Consulting Canadians on the regulation of self-care products in Canada

Table of Contents

• 1. Self-Care Products in Canada
• 2. Objective of the Consultation Paper
• 3. Overview of the Current System
• 4. Challenges in the Current System
• 5. The Proposal for Consideration
  • a. Impacts on Canadian Consumers
  • b. Impacts on Regulated Parties
• 6. How To Get Involved
• Annex 1: Consultation Questions

1. Self-Care Products in Canada

As committed to in the Regulatory Transparency and Openness Framework, Health Canada continues to make more information available to Canadians than ever before. Canadians are also being offered more opportunities to participate in discussions on government policies and priorities. This consultation document is one such opportunity for Canadians to provide feedback at an early stage on some policy proposals under development.

Most Canadians are aware that Health Canada regulates all prescription drugs sold in Canada. You may not realize that Health Canada also regulates vitamins and minerals, probiotics, pain and allergy medications, sunscreens, make-up, skin moisturizers, and deodorants that you can purchase at a pharmacy, grocery store, or other retail location without a prescription from your doctor. Canadians use these "self-care products" frequently - sometimes on a daily basis - to care for themselves and their families, for improving appearance, maintaining health and treating minor ailments.

When shopping for a self-care product, you will often see various options grouped together on store shelves based on the condition for which they are intended to be used. For example, a wide variety of products for skin care may be grouped together or a number of different products for headache relief may sit next to each other on the shelf. Many of the products you see might make the same or similar claims about what they do and they may have packaging that all looks alike. These similarities may lead a consumer to believe that these products are equally effective and have had to follow the same rules and oversight to be allowed to be sold, but this may not be the case.

Based on definitions in legislation and regulations, Health Canada considers self-care products to be made up of three different product types:

• Cosmetics, which are used for cleaning, improving or altering the complexion, skin, hair or teeth, such as moisturizing creams, deodorants, and shampoos;
• Natural health products, which include vitamin and mineral supplements, probiotics, herbal preparations, homeopathic remedies, and traditional medicines (such as traditional Chinese medicines); and
• Non-prescription drugs, also commonly referred to as "over-the-counter drugs" which include products for pain relief, cold and flu symptoms, and allergy relief.

Health Canada has different ways of overseeing the safety, efficacy, and quality of cosmetics, natural health products, and non-prescription drugs. By safety, we mean that the product will not be harmful or toxic when you use it according to the directions and warnings on the label. Efficacy refers to what the product is meant to do and is usually represented by a claim, e.g., "relieves headache". A health claim is a description on the product about what it does in relation to someone's health. Finally, quality means that the product is manufactured under controlled conditions and will be made properly.

While all of these products fall under one law in Canada - the Food and Drugs Act - they are regulated under three separate sets of regulations:

• Cosmetics sold in Canada must meet the Cosmetic Regulations;
• Natural health products sold in Canada must meet the Natural Health Products Regulations; and
• Non-prescription drugs sold in Canada must meet the Food and Drug Regulations.

Regulations, along with related policy and guidance documents, set the rules that companies have to follow so that their products can be sold in Canada.  These rules set out how products are evaluated and approved by Health Canada (including what claims can be made); how products should be manufactured, labelled and packaged; how safety and compliance will be monitored once products are on the market; and, what the consequences are for companies if they do not follow the rules.

Even though all three sets of regulations fall under the same Act, they do not set out the same rules for bringing self-care products to market. For example, not all self-care products currently require that the company provide scientific evidence to Health Canada to support the claims made on the label. Similarly, some products undergo a lot of scrutiny before coming to market, while others do not. This means that products could appear almost identical on a store shelf, even though the rules for bringing them to market are quite different. For a consumer weighing the options between similar-looking products, both claiming to treat the same symptom or condition, the differences in the approval process are not apparent. This means that consumers may be choosing a product without the information required to make an informed choice.

Health Canada is examining new approaches to the regulation of self-care products, including refocusing the approval of health claims to those based on scientific proof. A new approach will continue to allow for a wide range of products to be available for Canadian consumers, while, at the same time, taking a more consistent approach to the oversight of self-care products that will ultimately better support consumers’ ability to make an informed decision.

