Setting the Record Straight on the Self-Care Proposal

Canada is a global leader in regulating natural health products. In fact, every product legally available for sale in the country is reviewed by Health Canada and only approved if sufficient evidence is provided for safety, efficacy and quality. Canadian consumers can be confident that the products they choose have been approved by looking for the eight-digit Natural Product Number (NPN) on the label. This number is fully traceable through the Licensed Natural Health Products Database, which provides all of the information available about the product.

Following the release of the Consulting Canadians on the regulation of self-care products in Canada, Health Canada developed a myths and facts document, which was distributed to Members of Parliament and published online. After reviewing the self-care proposal and Health Canada’s myths and facts document, we had concerns that the information shared does not clearly explain the impact the self-care proposal could have on Canadians who rely on natural health products.

Below you will find Health Canada’s original myths and facts, followed by an expanded explanation of the proposed changes and the impact they will have, if the proposal from September 2016 was implemented.

On Product Availability

Myth: Health Canada wants to limit access to natural health products for Canadians.

Fact: Natural health products will continue to be readily available. Low-risk products, including many natural health products, will actually get to store shelves faster without compromising safety.

— Health Canada

CHFA's Fact Check:

For low-risk NHPs: According to the original consultation document, under this category, many products may get to store shelves faster but they could carry a disclaimer “not approved by Health Canada” and will no longer be allowed to make therapeutic claims. Under our current system, the claims used and the evidence that supports these claims are therapeutic claims. This means that for many traditional and homeopathic products, there will be a loss of important information and will leave vague statements to describe product benefits. As a result, it is expected that since manufacturers will not be able to clearly describe the benefits of their products, in many cases based on centuries of use, there could be less information available to Canadians. This will negatively impact informed choice of consumers and many manufacturers will need to re-evaluate bringing such products to the market in Canada.

For medium to high-risk NHPs: In some instances, the level of required evidence will be beyond what is currently available to support the product. Some of these products have been available for sale and used for many years in Canada and around the world, safely and effectively. These products could now require evidence that is more in line with what is needed to approve over-the-counter drugs. However, the consultation document does not define “scientific evidence” except for one note about a case study on toothpaste, which acknowledges that non-prescription drugs sold as toothpastes will need to meet prescription drug standards of evidence. This could result in the loss of products from store shelves.

On the Differences From Prescription Drugs

Myth: Self-care products will be treated like prescription drugs.

Fact: The rules for self-care products will not be the same as those for prescription drugs.

Self-care products would have the appropriate level of oversight to ensure consumer safety. This oversight would be different from what is required for prescription drugs since self-care products are generally lower risk.

— Health Canada

CHFA's Fact Check:

The self-care products proposal indicated that the way non-prescription drugs are regulated is the standard with respect to evidence requirements for claims, approaches to inspection, power of authority and application user-fees (i.e. the cost to apply for product approval). The wording of the proposal also suggested that the existing Natural Health Products Regulations (NHP Regulations) lack these elements and that Health Canada needs to develop a consistent approach for all products they define as self-care products. 

On the Ease of Bringing Products to Market

Myth: Health Canada is planning to add more rules and red tape for companies.

Fact: Companies will face less red tape to bring many self-care products to market. The rules will be applied based on the type of risk associated with the product, such as:

  • higher risk products could receive more review by Health Canada
  • lower risk self-care products could receive less review and get to market faster

— Health Canada

CHFA's Fact Check:

Since the introduction of the NHP Regulations, Health Canada has issued over 80,000 NPNs, representing over 100,000 products for sale in Canada. In its current iteration, the self-care products proposal would eliminate the existing system. This would create a burden for the companies many of whom are small- to medium-sized businesses, which have spent millions of dollars to comply with the NHP Regulations since their inception in 2004. Companies will need to gear up and prepare for a new and unknown level of scientific support to comply with these new rules. The truth is, many of these companies may not be able to continue their business based on the changes proposed. The ramifications of these companies going out of business is that Canadian consumers will no longer have freedom of choice, as many products may disappear from store shelves and potentially be replaced with products being imported under the personal importation program from outside of Canada with no Health Canada oversight.

