Traditional medicine involves the use of herbal medicines, animal parts and minerals. Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, which contain as active ingredients parts of plants, or other plant materials, or combinations. Traditional use of herbal medicines refers to the long historical use of these medicines. Their use is well established and widely acknowledged to be safe and effective, and may be accepted by national authorities.
The World Health Organization (WHO) defines traditional medicine as being ‘the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illnesses’1.
Traditional therapies are considered to include Traditional Chinese Medicine (TCM), traditional Ayurvedic medicine, traditional western herbal medicine, traditional homeopathic medicine, aromatherapy and other indigenous medicines.
Long historical use of many practices of traditional medicine, including experience passed on from generation to generation, has demonstrated the safety and efficacy of traditional medicine. However, scientific research is needed to provide additional evidence of its safety and efficacy.
In order for an ingredient to be eligible for a traditional use claim the Natural Health Products Directorate (NHPD) requires “a history of at least 50 consecutive years of traditional use of a medicinal ingredient within a cultural belief system or healing paradigm (e.g. Traditional Chinese Medicine)”2. This time period was chosen to determine sufficient safety data (i.e. reproductive side effects) for the traditional medicine over two generations. It is important to note that in order to make a traditional claim both the dose and the method of preparation must be traditional.
Evidence provided to support a traditional claim can be of two types: i) pharmacopoeial evidence for traditional use claims; and ii) other evidence for traditional use claims. The former require only one reference from a recognized pharmacopeia and a translation in English or French if the language of the publication is neither. The latter encompass products that do not have a pharmacopoeial reference. These products require a minimum of two independent references, consisting of at least one written reference. However, an expert opinion report based on practitioner experience and knowledge over a 50 year period is also considered acceptable when only one written reference is available. Supporting references should indicate the same method of preparation as has been used for each ingredient in the product. Preparations may be decoctions, tinctures, powders, juices and syrups to name a few. The main preparations are decoctions and tinctures.
Active ingredients refer to ingredients of herbal medicines with therapeutic activity. In herbal medicines where the active ingredients have been identified, the preparation of these medicines should be standardized to contain a defined amount of the active ingredients, if adequate analytical methods are available. In cases where it is not possible to identify the active ingredients, the whole herbal medicine may be considered as one active ingredient.
There are a number of important considerations when listing a traditional claim on a product. Firstly, it is not acceptable to use evidence from one paradigm to support the traditional use of a medicinal ingredient from a different paradigm. Additionally, the medicinal ingredient listed on the product licence application must be of the same species, source, method of preparation, dosage form etc. as described in the references of a dose that supports efficacy. Furthermore, evidence must be submitted to support the safety of the ingredient or product of the recommended subpopulation (e.g. children, pregnant women). Finally, claims must not include treatments for any disorders listed on Schedule A3.
Currently the NHPD is revising the draft document on “Pathway for licensing natural health products used as traditional medicines”. dicentra will be sure to update you when the document is finalized.
Completing a product licence application with traditional claims can be a challenging endeavor. At dicentra we have a team of scientific experts that are well versed in ensuring traditional claims are presented in such a way that they are accepted by the NHPD. We can be reached at 1-866-647-3279 or firstname.lastname@example.org.