2. Objective of the Consultation Paper

Health Canada wants Canadians to be able to trust that self-care products are safe and do what they claim to do. In order to achieve this, Health Canada wants to modernize its approach to self-care products, so that Canadians can have further confidence in the products they choose.  This means creating rules for self-care products that are consistent and that provide the right tools to efficiently manage a broad range of low-risk products.

The Department is proposing a new Framework for self-care products.The approach will include the following 3 main proposals:

1. Products of similar risk profiles would be treated in a similar manner.
   • This ensures rules for bringing products to market are:
     • more consistent

     • easier to understand

2. The Department would review health claims based on a new definition.

   • Companies would require scientific proof to support these health claims.

3. A risk-based approach to compliance and safety monitoring will continue.
   • This allows Health Canada to take quick action to protect consumers.

We want to hear directly from the consumers who choose these products, as well as from industry, health professionals, and all others who have an interest in this proposal. This consultation is intended to build on public opinion research conducted with 2,500 Canadians in April 2016, which was carried out to provide some baseline information on how Canadian consumers perceive and use self-care products. Health Canada will be conducting other activities in the months to come to learn more about the views of consumers, industry, health professionals, and other stakeholders. This discussion paper also builds on a previous consultation on consumer health products, for which more information can be found at: Summary Report on the Consultation on a Framework for Consumer Health Products: What We Heard.

3. Overview of the Current System

Here is a general overview of how the three types of self-care products are regulated under the current system.

The oversight of cosmetics is managed through a post-market system, meaning after products are on the market. Manufacturers and importers must notify Health Canada within 10 days of first sale of a cosmetic in Canada. When a company notifies Health Canada, it must provide information about its product, such as the ingredients and how much of each is in the product, the company's contact information, and the purpose for which the cosmetic is to be used. Health Canada has a variety of tools to identify what the Department considers to be prohibited or restricted ingredients in cosmetics. All cosmetic products must be prepared under sanitary conditions. In this system, the submission of a cosmetic notification does not represent an approval for sale, or that the product complies with all legal requirements.

To be sold in Canada, natural health products must be licensed by Health Canada. This means that before a natural health product can go on the market, a company must submit documents to Health Canada for review to show that the product is safe and effective, although the level of proof required can vary. Non-scientific information is accepted to demonstrate efficacy, for example texts demonstrating historical use of the product. More details are provided on this point later in the document. If Health Canada finds that this information meets the requirements under the regulations, it will issue a "product licence". You can identify licensed natural health products by looking for the eight-digit natural product number (NPN), or in the case of a homeopathic product, a homeopathic medicine number (DIN-HM). These numbers are found on the product label. In addition, Canadian companies that manufacture, package, label and import natural health products must have what are called "site licences" to be able to carry out these activities. In order to get a site licence from Health Canada, the company must submit documents to show they are capable of carrying out the activities based on certain standards.

Non-prescription drugs are regulated for the most part like prescription drugs. Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. When you see a DIN on a product label, this means that Health Canada's requirements for safety, efficacy, and quality have been met by companies through their provision of the necessary documents and evidence. This is similar to what is done for natural health products; however, the level of proof required and provided for non-prescription drugs is usually of a higher standard, particularly for a claim. A claim tells you what the product is intended to do to improve your health. The information required to support a claim for a non-prescription drug is typically stronger than that required for a natural health product. Further, claims for non-prescription drugs must be based on scientific evidence. Also, unlike natural health products, Canadian companies that manufacture, package, label and import non-prescription drugs not only need to be licensed for these activities, but they are also inspected by Health Canada in order to obtain a licence.

4. Challenges in the Current System

Health Canada has several key concerns relating to the current system for regulating self-care products, including issues Health Canada has identified in its regulation of the products as well as concerns that have been raised by Canadians, companies, health professionals, and researchers.

1. Self-care products are subject to three separate sets of regulations, each with different rules for how to bring a product to market, different evidence requirements for claims about what a product does, different approaches to inspections of the sites where companies make the products, and different powers and authorities that allow Health Canada to take action in the case of non-compliance or safety concerns once a product has been approved for the market.

