How Chinese Herbal Products Are Regulated: United States, Europe, China and Elsewhere
How Chinese herbal products are regulated in the United States, Europe, the UK, China and Canada, what the rules do and do not check, and which jurisdictions could not be read.
Content last updated . This page has not been medically reviewed.
Why the rules matter to you
A bottle or packet of Chinese herbs can be sold as a medicine, a supplement, a food or a traditional product, depending on where you are and how it is labeled. Each route checks different things. This page describes only what I could read from regulators and health agencies on 2026-10-22. Rules change and differ by product, so it is a map, not legal advice. For quality and contamination, see Chinese herbal products: quality, contamination and medicine interactions.At a glance
| Place | What I read | What it means |
|---|---|---|
| United States | Most herbs are sold as dietary supplements; FDA does not approve them before sale | The seller is responsible for safety first; FDA acts after problems appear |
| European Union | A traditional use registration exists, with no clinical trials required but a long-use requirement | Registered products are checked on safety data and plausible use, not proven by trials |
| United Kingdom | NHS: herbal medicines are not tested like standard medicines | I could not read the UK registration rules directly |
| China | Drug registration rules treat TCM as a category; special TCM rules took effect in 2023 | Registration rules name TCM as a category; details not fully read |
| Canada | Health Canada regulates natural health products under 2004 regulations | General aims read; licensing detail not read |
| Australia | Not read (the regulator's site would not load) | Proper evidence not found here |
United States
Under the Dietary Supplement Health and Education Act of 1994, FDA does not have the authority to approve dietary supplements before they are marketed. [1] In many cases firms can lawfully introduce supplements without even notifying FDA. [2] A firm does not have to give FDA the evidence it relies on to substantiate safety before or after it markets its products, with an exception for products containing a new dietary ingredient. [1] Manufacturers and distributors have the initial responsibility to meet the safety standards, and FDA is generally limited to enforcement after products reach the market. [1]A product sold as a supplement but represented for treating, preventing or curing a specific disease meets the definition of a drug. [1] FDA also keeps an import alert on products containing Aristolochia and related plants, because aristolochic acid is a potent carcinogen and kidney toxin, and lets districts detain such supplements and drugs without physical examination. [3] That is an example of after-the-fact action, not pre-approval. See Chinese herbs with known safety concerns.
European Union
The European Medicines Agency describes three routes. The traditional use registration (Directive 2001/83/EC) requires use for at least 30 years, including at least 15 within the EU, and no clinical trials on safety and efficacy as long as sufficient safety data and plausible efficacy are shown. [4] Such products are meant to be used without a medical practitioner's supervision and not by injection. [4] Most individual herbal products are still licensed nationally by Member States. [4] A review reported 1,719 traditional use registrations and 859 well-established use authorizations by the end of 2016. [5]United Kingdom
The NHS says herbal medicines and complementary therapies are not tested in the same way as standard medicines, and that herbal medicines are not available on the NHS. [6] I could not read the UK registration scheme itself, so I do not describe it.China
NMPA's English site says the Provisions for Drug Registration, issued by the State Administration for Market Regulation, came into force on July 1, 2020, and classify drug registration into categories including traditional Chinese medicines. [7] NMPA also issued Special Provisions for Traditional Chinese Medicines Registration, effective July 1, 2023. [8] I did not read the full texts, so I do not describe the categories. For standards, see The Chinese Pharmacopoeia and quality standards.Canada
Health Canada's Natural and Non-prescription Health Products Directorate is the regulatory authority for natural health products, and the 2004 regulations aim to ensure safety, efficacy and quality while enabling consumer access. [9] I did not read the licensing steps.Worldwide
WHO's Traditional Medicine Strategy 2025 to 2034 includes supporting safe and effective traditional medicine through appropriate regulatory mechanisms, and WHO's global report draws on contributions from 179 Member States. [10] Reviewers also warn that traditional experience may not by itself ensure safety without toxicological investigation. [11]What to do with this
Registration or a label is not proof of safety or benefit. NCCIH notes that many studies of Chinese herbal products have been poor quality, so no firm conclusions on effectiveness can be drawn. [12] Tell your doctor and pharmacist about every herbal product. See Buying Chinese herbs safely, how supplements are regulated and Reporting a problem.Frequently asked questions
Does the FDA approve Chinese herbs?
Not as supplements. FDA does not have authority to approve dietary supplements before they are marketed. [1]
Are Chinese herbal products regulated in Europe?
Yes, through national authorities and the EU traditional use registration, which does not require clinical trials but does require long traditional use. [4]
Does a "registered" product mean it is proven to work?
No. The EU route accepts plausible efficacy and mostly bibliographic data. [4]
How does China regulate Chinese medicine?
NMPA's registration rules treat TCM as a category and added special TCM provisions from July 1, 2023. [7][8] I could not read the details.
What about Australia and the UK?
I could not read the Australian regulator's pages or the UK registration scheme this session. Check the national regulator directly.
References
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Read 2026-10-22.
- U.S. Food and Drug Administration. Information for Consumers on Using Dietary Supplements. Read 2026-10-22.
- U.S. Food and Drug Administration. Import Alert 54-10: Detention without physical examination of dietary supplements containing aristolochic acid. Read 2026-10-22.
- European Medicines Agency. Herbal medicinal products. Read 2026-10-22.
- Qu L et al. European regulation model for herbal medicine: the assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in member states. Phytomedicine (2018). PubMed record. Read 2026-10-22.
- NHS. Herbal medicines and complementary therapies. Read 2026-10-22.
- National Medical Products Administration (China). Provisions for Drug Registration. Read 2026-10-22.
- National Medical Products Administration (China). Special Provisions for TCM Registration released. Updated 2023-02-10. Read 2026-10-22.
- Health Canada. Natural and non-prescription health products. Read 2026-10-22 (via web fetch tool).
- World Health Organization. Traditional, complementary and integrative medicine. Read 2026-10-22.
- Chan K et al. An overview on adverse drug reactions to traditional Chinese medicines. Br J Clin Pharmacol (2015). PubMed record. Read 2026-10-22.
- NCCIH. Traditional Chinese Medicine: What You Need To Know. 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.