The self-care proposal does entail more rules and red tape as follows:

  • Low risk products may have to be reformulated to precisely match Health Canada’s specifications for ingredients classified as low-risk. Changes to labels will also be needed to remove any therapeutic claims that were previously approved.
  • Low risk products may have to be relabelled to comply with Health Canada’s proposed requirements for a disclaimer and an identification number.
  • For NHPs classified as low-risk, going to market with a disclaimer and not being allowed to make health claims is an undesirable disadvantage.
  • While it appears that low-risk products may proceed to market without any Health Canada oversight, the consultation document states that Health Canada will maintain, on an ad hoc basis, three lists: one that will include ingredients for which a full review is required, regardless of claims; another that will restrict the use of certain ingredients, and; a list that will prohibit the use of certain ingredients in self-care products. This could severely limit the number of products that will be permitted for sale in Canada by virtue of manufacturers having to comply with the new rules or because some ingredients will be prohibited.
  • Companies with products deemed high-risk may have to submit evidence to the same standards as non-prescription drugs to maintain their health claims or to obtain new health claims.
  • The self-care proposal describes Health Canada’s new rules that state it will no longer review health claims based on traditional evidence, like pharmacopeias and traditional references. Instead, under the new self-care proposal, Health Canada would only approve health claims based on scientific evidence, similar to what is required for non-prescription drugs. 
  • Retailers would also be burdened to educate consumers on the changes from our current system (all products licensed and carrying an NPN) to Health Canada’s new self-care proposal where some products carry NPNs and other carry disclaimers warning the consumer.
  • The cancellation of thousands of NPNs that have already been issued would result in a loss of consumer confidence in NHPs.

On Making Health Claims

Myth: Health claims will be banned on self-care products.

Fact: Self-care products will be allowed to make claims if they’re supported by evidence as long as:

  • all claims are truthful and accurate
  • scientific evidence supports certain types of claims
  • claims on packages help consumers make informed choices

— Health Canada

CHFA's Fact Check:

Under the current NHP Regulations, all claims are reviewed and authorized by Health Canada on the basis that companies submit evidence appropriate to the type of claims being made and under the condition that all claims made are truthful and accurate. The stronger the claim, the higher the standard of evidence required to support it. 

Under the self-care proposal, products classified as low-risk will only be permitted to make structure function claims. A structure function claim describes the role a nutrient or ingredient plays in the normal functioning in the body (example calcium builds strong bones). However, since many traditional medicines, like Traditional Chinese Medicines, native North American and South Asian medicines, and homeopathic medicines are used for providing a therapeutic effect, they are not nutrients and therefore do not and cannot make structure function claims. As a result, these products would be re-classified as medium or high-risk. This is problematic because, while there is traditional evidence and a long history of safe use to support these claims, this evidence may not meet Health Canada’s definition of scientific evidence. This could result in products, which many Canadians rely upon, to be pulled from the market, because they will not be able to provide the level of evidence required for products classed as medium or high-risk, despite being currently categorized as low-risk.

The self-care proposal will reduce access to relevant and essential information about the nature and intended use of traditional medicines, which will lead to fewer Canadians being able to make the informed choice to consume traditional medicines. As a result, fewer of these products will be able to remain on store shelves.

On Canadians’ Knowledge and Understanding of the Safety, Efficacy, and Quality of Natural Health Products

Myth: Canadians are well-informed about the self-care products they use.

Fact: Polling shows that Canadians don’t feel informed when choosing and using self-care products. Public opinion research conducted in April 2016 showed that fewer than 2 in 5 Canadians feel knowledgeable about the effectiveness of self-care products.

Canadians feel like they have little knowledge of the safety and effectiveness of these products, and feel generally uninformed when making a purchase. The self-care proposal will support informed choice. 

— Health Canada

CHFA's Fact Check:

Health Canada’s referenced polling/public opinion research, which appears to be the sole basis for the entire self-care proposal, is based on a single, fundamentally flawed Consumer Health Products Survey. The Consumer Survey took place over a span of just 6 days and no additional research has been conducted nor any alternative proposals made.

Furthermore, the survey had critical design and interpretative shortcomings, including, but not limited to, flawed definitions of non-prescription drugs, which confuse these products with NHPs, questionable methodology, unsubstantiated claims, and misrepresentation of respondent opinions. Consequently, the Consumer Study’s results cannot be relied upon to confirm or reject any level of consumer knowledge, confusion, anxiety or preference with respect to NHPs, cosmetic products and non-prescription drugs.

In context, our current regulations were put into place in 2004 after a thorough review performed by the Standing Committee on Health (SCOH) in 1998. This review led to the development of the report, “Natural Health Products: A New Vision.”

Some of the guiding principles of the report include:

  • NHPs are different in nature from, and must not be treated strictly as either food or pharmaceutical products; 
  • NHP regulations must not unduly restrict access to consumers;
  • NHP consumers must be given pertinent information about the products they purchase; and
  • NHP regulations must respect freedom of choice, and philosophical and cultural diversity.