   Generally speaking, products fit under one of the three sets of regulations based on whether the ingredients are naturally occurring and whether the product makes claims related to a health outcome (as opposed to appearance, for example), instead of their risk level. This means that a toothpaste may have been treated in a manner similar to a prescription drug, whereas another product intended to treat a specific condition may have undergone far less scrutiny, even though the impact of the product not working may be more serious.

2. The level of evidence required for similar claims varies. Generally speaking, non-prescription drug claims require supporting scientific evidence. For natural health products, however, a wider range of supporting information is accepted for claims, ranging from scientific evidence to encyclopedias of health and wellness philosophies based on premises other than science. Health Canada's practice of accepting other non-scientific information to support claims for natural health products is based on an attempt to recognize that these products are not the same as conventional drugs, and often have a basis in philosophies that support the general health benefits of some ingredients through means other than scientific standards. Some products, like traditional Chinese medicines, are based on thousands of years of use. Homeopathic products (also a type of natural health product) are grounded in homeopathy, a system that is not supported by science.

   What this means for consumers is that a non-prescription drug and a homeopathic product could be making a similar claim (such as "relieves cough") but only the claim on the non-prescription drug would be supported by scientific evidence. In our current system, this difference may not be clear to the consumer because there is no signal on the product label, so these products could appear to consumers as if they are equally effective.

3. There are inconsistencies and gaps in post-market powers. Although self-care products are generally considered to be of lower risk, safety concerns can still arise when companies do not follow the regulations. The law provides Health Canada with powers to take action on products that are already on the market. At this time, Health Canada does not have the authority to order a recall or a label change for natural health products or cosmetics. Instead, Health Canada must work with a company to encourage it to remove a product from the market or change its label. In contrast, for non-prescription drugs, Health Canada has the power to demand a recall or a label change exists. Further, for those who break the laws for natural health products and cosmetics, the maximum fine is $5,000 compared with fines in excess of $5 million for non-prescription drugs.

   To protect the health and safety of Canadians, it is paramount for the Department to have the right set of tools to swiftly address a safety concern.

4. There is inconsistency in the application of user fees. Health Canada charges fees to companies that want to receive a licence to sell a non-prescription drug. This fee covers part of Health Canada's scientific assessment and other regulatory activities. There are currently no fees paid by companies bringing natural health products and cosmetics to market, even though companies benefit from the regulatory activities Health Canada conducts related to these products. Health Canada will be examining a more consistent approach to the application of user fees for self-care products.

5. The Proposal for Consideration

Proposal: Risk-based Approach to Self-Care Products

Self-care products are generally lower risk in comparison to other health products regulated by Health Canada (like prescription drugs, for example) if you use them as intended, following the label directions. However, within this family of self-care products there is a range of risk depending on the type of product, its ingredients, how it is meant to be used, and what is on its label. Many self-care products have a long history of use and have been shown to be safe under specific conditions. Therefore, these products do not need as much oversight by Health Canada before they go to market.

Other self-care products that contain new or higher risk ingredients or make claims to treat serious medical conditions require more attention by Health Canada.

The Department is considering a new structure for classifying self-care products that would be based on a product's risk. In this case, the risk level of the product is determined by the safety of the product (i.e., certainty around safety under established conditions) and the level of concern of failed efficacy (i.e., the impact to the user if the product fails to do what it claims).

Description of Figure 1: The above graphic describes the oversight that could be provided, including potential examples, in the proposed risk-based classification system. Lower-risk products would not require a licence prior to selling the product in Canada and would not require review by Health Canada. Products in this category would be allowed to make claims, but not health claims. For medium-risk products there would be some review, which would build on licensing standards, known as product monographs and would be limited to what is described in the monograph. For higher-risk products there would need to be a full review by Health Canada before companies would be able to make new or novel claims for the diagnosis, treatment, prevention, cure or mitigation of a disease or condition.

