Question Period Note: Strengthening the Regulatory Oversight of Natural Health Products

• There has been significant stakeholder concern related to recent initiatives to strengthen the regulation of natural health products (NHPs).
• The NHP industry has been very vocal about its opposition and has launched campaigns to gain consumer and political support.
• The Official Opposition is a supporter of the campaigns and introduced a Private Member’s Bill in December 2023 to reverse the changes made by the 2023 Budget Implementation Act, which provided the Department with additional authorities to keep Canadians safe.
• The recent Health Canada initiatives aim to improve the safety of NHPs available to Canadians.

• While natural health products are generally lower risk products, they are not without risk.
• Health Canada works continuously to create a safer marketplace for people in Canada. This includes introducing new regulatory and legislative changes to improve the safety of natural health products and respond to a changing marketplace.
• We know how important natural health products, such as vitamins and minerals, herbal remedies, and sunscreens, are in our daily routines. Yet, Health Canada has seen serious non-compliance that could potentially be harmful to consumers, such as product contamination and the presence of ingredients not listed on the label.
• In 2021, the Commissioner of the Environment and Sustainable Development completed an audit of Health Canada's natural health product program and reported gaps in the regulatory oversight of these products. Health Canada committed to undertaking a number of activities to improve the safety of these products.
• The Government has already introduced new labelling regulations to support consumers in making informed choices and has been supporting stakeholders on the implementation of the regulations. Health Canada is further consulting with stakeholders to identify additional flexibilities for the labelling of natural health products.
• Health Canada is proposing fees for industry to establish an inspection program that ensure companies are following good manufacturing practices, and strengthen the post-market monitoring of these products.
• Our government understands the importance of small businesses to our economy and that is why the fee proposal includes significant cost reductions for small businesses, such as reductions ranging between 25% to 50%, and a full waiver for small businesses marketing their first product.
• Health Canada is presently considering how best to adjust its fee proposal based on the thousands of comments from stakeholders. The Department engaged stakeholders in March 2024 for further discussions and continues to take feedback until May 25, 2024.
IF PRESSED ON WHY HEALTH CANADA IS PROPOSING FEES FOR NATURAL HEALTH PRODUCTS
• Health Canada is proposing fees for industry to begin recouping a portion of the costs of services it provides to industry and to expand its oversight to create a safer marketplace for consumers. Presently, natural health products are the only line of health products whose regulatory activities are fully funded by Canadian taxpayers.
• The proposed fees would be accompanied by updated performance standards. This means companies would have more predictable service delivery timelines for regulatory activities, such as the scientific evaluation of new products and the licensing of new manufacturing sites.
• Health Canada knows that many NHP companies are small businesses and is committed to supporting them. The Department is considering measures to help alleviate the impact of fees on businesses. This includes fee reductions for small businesses of 25% to 50% and a full waiver of pre-market evaluation fees for small businesses marketing their first product.
• Health Canada completed the review of the thousands of comments received on the fee proposal and published a revised proposal in March 2024. The Department engaged stakeholders in March 2024 for further discussions and continues to take feedback until May 25, 2024.
IF PRESSED ON COST TO SMALL BUSINESSES
• Small- and medium-sized businesses are the backbone of our economy, and we know they care for the wellbeing of all Canadians. Just like them, we want to support the health of Canadians by ensuring the products sold across the country are safe and effective.
• Companies have been provided with several years, until 2028, to comply with the new labelling requirements and the new legislative changes won’t affect those companies already following the rules. Health Canada is further consulting with stakeholders to identify additional flexibilities for the labelling of natural health products. We acknowledge the impact this may have on implementation timelines for the new labelling requirements, and as such, this will be an integral part of the consultations.
• We understand that many small businesses worry about the additional costs new fees will bring. This is why we have proposed significant measures to mitigate their impact, such as fee reductions for small businesses ranging between 25% to 50%, and a full waiver of the pre-market evaluation fee for small businesses marketing their first product.
• Informed by the feedback received on its fee proposal, the Department published a revised proposal in March 2024. The Department engaged stakeholders in March 2024 for further discussions and continues to take feedback until May 25, 2024
IF PRESSED ON WHY CHANGES ARE NECESSARY NOW
• Canadians should be able to trust that the natural health products on store shelves are safe and contain what they say they contain, and that all safety information is available. While natural health products are generally lower risk, that does not mean they are without risk.
• These regulatory and legislative changes will create a safer marketplace and will help everyone make more informed choices about the products that we value.
• Between 2021 and 2023, there were 100 voluntary recalls of licensed natural health products for safety issues including bacterial contamination and the presence of foreign matter such as fibreglass in a product.
• Health Canada conducted a pilot inspection program between March 2021 and March 2022 to assess whether 36 manufacturers and importers were following regulatory requirements for good manufacturing practices. All of the inspections identified compliance issues ranging in severity.
• These findings support the need to educate industry about its regulatory obligations as well as to increase oversight of the industry.
• Right now, unlike with all other health products, natural health product manufacturing sites do not have a regular cycle of inspections to ensure that companies adhere to quality standards. The fees will provide Health Canada with the resources to conduct the necessary oversight and to ensure that the products we use and trust are in fact safe, effective, and high quality.
IF PRESSED ON LIMITING ACCESS TO CANADIANS
· We know how important natural health products, such as vitamins and minerals, herbal remedies, and sunscreens, are for Canadians in their daily routines. Changes to the program will support access to safe and high-quality natural health products.
· We understand that many small businesses also worry about the additional cost the proposed new fees will bring. That’s why Health Canada revised the initial proposal to help support them in continuing to provide the variety of products consumers depend on.
IF PRESSED ON DRIVING CANADIANS TO PERSONAL IMPORTATION
• We know how important natural health products, such as vitamins and minerals, herbal remedies, and sunscreens, are for Canadians in their daily routines. That is why Health Canada has been working to introduce important improvements to ensure that the natural health products they buy and use every day are safe and of high-quality.
• All domestic or international companies that sell natural health products – whether online or at retail outlets in Canada must comply with Canadian regulations to keep people in Canada safe.
• While residents of Canada and visitors are permitted to bring into Canada a personal use quantity of a 90-day supply or single course of treatment of a natural health product, or any other health product including a prescription drug, without requiring specific licences for the import, Canadians are encouraged to buy licensed health products in Canada that have been assessed to be safe and of high quality.
• Health Canada works in partnership with the Canada Border Services Agency to assess the compliance of health products at the border against the Act and its Regulations.
• Collecting fees for natural health products will let us support industry in complying with standards through education and guidance and do more inspections so that consumers can use natural health products without worry.

