Consumer Health Products Framework:
Frequently Asked Questions (FAQs)
Consumer Health Products Framework
1. What is a consumer health product?
Consumer health products are products sold directly to consumers. Unlike prescription drugs, selection and use of consumer health products does not require the oversight of a health care practitioner. Based on the supporting information and instructions available on the label, Canadians can safely select and use these products to maintain and improve their health.
Consumer health products cover a broad range of products including:
- non-prescription drugs (e.g., pain relievers, cold and allergy remedies, acne therapies);
- disinfectants (e.g., for use on countertops, contact lens solution);
- cosmetics (e.g., make-up, shampoos, deodorants); and
- natural health products (e.g., vitamin and mineral supplements, traditional and homeopathic medicines, probiotics, toothpastes).
Figure 1 Examples of Products under the Consumer Health Products Framework
2. What is the reason for creating the Consumer Health Products Framework?
Demand for consumer health products continues to increase as Canadians are becoming more informed of self-care options. The consumer health product market is growing and changing. These products are being sold in an increasingly wide range of locations from gas stations, to pharmacies, to health food stores, to supermarkets, and the range of products available is also increasing due to industry innovation and diversification.
Health Canada needs a regulatory approach that will be flexible and responsive enough to adapt to these changes. By establishing a consistent and aligned approach to the regulation of health products intended for consumer use (disinfectants, natural health products, non-prescription drug products and cosmetics), Canadians will have access to information that will help them to identify what products are regulated by Health Canada and enable them to make safe, informed choices about products and their use.
This approach is known as the Consumer Health Products Framework (Framework) and seeks to modernize the oversight of consumer health products while continuing to ensure that Canadians have access to safe and effective products. Under this approach, the potential risk of the product will be taken into account in order to ensure that the right level of oversight through regulations is applied. The Framework is designed to ensure that the safety of Canadians always remains the priority.
3. What are the guiding principles of the Consumer Health Products Framework?
Health Canada recognizes that not all consumer health products have the same risk profile. The approach will be based on the management of benefits, harms and uncertainties by considering the nature, intended use and exposure of the product.* This will support a regulatory system that is more open, predictable, transparent and does not compromise safety.
The new framework is built on the following elements:
- protecting the health and safety of Canadians;
- a science-based approach;
- transparency of important product information;
- proportional oversight for products both pre- and post-market;
- flexibility to address varying risk profiles;
- international alignment;
- operational efficiency and sustainability;
- responsive regulatory approach; and
- reduction and prevention of regulatory barriers to small business.
* For cosmetics, the approach is somewhat different. Ingredients are assessed for safety based on hazard and exposure. This means that Health Canada looks carefully at both the characteristics of the ingredients in a cosmetic as well as how consumers are exposed to those ingredients.
4. How are consumer health products regulated?
- Natural health products are regulated under the Natural Health Products Regulations;
- Cosmetics are regulated under the Cosmetic Regulations; and
- Non-prescription drugs and disinfectants are regulated under the Food and Drug Regulations. It is proposed under the Framework that new regulations would be created for non-prescription drugs.
Each set of regulations has safeguards in place to protect the health and safety of Canadians.
5. What will change under the Consumer Health Products Framework?
Health Canada is changing its approach to how it regulates consumer health products. This means that new policies, guidance, and operational changes will be introduced to facilitate alignment in our approach to these products and achievement of the right level of oversight.
Health Canada will propose new regulations for non-prescription drugs. The existing Food and Drug Regulations do not include provisions common to more modern regulations that enable an optimal approach to health and safety. This process could take a couple of years. In the meantime, operational and policy changes will be advanced.
While there are no plans at this time to change the Cosmetic Regulations and the Natural Health Products Regulations, the proposed non-prescription drug regulations include provisions which may make sense to extend to other types of products under the Framework. For example, consideration would be given to revising the Natural Health Products Regulations at a later date to include the distribution of samples of approved natural health products.
What will not change under the Framework is Health Canada's commitment to protecting the health and safety of Canadians when it comes to consumer health products.
6. Why do new regulations for non-prescription drugs need to be created? Didn't the government just amend the Food and Drugs Act by passing the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)?
Canada has one of the safest and most rigorous drug and medical device approval systems in the world. The Food and Drugs Act, however, has not been updated in over 50 years. Science and medicine have evolved considerably in those 50 years, and there has been significant progress internationally to improve patient safety through enhanced regulatory oversight of products on the market.
The amendments brought to the Food and Drugs Act by Vanessa's Law will improve patient safety and health outcomes by providing Health Canada with the post-market authorities it needs to better understand the benefits and harms associated with a therapeutic product.