Under the proposed Framework, there would be a group of lower risk self-care products that would not be reviewed by Health Canada prior to going to market. They would already have established safety (based on their history of use) and would not be making any diagnostic, treatment, prevention, cure, or mitigation claims. Products in this category would need to meet requirements set by Health Canada about what the product can and cannot contain, what information needs to be on the product label, and what should be done to provide a product of good quality. For this category of products, Health Canada would not be reviewing each product, and therefore, these products would not be approved by Health Canada. Instead, companies would have to notify Health Canada that their product is on the market, and they would be responsible for following our standards. This model borrows some features from the one currently in use for cosmetic products.

At the other end of the spectrum, there would be a group of higher risk self-care products for which Health Canada would review the safety of each product and whether there is scientific evidence to support the claim about what the product will do. If the product meets the necessary standards, it would be approved by Health Canada and there would be a number on the product to show that it has been approved. Products in this category would include new ingredients, new claims, or new uses in at risk groups like children, or pregnant or breastfeeding women.

In the middle, there would be a group of moderate risk self-care products whose approval would be based on documents called monographs, which outline specific standards for types of products. In contrast to the lower risk self-care products which have standards for safety only, the monographs established for moderate risk self-care products also outline acceptable statements and conditions for what a product can say that it does (i.e., efficacy). Companies would need to meet these safety and efficacy standards. If they do, they would be approved for sale by Health Canada, and there would be numbers on the products to show that they have been approved.

Finally, what is known about the safety of a self-care product can change, even for products that have been on the market for a long time. A new safety issue, such as poor product quality, false claims, or product misuse, could arise with any self-care product. In such cases, Health Canada would continue to take the appropriate action.

Proposal: Health Canada Approval of Health Claims Only

At this time, all self-care products are allowed to make claims. Health Canada reviews only claims for non-prescription drugs and natural health products, and claims for these products are considered health claims. In doing reviews, the Department determines whether health claims are acceptable before a company can legally sell. Claims made on cosmetics, however, are not considered health claims and are not reviewed.

Other claims, such as more general ones that speak to the function of a product, would no longer be considered health claims. Moving forward with such an approach would mean that Health Canada would only review and approve health claims for self-care products as per the new definition. The reason is that if products with such claims do not do what they claim to do (e.g., not reducing a fever in children), there could be a risk to consumers. For these claims to be approved, companies would have to provide scientific evidence to support them. This would mean that two products making a similar claim, such as "relieves cough and cold", would have to provide the same level of scientific evidence.

Companies could still bring a product to market that makes claims other than those five types of health claims identified above. For example, a company could make a claim such as "source of omega-3" provided there are no safety concerns, and the claim is truthful and accurate.

Health Canada wants to provide Canadians with information that can assist them in making choices about health products and is exploring ways to do so. For products that are not reviewed by Health Canada for effectiveness, the Department is considering informing Canadians through the use of a disclaimer on the product label. This would allow consumers to do more research, if they wish, about those products. At the same time, under the proposed approach, Canadians would be able to have confidence in the claims present on products approved by Health Canada, as these would be reviewed by the Department and would have scientific proof to support them.

Proposal: Compliance monitoring and addressing inconsistencies in post-market powers

Compliance monitoring for health products means that Health Canada watches whether companies are following the rules. The Department already monitors products on the market and responds when a risk to the health and safety of Canadians is found. We propose to continue to do this in a way that is appropriate to the family of self-care products. The intensity of compliance activities would continue to be tailored for each of the three risk categories of self-care products. This means that as the potential risk of the product increases, Health Canada would apply more oversight to it. Our approach would continue to include many important actions, such as the inspection of facilities, responding to complaints about products, and testing of some products.

We may also need to explore whether our current powers and authorities are sufficient, or if additional tools are needed to enable Health Canada to do such things as order the removal of an unsafe product from the market, require a company to change a product label to reduce risks to consumers, or require a company to pay a fine when it does not follow certain rules.