IF PRESSED ON DRIVING CANADIANS TO UNREGULATED (ILLEGAL) PRODUCTS
• Our number one priority is to keep Canadians healthy and safe.
• The Government of Canada supports access to safe and high-quality natural health products for Canadians.
• All domestic or international companies that sell natural health products in Canada – whether online or at retail outlets – must comply with Canadian regulations.
• Changes to the natural health products program will support access to safe and high quality natural health products.
IF PRESSED ON WHY VANESSA’S LAW IS NEEDED
• Extending the Protecting Canadians from Unsafe Drugs Act to natural health products allows Health Canada to order a recall of a product or add warnings on labels to support safe use, if necessary, which it couldn’t do before. These new authorities will only need to be used if a serious risk to health is identified or if a company refuses to partake in voluntary mechanisms. The majority of natural health product companies are not affected by these new authorities and they simply serve to protect Canadians against what can be serious health risks.
• Health Canada will consult with stakeholders on any further regulatory changes needed to support these authorities.
IF PRESSED ON REGULATING NATURAL HEALTH PRODUCTS SIMILAR TO HIGHER-RISK DRUGS
• Health Canada continues to support access to safe and high-quality natural health products for the people of Canada. Health Canada recognizes natural health products are lower-risk than prescription drugs. That is why these products are regulated under the Natural Health Products Regulations, which is a separate regulatory framework from that of prescription drugs.
• While NHPs are generally lower risk, they are not without risk, with some issues reported before such as contamination with foreign matter, mold, mildew, lead, arsenic, salmonella or E. coli. Health Canada will continue to take action to protect the people of Canada.
• The Government passed legislative changes in June 2023 that provide Health Canada with additional abilities, such as to remove unsafe products from the market or require warnings on a product label when a serious health risk is identified. Health Canada will only use these authorities if a company refuses to take voluntary actions to address a risk.
IF PRESSED ON THE DELAY IN IMPLEMENTING THE SELF-CARE FRAMEWORK
• Health Canada is advancing initiatives under the Self-Care Framework that meet the needs of Canadians, including having labels that are easier to read and ensuring products can be promptly recalled if a serious risk is identified.
• Health Canada will continue to advance, in consultation with stakeholders, other aspects of the Self-Care Framework over the next several years to ensure the regulatory oversight of both natural health products and non-prescription drugs is proportional to risk.
IF PRESSED ON WHY HEALTH CANADA INTRODUCED NEW RULES FOR LABELLING
• Health Canada introduced new requirements to make natural health product labels easier for Canadians to read and understand, to address concerns about small font sizes and missing or unclear safety information such as relating to contraindications or allergens.
• Health Canada recognizes that label changes will take time for industry to implement. This is why there is a multi-year transition period (up to six years) to implement the new regulations by 2028.
• Health Canada has consulted extensively and has designed regulations that balance the burden to industry while improving clear labelling for Canadians.
• Health Canada is further consulting with stakeholders to identify additional flexibilities for the labelling of natural health products.

