11 Dec More from the CHFA on NPN Licensing
Further to our last post about NHN quality in Canada – here are some details via the CHFA about how companies go about actually getting their licenses to sell NHP’s.
Under the “Management of product licence applications for natural health products,” products eligible for approval within 10 days are part of what NNHPD considers Class I products. To be eligible for this category, the product must comply with all parameters of an individual (a single) Health Canada monograph.
Monographs are documents developed and maintained by NNHPD that contain a compilation of the known efficacy and safety information of a certain well-known ingredient. The use of a monograph is efficient for both applicants and the NNHPD since the safety and efficacy of the ingredient has already been established by Health Canada when it is used under the conditions specified in the monograph.
Since the information needed to support the safety and efficacy has been vetted and is thoroughly understood, an applicant can attest to meeting the monograph for their product and the application is then reviewed for completeness. These applications are for the lowest risk, highest certainty products.
To add further scrutiny to the review, NNHPD conducts random and risk-based post-licensing audits of monograph-based applications. This ensures that the parameters against which applicants have attested were met.
Scientific developments in quality assurance testing and analytical methodologies continue to evolve worldwide. As new technologies are developed, those technologies may lead to new test methods and analytical procedures that are faster, cheaper and more precise. However, emerging test methods must be validated for accuracy and acceptability before being promoted for general use.
As an example, the use of DNA barcoding technology for testing the identity of botanical products is useful but presently limited. DNA testing is rarely able to properly identify chemically complex herbal extracts, as little or no DNA is extracted during the extraction processes. This technology would be more appropriate for raw material identification than herbal extracts found in finished products.
In the case of DNA testing specifically for finished products containing herbal ingredients, additional scientific analysis should be used to confirm the initial DNA results. Drawing conclusions on the basis of one testing technology from one laboratory should only be considered as preliminary and requires further substantiation.
Canada’s Natural Health Product Regulations reinforce that quality assurance and quality control are critical for manufacturing safe and effective NHPs. Canadian consumers demand and deserve safe and high-quality NHPs. CHFA supports this demand and encourages the entire supply chain, from raw material suppliers to NHP manufacturers, to use recognized quality standards that are well characterized and deemed fit for purpose.
Evidence requirements for natural health products are proportional to the level of risk of the product. The referenced slide in The Fifth Estate episode referring to weak evidence is from a presentation given in 2012, prior to the implementation of the current risk-based system. Since then, Health Canada has published two guidance documents that outline evidence criteria for NHPs. Under these documents, NHPs that are defined as medium- to high-risk require phase III or IV clinical studies or well-designed meta-analysis to demonstrate safety and efficacy.
On the other hand, low-risk NHPs that make general claims for minor, self-resolving health conditions or for general health maintenance claims have evidence requirements that reflect the low-risk nature of these products. Evidence such as traditional/botanical medicine textbooks or published peer-reviewed studies are acceptable as long as the entirety of evidence submitted supports the safety and efficacy of these low-risk products.
The guidance documents also provide predictable, consistent and clear instructions on what is required when filing a product licence application. These new tools have drastically improved the quality of submissions as applicants now know with greater certainty what evidence is likely to be acceptable to Health Canada.
Vitamins and Minerals Products
In Canada, the commercial sale of NHPs is strictly regulated by the “Natural Health Products Regulations,” which requires products to be licensed by NNHPD before they can be sold. In order to be licensed, a product must demonstrate that it is safe, effective and high quality.
An important tool for product licensing is product monographs for common medicinal ingredients found in many NHPs. A product monograph is a factual scientific document on the specific medicinal ingredient that prescribes the safe and effective dose, as well as other parameters.
Using vitamin D as an example, the monograph outlines a maximum daily dose of 1,000 IU. If using a monograph to get a licence, NNHPD does not permit products providing more than 1,000 IU on a daily basis. As of today, there are no licensed products on the Canadian market with daily doses of vitamin D greater than 1,000 IU. Companies seeking a licence for a product containing more than 1,000 IU per day would be required to submit additional safety and efficacy evidence to support the dose. NNHPD would thoroughly review the application and supporting documents to ensure it is, in fact, safe and effective.
CHFA recommends consulting a health care practitioner prior to making changing a health care regime.
Role of the Inspectorate
The slide in The Fifth Estate episode referring to the “Role of the Inspectorate” that discusses NHP complaints and quality is from a 2012 presentation. As of June 2014, there are 54,706 licences issued by NNHPD, representing 81,629 products on the market. There are approximately seven times more licensed NHPs on the market than licensed prescription and non-prescription drugs, combined. The statistic doesn’t surprise us when you take into consideration the sheer number of licensed NHPs on the market compared to other health products.
Another important point regarding the Fifth Estate episode is the fact that the Inspectorate receives complaints for numerous product-related issues. Complaints can range from low-risk complaints, to not tasting as desired, to concerns regarding public health. After the Inspectorate has verified the complaints for risks to health and safety, only the legitimate complaints are pursued by the Inspectorate. The Fifth Estate 2012 presentation statistic reflects all complaints submitted to the Inspectorate and not just the identified legitimate complaints.