Exemption Order in Respect of Labelling Requirements for Certain Natural Health Products: SOR/2025-94

Canada Gazette, Part II, Volume 159, Number 7

Registration
SOR/2025-94 March 7, 2025

FOOD AND DRUGS ACT

Whereas the Minister of Health believes on reasonable grounds that the annexed Order is necessary for a health or safety purpose or is otherwise in the public interest;

And whereas the Minister of Health believes on reasonable grounds that, having regard to its benefits and condition, the annexed Order is unlikely to result in unacceptable health, safety or, if applicable, environmental risks or an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks;

Therefore, the Minister of Health makes the annexed Exemption Order in Respect of Labelling Requirements for Certain Natural Health Products under section 30.05footnote a of the Food and Drugs Act footnote b.

Ottawa, March 7, 2025

Mark Holland
Minister of Health

Exemption Order in Respect of Labelling Requirements for Certain Natural Health Products

Interpretation

Definitions

1 (1) The following definitions apply in this Order.

commencement day
means the day on which sections 17 to 22 of the Regulations Amending the Natural Health Products Regulations, made by Order in Council P.C. 2022-710 of June 20, 2022 and registered as SOR/2022-146, come into force. (date de référence)
former Regulations
means the Regulations as they read immediately before the commencement day. (ancien règlement)
new Regulations
means the Regulations as they read on the commencement day. (nouveau règlement)
product licence
means a product licence issued under section 7 of the Regulations. (licence de mise en marché)
Regulations
means the Natural Health Products Regulations. (Règlement)

Words and expressions

(2) Unless the context otherwise requires, words and expressions used in this Order have the same meaning as in the Regulations.

Conditional Exemption

Exemption — certain natural health products

2 (1) Subject to the condition set out in subsection (2), every natural health product for which a product licence has been issued on or after the day on which this Order comes into force and that is not labelled in accordance with the new Regulations is exempt from the application of sections 86 to 94 of the new Regulations as they apply to labelling.

Condition — former labelling requirements

(2) The natural health product must, when it is sold, be labelled in accordance with the former Regulations.

Non-application of condition

(3) The condition does not apply if the sale of the natural health product is to a manufacturer or distributor.

Repeal

3 This Order is repealed on June 21, 2028.

Coming into Force

Coming into force

4 This Order comes into force on June 21, 2025, but if it is registered after that day, it comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

On July 6, 2022, the Regulations Amending the Natural Health Products Regulations (the Amending Regulations)footnote 1 were published in the Canada Gazette, Part II. These amendments introduced new labelling requirements for natural health products (NHPs) that are set to come into force on June 21, 2025. NHPs that are licensed in Canada on or after June 21, 2025, would need to comply with the new labelling requirements in the amended Natural Health Products Regulations as of this date. However, NHPs licensed in Canada prior to this date are provided with an additional three-year transition period to comply (i.e. a compliance date of June 22, 2028).

Some stakeholders have raised concerns to Health Canada (“the Department”) relating to implementation of the new labelling requirements. The concerns range from clarity and accuracy of the guidance materials, which are a key tool used by industry to support implementation, to concerns about prescriptive formatting requirements and fitting all required information on the label. Lack of clear guidance materials can cause uncertainties for certain NHP suppliersfootnote 2 regarding whether their product complies with the new requirements whereas increased information requirements combined with prescriptive formatting can make it challenging for certain NHPs to comply with the new requirements without compromising readability.footnote 3

Given these uncertainties, if the new labelling requirements come into force as scheduled, there could be negative consequences for consumers: for instance, fewer NHPs could be marketed in Canada depriving consumers of choice of products that may benefit their health, and there could be a risk that important safety information on NHP labels is missing, inadequate, or hard to locate or understand, leading to negative health impacts for consumers.footnote 4 However, because certain NHP suppliers may have already begun working towards implementation, a solution is needed to allow NHP suppliers to label their NHPs with either the existing or new labelling requirements.

Background

NHPs are made from naturally occurring substances (or their synthetic duplicates) that are used to restore or maintain good health. Many everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are classified as natural health products in Canada and come in a variety of forms such as tablets, capsules, tinctures, solutions, creams, ointments and drops. As NHPs do not require a prescription, NHP consumers generally select a product that best suits their personal health needs by comparing products and gathering information from labels, thus making the information provided on the label of an NHP and its legibility very important for consumer health and safety.