The report was prepared after the SCOH met with hundreds of witnesses from across Canada, including consumer groups, Health Canada, the Canadian Food Inspection Agency and international regulators, and received and subsequently reviewed numerous submissions over a six-month period.

Following the enactment of the NHP Regulations, the industry went from 50,000 non-compliant NHPs to the current 100,000 compliant NHPs.  Nothing in the consultation document indicated a problem with the current regulatory framework other than unsupported statements relating to consumers being misled. No issues related to health and safety of consumers were raised. If, in fact, the issue is really about information being provided to the consumer, then the document should have suggested options to providing clearer information on the label to inform consumers for the basis of the approval of the product. This would give consumers access to the information they need to make an informed choice, while still respecting freedom of choice and cultural diversity.   

On the Risks Associated With Using Natural Health Products

Myth: Natural health products are safe and don’t need many rules.

Fact: Most natural health products are low risk, but they are not without risk.

There is a wide range of natural health products, some of which can interact with other medications and/or cause serious adverse reactions. Health Canada will continue to have safety checks in place.

— Health Canada

CHFA's Fact Check:

We believe NHPs do need rules that are reflective of their low-risk nature when compared to drugs. These appropriate rules are reflected in the NHP Regulations which have been in place since 2004. Under the current system, Health Canada reviews all products for safety, efficacy and quality before allowing them on the market. Health Canada’s review and the prescribed labelling requirements in the existing regulations ensure that the risk posed by NHPs are minimized. Cautionary statements on product labels indicate known interactions with medications as well as serious adverse reactions to ingredients in the product.

The self-care proposal would allow NHPs categorized as low-risk on the market without being reviewed by Health Canada, which does not minimize the risks highlighted by Health Canada. The proposed disclaimer on the product label would not provide information about interactions or adverse reactions, nor would it protect Canadians against any risks posed. This is akin to the current American approach for similar products, which is itself being questioned in the US and categorically rejected by the Standing Committee on Health in the past.

On the Type and Level of Evidence Required for Natural Health Products

Myth: There is no scientific evidence to support any natural health products.

Fact: Many natural health products are supported by scientific evidence, while others rely on a history of traditional use or non-scientific information.

— Health Canada

CHFA's Fact Check:

Health Canada is correct that many NHPs are supported by scientific evidence and many others rely on a long history of traditional use evidence. However, the definition of “scientific evidence” is not provided in the consultation document. This is concerning because the existing, acceptable evidence for traditional products may not meet the scientific standards set forth under the self-care proposal. The self-care proposal does not reflect the diversity of products under the definition of NHPs, which are proven to be safe and effective by a range of supporting evidence, depending on the strength of the claim being made.

On the Transparency With Which Health Canada Released the Self-Care Proposal

Myth: Health Canada’s new self-care proposal came out of the blue.

Fact: Health Canada has been looking to modernize the rules for self-care products for some time. Health Canada has been working to modernize its approach to health products, including launching the regulatory roadmap in 2012 and conducting a consultation on consumer health products in 2014. Through the current consultation, the Department wants to hear from Canadians to inform the way forward.

— Health Canada

CHFA's Fact Check:

It’s true that Health Canada has been working to modernize their approach to health products for some time. However, the framework discussed in 2014, referred to then as the Consumer Health Products Framework, is fundamentally different to what is being proposed in 2016.

In 2014, Health Canada’s proposed framework highlighted the existing NHP Regulations as the most modern approach to regulating self-care products and would help guide the development of the non-prescription regulations. However, the recently released self-care proposal pivots from this approach, and appears to be suggesting that the NHP Regulations be abandoned for a new system that would no longer approve non-scientific substantiated health claims for natural health products. This is a fundamental departure from the previous consultation.

While Health Canada wanted to hear from Canadians to inform the way forward, the proposal does not provide multiple approaches or solutions for consumers to provide feedback upon. In addition, the identified issues are based on a single survey with critical design and interpretative shortcomings, including, but not limited to, questionable methodology, unsubstantiated claims, and misrepresentation of respondent opinions. Consequently, the survey’s results cannot be relied upon to confirm or reject any level of consumer knowledge, confusion, anxiety or preference with respect to NHPs, cosmetic products and non-prescription drugs (collectively, “self-care products”).

Our current regulations take into account the unique properties and low-risk nature of these products, ensuring Canadians have access to NHPs that are safe, effective and high-quality, while respecting your freedom of choice, and the philosophical and cultural diversity of our country.

It will take less than one minute to send a message to your Member of Parliament using the link below, letting him or her know these proposed changes are unacceptable.