What is being proposed by Health Canada?
In early September 2016, Health Canada published a consultation document titled Consulting Canadians on the Regulation of Self Care Products in Canada proposing the replacement of existing individual regulatory approaches for non-prescription drugs, Natural Health Products and cosmetics with an overarching system for all self-care products. In this new system, products would be categorized as being either lower, medium or higher risk self-care products. Categorization would depend on such things as the type of claim being made and the ingredient it contains.
Though not final, for lower risk self care products, Health Canada is proposing a notification system with no pre-market review of information by the department. In this category, products would not be able to make claims about the diagnosis, treatment, prevention, mitigation of a disease or condition and may need to carry a disclaimer saying that the claim has not been reviewed by Health Canada. In effect, this is a similar approach taken to that in the United States.
For medium and higher risk products, Health Canada will review applications and allow a higher level of indication referred to as a Health Claim. Health Claims would need to be supported by “scientific evidence” or “scientific proof” either supported through approved monograph or review by Health Canada or individually reviewed by Health Canada.
In addition to this classification system, Health Canada is also looking to create a more comprehensive and uniform approach to items such as recall provisions, authority to require labeling changes and cost recovery mechanisms.
More information about what is being proposed can be found at http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/selfcare-autosoins/document-eng.php
What are self-care products?
Generally, self-care products are health care products available to consumers that can be selected and used without direction from a health care provider such as a medical doctor, pharmacist, naturopathic doctor or nurse. In this document, Health Canada considers a self-care product to be made up of three different product groups: cosmetics; Natural Health Products such as vitamins, minerals, herbal medicines and traditional medicine; and non-prescription drugs such as acetaminophen and conventional cough remedies.
How are self-care products currently regulated in Canada?
Though cosmetics, Natural Health Products and non-prescription drugs all fall under the Food and Drugs Act, they are actually regulated in three distinct ways:
• Cosmetics are regulated under a post-market system, that is manufacturers and importers must notify Health Canada within the first 10 days a cosmetic is sold in Canada providing details of such things as ingredients and company contact information.
• Natural Health Products (NHP) are regulated under the Natural Health Products Regulations (NHPR) that are the most current and up to date regulatory framework for any therapeutic product. The regulations are pre-market which means Health Canada is required to review information provided by the manufacturer or importer and approve all NHPs before they are allowed to be sold on the Canadian market. This information includes evidence to support the claim being made, as well as information about risks and dosage ranges. Companies must also submit information about where the product is made and a site license is required before a product can be sold. All approved NHPs for sale on the Canadian market must carry an 8-digit Natural Product Number (NPN) or a Drug Identification Number-Homeopathic Medicine (DIN-HM; for homeopathic medicines).
• Non-Prescription Drugs are regulated largely like other conventional drugs. Like NHPs, companies must submit evidence to support safety and efficacy as well as information about where the product is made. Since all non-prescription drugs are conventional or mainstream health care products, unlike NHPs they only need to consider “scientific” evidence rather than that from traditional forms of health-care such as traditional Chinese medicine.
Isn’t appropriate regulation of self-care products important?
Absolutely and in fact in its most recent strategy for traditional medicines, the World Health Organisation (WHO) has identified the regulation of self-care products as a key priority. Health Canada should be commended and supported in recognizing the importance of self-care. The challenge is whether newer regulations, such as the NHPR, should be the priority rather than continuing what had been initially planned: to focus on revising the more dated regulations such as those for non-prescription drugs.
Why is Health Canada looking to change the way self-care products and NHPs are regulated?
Health Canada says that currently there are three separate sets of regulations—the cosmetic regulations, the Natural Health Product Regulations (NHPR) and the Food and Drug Regulations, depending on the type of self-care product. This may lead to confusion in market place making it difficult for consumers to understand how these products are regulated and what that means for product claims, the differences in the types of evidence used to support a use and what approval by Health Canada means for each of these three categories of products. There is also concern that the current complex set of regulations do not work well together and that there is the potential for the same product to be classified as a cosmetic, a NHP or a non-prescription drug depending on what claim the product is making and what ingredients it contains. Health Canada also cites inconsistencies in its powers to recall products deemed to be unsafe or to require label changes to reflect new evidence.
If there are changes to the NHP regulations how long will it be before we see these changes?
It depends on what Health Canada decides to do after it has considered all the comments made in response to its proposal. If Health Canada does want to proceed with radical changes as proposed in the consultation document, then it is very likely that a change in the regulations will be required. This will take a number of years to complete with consultations at every stage of the way. If, on the other hands, Health Canada does not make major changes and reverts to the original plan of ensuring that the three types of regulations remain separate with changes focused on making sure that they work better together as a set of regulations, then changes could be made in far less time. Irrespective of what is being proposed, consultations must be ongoing throughout the process and Health Canada has made a commitment to do this.
I thought the NHPR were very new, why change them now?
Yes, the NHPR are the most current and complete framework for any health product category in Canada and were developed through extensive consultation with all stakeholder groups, including the public. In addition, the NHPR were developed at the request of the Canadian government that recognized the importance of such things as the importance of evidence from traditional forms of health and healing.
What is the problem with having claims based on “scientific evidence” and “scientific proof”?
Before we can answer this question we need to know what Health Canada means by these terms. Does this mean that the evidence used for conventional drugs such as randomized clinical trials can only be used to support health claims? Does this include scientific evidence currently respected within the NHPR? Should traditional forms of evidence such as traditional Chinese medicine and medical herbalism be recognized as valid proof by Health Canada and included in the definitions of “scientific evidence” and “scientific proof”. One question that still needs to be answered is why Health Canada has moved from recognizing a broader and respectful range of evidence for a claim base that includes traditional forms of health and healing to requiring that everything to be scientifically proven.
Will the changes help consumers make informed choices about choosing NHPs?
Until we know exactly what is being proposed, this question cannot be completely answered. In reviewing the Health Canada proposal, it seems that less information would be provided to consumers on the labels of products and that quality issues would not be addressed appropriately. This could limit the ability of consumers to make informed choices about NHPs.
So, has there been any progress since this document was published?
There was quite a response from Canadians—Health Canada received over 3500 comments to the proposal document with about 70% of the comments coming from consumers. At the time of posting this article Health Canada has not yet published a “What we heard report”, however it does seem to be taking the comments received very seriously. To continue the consultation process, Health Canada is planning to host two series of town hall meetings across Canada in the spring and early summer of 2017. Each series will focus on specific aspects of what is being proposed. It appears that Health Canada has heard the comments that have been made and are expanding the discussion topics to include those dealing with quality, particularly concerning good manufacturing practices and site licensing.
You can keep up to date with developments as well as the dates and times for the town-hall meetings by going to https://www.canada.ca/en/health-canada/topics/self-care-products.html. This is an opportunity for you to make your opinions heard.
About the author: Dr. Michael Smith is trained as a pharmacist and a naturopathic doctor and is recognized internationally as an expert in NHPs and Complementary and Alternative Medicine. For more than 10 years, he worked in senior regulatory positions at the then Natural Health Products Directorate, Health Canada and the Therapeutic Goods Administration in Australia. In addition to his work as a consultant, he is an Adjunct Professor at the National Center for Natural Products Research at the University of Mississippi in the USA and an Adjunct Fellow at the National Institute of Complementary Medicine at Western Sydney University in Australia. Michael is a member of ISURA’s Scientific Advisory Committee.