In modernizing the regulations for non-prescription drugs, Health Canada can also make use of new regulation-making authorities in the Food and Drugs Act. For example, the ability to add terms and conditions to a market authorization or to incorporate documents by reference in the regulations will allow for more proportional and targeted oversight while bringing efficiencies to the regulatory process.
7. What work is currently underway to support the Consumer Health Products Framework?
While the department is proposing to create new regulations for non-prescription drugs, it is making many improvements to its regulatory approach to consumer health products. Efforts are focused on examining current policy, guidance and operational processes to support the alignment of the following consumer health products:
- Non-prescription drugs;
- Natural health products; and
8. What is Health Canada proposing to do to address challenges related to the regulation of non-prescription drug disinfectants?
Disinfectants are currently regulated under the Food and Drug Regulations and are subject to the same requirements as non-prescription drugs with some exceptions. While Health Canada launched a new approach to non-prescription disinfectant drugs in spring 2014, the existing regulations continue to pose challenges to proportionate regulation of the products. The new proposed non-prescription drug regulations will include distinct provisions for disinfectants that are tailored appropriately to the products.
Note that certain disinfectants (e.g., for use in swimming pools and spas) will continue to be regulated under the Pest Control Products Act.
9. Why is Health Canada proposing to develop non-prescription drug regulations?
The Food and Drug Regulations regulate both prescription drugs and non-prescription drugs together under the same provisions (from cold remedies to cancer drugs). The two major Divisions, 1 and 8, of Part C the Food and Drug Regulations apply to the pre-market review of drugs and are not flexible enough to account for a drug's relative benefit, harm and uncertainty profile. Further, the existing regulations do not include provisions common to more modern regulations that enable an optimal approach to health and safety.
This lack of flexibility in regulation complicates the determination of the appropriate level of oversight and consistency between products of similar risk profiles for both their pre-approval data requirements and their post-approval monitoring requirements.
Without new regulations for non-prescription drugs, it will be very difficult to apply to non-prescription drugs the aligned approach for consumer health products that is proposed in the Framework. Also, non-prescription drugs would continue to be subject to disproportionate requirements.
10. What are the objectives of the proposed non-prescription drug regulations?
- Modernize out-dated regulations for non-prescription drugs and disinfectants;
- Align with other regulatory frameworks, building on identified best practices and lessons learned;
- Provide compatible but distinct oversight from prescription drugs;
- Address regulatory irritants; and
- Include new authorities provided under Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).
11. What will the proposed non-prescription drug regulations look like?
The proposed regulations for non-prescription drugs will be separated from the current regulations for prescriptions drugs. The provisions in these regulations will reflect the life-cycle approach and will include pre- and post- marketing oversight, such as requirements for product authorization and site licensing, good manufacturing practices, clinical trials and post-market surveillance. There will also be distinct provisions for disinfectants that are tailored to their unique nature of intended use.
Market authorization: Various product licensing pathways are proposed, and these are based on the exposure, intended use and nature of the product, as well as whether Health Canada has previously reviewed the benefit, harm and uncertainty profile of the product. Based on this approach, Health Canada would establish the compendia of monographs that would provide an efficient means to seek approval of products that follow a monograph.
Good manufacturing practices and establishment licensing: Most of the changes to good manufacturing practices proposed are already widely implemented on a voluntary or interpretative basis. The proposed regulations would establish a general good manufacturing practice standard that would be expected for all non-prescription drugs, regardless of their risk profile. However, the interpretation of each good manufacturing practice requirement would be further supported in guidance documents and tailored to the nature of the drug, the activity being conducted and the associated risks.
It is also proposed that the current establishment licensing model will be maintained for parties carrying out regulating activities for most non-prescription products and supplemented with a risk-based approach to include a site registration model for certain lower-risk activities and products.
Finally, the new authorities in the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (e.g., incorporation by reference) will be used to incorporate lists of documents such as product, class or substance-specific monographs, allowing for more efficient product approval through the use of compendia. This streamlined application process would be balanced by the new post-market authorities in Vanessa's Law (e.g., mandatory label change or recall) that give Health Canada the ability to respond rapidly to safety issues.
12. Under the Consumer Health Products Framework, will the regulatory approach to cosmetics change?
The Cosmetic Regulations will not be amended at this time. The current regulatory requirements will continue to apply, such as product and ingredient safety, notification, and disclosure of ingredients on product labels.
The Framework's goal is to further clarify the oversight of some categories of products that interface with cosmetics.
13. Under the Consumer Health Products Framework, will the regulatory approach to natural health products change?
There are no plans at this time to change the Natural Health Products Regulations. Existing product and site licensing requirements will continue to apply under the Framework.
Want to know more?