Findings from the Commissioner of the Environment and Sustainable Development's Audit of the Natural Health Product (NHP) Program

An audit of Canada’s NHP program was conducted in 2019 by the Commissioner of the Environment and Sustainable Development (CESD), and the findings were published in a report to Parliament in April 2021.

The focus of the audit was to determine whether Health Canada ensures that NHPs available for sale in Canada are safe and accurately represented to consumers. The audit period covered January 2017 to May 2020.

Overall, the audit by the Auditor General of Canada of the NHP Program identified both strengths and areas for improvement.

The audit found that Health Canada licensed products appropriately, based on evidence of
safety and efficacy. The audit also found that when an issue was brought to Health Canada’s attention, immediate action was taken. Additionally, the audit established that Health Canada’s approach to increase the supply of alcohol-based hand sanitizers during the pandemic was appropriate.

The audit also identified areas for improvement:
• the need for increased oversight of NHP quality,
• greater monitoring of labels and advertising (including online),
• improved labelling, and
• proactive risk-based compliance and enforcement activities.

The recommendations validated key gaps that the Department had already identified and had started working to address. The audit supports the direction Health Canada has been taking to strengthen oversight of these products.

The auditors made five recommendations, all of which the Department has accepted and had already started work to address.

The findings of the audit were reinforced in 2022 by the report issued by the Standing Committee on Public Accounts (PACP) following a study of the audit.

The Self-Care Framework:

In 2016, the Department introduced the Self-Care Framework to modernize the regulation of self-care products, including NHPs and non-prescription drugs.

The Self-Care Framework is intended to provide oversight proportional to risk and proposes to:
• Better protect Canadians against health risks and harms – given that low risk is not no risk;
• Reduce unnecessary regulatory burden and costs for industry and Canadians; and,
• Support Canadians’ efforts to improve their own health and make informed decisions.

This proposal introduced Health Canada’s intention to improve NHP labelling, examine a cost recovery approach for NHPs, as well as consider post-market tools for NHPs such as fines and penalties and the ability to order a recall.

Health Canada continued broad public consultations in 2017, and announced, in 2018, a phased approach to implementing the Self-Care Framework:

• Element 1 encompassed changes to improve NHP labelling to ensure that labels are clear, consistent, and easy to read. This was completed with the new regulations published in July 2022.
• Element 2 will introduce regulatory amendments to create a more risk-based approach to the regulatory oversight for non-prescription drugs (OTCs).
• Element 3 introduces changes to improve oversight for NHPs, including quality, post-market authorities under Vanessa’s Law and cost recovery.

Industry associations are diverse in terms of both make-up of members and their interest in the Self-Care Framework:
• Cosmetics Alliance Canada (CAC), which represents OTCs, NHPs and cosmetics (regulated under separate regulations), is focused on advancing all elements of the Framework to ensure a more consistent regulatory approach for cosmetics and cosmetic-like NHPs and OTCs.
• The Canadian Health Food Association (CHFA), which represents a broad range of NHP stakeholders (including small and medium sized manufacturers and retailers), has consistently raised concern regarding the impacts on the industry of various changes happening at the same time.
• Food, Health and Consumer Products Canada (FHCP), which represents many large multinational drug companies who manufacture both NHPs and OTCS (such as Pfizer, Johnson and Johnson, and Bayer) has been supportive of measures to better align NHP and OTC regulatory oversight. Their principal concern is a lack of progress on Element 2 of the Framework.