5a. Impacts on Canadian Consumers

Under the proposed Framework, as a consumer, you would continue to have access to a wide range of self-care products. Safety would be established for all products, and the product label would provide you with valuable information to inform your selection and decision to use a self-care product. More specifically, you would be able to note the following based on the product label:

• If there is an authorization number on a product, you would know that Health Canada has reviewed and approved the product, and that the claim on the product is based on scientific evidence; and
• If there is a disclaimer, you would know that Health Canada has not reviewed or approved the claim on the product. That said, companies would not be allowed to make untruthful claims.

There may be some situations where it might not be necessary to include a disclaimer, such as cosmetic products used to beautify (e.g., lipstick) or for cleansing (e.g., soap, shampoo). Health Canada continues to explore this issue further and would appreciate feedback on how we can communicate to consumers that certain claims have not been reviewed for effectiveness.

Although Health Canada would continue to have safety checks and balances in place and products would be regulated, Health Canada would not be reviewing and approving products in the lowest risk group, and this would be a significant change for some products. Health Canada does not seek to limit or restrict access to products that pose minimal risk to Canadians. Rather, we are seeking ways to continue to provide consumers with access to a wide range of choices of self-care products and make the necessary information available to support informed decision-making.

For higher-risk products, Health Canada would review and approve all products before they could legally be sold in Canada. As part of this review, scientific evidence would be required to support the health claims made on the product. This would remove the inconsistencies that currently exist, where there are differences in the information that companies must provide to demonstrate that the product will do what it claims to do, depending on what type of product it is. Under the proposed approach consumers would know that products making the same health claim were held to the same standard.

Despite the type of product and whether it has been reviewed and approved by Health Canada, should a safety issue arise, you can be confident that the Department has the ability to take action.

5b. Impacts on Regulated Parties

Health Canada will continue a risk-based approach to compliance and safety monitoring enabling Health Canada to take quick action to protect Canadians.

The Department is proposing a simplified classification of self-care products that would provide more clarity and transparency to the rules for cosmetics, natural health products and non-prescription drugs. The requirements for bringing these products to market will be more consistent and easier to understand, meaning that products of similar risk would be treated in a similar manner.

Under the proposed approach, redefining health claims that are supported only by scientific proof will result in many self-care products not requiring review or approval by Health Canada before being sold. Unlike the present approach, many products could go to market right away and companies would notify Health Canada of the product being available for sale, similar to how cosmetics are currently regulated.

It is proposed that the notification process would be electronic and would require simple information, such as (but not limited to) the person responsible for the product and their contact information, what the product is, what it contains, and an attestation of compliance with all of the applicable requirements in the making and selling of the product, including manufacturing and labelling requirements.

A company would have to check Health Canada's website to verify such things as:

1. If a monograph exists for the product or ingredient;
2. If the product or ingredients are on a list indicating that a full review is required; and
3. If the product contains prohibited or restricted ingredients.

If the product or its ingredients do not appear on these lists, then the product would not require review or approval by Health Canada before being sold. If, however, the product or one of its ingredients is found on one of the first two lists, then a licence would be required.

In some instances, even if the product is not making a diagnosis, treatment, prevention, cure, or mitigation claim, there may be a need to ensure that the product is reviewed for safety only. A pathway would be created to enable this.

There would be checks and balances to ensure that all products notified or licensed are safe and of high quality. This includes the responsibility on the companies to ensure that all products are made to the appropriate quality standard, which may vary depending on the risk category in which the product is classified.

Making claims for products that would go to market via notification

Even if a licence is not required, a company could still make a claim on a product. Many of those claims would be the same as those that appear on labels today, like claims of a general nature such as structure-function claims (i.e., "calcium builds strong bones", etc.), claims based in traditional systems of medicines, alternative modalities and nutritional- or composition-based claims (e.g., "source of fibre", etc.). These claims would need to be truthful and adequate supporting information for claims would need to be maintained by the company so that it could be provided to Health Canada upon request.  To ensure that the difference between these claims and a health claim is clear to consumers, Health Canada is considering the inclusion of a disclaimer on products not reviewed by Health Canada, as described earlier in the document.

Finally, as noted earlier, there could be situations where it might not be necessary to include a disclaimer. Health Canada is exploring potential exclusions, such as for some cosmetics used to beautify (e.g., lipstick) or clean (e.g., soap, shampoo). Such exclusions would require clear guidance to avoid any potential confusion.