In 2022 when the Amending Regulations were published, it was recognized that NHP use among people in Canada has been increasing and this trend is expected to continue due to several factors such as Canada’s aging population, greater access to the Internet and other sources of information, and an increase in consumers’ role in their own self-care. In addition, the COVID-19 pandemic caused an unprecedented increase in the use of certain categories of NHPs, such as alcohol-based hand sanitizers.footnote 5 Public opinion research published in 2024, reports that more than 73% of people in Canada used NHPs, with 57% of those reporting daily use.footnote 6 As consumers generally self-select and self-administer NHPs (as opposed to prescription drugs, which require heath practitioner intervention), proper labelling of NHPs is critical to preventing incorrect purchasesfootnote 7 which could negatively affect the health and safety of NHP consumers. Additionally, incorrect NHP use can result in preventable harms. Such harms may result from ingredients in a given NHP that may be harmful to certain individuals (e.g. allergens); it should also be noted that using certain NHPs concurrently with certain drugs can affect the efficacy of the drug treatmentfootnote 8 or, in rare cases, cause serious adverse reactions.footnote 9 As such, key information on the NHP label needs to be presented in a clear, legible and consistent format, otherwise preventable harms can occur.

On July 6, 2022, the Amending Regulations were published in the Canada Gazette, Part II. These amendments updated certain labelling requirements to improve the self-selection and safe use of NHPs (by making labels easier to read with clear and readily accessible information in a consistent format) and to protect the health and safety of people in Canada (by reducing the number of preventable harms associated with NHP use). Specifically, these amendments introduced new requirements with respect to:

Based on stakeholder feedback received during the Canada Gazette, Part I, Consultation, the Department incorporated several flexibilities. These include exemptions from use of the Product Facts table for lower-risk NHPs such as toothpastes, mouthwashes, throat lozenges, and cosmetic-like skin care products as well as additional flexibilities and exemptions for NHPs with very small packages (defined as those with a surface area available for a label of 90 cm2 or under) from use of the Product Facts table. Product and safety information are still required including an allergen statement if the NHP contains food allergens, gluten, added sulphites and/or aspartame.

The labelling-related amendments in the Amending Regulations come into force on June 21, 2025, three years following registration.footnote 10 This delayed coming into force was designed to prevent businesses with NHPs that were already on the market, or had submitted product licence applications to the Minister and were awaiting a decision, from having to redesign and relabel products. NHPs licensed in Canada prior to the day the new labelling amendments come into force are provided with an additional transition period of three years - a period during which they can continue to be sold without complying with the new labelling requirements - for a total period of six years following registration of the Amending Regulations.

NHPs licensed on or after June 21, 2025 (henceforth referred to as newly licensed NHPs) would need to comply with the new labelling requirements immediately. Subsequent to publication of the Amending Regulations, some stakeholders raised concerns with implementing new labelling requirements. Concerns raised included: whether certain NHPs would be able to fit all information required by the amended Natural Health Products Regulations on the label; negative impacts on readability of the label when there is a lot of information or when multiple permitted flexibilities are used concurrently; and a lack of clarity in the guidance materials provided by the Department regarding how to comply with the new labelling requirements. Given the concerns raised, the Department undertook further engagement with these stakeholders to better understand the challenges they are facing and to find solutions to address industry concerns.

Objective

The objective of this Ministerial Order is to provide an exemption for newly licensed NHPs from the new labelling requirements of the Amending Regulations, provided they meet the existing labelling rules applicable to NHPs. This would effectively extend their compliance date from June 2025 to June 2028 which would align with the transition period in place for currently licensed NHPs. The extension of the compliance date via this Ministerial Order will benefit the health and safety of people in Canada by helping to prevent the marketing of incorrectly labelled NHPs that could lead to negative health consequences and by providing consumer choice without undue negative impact on the health and safety of Canadians.

Description

This Ministerial Order exempts newly licensed NHPs that are not labelled in accordance with the amended Natural Health Products Regulations, from needing to comply with the new labelling requirements as long as they are labelled in accordance, when they are sold, with the Natural Health Products Regulations as these regulations read on June 20, 2025 (the day before sections 17 to 22 of the Amending Regulations come into force). Consistent with the Natural Health Products Regulations, if an NHP is sold to a manufacturer or distributor, labelling requirements do not apply and are not a condition of the exemption.