Learn about natural health product regulation.
Of all the regulatory components in the Framework, the approach to natural health products represents the most modernized approach. Since the coming into force of the Natural Health Products Regulations in 2004, Health Canada has improved operational capacities, established effective, efficient licensing instruments (i.e., pre-cleared information or compendia of monographs), and created a three-class system for reviewing natural health products.
The Framework aims to build on recent natural health product best practices to provide consistent oversight, to the extent possible, for all consumer health products, while always making safety the priority.
14. Under the Framework are the evidence standards for consumer health products being lowered?
No, neither the Framework nor the proposed non-prescription drug regulations involve lowering Health Canada's standards for ensuring safe products. The objective is to ensure similar requirements for products of similar risk.
Under the proposed non-prescription drug regulations, various product licensing pathways are proposed. These are based on the exposure, intended use and nature of the product, as well as whether Health Canada has previously reviewed the benefit, harm and uncertainly profile of the product. Based on this approach, Health Canada would establish the compendia of monographs that would provide an efficient means to seek approval of products that follow a monograph.
15. What is a monograph?
Health Canada develops monographs for both non-prescription drugs and natural health products. A monograph is a scientific standard. It contains information about an ingredient, product, or class of products: its properties, acceptable use or purpose, dosage, duration of use, risk information, etc. The monograph represents Health Canada's knowledge and experience about what is necessary for the safe and effective use of the ingredient, product, or class of products.
If a company wants to market a product that follows the monograph exactly, the process to obtain approval will be short because Health Canada has already pre-cleared the information. Sometimes, however, companies want to market products with a dose or recommended purpose, etc. that is not in the monograph. In such cases, they must submit evidence to Health Canada to support the safety and/or effectiveness of their request. Health Canada then reviews this information to determine whether safety and/or effectiveness standards are met.
Right now, there are limits to how much Health Canada can take advantage of monographs to provide efficient approval of certain non-prescription drugs. The new proposed non-prescription drug regulations are designed to address this challenge.
16. How do the proposed regulations impact good manufacturing practices and establishment licensing for non-prescription drugs?
Most of the changes to good manufacturing practices proposed in the regulations are already widely implemented on a voluntary or interpretative basis. The regulations would establish a general good manufacturing practice standard that would be expected for all non-prescription drugs, regardless of their risk profile. However, the interpretation of each good manufacturing practice requirement would be further supported in guidance documents and tailored to the nature of the non-prescription drug, the activity being conducted, and the associated risks.
The current establishment licensing and good manufacturing practice requirements taken together ensure the production of high quality non-prescription drug products and facilitate their export to other jurisdictions with equivalent regulatory requirements and inspection programs (e.g., Canada's Mutual Recognition Agreement partners and the participating authorities of the Pharmaceutical Inspection Co-operation Scheme).
It is proposed that the current establishment licensing model will be maintained for parties carrying out regulated activities for most non-prescription products and supplemented with a risk-based approach to include a site registration model for certain lower-risk activities and products.
17. What about compliance and enforcement? Is the approach to natural health products and non-prescription drugs changing under the Framework?
No, Health Canada continues to take a risk-based approach to natural health products and non-prescription drugs. When non-compliance is identified, Health Canada takes risk mitigation actions proportional to the risk posed by the non-compliant product. The initial approach is usually to request voluntary actions from the regulated party. However, this approach may change based on various factors such as compliance history and the level of cooperation offered. For further information refer to the Compliance and Enforcement Policy (POL-0001).
18. How does this Framework benefit consumers?
The Framework is designed to ensure that the safety of Canadians always remains the priority. By regulating consumer health products of similar risk profiles in a similar manner, the regulatory process will be more consistent as will be the standards. This will enable Health Canada to continue to focus on providing credible, timely information to Canadians as well as greater openness and transparency about its health and safety decisions on consumer health products.
As a result, Canadians will benefit from increased access to consumer health products and to more tools such as the licensed health product databases for natural health products and non-prescription drugs to support their informed decision making when selecting products that are available on the Canadian market.
19. What does this Framework mean for health professionals?
Health Canada acknowledges that the provincial/territorial regulation of health professionals and what they can prescribe is changing such that more types of professionals are able to prescribe certain kinds of medications. There is also an evolution in how some consumer health products such as non-prescription drugs are scheduled including in what types of stores they can be sold and whether they are available in front of or behind the counter.
Moving forward, the department envisions an integrated approach to consumer health products that brings together the Health Portfolio, the provincial and territorial governments, and relevant stakeholder associations such as the National Association of Pharmacy Regulatory Authorities (NAPRA). This work will help to address issues around Canadians' access to safe consumer health products, point of sale issues, informed use of self-care, and the need to reduce overall healthcare system costs by promoting self-care options.
