With the legalization of cannabis in Canada, people also have questions about related compounds like cannabinoid (CBD). In particular, there are questions about whether CBDs are natural health products (NHPs) and what implications that might have in Canada and in the United States. Check out our Q&A for recent information. Learn More.
It has been well over a year since this process started, so this update also includes some useful background information on Health Canada’s consultation re. self-care products.
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.
In this initial proposal, for lower risk self care products, Health Canada proposed 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 would 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 also plans to create a more comprehensive and consistent approach to items such as recall provisions, authority to require labeling changes, and cost recovery mechanisms.
There was quite a response from Canadians —Health Canada received over 3,500 comments to the initial proposal document with about 70% of the comments coming from consumers. Health Canada collected and summarized the these comments and feedback in a What We Heard Report available online.
The consultation process continued in 2017 with Health Canada holding a series of national town halls, in addition to having meetings with groups from consumers, industry, academia. An updated proposal document has yet to be published, but various modifications to the original proposal document were presented at these town halls and meetings.
As for next steps, Health Canada is now planning to create a number of working groups and expert advisory groups that will work over the winter to come up with an updated proposal in 2018.
More information about what is being proposed and the process to date 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 changing the newer regulations, such as the NHPR, should be the priority rather than continuing what was 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.
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.
So, has any progress been made?
Until Health Canada provides a new proposal document (expected in 2018) it is difficult to fully answer this question. Will it strengthen or limit consumers’ ability to make informed choices? We still don’t know.
Although Health Canada has presented various options at the town halls and consultations, they have been reluctant to share, officially, more detailed information. This includes the various presentations made at the recent town halls. The reason Health Canada cites for this is that the process is ongoing and that until they have reached a final proposal, they don’t want to confuse participants in the consultation.
From the presentations made at the various town hall meetings, it does seem that Health Canada have identified product quality as an important topic, especially as it relates to good manufacturing practices and site licensing. In addition, the importance of accurate labeling, the role of product identification numbers and the need to ensure that consumers have the necessary information to make informed choices have been identified as key.
Despite having gone through a number of iterations, the presentations consistently present the idea of a three-category system within one regulatory approach. This concept still implies that similar claims should be based on similar forms of evidence and that “scientific” evidence will be needed to support therapeutic claims. The fundamental role of traditional and historic evidence in supporting product claims and informing consumers is still uncertain.
So, what do you think?
From what we have seen to date, Health Canada still wants to make quite radical changes to how NHPs are regulated in Canada—a lengthy and detailed process. If this is the case then, just as when the NHP regulations were developed, Health Canada will need to publish exactly what they are proposing in the Canada Gazette I and then provide a limited time for Canadians to respond with their comments. Health Canada will also need to conduct a detailed analysis of what impact any changes will have on the NHP sector.
Big questions still need to be answered before any formal regulatory changes are seen. Most notably, the importance of evidence from traditional forms of health and healing in a multicultural Canada, the role of product identifiers, and what exactly needs to be on a product label. Hopefully these questions will be answered by Health Canada and if changes to the regulations or guidelines are proposed that they will share a new official and complete proposal so that Canadians know the plans for the future. If changes are to be made, they should not be rushed.
Though I still commend Health Canada for highlighting the importance of self-care products and agree with the need to update the current dated regulations for non-prescription medicines and cosmetics, do we really need to radically overhaul NHP regulations that only came fully into effect a few years ago? It does seem that what is being proposed is to replace a three-category system (cosmetics, NHPs and non-prescription drugs) with another three-category system that could end up capturing the exact same set of products.
Though the current NHP regulations are modern, “state of the art” regulations, they are not perfect. After being in force for a number of years, we now know what works and what doesn’t. We have an opportunity now to fix any problems as well as use lessons learned from the NHPR in updating the regulations for cosmetics and non-prescription medicines. This, in my opinion, is where the focus should be.
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.
 A monograph typically sets out information such as claims, dosage and potential side effects preapproved that are permitted by Health Canada.
Recently there has been a lot of news about the regulations and quality of vitamins, minerals, herbals and other supplements available in Canada. To better navigate the market place, there are some important points that need to be remembered
Are vitamins, minerals and other supplements regulated in Canada?
In a word yes, these types of products often referred to as “supplements” are regulated as Natural Health Products or NHPs for short.
What is a Natural Health Product?
Natural Health Products are defined by Natural Health Product Regulations as:
- Vitamins and minerals;
- Herbal remedies;
- Homeopathic medicines;
- Traditional medicines such as traditional Chinese medicines;
- Probiotics; and
- Other products like amino acids and essential fatty acids
The regulations and Health Canada require NHPs to be “safe to use as over-the-counter products and not need a prescription to be sold”. If a prescription is required due to such things as the amount that needs to be taken or the illness it is being used to treat, then the product will be regulated as some other form of therapeutic good such as a prescription drug.
How are NHPs regulated in Canada?
As with things such as drugs, foods and medical devices, in Canada NHPs are regulated under the Food and Drugs Act. In fact, unlike in countries such as the United States where products such as these are regulated as a type of food, in Canada, NHPs are regulated as a type of drug with specific regulations developed to reflect the sector’s specific characteristics.