The Ministerial Order will be repealed on June 21, 2028, which means that the final day the Ministerial Order would remain in force will be June 21, 2028. Newly licensed NHPs will need to comply with the amended Natural Health Products Regulations as of June 22, 2028.

This Ministerial Order will come into force on June 21, 2025, but if the Order is registered after that day, the Order will come into force on the day on which it is registered.

Regulatory development

Consultation

Subsequent to the publication of the Amending Regulations in June 2022, the Department continued to hear from, and engage with, stakeholders regarding concerns with new labelling requirements, which were initially of a general nature (e.g. costs, administrative burden etc.). The Department also organized a series of targeted engagement sessions starting in August 2024footnote 11 to better understand the challenges encountered by NHP suppliers and discuss specific concerns relating to the implementation of the new labelling requirements.

These engagements made it clear that the available guidance materials are not effective in supporting implementation and updates are required. With respect to guidance materials, Health Canada committed to holding an engagement session specific to the guidance document, accepting written comments and developing an updated industry labelling guidance document. Stakeholders have also suggested that, despite the previously mentioned flexibilities set out in the Amending Regulations, additional targeted regulatory amendments are required to reduce uncertainties concerning compliance and facilitate implementation for certain NHP suppliers. The Department recognizes that certain NHP suppliers have encountered difficulties implementing the new labelling requirements and has committed to further analysing identified issues and working with NHP suppliers to develop solutions.

Notice of Intent

On February 25, 2025, Health Canada published a notice of intent (NOI) online informing stakeholders of the Minister of Health’s intention to provide a transitional period for the labelling requirements to newly licensed NHPs. The Department invited interested parties to an engagement session to address any questions. During the call on March 3, stakeholders were supportive of the approach.

Indigenous engagement, consultation and Modern Treaty obligations

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation an assessment of modern treaty implications was conducted. The assessment did not identify any modern treaty implications or obligations.

In addition, a United Nations Declaration Consistency Analysis was conducted. The assessment did not identify potential intersections between the proposal and the rights and interests of First Nations, Inuit and MĂ©tis, and no inconsistencies with the United Nations Declaration on the Rights of Indigenous Peoples (UN Declaration) are apparent.

Instrument choice

Regulatory and non-regulatory options have been considered to extend the compliance date.

Option 1: Status quo

Option 1 would not entail a regulatory intervention and would require NHP suppliers to comply with the new labelling requirements in accordance with the relevant compliance dates. This would mean that newly licensed NHPs would need to comply with the new requirements as of June 21, 2025 (on the coming into force date) and existing NHPs would need comply with the new requirements as of June 22, 2028 (subsequent to the end of the transition period on June 21, 2028). Under this scenario, consumers would receive the benefits associated with the new labelling requirements for a subset of products, namely new products coming onto the market would have updated labelling information, which is intended to benefit consumers.

However, this scenario would allow for the possibility that new products entering the market will be non-compliant due to a lack of clarity in the guidance materials provided by the Department and/or inability to fit all required information on the label. Furthermore, industry has suggested that some NHPs that attempt to comply with the new requirements may display less readable labels compared to the existing labelling requirements which could ultimately lead to potential negative health outcomes. While some of these consequences could be mitigated through implementation of an interim policy (e.g. deprioritized enforcement of non-compliant labels provided they are compliant with the Natural Health Products Regulations as they were prior to June 21, 2025) such interim measures would not have the force of law.

Under the status quo, some NHP suppliers may choose not to market certain NHPs, or to delay their entry into the market, due to either an inability to comply with the requirements or uncertainty regarding the requirements. This would likely result in consumers having fewer products to choose from to address their health issues.

Option 2: Regulatory Approach (Regulatory Amendments)

The Department considered regulatory amendments to the Amending Regulations to extend the deadline for newly licensed NHPs to comply with the requirements to align with the transition period that applies to currently licensed NHPs. Notably, this approach would allow for more fulsome consultation with health and industry stakeholders, which could include exploring potential readability issues. However, this option does not allow Health Canada to complete the necessary changes prior to June 2025, and so an interim solution would still be necessary. Given that this option would take longer to implement (compared to option 3), this could result in NHP suppliers who are uncertain whether their products would comply with the new labelling requirements being less inclined to bring new NHPs into the Canadian market prior to June 2028, likely depriving consumers of choice. Additionally, there could be a risk that NHP suppliers bring new NHPs to the Canadian market, with labels where important safety information on NHP labels is missing, inadequate, or hard to locate or understand, which could cause confusion and possibly lead to negative health impacts for consumers . As a result, this option was not selected at this time.

