category of food, not a drug, and the manufacturer is responsible for its safety before it goes to market.
| Element | How it works |
|---|---|
| Legal category | Food, under DSHEA, not subject to pre-market drug approval |
| Who is responsible for safety | The manufacturer/distributor, not FDA pre-clearance |
| FDA’s role | Post-market oversight — enforcement, inspection and action against unsafe or mislabelled products |
| What this means for a Japan-made product | No FDA “approval” is granted or claimed; compliance is the importer’s and manufacturer’s own responsibility |
Because DSHEA does not require FDA pre-approval, no US import document says a product is “FDA approved.” Any label or marketing claim implying otherwise is itself a compliance problem.
Facility registration for the Japanese factory
A foreign facility that manufactures, processes, packs or holds a dietary supplement for the US market must be registered with the FDA, whether or not the facility is in Japan.
| Requirement | Detail |
|---|---|
| Who registers | The facility itself (the Japanese factory), not the brand owner |
| Legal basis | 21 CFR Part 1, Subpart H — registration of food facilities, which covers dietary supplements as food |
| US agent | A foreign facility must designate a US agent as its point of contact with the FDA |
| Renewal | Registration must be kept current; FDA obtains the facility’s contact details from this registration |
| Inspection | A registered facility making dietary supplements is inspected against 21 CFR Part 111 (cGMP), including foreign inspections |
Confirm with your Japanese manufacturer that its facility registration is current and correctly lists dietary supplements among its registered activities — an expired or missing registration is a common, avoidable cause of an import being refused entry.
Prior Notice for each shipment
Every food shipment, including dietary supplements, arriving in the United States requires advance electronic Prior Notice to the FDA before it arrives at the port.
Prior Notice is a shipment-level requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (21 CFR 1.276–1.285), separate from the facility’s own registration. It gives FDA, working with US Customs and Border Protection, the chance to target import inspections before the goods land. Missing or inaccurate Prior Notice can result in the shipment being held or refused, regardless of whether the underlying product and facility are fully compliant.
New Dietary Ingredient notification
An ingredient that was not marketed in the US food supply before 15 October 1994, and is not otherwise exempt, needs a New Dietary Ingredient (NDI) notification filed with FDA at least 75 days before the product reaches interstate commerce — not 30 days.
| Step | What happens |
|---|---|
| Is the ingredient “new”? | Check whether it, or the exact form and source used, was marketed in the US as a dietary ingredient before 15 October 1994 |
| If yes and already in another company’s supplement | May not need a fresh NDI notification, if the identity and conditions of use match a previously accepted use |
| If genuinely new | The manufacturer or distributor submits safety information supporting that the ingredient is reasonably expected to be safe, at least 75 days before marketing |
| Effect of filing | The 75-day period is a review window, not an approval — FDA can raise safety objections during it |
This is a distinct process from the 30-day notification used for structure/function claims below; the two are often confused because both involve a pre-market filing window.
💬 Not sure whether an ingredient in your formula needs an NDI notification? Send us the formula and we will flag anything that looks new to the US market.
Supplement Facts labelling
A US-market dietary supplement label needs a “Supplement Facts” panel, not the “Nutrition Facts” panel used for conventional foods, listing every dietary ingredient and its amount per serving.
| Element | US requirement |
|---|---|
| Panel name and format | ”Supplement Facts,” in the FDA’s prescribed format, distinct from the Nutrition Facts panel |
| Ingredient listing | Every dietary ingredient and the quantitative amount per serving |
| Serving size | Stated on the panel; claims and amounts are expressed per serving |
| Other panel content | Directions for use, other ingredients (excipients, capsule shell) listed outside the Supplement Facts box |
A Japanese domestic label, built around the Japanese Food Labeling Standard, will not satisfy this format — a US Supplement Facts panel has to be built from the formula’s specification sheet, not translated line-by-line from the Japanese pack.
Structure/function claims and the disclaimer
A structure/function claim describes how an ingredient affects the body’s structure or function, and it must carry a specific, unmodifiable disclaimer plus a notification to FDA within 30 days of first use.
| Requirement | Detail |
|---|---|
| What the claim can say | How a nutrient or ingredient affects the structure or function of the body (for example, supports a normal function) — not that it diagnoses, treats, cures or prevents a disease |
| Required disclaimer | ”This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease,” in the singular or plural form, prominent and in boldface, and not otherwise reworded |
| Notification timing | The company making the claim must notify FDA with the exact text of the claim no later than 30 days after the product carrying it is first marketed |
| Substantiation | The notifying firm must have substantiation on file that the claim is truthful and not misleading, even though FDA does not pre-approve it |
Before you ask for a quotation
- Whether your Japanese manufacturer’s facility is currently FDA-registered for dietary supplements, with a designated US agent
- Whether any ingredient in the formula could be a New Dietary Ingredient, and whether a notification is needed
- Any structure/function claim you plan to use, checked against Permitted wording and the mandatory disclaimer
- Who will file Prior Notice for each shipment
- Supplement Facts panel content built from the specification sheet, not translated from the Japanese label
💬 Ready to plan a US-bound Japan-made supplement? Tell us your formula and target claims and we will map out what the factory needs to provide.
Frequently asked questions
1. Does the FDA “approve” dietary supplements before they can be sold in the US?
No. Supplements are regulated as food under DSHEA, and the manufacturer is responsible for safety before marketing; FDA acts after the fact through inspection and enforcement, not pre-market approval.
2. Does a Japanese factory need to register with the FDA even if it never ships from Japan directly?
If the facility manufactures, processes, packs or holds a dietary supplement that reaches the US market, it needs to be registered as a foreign facility with a designated US agent, regardless of who arranges the shipping.
3. Is Prior Notice the same as facility registration?
No. Facility registration covers the site itself; Prior Notice is a separate, shipment-by-shipment notice filed before each import arrives.
4. How long before launch does an NDI notification need to be filed?
At least 75 days before the product is introduced into interstate commerce, if the ingredient qualifies as new and is not otherwise exempt.
5. Can I use the same “supports relaxation” wording that a Japanese Foods with Function Claims product uses?
Not automatically. A US structure/function claim needs its own substantiation on file and its own 30-day notification with the mandatory FDA disclaimer; a Japanese notification is a separate regulatory mechanism that does not carry over.
Sources: FDA, “Dietary Supplement Labeling Guide” (Supplement Facts panel, claims, disclaimer wording), fda.gov; FDA, “Registration of Food Facilities and Other Submissions” and 21 CFR Part 1 Subpart H, fda.gov; FDA, “New Dietary Ingredient (NDI) Notification Process” and 75-day premarket notification guidance, fda.gov; FDA, “Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments” and 21 CFR 1.276–1.285, fda.gov; FDA, “Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling,” fda.gov; eCFR, 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements), ecfr.gov. Checked on 25 September 2026.