In December 2012, the Natural Health Products Directorate (NHPD) released two new guidance documents to provide clarity on the evidence for safety and efficacy of natural health products (NHPs) required to support modern, general and traditional health claims in Canada.

The Pathway for Licensing Natural Health Products Making Modern Health Claims, Version 1.0 and the Pathway for Licensing Natural Health Products Used as Traditional Medicines, Version 1.03 were officially published in December of 2012 and are meant to replace the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document which was published in December 20061. This article has been compiled to highlight the main differences between the current guidance document (2012) and that previously published in 2006.

Evidence for safety and efficacy of NHPs Required for Modern Health Claims

The guidance document, Pathway for Licensing Natural Health Products Making Modern Health Claims has undergone extensive revisions to provide applicants with clear requirements to support the safe and efficacious use of their NHPs in Canada¹.

Products are now categorized according to their level of risk as opposed to the strength of the desired health claims. The level of evidence needed to substantiate a low, medium and high risk claim has been clearly outlined in the updated guidance document (2012). This differs from the 2006 version which outlined that the evidence requirement was based on the strength of claim and did not explicitly state the types of required evidence for particular types of health claims.

The new risk-based approach focuses on the severity of symptoms and the risk associated with the possible inefficacy of the product for the claimed effect – products with higher risk claims require higher levels of evidence to ensure the safety and efficacy of the product is fully supported. To assist with the identification of appropriate evidence to support your desired health claims, the NHPD has compiled a table explicitly outlining the type and quantity of evidence required to support claims associated with all levels of risk with weaker evidence supporting low risk claims and high quality evidence supporting high risk claims

Evidence for safety and efficacy of NHPs Required for Modern General Health Claims

The NHPD has also published a General Health Claims Annex to the Pathway for Licensing Natural Health Products Making Modern Health Claims. The evidence requirements have been revised slightly from the December 2006 version of the guidance document which commented briefly on the use of general health claims, but did not provide detail as to what is required to support a general health claim. In general, this annex provides specific details on how to utilize weaker forms of evidence to help support your desired health claims².

Also discussed within the annex is the acceptability of general claims which do not explicitly state a health context. In cases where the health context is implied and the effects of the product/ingredients are known to be beneficial by the consumer, the qualifier “for the maintenance of good health” is not necessary. For example, the claim “a source of fibre for the maintenance of good health” may be shortened to “source of fibre” since the general consumer recognizes that fibre is beneficial for general gastrointestinal health

Overall, the Pathway for Licensing Natural Health Products Making Modern Health Claims offers clarification to applicants on how to utilize the available evidence to substantiate their specific health claims.

Evidence for safety and efficacy of NHPs Required for Traditional Medicines

One main revision to this guidance document includes the definition of a traditional medicine. Previously, the NHPD required “at least 50 consecutive years of traditional use of a medicinal ingredient within a cultural belief system or healing paradigm… for the product to be considered traditional” (NHPD, 2006). Whereas, the current guidance document (2012) reports the following criteria must be met to demonstrate a long history of traditional use for the formula/medicinal ingredients:

• Demonstration of a timespan representing two generations of safe traditional use
• Demonstration that the product meets the European Directive on traditional herbal medicines
• References supporting traditional use as per the Australian Therapeutic Goods Administration, (i.e. used over three or more generations of recorded use for a specific health related or medicinal purpose)³

The updated document (2012) also clarifies that traditional evidence is not sufficient to support serious conditions or actions which are broad in scope. More specifically, clarity has been provided to confirm claims may only refer to treatment, prevention, risk reduction, or general health maintenance. In the cases where the traditional evidence specifies a serious condition, the applicant is permitted to rephrase and weaken the claim to ensure its applicability for self-use.

In summary, the Pathway for Licensing Natural Health Products used as Traditional Medicines offers clarification to applicants on how to utilize the available traditional evidence to support the use of their traditional medicines.

dicentra specializes in scientific evaluation. If you are looking for evidence to support the safety of your formulation or to substantiate your novel health claims, our team of specialists can assist in the process. We can be reached at 1-866-647-3279 or info@dicentra.com  

References:

1. Natural Health Products Directorate. Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0. December 2006.

2. Natural Health Products Directorate. Pathway for Licensing Natural Health Products Making Modern Health Claims, Version 1.0. December 2012.

3. Natural Health Products Directorate. Pathway for Licensing Natural Health Products used as Traditional Medicines. December 2012.