Option 3: Regulatory Approach (Ministerial Order) – chosen option

Under section 30.05 of the Food and Drugs Act, the Minister of Health may issue a Ministerial Order if the Minister believes, on reasonable grounds, that it is necessary for a health or safety purpose or is otherwise in the public interest and having regard to its benefit and conditions, it is unlikely to result in unacceptable health, safety or, environmental risks, or an unacceptable degree of uncertainty with regard to these risks. A Ministerial Order may provide an exemption from the application of certain provisions of the Food and Drugs Act or regulations made under the Food and Drugs Act, which includes the Natural Health Products Regulations.

Under this option, all NHP suppliers can benefit from the longer transition period (i.e. until June 2028). This regulatory option has been supported by stakeholders in the most recent engagement sessions. The Ministerial Order will help prevent the marketing of incorrectly labelled NHPs (that were labeled based on a mistaken understanding of the new requirements) that could lead to adverse health consequences, provide additional time for the Department to explore appropriate labelling solutions, and provide additional time for the Department to revise guidance to support implementation. Additionally, this option will help industry avoid non-compliance by allowing the use of known labelling requirements, it should increase consumer choice by enabling new NHPs to enter the market under the existing Natural Health Products Regulations labelling rules, and provide the Department additional time to make regulatory amendments, if needed, in order to provide greater certainty with respect to NHP labelling requirements.

The Ministerial Order does not exempt from all labelling requirements; rather, it requires compliance with the existing labelling requirements (prior to June 21, 2025). Deferred compliance with the new requirements could result in some health and safety risks, for example, NHPs may not have certain warnings (i.e. allergens). However, these would not constitute an unacceptable risk as NHPs still must comply with the existing labelling rules in the Natural Health Products Regulations until 2028. This Ministerial Order will help to ensure greater consumer choice and help prevent non-compliant labels on the market and is unlikely to result in unacceptable health or safety risks or an unacceptable level of uncertainty respecting the health and safety of people in Canada. Issuance of a Ministerial Order was, therefore, the chosen instrument given the urgency of providing an exemption to NHPs that are unable to comply with the new labelling requirements in advance of the coming into force of these new requirements.

Regulatory analysis

This section describes the potential impacts of the Ministerial Order on NHP suppliers in Canada, consumers of these products, and Health Canada.

Benefits and costs

Baseline scenario

The Amending Regulations require that the NHP comply with changed labelling and packaging provisions in order to be sold to someone other than a manufacturer or distributor. On June 21, 2022, the Natural Health Products Regulations were amended to introduce new requirements relating to:

All existing NHPs (defined as NHPs licensed by Health Canada before June 21, 2025) must comply with these new labelling requirements by June 22, 2028. For newly licensed NHPs, NHP suppliers must comply with these labelling requirements immediately in order to market their products in Canada.

Policy scenario (the Ministerial Order)

The Ministerial Order permits suppliers with NHPs being licensed between June 21, 2025, and June 21, 2028, to label these products using either the new labelling requirements (i.e. as amended by sections 17 to 22 of the Amending Regulations) or those that existed in the Natural Health Products Regulations before June 21, 2022. However, all NHPs licensed during this impacted period (June 2025 to June 2028) will need to comply with the new labelling requirements as of June 22, 2028.

This means that NHPs licensed between June 21, 2025, and June 21, 2028, that are being sold in Canada must comply with the new labelling requirements either:

Only suppliers of products in part (ii) would be impacted by this Ministerial Order while part (i) refers to other product suppliers who would choose to comply with these new labelling requirements as in the baseline scenario if they could, to minimize relabelling or repackaging cost within the three-year period.

Key assumptions for the cost benefit analysis

In this analysis, it is assumed that when the supplier of a product introduces a product to the Canadian market, the supplier of the NHP will choose the least costly approach to complying with the labelling requirements. That is, suppliers would comply with the new labelling requirements if they are able to do so.

