By: Ashleigh Hampton, MSc
Manager, Scientific Affairs
On May 23, 2012, the Natural Health Products Directorate (NHPD) released the Draft: Pathway for Licensing Natural Health Products (NHPs) Making Modern Health Claims and the Draft: Pathway for Licensing NHPs Used as Traditional Medicines guidance documents. The following details will highlight the proposed changes and outline how it will impact the evidence needed to obtain your desired claims.
Draft: Pathway for Licensing NHPs Making Modern Health Claims
This guidance document provides insight into the manner in which the NHPD plans to review the non-traditional NHP Product License Applications (PLA). The main objective of this draft guidance document is to outline the risk-based approach proposed to be taken by the NHPD when assessing the evidence provided to support the safe and effective use of your NHPs.
The NHPD has categorized the types of claims applicants may wish to apply for into 3 categories:
- High Level of Risk (e.g. products claiming to treat/prevent/cure serious diseases, such as those present on Schedule A of the Food and Drug Act)
- Medium Level of Risk (e.g. products claiming to treat/prevent/cure major diseases or health conditions which may not be resolved in a timely manner and which if untreated may worsen or persist, such as hypercholesterolemia)
- Low Level of Risk (e.g. products containing ingredients which have good evidence to support their safe use and are making general health maintenance/support claims, treatment/prevention claims for minor diseases or risk reduction claims for major diseases or health conditions).
In summary the evidence required to support the safe use of your product will be dependent on the strength of the claims you wish to make. The NHPD’s Pre-Cleared Information (PCI) stands as the most acceptable evidence available. Second to which are high quality phase III clinical trials and the inclusion of 2 prospective observational studies, with some additional required study criteria. These types of evidence will be sufficient to support all types of health claims.
To support your low and lowest risk health claims the following types of evidence will be acceptable to support the safety and efficacy of your product:
- Evidence from a regulatory agency
- Systematic reviews
- Phase II clinical trial
- 2 Retrospective observational study
- 2 Epidemiological studies
- Published, peer-reviewed review articles which cite primary clinical evidence
- Reputable textbooks reporting human clinical data
- Demonstration of food use (safety only)
With regards to evidence to support the weakest type of health claim, an antioxidant claim, the NHPD is proposing to accept in vivo animal studies using a validated model as stand alone evidence to support the efficacy of your product. This is beneficial as products which are safe, but do not have high quality efficacy evidence will be granted licenses, provided they contain recognized antioxidant ingredients.
In summary, weak evidence will support low risk claims for low risk products and strong evidence will support strong claims even with higher risk products, provided the Draft: Pathway for Licensing NHPs Making Modern Health Claims guidance document is approved.
Another proposed change outlined in this guidance document is the inclusion of traditional claims in a non-traditional PLA. The NHPD is proposing to allow traditional claims on non-traditional products, provided that the traditional claims are not the only claims present on the product label. Additionally, the label must include a non-traditional claim and the traditional claim must include the name of the ingredient and the traditional paradigm in which it has been traditionally used (e.g. Dandelion is traditionally used in Herbal Medicine as a diuretic). It is also important to note that traditional claims from more than one traditional healing paradigm can be present on a single non-traditional PLA – this may alleviate the issues that some applicants have been having when trying to make traditional claims from more than 1 paradigm.
Draft: Pathway for Licensing NHPs Used as Traditional Medicines
The criteria required for a traditional PLA has not changed drastically. The NHPD is proposing to require that all ingredients in a traditional product have evidence to support their use in a single traditional healing paradigm and that the traditional evidence to support the efficacy of the product be supported by evidence demonstrating that each of the herbs have been used in the same traditional healing paradigm for at least 50 consecutive years or 3 generations.
The NHPD is accepting comments on these draft guidance documents until August 21, 2012. Comments can be submitted to email@example.com.
For more information on the draft guidance documents, please visit the following links:
Draft: Pathway for Licensing NHPs Making Modern Health Claims – http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_modern-eng.pdf
Draft: Pathway for Licensing NHPs Used as Traditional Medicines –http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_tradit-eng.pdf.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com