What is the health portfolio?
Health Canada, the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Patented Medicine Prices Review Board and the Canadian Food Inspection Agency are all part of the Health Portfolio.
Consumer Health Products
20. What is self-care?
In health care, this term refers to a person's decision-making to maintain and improve their health. It could include decisions about which consumer health products to use or lifestyle choices.
As Canadian consumers have access to more health information than ever before, they have been taking a bigger role in their own health care. This is particularly evident in the area of self-care where Canadians are making more decisions about how to improve and maintain their health with the use of products that they can chose and use on their own.
21. What is a health claim?
It is a statement on a health product about what it does in relation to your health. Examples include: “relieves pain”, “helps in the development of bones and teeth”, “provides fast relief from allergies”, “helps prevent tartar build-up”.
Health Canada reviews the evidence behind health claims to make sure that products do what they claim to do. Advertising preclearance agencies also play a role. These agencies, independent of government, work with advertisers to make sure that health product advertising for television, newspapers, etc. meets Health Canada's rules and standards.
22. How do I know if a consumer health product is right for me?
The labels of consumer health products contain important information to help you decide which products are right for you. Look for the health claim to understand what the product claims to do in relation to your health. On the label you will also find:
- cautions or warning statements such as "do not use if you have certain health conditions such as heart disease or when pregnant or breast feeding";
- a list of the product's ingredients;
- how to use the product; and
- how much of the product should be taken.
Did you know?
The Government has created new rules for plain language labelling that will help improve the safe use of prescription and non-prescription drugs by making their labels and packaging information easier to read and understand.
23. How can I identify a consumer health product?
Consumer health products include non-prescription drugs, disinfectants, natural health products and cosmetics.
For non-prescription drugs, disinfectants and natural health products, Health Canada reviews these consumer health products to make sure they are safe, effective and high quality. You can tell a product has been reviewed by the presence on a label of a drug identification number (DIN), natural product number (NPN) or a homeopathic medicines number (DIN-HM).
For cosmetics, ingredients are assessed for safety based on hazard and exposure. This means that Health Canada looks carefully at both the characteristics of the ingredients in a cosmetic as well as how consumers are exposed to those ingredients.
24. How can I verify if a consumer health product has been approved by Health Canada?
To date, Health Canada has approved more than 85,000 natural health products and non-prescription drugs. Consult the licensed databases to learn more about a specific product's ingredients and health claims.
25. Who can report an adverse reactions and how?
Anyone—industry, health care professionals and Canadians can report adverse reactions for natural health products and non-prescription drugs, and health and safety incidents involving cosmetics.
These reports help Health Canada identify rare or serious adverse reactions previously unknown, make changes in product safety information, issue public warnings and advisories, and/or remove unsafe products from the Canadian market.
Follow the instructions at MedEffect™ Canada to access further information on adverse reaction reporting for natural health products and non-prescription drugs.
Report an incident involving a cosmetic online using the Health Canada website.
26. As a retailer, how can I support Canadians' access to safe, effective and high quality consumer health products?
Retailers can support access to safe consumer health products by ensuring the products sold at their locations are authorized by Health Canada. Natural health products, non-prescription drugs and disinfectants (i.e., disinfectants regulated under the Food and Drug Regulations) sold in Canada require approval by Health Canada. Approved products will bear a Natural Product Number (NPN), a Homeopathic Medicine Number (DIN-HM) or a drug identification number (DIN) on their label.
While there is no licensed database for cosmetics, retailers have access to the Cosmetic Ingredient Hotlist which details certain substances that are considered inappropriate for cosmetic use, or which require labelling. Retailers may contact the Cosmetics Program at any time with questions or complaints related to cosmetics.
27. I have advertising material available for consumer health products sold at my store. What should I know prior to accepting the advertising material from a distributor?
Only consumer health products that Health Canada authorizes for sale in Canada may be advertised. Health Canada reviews the evidence behind these health claims to make sure that products do what they claim to do. Advertising preclearance agencies also play a role by reviewing advertising material for non-prescription drugs and natural health products directed to consumers. These agencies, independent of government, work with advertisers to make sure that health product advertising for television, newspapers, etc. meets Health Canada's rules and standards.
Although Health Canada does not review cosmetic label claims prior to sale, retailers may consult guidelines about the types of health claims that require pre-market authorization, which should not appear on cosmetic labels or advertising. Retailers may also contact the Cosmetics Program at any time with questions or complaints related to cosmetics.
By supporting the sale and advertisement of products with valid and truthful claims, together government, industry and consumers can help ensure access to safe consumer health products.
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