The analysis further assumes that when a supplier does not comply with the new labelling requirements, it is either due to:

It is not known how many new NHPs will be unable to comply with the amended Natural Health Products Regulations. Furthermore, while some NHPs may become licensed and enter the market within a few months, others may never be marketed in Canada at all. Since the estimation of the incremental costs and benefits to stakeholders is dependent on knowing either the number of stock keeping units (SKUs) that cannot comply with the amended Natural Health Products Regulations or the percentage of the market they would represent, it is therefore not possible to quantify or monetize the analysis without this information. However, based on Health Canada’s estimations, it is unlikely that the number of products unable to comply with the amended Natural Health Products Regulations is high enough that the foregone benefits would exceed $1M per year.

Benefits

Benefits to businesses

Suppliers of newly licensed NHPs that raised concerns with their ability to comply with the new labelling requirements but intend to continue supplying their products to the Canadian market will benefit from the Ministerial Order. These suppliers will have more time to understand the amendments to the Natural Health Products Regulations, consult with Health Canada, and potentially redesign their product labels or packaging to comply with the new labelling requirements if they choose to continue supplying their products on the Canadian market after June 21, 2028. Effectively delaying the date in which they need to be in compliance would allow them to defer costs.

Businesses that cannot comply with the new labelling requirements but believe they can benefit from access to the Canadian market for a short time can also benefit from the Ministerial Order. Products can still be brought to the Canadian market even if businesses do not intend to comply with the new requirements; however, this is considered a business decision if it were deemed profitable to do so.

Benefits to consumers

It is anticipated that consumers will benefit from the Ministerial Order as newly licensed NHPs that may not have previously been able to comply with the new labelling requirements may enter the Canadian market. Consumers in Canada would continue to have access to existing products and potentially gain access to new products that would comply with the existing Natural Health Products Regulations.

Costs

Costs to businesses

It is anticipated that cost impacts to businesses due to the Ministerial Order will be negligible. In order to avoid having to change labels twice, it is likely that most firms that can comply with the amendments to the Natural Health Products Regulations will have compliant labels. Only those suppliers with products that cannot comply with the amendments due to a lack of flexibilities or a lack of clarity in guidance will choose to use the exemption provided in the Ministerial Order.

If after June 21, 2028, these new products cannot be brought into compliance with the amended Natural Health Products Regulations, they are expected to be removed from the market by suppliers.

Costs to consumers

It is anticipated that consumers of these newly licensed NHPs will experience losses due to labelling that does not provide the information required by the amendments to the Natural Health Products Regulations that come into force in June 2025. As indicated by respondents of a short survey conducted in the first quarter of 2022, the key reasons that contributed to incorrect purchases of product could be attributed to illegible information displayed on product labels, unnoticed food allergens or ingredients in the product that they could not consume, or confusing information on product labels, which are issues being addressed by the new labelling requirements. Therefore, without full compliance with the new labelling requirements, the incidence of incorrect purchases may remain the same as before introducing the new labelling requirements.

Less legible product labels may impede appropriate product selection and/or increase the incidence of adverse reactions, particularly resulting from concurrent NHP-prescription drug or NHP-non-prescription drug use. The extension of a transition period to newly licensed NHPs, results in incremental cost to consumers and the health care system relative to baseline scenario.

Suppliers of newly licensed NHPs would be exempted from prominently displaying a safety statement regarding things like allergens, gluten, added sulphites, and aspartame in NHPs under a “Warnings” heading during the impacted period (June 2025 to June 2028), thus the previously identified risk will continue.

The continued lack of modernized contact information will reduce the options for consumers to contact product manufacturers or importers to pose questions, or to report harms. This may increase incorrect purchases and increase adverse drug reactions since it may reduce consumer access to the most up-to-date NHP-related health and safety information.

Some consumers may experience inconvenience if any supplier decides to discontinue any of these newly licensed NHPs in Canada due to the inability to later comply with the new labelling requirements with which all NHP suppliers must comply with after June 21, 2028.

The total costs of the Ministerial Order cannot be estimated given the lack of data. For illustrative purposes only, Health Canada estimates that the total forgone benefits from incorrect purchases and lack of information on labels could only approach $1M annually if approximately 5 out of 6 new SKUs introduced to the Canadian market do not comply with the new labelling requirements over the three years (June 2025 through June 2028) while the Ministerial Order is in force.

Costs to government

The Ministerial Order will delay compliance with the amended Natural Health Products Regulations and therefore may increase the number of incidences of interactions between NHPs and prescribed drugs or non-prescribed drugs, which could increase the burden to the existing health care system.

