Traditional herbal products: choose the UK medicine route or the US supplement route on evidence
Choose the route for each market first: a UK traditional herbal registration allows a traditional indication; a US supplement label does not.
In Short
- UK THR: conditions A to E.
- 30 years' use, 15 in the region.
- US labels: no disease claims.
Brands bringing traditional Chinese, Ayurvedic, Kampo or other herbal products to the UK or US need to know which route the product's claims put it on. Opened: Part 7 of the UK Human Medicines Regulations 2012 on legislation.gov.uk (revised text; outstanding changes not checked), including regulations 124A, 125, 125A and 127, and 21 U.S.C. 321(ff) and 343(r)(6) (GovInfo 2023 edition). Not opened: MHRA guidance, the traditional-use lists themselves, Northern Ireland routes in detail, UK food supplement law, US new dietary ingredient rules, and Indian, Japanese and Chinese rules. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Why the route comes first
A traditional indication can make a product a medicine in one market and an unlawful claim in another. In the UK, a herbal medicinal product with a traditional-use indication may obtain a traditional herbal registration under Part 7 of the Human Medicines Regulations 2012.
One product, two markets (invented formula TH-12)
| Question | UK (THR) | US (supplement) |
|---|---|---|
| Route | Traditional herbal registration | Dietary supplement |
| Wording | Traditional-use indication | Structure/function, no disease claim |
| Administration | External, oral or inhaled | Ingested listed form |
| Evidence | 30 years' use, 15 in region | Substantiation for the statement |
- Route
- UK (THR)
- Traditional herbal registration
- US (supplement)
- Dietary supplement
- Wording
- UK (THR)
- Traditional-use indication
- US (supplement)
- Structure/function, no disease claim
- Administration
- UK (THR)
- External, oral or inhaled
- US (supplement)
- Ingested listed form
- Evidence
- UK (THR)
- 30 years' use, 15 in region
- US (supplement)
- Substantiation for the statement
More on why the route comes first
In the US, an herb or other botanical can be a dietary ingredient under 21 U.S.C. 321(ff)(1)(C), but supplement statements are limited by 343(r)(6). Decide the route for each market before formula, artwork or marketing is fixed, because the route sets what you can say.
UK Conditions a to E
Regulation 125 applies Part 7 when five conditions are met. A: by its composition and indications the product is appropriate for use without a medical practitioner to diagnose, prescribe or monitor.
Regulation 125 conditions (summary)
More on uK Conditions a to E
B: it is intended for a particular strength and posology. C: it is intended to be administered externally, orally or by inhalation. D: it has been in medicinal use for a continuous period of at least 30 years, including at least 15 years in the UK or a listed country for a THR(GB), or in the European Union for a THR(NI) or THR(UK). E: there is sufficient information that the traditional use is not harmful and its effects are plausible on long-standing use and experience.
Vitamins, Minerals and Herbal Lists
Part 7 allows a vitamin or mineral in a traditional herbal medicinal product where there is well-documented evidence of its safety and its action is ancillary to that of the active herbal ingredients for the registered use. Regulation 124A refers to a relevant list of herbal substances, preparations and combinations, and the licensing authority may publish its own list setting out indication, strength and posology, route of administration and other information for safe use.
More on vitamins, Minerals and Herbal Lists
The lists themselves were not opened, so this guide names no listed substance.
US: the supplement route and its limits
Under 21 U.S.C. 343(r)(6), a supplement statement may describe the role of a nutrient or dietary ingredient in affecting structure or function, its documented mechanism, or general well-being, if the manufacturer has substantiation that it is truthful and not misleading, carries the boldface disclaimer and notifies FDA within 30 days of first marketing.
Claim wording check (invented lines)
- Not a US structure/function statement.
- Counsel decides.
More on uS: the supplement route and its limits
The statement may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases. Traditional disease indications therefore do not transfer to a US supplement label.
An evidence file for each market
For each product and market, record the traditional-use sources and the years and countries they cover, how the formula and preparation match the traditional product, botanical identity evidence, the route chosen and who chose it, the indication or claim wording allowed, and the label version used. UK registration applications follow regulation 127 and MHRA guidance, which this guide did not open.
More on an evidence file for each market
Your regulatory team decides the route and files any application; the file shows what the decision rested on.
Questions
How long must a herbal product have been in use for a UK THR?
Under regulation 125 condition D, at least 30 continuous years of medicinal use, including at least 15 years in the UK, a listed country or the EU, depending on the registration type.
Can a product given by injection qualify for a THR?
No. Condition C requires the product to be intended for external, oral or inhaled administration.
Can a US supplement label repeat a traditional disease indication?
No. A 343(r)(6) statement may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases.
Does V5 decide the regulatory route?
No. V5 keeps formulas, evidence documents and label versions linked by market. Your regulatory team decides the route and files any application.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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