Reading "Traditionally Used For" Claims on Labels

United States: structure/function claims and the disclaimer

In the US, herbal products are often sold as dietary supplements. The FDA says that even though it does not approve dietary supplements, it has roles in regulating them, and it mainly acts after a product reaches the market. [1]

Supplements can carry "structure/function" claims, which describe the role of an ingredient in affecting the normal structure or function of the body. [2] These claims are not pre-approved by the FDA. The company must have substantiation that the claim is truthful and not misleading and must notify FDA within 30 days of marketing. [2]

If a supplement label has such a claim, it must carry a disclaimer that FDA has not evaluated the claim, and that the product is not intended to "diagnose, treat, cure or prevent any disease." [2] A product intended to treat, prevent, cure or alleviate symptoms of a disease is a drug. [1]

What to take from this: a US supplement may say an herb "supports" something, and that wording has not been reviewed by the FDA before sale. The phrase "traditionally used" on such a label does not change this.

European Union: traditional use registration

The EU has a separate route for traditional herbal medicinal products. Under it, no clinical tests or trials on safety and efficacy are required, as long as sufficient safety data and plausible efficacy are demonstrated. [3] The product must have been used for at least 30 years, including at least 15 years within the EU, and be meant for use without a medical practitioner's supervision. [3]

Two things stand out. First, "plausible efficacy" based on long use is a lower bar than proof from trials. Second, a full quality dossier is still required for all herbal medicinal products, along with rules on good manufacturing practice, safety monitoring and labeling. [3] A registered product therefore has been checked for quality and safety, but the "traditional use" wording tells you the claim rests on history.

United Kingdom: Traditional Herbal Registration

The UK's medicines regulator, the MHRA, runs a Traditional Herbal Registration (THR) scheme. An applicant must show the product has been traditionally used for the stated condition for at least 30 years. [4] For products sold across the whole UK or in Northern Ireland, at least 15 of those years must relate to use in the EU or EEA. [4] The "indication" is the medical condition the product has traditionally been used to treat. [4] The MHRA says the evidence required is bibliographic or expert evidence of traditional use. [5]

A quick way to compare

How to read a label

• "Traditionally used" or "traditional use": history, not proof.
• "Supports ..." or "promotes ...": in the US, possibly a structure/function claim with the FDA disclaimer. [2]
• A named condition: in the US, a claim to treat or prevent a disease would make a product a drug. [1] Be cautious about a supplement that does so.
• A registration number or mark: in the EU or UK, this shows the product went through a traditional-use scheme. It still rests on history for the claim.
• Ingredients and amounts: read the ingredient list yourself. See reading supplement labels and how supplements are regulated.

What history can and cannot tell us

Long use can point researchers toward plants worth testing, but it does not establish that an herb works or is safe. See why "used for thousands of years" is not proof and historical use vs clinical evidence.