How Traditional Medicines Are Regulated by Country: United States, EU, India, China, Africa and Elsewhere
How the United States, European Union, India, China and parts of Africa regulate traditional medicines and practitioners, as read from official and primary sources, and what it means for buyers.
Content last updated . This page has not been medically reviewed.
Why the rules matter to you
The same herbal product can be sold as a food, a dietary supplement, a registered traditional medicine or a prescription-style medicine, depending on the country. That changes what was checked before it reached the shelf, what the label may claim, and who you can report a problem to. This page summarizes what we could read from regulators and primary sources as of 2026-10-22. It is not legal advice, rules change, and it does not cover every country. The WHO says that for centuries traditional knowledge has been an integral health resource, and that its work includes helping countries build regulatory systems. [1]At a glance
| Place | How it is regulated (as read) | What it does not mean |
|---|---|---|
| United States | Dietary supplements, including herbal ones, fall under the DSHEA law. FDA does not have authority to approve supplements before they are marketed. [2] | A product on a US shelf has not been approved as safe or effective. |
| European Union | Herbal medicines can be registered by "traditional use" if used for at least 30 years, including 15 within the EU, with no clinical trials required, as long as safety data and plausible efficacy are shown. A full quality dossier is still required. [3] | Registration on traditional use is not proof the remedy works in trials. |
| India | A chapter of the Drugs and Cosmetics Act, 1940 covers Ayurvedic, Siddha and Unani drugs, including rules on misbranded, adulterated and spurious drugs. [4] | We read an amended copy of the Act and not the Ministry of AYUSH's own pages. |
| China | A law on traditional Chinese medicine took effect on 1 July 2017, according to Xinhua. [5] | We could not read the official legal text. |
| Africa | See below. | Rules differ country by country. |
United States in more detail
FDA says manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing, and that FDA can take action against adulterated or misbranded products after they reach the market. [6] Because FDA does not approve supplements first, the agency often does not know when new products come on the market. [2] Labels may carry "structure/function" claims, which need substantiation but not FDA approval. [2] Supplement labels must give a domestic address or phone number for reporting serious adverse events. [2] Rules for practitioners are separate from rules for products and can differ by state: see credentials, licensing and scope of practice and TCM qualifications and licensing.European Union
The EU has a separate herbal medicines route. The European Medicines Agency's committee issues scientific opinions on herbal substances, and companies apply through national authorities. [3] The traditional-use route must be for products used without a doctor's supervision and not by injection. [3] Good manufacturing practice and pharmacovigilance still apply. [3]India and China
India's Act prohibits manufacture for sale of Ayurvedic, Siddha and Unani drugs except in accordance with prescribed standards. [4] Practitioner training and licensing sit under separate systems; see Unani in India and Pakistan and Siddha training and regulation.In China, Xinhua reports that all TCM practitioners must pass tests, and apprentices may start practice only with recommendations from at least two qualified practitioners and passing relevant tests. [5] For Korea and Japan see Korean medicine regulation and Kampo and Japanese insurance.
Africa
A 2025 review of WHO African Region member states found significant steps toward standardizing herbal medicines (policies, ministry offices, registration systems, research and training facilities), but only a few had all four in place and several lacked dedicated registration systems. [7] A 2025 Ethiopian study of 237 regulatory staff found the country's framework still developing: 82.3% had no formal training on traditional medicine regulation, and 49.8% rated regulatory implementation as not satisfactory. [8] For healers, see traditional health practitioners in South Africa.Reporting problems and the world picture
A 2026 scoping review of 12 jurisdictions (including Australia, Brazil, Canada, China, India, Japan, Korea, South Africa, Switzerland, the UK, the US and the EU) found definitions of natural health products vary, and that most require industry to report serious adverse reactions within 15 days; food-regulated products usually face fewer requirements. [9] The WHO says 124 member states have passed laws or regulations for herbal medicines, and that setting up pharmacovigilance for traditional products is a common challenge. [1]What to take from this
- "Registered", "licensed" and "approved" mean different things in different places. Look up the exact term on the regulator's own site.
- Regulation of a product does not equal regulation of the person who sells or applies it.
- Imported products may follow the rules of another country. For quality problems, see heavy metals and undeclared drugs.
For how to check a person, see how to check a traditional practitioner.
Frequently asked questions
Does the FDA approve herbal supplements?
No. Under DSHEA the FDA does not have the authority to approve dietary supplements before they are marketed. [2]
What does traditional use registration in the EU mean?
It is a pathway for herbal medicines with at least 30 years of use, 15 of them in the EU, which does not require clinical trials if safety data and plausible efficacy are shown. [3]
Are traditional medicines regulated in India?
Ayurvedic, Siddha and Unani drugs have their own chapter in the Drugs and Cosmetics Act, 1940, which bars misbranded, adulterated or spurious drugs. [4]
Is traditional medicine regulated in Africa?
It varies. A 2025 review found many WHO African Region states have taken steps, but few have all four elements of standardization and registration. [7]
Who do I ask if I am unsure about a product?
Ask a pharmacist or clinician, and check the regulator's site for your country. See talking to your doctor.
References
- WHO. Traditional medicine: questions and answers (28 November 2025). Read 2026-10-22.
- FDA. Questions and Answers on Dietary Supplements. Read 2026-10-22.
- European Medicines Agency. Herbal medicinal products. Read 2026-10-22.
- India. The Drugs and Cosmetics Act, 1940 (amended copy hosted by Tripura High Court; Chapter IVA, Ayurvedic, Siddha and Unani drugs). Read 2026-10-22.
- Xinhua / China Daily. China adopts law on traditional medicine (state-media summary). Read 2026-10-22.
- FDA. Dietary Supplements. Read 2026-10-22.
- Kithinji D et al. Steps taken by the WHO African Region Member States to standardise herbal medicines: a literature review. J Glob Health 2025. PubMed abstract. Read 2026-10-22.
- Dubale S et al. Traditional herbal medicine legislative and regulatory framework: a cross-sectional quantitative study and archival review perspectives. Front Pharmacol 2025. PubMed abstract. Read 2026-10-22.
- Lim XY et al. Pharmacovigilance regulatory requirements for the natural health products industry in WHO-defined high health expenditure countries (2020): a scoping review. Drug Saf 2026. PubMed abstract. Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.