Currently, industry associations are advocating for the Framework to be completed as initially outlined by Health Canada in 2018, prior to advancing initiatives such as NHP cost recovery, which was expedited in part due to the results of the 2021 program audit and the related action plan to respond to the findings.

Key associations representing consumer and patient safety, such as the Institute for Safe Medication Practices Canada, are supportive of stronger oversight and greater alignment with other health products under the Self-Care Framework.

Over the past 7 years, Health Canada has consulted extensively with stakeholders regarding proposed changes to the regulation of Self-Care products and will continue to be open and transparent as it works to implement other elements of the Self-Care Framework over the next several years.

Improved Natural Health Product Labelling:

Health Canada amended the Natural Health Products Regulations to support consistent and prominent labelling of key information to support consumers in selecting and using NHPs, including:

• Larger font size and better contrast;
• Important product information, such as warnings and directions for use, would be required in a facts table;
• Consistent and prominent labelling of priority allergens; and
• Modernized contact information on the package such as a website.

The Department has been consulting on this initiative since 2016 in the context of the Self-Care Framework and has made a public commitment in February 2018 to introduce these changes as the first phase of the Self-Care Framework.

An audit of Canada’s NHP program was conducted by the Commissioner of the Environment and Sustainable Development (CESD) and the findings were published in a report to Parliament in April 2021. This report noted that information on NHP labels was not easy to read. The recommendations listed in the report included improving the labelling of NHPs to ensure that information on product labels is clear, consistent and legible for consumers and can be read without the need for a magnification tool. In the formal response to the report, Health Canada committed to addressing this recommendation through these amendments.

The changes in the labelling regulations and related guidance were the outcome of extensive consultations with industry, patient safety organizations, and healthcare professionals.

To support industry in implementing these changes, the Department put in place a multi-year transition period ending June 2028. The multi-year transition period will minimize the environmental impact and costs for companies by allowing most companies to make the label changes at the normal re-labelling timeline of their products and enable most companies to use their existing stock without having to recall or destroy existing product.

Vanessa’s Law Powers:

Health Canada has observed evidence of low regulatory compliance across the NHPs industry as well as potential safety issues which highlight the need for more robust systems to ensure regulatory compliance. For example:

• Since 2004, approximately 470 voluntary NHP recalls have been issued.
• From 2004 until December 2021, Health Canada received reports of over 8,000 adverse reactions in which NHPs use had a suspected role, of which over 5,000 were serious.

Since 2016-17, Health Canada received over 3,500 consumer complaints implicating NHPs. This includes cases where products were contaminated with mold, mildew, lead, arsenic, and other toxic elements.

The 2021 audit by the Commissioner of the Environment and Sustainable Development and by Health Canada’s own inspections of NHP manufacturing sites noted significant non-compliance gaps that required effective regulatory tools to manage, such as those in Vanessa’s Law.

The Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law) received Royal Assent in November 2014 and amended the Food Drugs Act to give Health Canada additional transparency, post-market monitoring, and compliance and enforcement tools for therapeutic products such as prescription and over-the-counter drugs, biologic drugs, and medical devices. Through the Budget Implementation Act, these tools have been extended to NHPs as of June 22, 2023.

Some authorities came into force upon Royal Assent to support immediate program enhancements, including the provisions to:

1. order the recall of NHPs that present a serious or imminent risk of injury to human health
2. require a label change/package modification, if necessary to prevent serious injury to health
3. impose higher fines and penalties e.g., for having unauthorized products on the market
4. order a person to provide information that is in the person’s control and is necessary to determine if a product presents a serious risk of injury to human health
5. disclose confidential business information in circumstances where the product may present a serious risk of injury to human health or for the protections or promotion of human health or the safety of the public
6. apply for a court injunction to stop or prevent the commission of an offence
7. prohibit false or misleading statements or information
8. incorporate by reference
9. apply for a court injunction to stop or prevent the commission of an offence
10. make publicly available any order of a recall, label change, tests and studies, and assessment.

The remaining authorities noted below have a delayed coming into force and an Order in Council and/or regulations are needed to bring them into force. When and how these regulations come into force for these provisions will be subject to consultation.