The Canadian NHP Regulations take a life cycle approach in that they look at both what happens before (premarket) and after (post-market) a NHP is available for sale. Before a NHP can be sold, a product license must be obtained from Health Canada and requires information such as the product’s ingredients (both medicinal and non-medicinal), what it can be used for, any potential side effects or things that should be avoided and recommended dosage. When a NHP is licensed by Health Canada it is assigned a Natural Product Number (NPN) that must be displayed on the product’s label. Also, a site license providing details of the site where the product is made and verification that they follow recognized Good Manufacturing Practices (GMPs) must also be submitted and approved by Health Canada. Again, both of these steps must be successfully completed before a NHP can be sold.
Regulatory oversight does not end once the NHP is on the market. Products are required to submit any details they receive about unexpected or serious adverse effects they discover. This approach allows Health Canada to make sure the information that they have is current. At any point, if a problem is identified either with safety or product quality, Health Canada can take action to mitigate this risk. These steps can range from requiring new labeling to asking that the product be stopped for sale. More information about the Canadian NHP regulations can be found at www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php.
What kind of evidence is needed to support a product claim?
The NHP regulations recognize the importance of scientific research as well as a respect for traditional forms of health and healing. This approach supports innovations in the market place together with the health care traditions that reflect Canada as a multi-cultural nation. To do this, the NHP regulations balance the type and quantity of the evidence with the claim a company can make on the label.
For example, if a company wishes to make a claim based on traditional evidence, then the product license application needs to make reference to a set of approved texts being used. These claims are appropriately limited and must used wording such as “Traditionally used for………” If a company wants to make a specific clinically-proven claim, then in most cases, they must submit results from a high quality clinical trial for review by scientists at Health Canada.
Since there are so many similar products on the Canadian market, Health Canada has developed an extensive set of NHP monographs for the most popular ingredients such as echinacea, glucosamine and fish oils. These monographs are constantly updated when more information comes to hand. If a company wants to use one of these monographs in a product license application, then their product must comply completely with the monograph regarding such things as dosage, indication for use, usage and warning labels. Health Canada audits these types of NHPs once they are on the market to make sure that companies are following the contents of the monograph they are using. You can learn more about the NHP monographs at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.
Remember, a NHP cannot be marketed for anything but a self-limiting condition or for health promotion. So, for conditions such as heart disease, cancer and serious infections, the only route open for approval is as a prescription drug or biologic therapy.
Are the claims for NHPs evaluated less stringently than for conventional drugs?
The claims that specific NHPs can make are assessed in a way appropriate for the products themselves. For conventional prescription drugs, the evidence required reflects the serious conditions they are intended to treat together with the potential for serious side effects. This can only be obtained through extensive clinical trials. For a number of drugs used over-the-counter, many of which have been available for many decades, a monograph system is used just like with NHPs.
How were these NHP regulations developed?
Input from all sectors of the community was sought in both the development and implementation of the NHP regulations. This input came through numerous consultations held across the country ranging from large meetings to face-to-face conversations as well as information received on line. They reflect a gold standard in how to develop modern health product regulations.
How can I find out more about what specific products are regulated?
Health Canada maintains the Licensed NHP database which lists all the approved product licenses in Canada, and also provides some information as to whether the licenses are active or not. This database lists the NPN (Natural Product Number), approved claim, ingredients, recommended dosage as well as any possible side effects or safety concerns. This information being on line from a government agency is pretty unique in world. More information can be found about the Licensed NHP database at www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php
Are the Canadian NHP regulations current?
Yes, they are very current and are considered by many to be cutting edge. They came into force in 2004 and are one of the newest regulatory frameworks for a therapeutic good or food in Canada at the moment. They are newer than the frameworks for prescription drugs, for over-the-counter drugs, biologics and foods, in some cases by decades.
These regulations are not static and change to reflect the sector. For example, some products in a food-like format such as energy drinks or supplements were initially regulated as NHPs. Since this may confuse consumers, these products are now more appropriately regulated as a type of foods. Also, Health Canada is considering whether they need to strengthen regulations around site licenses by requiring more detailed inspections.
How do the Canadian regulations compare to the regulation of similar products in other countries?
There is no uniform approach used around the world with respect to NHP regulation. Some countries simply have a basic registration system where companies must notify the national regulator if a product is marketed. Most countries have no specific process in place at all. Many countries have no specific process in place, not even a national registry for NHPs. Canada is one of only a few countries that have specific regulations for NHPs that ensure that all such products must be approved by a national regulator before they can be put on the market.
Should I be concerned about the quality of Natural Health Products available in Canada?
Though the Canadian consumer is in a better position than most consumers in other countries, concerns about quality should always be front and centre when you decide to take, or not take, a NHP. The market for NHPs is now global and very lucrative, with source ingredients and even finished products coming from places around the world. This has meant continued concerns about products containing or being adulterated by cheap ingredients, impurities or, in some cases, pharmaceutical drugs.
What should I look for in selecting a NHP?
Consumers should only take NHPs that are approved by Health Canada. For non-homeopathic NHP such as herbal medicines, vitamins and minerals, this can be confirmed by looking on the product’s label for an 8-digit Natural Products Number (NPN). An approved product has all the required information on the label including dosage, ingredients, and indications as well as any safety issues. Always remember to inform members of your health care team what NHPs you are taking.