Enforcement of compliance with the new labelling requirements will be incorporated into existing compliance and enforcement activities managed by Health Canada for NHPs. It is anticipated that the Ministerial Order will result in negligible impact to the government on enforcement activities. All NHPs must still comply with the Natural Health Products Regulations using either the existing or new labelling requirements until and including June 21, 2028. Health Canada will continue to engage with NHP stakeholders on an ongoing basis and these types of activities fall within the normal day-to-day business of the Department.

The Ministerial Order’s optional extension of the status quo for newly licensed products could increase the number of product licence applications. However, given the length of the policy period and need for all products to comply with the amended Natural Health Products Regulations after June 21, 2028, it is unlikely the increase will be substantial.

Small business lens

The small business lens applies as there are impacts on small businesses associated with this Ministerial Order. As reported in the 2011 Functional Food and Natural Health Products Survey, the functional food and NHP sector’s success is highly influenced by the wide range of products as well as market segments and economic conditions.footnote 12 It is believed that small businesses are more vulnerable to any external challenges, including compliance with new regulatory requirements. This Ministerial Order defers the requirement for suppliers of newly licensed NHPs to comply with the new labelling requirements, which would equally impact small and large suppliers. This Ministerial Order will remove market entry barriers related to compliance with the new labelling requirements, such as increased costs or inability to supply a product due to insufficient labelling space to accommodate all information outlined by the new requirements. This Ministerial Order could provide an opportunity for small businesses to test their products on the Canadian market if they plan to bring their products to the Canadian market in the long run. Small businesses may have to manage subsequent outcomes if they decided not to continue supplying their products to the Canadian market as outlined in the cost section above.

One -for -one rule

The one-for-one rule applies to this Ministerial Order as it is a new regulation (which is normally considered an “IN”). The Ministerial Order provides a temporary optional exemption from the new rules and permits compliance with the old rules, which would not increase administrative burden to businesses supplying NHPs to the Canadian market. Since it does not increase administrative burden, it is exempt from the one-for-one rule.

Regulatory cooperation and alignment

Regulatory cooperation does not apply to this Ministerial Order as it does not impose any new requirements.

International Obligations

As this Ministerial Order does not impose any new requirements, it is not subject to obligations under Canada’s international trade agreements.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment this Ministerial Order is exempt from Climate, Nature and Economy Lens analysis as the elements of this proposal were previously assessed under the Amending Regulations (published in 2022) and that assessment did not identify important environmental impacts.

The Ministerial Order allows for the sale of new products in accordance with the existing labelling rules, that could later need to relabel such products to comply with the new labelling rules in 2028. The process of re-labelling or repackaging, and potentially disposing of unused stock, may result in an incremental environmental impact.

Gender-based Analysis Plus

The gender-based analysis plus conducted for the Amending Regulations (published in 2022) concluded that the improved labelling requirements would likely positively impact all consumers in Canada regardless of sex or gender, by helping them more easily access and understand the important safety and usage information on NHP labels. During this analysis it was determined that some groups of Canadians are more frequent users of NHPs, and that they were most likely to benefit from the new labelling requirements.

Public opinion researchfootnote 13 conducted on behalf of Health Canada and published in 2024 found that NHP use across age ranges was generally consistent, but that daily use was highest in the older population, those 55 years of age and older. Further, women were more likely to use NHPs, along with parents and other caregivers, members of the 2SLGBTQI+ community and Indigenous respondents.

This research also shows that labels continue to be an important source of information for people in Canada. In the 2024 opinion research, participants were asked about their interest in accessing information via a QR code. Results showed that the older population may rely more heavily on label information with only 64% of those 65 and older having access to mobile data in store and 61% of those 65 and older who do have mobile data indicating that they would not use a QR code.

The new labelling requirements in the Amending Regulations were expected to benefit all people in Canada (rather than specific population sub-groups) who use or are considering using NHPs. The Ministerial Order may delay these benefits, which could disproportionately impact populations who are frequent NHP users.

Implementation, compliance and enforcement, and service standards

This Ministerial Order will come into force on June 21, 2025, but if the Order is registered after that day, the Order will come into force on the day on which it is registered.

Compliance and enforcement of this Ministerial Order will be incorporated into existing activities carried out by Health Canada under the provisions of the Food and Drugs Act and its regulations.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca