Herbs and the Law: What Is Allowed to Be Sold and Claimed
How the United States, European Union, United Kingdom and Canada regulate herbal products, what claims are allowed on labels, and which herbal ingredients have been banned or removed.
Content last updated . This page has not been medically reviewed.
Safety first. Natural products can cause side effects and interact with medicines. Read herb safety and interactions before you use anything on this page.
There is no single worldwide rule for herbs. The same plant can be sold as a food, a supplement or a registered medicine depending on the country and on what the label says. In the United States, herbs sold as dietary supplements are not approved by the Food and Drug Administration (FDA) before sale. In the European Union and the United Kingdom, a herbal product sold with a medicinal claim goes through a registration or authorization route. This page describes the rules in the sources we read. It is information only, not legal advice.
United States: herbs as dietary supplements
The FDA says a "dietary ingredient" includes vitamins and minerals; herbs and other botanicals; amino acids.[1] NCCIH adds that herbal supplements are a type of dietary supplement containing one or more herbs, made from plants, algae, fungi, or a combination of these.[2]
What the law does and does not do, according to the FDA:
- Under the Dietary Supplement Health and Education Act (DSHEA), FDA does not have the authority to approve dietary supplements before they are marketed.[1]
- Firms are responsible for evaluating the safety and labeling of their products before marketing,[3] and FDA can take action against such a product after it reaches the market.[3]
- For a supplement with a new dietary ingredient that is not present in the food supply, the maker must submit a notification to FDA with the information on which it concluded the product is expected to be safe.[1]
- FDA rules require makers to follow current good manufacturing practices that help ensure the identity, purity, quality, strength, and composition of dietary supplements.[1]
- FDA generally does not approve dietary supplement claims or other labeling before use.[1]
- Because FDA does not approve supplements before marketing, the agency often does not know when new products come on the market.[1]
NCCIH contrasts this with drugs: companies must show the FDA evidence that prescription and over-the-counter drugs are safe and effective before they are marketed.[2]
What a label is allowed to claim (US)
Labels on dietary supplements cannot claim that the product can diagnose, treat, cure, mitigate, or prevent any disease; those claims are permitted only for drugs.[2] Structure/function claims are allowed but must be accompanied by a disclaimer that begins: "This statement has not been evaluated by the Food and Drug Administration."[2] The Federal Trade Commission, which regulates advertising, requires that advertising be truthful and not misleading.[2]
Claims still go wrong. NCCIH cites a 2012 government study of 127 dietary supplements marketed for weight loss or to support the immune system, which found that 20 percent made illegal claims.[2] The practical point: a claim on a bottle is a marketing statement unless it is backed by evidence you can check. See reading supplement labels.
Herbal products compared by country
| Place | How herbal products are handled, per the sources we read | Source |
|---|---|---|
| United States | Herbal supplements: no FDA approval before sale; makers responsible for safety and labeling.[1] | FDA |
| European Union | Herbal medicinal products follow national procedures with three main pathways. Traditional use registration needs at least 30 years of use, including at least 15 years within the EU, and no clinical trials if sufficient safety data and plausible efficacy are shown.[4] A full quality dossier is required for all herbal medicinal products.[4] | EMA |
| United Kingdom | A traditional herbal registration (THR) is required before marketing a traditional herbal medicinal product, and is granted only for minor conditions where medical supervision is not required, such as a cold.[5] Products that claim to treat major health conditions need a marketing authorisation.[5] | MHRA |
| Canada | Health Canada says all natural health products are regulated under the Natural Health Products Regulations, and that these products are generally lower risk but are not without risk.[6] | Health Canada |
| Australia and other countries | Not described in the sources we read. We could not open the Australian regulator's pages for this page. | none |
A registration is not the same as proof that a herb works. The UK regulator's mark is placed on a label to show a product meets required standards of quality, safety and evidence of traditional use,[5] and the EU route accepts plausible efficacy from long use rather than new trials.[4] In both cases the evidence behind the label is "traditional use" and should be read as such. The NHS also notes that herbal medicines are not tested in the same way as standard medicines to see how well they work.[7] See the UK and EU registration page and US regulation of herbal supplements.
Herbal ingredients that have been banned or pulled
"Banned herbs" is a common search. The sources we read describe these specific US actions:
- Ephedra (ma huang): NCCIH says the FDA banned dietary supplements containing ephedrine alkaloids in the United States in 2004, because they have serious safety risks.[8] See ephedra and other restricted herbal ingredients.
- Comfrey: in a July 2001 letter to industry groups, the FDA said comfrey is a source of pyrrolizidine alkaloids that present a serious health hazard to consumers when ingested, and it strongly recommended firms marketing comfrey products remove them from the market.[9]
- Aristolochic acids: the National Cancer Institute says the plants that contain them are used in some herbal products that have not been approved by the FDA and are often marketed as dietary supplements or traditional medicines, and advises people not to use herbal products that contain aristolochic acids.[10]
We did not read a complete list of herbs that are banned or restricted in any country, so none is given. A product being on sale does not mean it was checked first; the FDA can act after a product reaches the market.[3]
Safety: what a reader can do
- Look for the plant's scientific name and part on the label.
- In the UK, the NHS advises checking that a herbal medicine has a THR mark and product code.[7]
- Ask a pharmacist before combining any herb with medicines. Pharmacists check interactions; see medicine interactions.
- Tell your surgical team about every herbal product before an operation, and ask a clinician if you are pregnant, breastfeeding, or have liver or kidney disease.
- Report problems; see side effects and reporting.
Frequently asked questions
Does the FDA approve herbal supplements?
No. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed.[1]
Can a supplement label say it cures a disease?
No. NCCIH says labels cannot claim to diagnose, treat, cure, mitigate, or prevent any disease; that is only for drugs.[2]
What does the THR mark mean in the UK?
The MHRA says its certification mark shows that a product meets the required standards of quality, safety and evidence of traditional use.[5] It rests on evidence of traditional use.
Is ephedra illegal?
In the US, the FDA banned dietary supplements containing ephedrine alkaloids in 2004, according to NCCIH.[8] Rules in other countries are not described in the sources we read.
Are herbal medicines regulated the same everywhere?
No. The EU, UK and Canada each use their own registration or licensing system,[4][5][6] and the US treats most herbs as supplements.[1] Check your own country's regulator.
References
- FDA, Questions and Answers on Dietary Supplements (US). FDA, Questions and Answers on Dietary Supplements (US). Read 2026-10-23.
- NCCIH, Using Dietary Supplements Wisely (US). NCCIH, Using Dietary Supplements Wisely (US). Read 2026-10-23.
- FDA, Dietary Supplements overview (US). FDA, Dietary Supplements overview (US). Read 2026-10-23.
- European Medicines Agency, Herbal medicinal products (EU). European Medicines Agency, Herbal medicinal products (EU). Read 2026-10-23.
- MHRA (gov.uk), Apply for a traditional herbal registration (THR) (UK). MHRA (gov.uk), Apply for a traditional herbal registration (THR) (UK). Read 2026-10-23.
- Health Canada, Natural health products regulation (Canada). Health Canada, Natural health products regulation (Canada). Read 2026-10-23.
- NHS, Herbal medicines and complementary therapies (UK). NHS, Herbal medicines and complementary therapies (UK). Read 2026-10-23.
- NCCIH, Ephedra (US). NCCIH, Ephedra (US). Read 2026-10-23.
- FDA, letter advising supplement manufacturers to remove comfrey products from the market, 6 July 2001 (US; archived copy). FDA, letter advising supplement manufacturers to remove comfrey products from the market, 6 July 2001 (US; archived copy). Read 2026-10-23.
- National Cancer Institute, Aristolochic Acids (US). National Cancer Institute, Aristolochic Acids (US). Read 2026-10-23.