We now finally have the proposed, revised and updated guidance for outlining the pathway for licensing natural health products in Canada by the NHPD. It was posted on May 23, 2012, with the review period ending Aug 21, 2012. It is great to have a rulebook, (even if it is still just proposed) after over 4 years of submitting products for licensing. This document is called Modern Standards of Evidence (MSOE) by many, but goes by the official name of “PATHWAY FOR LICENSING NATURAL HEALTH PRODUCTS MAKING MODERN HEALTH CLAIMS”. You can find it at the above link or as a PDF attached to this blog.
We are quite happy that we now have a proposed set of rules to work with. The process that has created this document has been long and hard from a government, stakeholder’s (practitioner, professional and industry) and consumer’s point of view.
At the first look, we have to give the government kudos for writing this document in a way that most people can understand it. It is not written in normal legal language that is almost always seen in government material meant for regulations. It also has knockout highlight information to ease the reader towards help if needed. An example would be:
Did you know that you can submit evidence to Health Canada that is not outlined in this document? If you have an alternative way of supporting the safety and efficacy of your product, we’ll look at that information!
I would have to say as a whole, this is a positive document for both the health food industry and consumers alike. There has been a refreshing change in the NHPD since it has been headed up by Scott Sawler. We have seen a more logical and deeper understanding of how things work both from the government and industry point of view. That being said, now that we have found Mr. Sawler’s involvement to be good news, the bad news is that as of June 11, he is off for the mandatory 14-week French language school for government employees. This means that he will not be in place for the end of the comment period of August 21, 2012. We have lost other Director Generals before to the language education process. The good news is that Scott Sawler’s wife is French and his kids speak French in the home, so he could have an easier time with this than some would. We are hoping he returns to the NHPD position to run it until this whole subject is finalized.
Let’s take an overview of the highlights of the document. Right up in the front the document states that it is meant to be a “more nimble regulatory approach to natural health products that focuses on getting the level of oversight for these products right. This means eliminating unnecessary red tape for companies trying to bring products to market, while continuing to protect consumer safety. We can and will do more to support consumer choice and access, as well as industry innovation and growth.”
This of course is an excellent way to start, but what about the meat of the issue? Well for the most part it does not fall short of this target. Again I would have to say I feel that it is a good document that we can live with. The NHPD has decided to split the different pathways to obtaining licensing of Natural products into more than one document. This document is meant to look at “modern health claims” and does not apply to traditional medicines, homeopathic medicine and a few similar mechanisms to get licensing. Of course from a herbalist’s point of view, we are most interested in reviewing the separate document “Pathway for Licensing Natural Health Products Used as Traditional Medicines.”
Here the terms are defined as follows:
Modern Health Claims
Claims based on evidence from a range of sources, including (but not limited to) clinical studies, animal and in vitro studies, pharmacopoeias, textbooks, peer-reviewed published articles, and regulatory authority reports.
Traditional Health Claims
Claims based on the sum total of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture, used in the maintenance of health, as well as prevention, diagnosis, improvement, or treatment of physical and mental illness.
For a claim to be categorized as “traditional use,” it should be founded upon the theories, experiences and beliefs embodying the respective ancient practice of medicine.
This is the first area I find a big difference from previous editions of the SOE. Here it states ‘traditional’ is based on an ancient practice of medicine. What does that mean? In earlier versions, the benchmark of 50 years was used, meaning that if people were doing it before 1962, it could be considered traditional. I hope this is clarified in the Pathway for Licensing Natural Health Products Used as Traditional Medicines, when it comes out. This version gives us the concept that we would have to rely on information from the ancient of, let’s say, 100 BCE, just a 2,000 year earlier date then what we have been working with.
One of the new approaches the NHPD has taken (that I particularly like) is to channel the application according to risk. It is split into three levels of risk: Low, Medium and High. The claim for and/or ingredients in a product will determine the level of research, documentation and review the government will demand. This of course speeds up many of the general and simple requests, giving more time and resources to more complicated applications.
They have also opened new groups of claims that were not available before:
Health claims can be further classified as those intended to help diagnose, treat or prevent a health condition or symptom, those intended to reduce the risk of a health condition or symptom, or those intended to have a more general health-related function:
Diagnostic claims relate to the diagnosis of a disease, disorder, or abnormal physical state or its symptoms in humans (e.g., indicated for the detection of glucose intolerance in the diagnosis of diabetes mellitus).
Treatment claims relate to the treatment or partial treatment and mitigation of a disease, disorder, or abnormal physical state or its symptoms in humans.
Cure claims describe a therapeutic effect that results in the elimination of a disease, disorder, or abnormal physical state in humans, either permanently or for a significant length of time.
Risk reduction claims are based on significantly altering a major risk factor(s) for a disease or health-related condition. Diseases have multiple risk factors and altering one of these risk factors may or may not have a beneficial effect in preventing the health condition. The presentation of risk reduction claims should ensure that consumers do not interpret them as prevention claims. This can be accomplished, for example, by use of appropriate language and reference to other risk factors.
Prevention claims relate to interventions which are proven to significantly reduce the incidence of the disease.
General health maintenance, support and promotion claims describe the effect of a medicinal ingredient on restoration, correction, or modification of a structure or physiological function in the human body in a manner that maintains, supports or promotes health. Health function claims can vary from health maintenance (e.g., maintains healthy gums) to treatment of the symptoms or risk factors of a disease or condition (e.g., reduces plaque build-up along the gum line).
Antioxidant claims are for products with at least one medicinal ingredient that has antioxidant properties. Antioxidant claims should be worded as general health support claims when the medicinal ingredient is an essential nutrient (e.g., “provides antioxidant(s) for the maintenance of good health”) or as “source of claims” for other types of antioxidant ingredients (e.g, “source of antioxidants”). If a more specific antioxidant claim is desired, the claim will be evaluated according to the conditions/diseases specified or implied within the claim.
This is good news and bad news. Some feel many manufactures will take the easy route to get access to the market place before the deadline of Feb 2013. We might have half the product in the market place with claims such as “general health and/or antioxidants.” Even though this will give us a bigger choice of products, it could cause confusion for the consumer, as everything could have the same claims. This is important, as every product will now have to have a claim. This is the opposite of what the industry has said for the last 40 years, when we couldn’t have any claims.
There are suitable tables and information to help the application of products, something that was sorely missing in past documents. We finally have a proposed rulebook to work with some four years into the process.
After the main body of the document you have the following:
Appendix A: Examples of Health Claims by Health Condition
Appendix B: Linking Evidence to Conditions of Use
Appendix C: Linking Evidence to Ingredient Form
Appendix D: Linking Evidence to Use of Extracts
Appendix E: Additional Guidance
Appendix F: Evidence Screening Criteria for Modern Health Claims
Annex I: General Health Claims
Annex II: Combination Ingredients
This makes the whole document quite useable and easily expanded, without affecting the main core of the document.