1. Power to require an assessment
2. Power to require tests or studies
3. Ability to add terms and conditions
4. Mandatory reporting of serious reactions by healthcare institutions
5. Duty of the Minister to publicize certain clinical trial information

The powers under the Protecting Canadians from Unsafe Drugs Act allow unsafe NHPs to be more quickly removed from the market, protecting Canadians from serious or imminent health risks. This will also help increase consumer confidence in NHPs on the market.

Some NHP industry stakeholders remain opposed to the extension of Vanessa’s Law powers to NHPs. The Natural Health Products Protection Association (NHPPA), an active stakeholder advocating to repeal the elements of the Budget Implementation Act pertaining to Vanessa’s Law, led the drafting of a Private Member’s Bill (Bill C-368) for this purpose.

On December 5, 2023, MP Blaine Calkins (CPC) introduced Bill C-368 – An Act to amend the Food and Drugs Act (natural health products) to exclude NHPs from Vanessa’s Law. The first hour of the second reading of the Bill C-368 occurred May 6, 2024.

NHP Fee Proposal:

Health Canada has noted throughout the development of the Self-Care Framework, and in its response to the 2021 Commissioner of the Environment and Sustainable Development audit of the NHP program, that expanding fees to NHPs is critical to strengthening the NHP program to meet the needs of Canadians and support its long-term sustainability.

The fee revenues would enable Health Canada to strengthen its oversight of NHPs, monitor labelling and advertising, and put in place a permanent inspection program. The increased revenue would also help improve Health Canada’s ability to:
• detect and respond to quality issues;
• address issues of non-compliance for unlicensed products; and
• prevent harmful products from making their way into the marketplace.

The proposed fees reflect the costs associated with performing regulatory activities for NHPs. Three types of fees are proposed that include significant cost reductions for small businesses:
- Fees to evaluate applications for new NHPs or to amend existing NHPs (starting as low as $562 for qualifying small businesses on the simplest applications to $58,332 for the most complex applications, which are expected to be very rare);
- Fees to assess new NHP site licence applications or amendments to existing site licences ($3,588 for qualifying small businesses and $4,784 for larger businesses), and an annual site licence fee to support site licence renewal and compliance and enforcement activities for products that are already on the market (ranging from $5,191 for qualifying small business labelling facilities to $40,071 for larger business sterile manufacturing facilities); and
- Annual “right” to sell fees to allow companies the right to sell their NHPs in Canada ($406.50 for qualifying small businesses and $542 for larger businesses annually).

Performance standards are also proposed for each of the fee lines, ranging from 30 days to 210 days depending on the complexity of the review required.

While the proposed fees are also important to ensure the safety, reliability and quality of our NHPs, we are considering a number of measures to help alleviate the impact of these fees on businesses, such as fee reductions for small businesses (companies with fewer than 100 employees or between $30,000 and $5M in annual revenue) ranging between 25% to 50%, and a full waiver for small businesses on their first pre-market evaluation.
The Department held a public consultation on its fee proposal from May 12, 2023, to August 10, 2023, as well as stakeholder information sessions to explain the proposal and respond to questions. Health Canada is actively reviewing thousands of comments on its fee proposal, including the fee reduction for small businesses, as part of an open and transparent consultation process with Canadians and businesses.
The Department published a revised proposal in March 2024. The Department engaged stakeholders in March 2024 for further discussions and continues to take feedback until May 25, 2024.

• Health Canada supports access to safe and high-quality natural health products for Canadians. These products are regulated under the Natural Health Products Regulations, which is a separate regulatory framework compared to that of prescription drugs.
• While NHPs are often perceived as lower-risk, they are not without risk, especially if products are adulterated, if used improperly or in combination with other products and without appropriate regulatory oversight.
• Since introducing the regulatory framework for NHPs in 2004, Health Canada has seen cases of safety issues and evidence of low regulatory compliance across the NHP industry.
• In 2021, the Commissioner of the Environment and Sustainable Development completed an audit of the NHP program, which found both strengths and areas for improvement. The Department committed to undertaking a number of activities to improve the safety of these products, including introducing user fees that take small businesses into consideration.
• Health Canada’s initiatives, including the introduction of additional post-market authorities for NHPs through the 2023 Budget Implementation Act and the proposed introduction of cost-recovery fees, will support the access of safe and high quality NHPs. These regulatory changes are not about removing choice or reducing access. NHPs are important to Canadians to help support and maintain their health and Health Canada is committed to ensuring the continued availability of safe, effective and high-quality products.