Finished product labels

Health Canada is exploring options for obtaining a copy of the finished product label for all self-care products so that the Department could easily and quickly determine whether or not a new safety issue not already identified on the product label might arise.  This may include any issues related to the instructions for how to use a product properly that might lead to confusion.  Having a record of the finished product label could also allow the Department to more easily follow up on advertising complaints. Labels would be used only for baseline information, and would not be reviewed unless needed.

Unique identifiers for products that go to market via notification

The Department is also exploring the use of a unique "tracking" number or identifier for products with no authorization number (i.e., products that are not reviewed or approved by Health Canada before being sold). Such a number would not be used to indicate product approval and would not necessarily be included on the main display panel. The objective would be to enable a specific product to be quickly identified and traced. This is particularly important where products have the same or similar name but a safety issue occurs with only one specific product.

Health Canada acknowledges that some products fall outside what is considered self-care, including supplemented foods, injectable products, medical devices, and radiopharmaceutical products. Additionally, there are other products that are currently treated as non-prescription drugs that would not fit within the "self-care" model, including disinfectants and health products that require the oversight of a health professional for which the Department is developing solutions to address in parallel to the self-care proposal.

6. How to Get Involved

The proposals outlined in this document represent potential building blocks for a new approach to self-care products in Canada. We would like to hear from you. We encourage you to provide your feedback by completing the online consultation that Health Canada has developed.

You also have the option to submit comments by email or through traditional mail. For your reference, we have provided a list below of the same questions that are used in the online consultation.

By Email: nnhpd_consultation_dpsnso@hc-sc.gc.ca

By Mail: Health Canada
Health Products and Food Branch
Natural and Non-Prescription Health Products Directorate
250 Lanark Avenue, A.L. 2003C
Ottawa, Ontario K1A 0K9
Attention: Consultations

Health Canada is committed to reviewing and considering all comments received by October 24, 2016.

Please note that the public opinion research referenced in this document is available online.

Annex 1: Consultation Questions

To be more user-friendly, Health Canada has embedded the following questions within an online consultation. Health Canada encourages respondents to provide your feedback through this online format, which is a combination of multiple choice questions as well as text boxes in which you can provide your views or further details on multiple choice selections. If you choose to submit comments by email or through the traditional mail system, please feel free to do so. We would encourage you to use the following questions as a guide.

To safeguard privacy, you should ensure that any written comments you may provide are sufficiently general that you cannot be identified as the author and that individual identities are not disclosed.

1. The category that best describes your perspective is:
   Consumer/Healthcare professional/Public interest group/Academic/researcher/Federal government official/Provincial government official/Cosmetic manufacturer/Non-prescription drug manufacturer/Natural health product manufacturer/Other (please specify)
2. What do you think of the risk-based approach for self-care products proposed in this document?
3. What do you think about Health Canada's proposal to group self-care products according to the above-mentioned levels of risk, i.e., risk-based grouping?
4. How would the risk-based grouping impact your decision-making and your purchases of these products?
5. What are your thoughts on the proposal to require scientific data to support a health claim?
6. If you do not support, please explain why.
7. Health Canada is exploring ways to provide Canadians with information that can assist them in making choices about self-care products, including the use of a disclaimer on product labels to identify claims that are not reviewed by the Department. What do you think about this approach? Would this type of information be helpful to you as a consumer?
8. Do you think that a product identifier (i.e., a number on the product) is necessary to help consumers identify a product in the event that they wish to report an issue with the product?
9. Do you feel confident that the proposed safety oversight approach will allow you to continue accessing good quality, safe and effective products?
10. If no, what are your concerns?
11. Do you believe that additional powers to change labels, require a recall and new penalties would help address safety issues and discourage companies from breaking the law?
12. If no, why not?
13. Do you think the frequency of inspections of companies should vary depending on the risk category of the products these companies make?
14. Do you feel that the proposed Framework addresses any concerns you have with self-care products?
15. What else could Health Canada include in the Framework to address your concerns?