E-IRNs & Traditional Claims Submissions

June 30, 2011 By

By:Ashleigh Hampton, MSc
June 30, 2011

In August of 2010, Health Canada issued a notice to natural health product license applicants to provide clarification on the requirements for traditional claim submissions. Most recently, the NHPD has been re-issuing Evidence Information Request Notices (E-IRNs) to give applicants a chance to review their requirements and take action to ensure their traditional applications are up to par. When an application is classified as traditional, there are certain criteria the NHPD requires the product to meet in order to be considered a traditional formulation.

Each ingredient present in a traditional formulation must have supporting evidence demonstrating its history of traditional use. This evidence must be published in an authoritative, primary, traditional reference which outlines the traditional route of administration, dosage and method of preparation used in the specific traditional healing paradigm (e.g. Herbal Medicine, Traditional Chinese Medicine (TCM), Ayurveda). Furthermore, provided references must support the traditional use of the ingredient in the same traditional healing paradigm, meaning that if you have a claim such as “traditionally used in Herbal Medicine to help relieve nervousness”, evidence from the TCM or Ayurvedic paradigms will not be sufficient to demonstrate the traditional use of any of the ingredients in the formulation. In this case, all provided references must support the use of each medicinal ingredient in the Herbal Medicine paradigm.

Additionally, it is imperative that the method of preparation of the ingredients match the traditional evidence for every ingredient in the formulation. For example, you have an ingredient which has been prepared by supercritical CO2 extraction, a non-traditional method of preparation, the NHPD will consider this to be non-traditionally prepared ingredient. In this case, a non-traditional application should be filed. Again, it is important that the method of preparation of the ingredient match the method of preparation indicated in the authoritative traditional references for the specified traditional healing paradigm.

It is important to note that traditional evidence does not typically support the safe use of traditional ingredients in certain high risk subpopulations, such as pregnant women, breastfeeding women or children. If you wish to target your product to one of the higher risk sub-populations, clinical evidence would be required to support the safe use of each ingredient in these sub-populations.

TCM Claims

Applications making claims based on the theory of Traditional Chinese Medicine have additional evidence requirements. The NHPD considers all herbs listed in the TCM references to be prepared by water decoction. As such, it is required that ingredients in a traditional TCM product be water decocted, unless otherwise stated in the authoritative traditional evidence.

Furthermore, acceptable TCM formulas should stem from a TCM base formula. The applicant is required to submit a detailed combination rationale outlining any and all deviations from the base formula, including herb substitutions and dosage revisions.

Without a TCM base formula, the NHPD requires a highly detailed combination rationale outlining the actions of each medicinal ingredient based on the theory of TCM. The combination rationale must address the roles of the herbs (i.e. the king, minister, assistant and messenger) and outline how each of these herbs contributes to the overall efficacy of the formulation. Please note, compilation of the combination rationale for these applications requires sufficient expertise and understanding of the theory of TCM.

In summary, if you are using ingredient with methods of preparations which may not be considered traditional or are not present in the authoritative traditional references, it is best to file a non-traditional application. Dicentra offers a full range of scientific support, including formula reviews to help you determine whether your formula meets the criteria for a traditional claim submission.

For additional information on traditional claims submission please refer to the following NHPD Guidance Document: