Canada Gazette, Part I, Volume 155, Number 26: Regulations Amending the Natural Health Products Regulations

June 26, 2021

Statutory authority
Food and Drugs Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive Summary

Issue: Natural health product (NHP) use among Canadians has been increasing, and is expected to increase further due to a number of factors such as Canada's aging population, the COVID-19 pandemic, greater access to the Internet and other sources of information, and an increase in consumers' role in their own self-care. When key information on NHP labels is not presented in a clear, consistent, and legible format, it makes it difficult for consumers and health professionals to locate, read, and compare important safety information. Poor communication of key information on health product labels can lead to incorrect purchases and preventable harms. These preventable harms and delays in effective treatments due to incorrect purchases or use, negatively impact the health and safety of Canadians, add burden to the health care system, and impact the Canadian economy through lost productivity.

Description: Health Canada is proposing to amend the Natural Health Products Regulations (NHPR) to introduce the following requirements that would improve the labelling of NHPs so that information is clear, consistent, and legible for consumers and is in alignment with rules that have already been established for comparable non-prescription drugs (NPDs):

1) A Product Facts table: Important product information would be required in the format of a standardized facts table. Certain exemptions would be provided to accommodate products in very small packages, products that are relatively low-risk, products with a duration of use of one day or less, and products containing, at most, three dosage units.

2) Labelling of food allergens, gluten, and aspartame: If a product contains a priority food allergen (i.e. one that is likely to lead to anaphylaxis in affected communities), gluten, or aspartame, a statement indicating the source of the food allergen, gluten or aspartame would be required on the product's label.

3) Clearly and prominently displayed label text: Regulatory text on the label, including within the Product Facts table, would be subject to improved legibility requirements, including a minimum type size, font types, and contrast. Exemptions from these requirements would be provided for certain label information (e.g. the product number and marketing information), as well as products with very small packages, products with a duration of use of one day or less, and products with, at most, three dosage units.

4) Modernized contact information: A manufacturer or importer could display an e-mail address, telephone number, or website address within an NHP's Product Facts table (or elsewhere on the label if the NHP is exempt from the facts table requirement) instead of a postal address, as is currently required.

In addition, Health Canada would take this opportunity to bring forward certain amendments to the NHPR to clarify existing rules. These amendments do not set out new requirements, nor remove existing requirements and are expected to be cost neutral to both government and regulated parties.

Rationale: The proposed amendments are necessary to make NHP labels more legible and easier to understand for consumers in order to reduce the risk of harm associated with ineffective and inadequate communication of important safety information. More clearly and prominently displayed text, a standardized facts table, and the inclusion of new, bolded warning statements (i.e., for allergens) would facilitate appropriate product selection and prevent avoidable harms, leading to safer consumer use. The proposed amendments may also increase the rate of reporting of adverse reactions to manufacturers and, in turn, to Health Canada. This will expand Health Canada's ability to use real world evidence to monitor the safety and effectiveness of NHPs and to mitigate any identified risks.

Without the proposed amendments, there is a high likelihood that NHP labels would continue to present key health and safety information in a format, type size, font type, or with a contrast that may make it difficult, if not impossible, for consumers and health professionals to locate, read, compare, and select appropriate products. Among other things, warning information relating to contraindications or allergens may easily be missed, which would continue to expose Canadians to the associated risks, such as anaphylactic reactions.

This is in contrast to the clarity and standardization provided for other self-care products, such as NPDs, that have rules in place to ensure clear and legible labelling. The current, inconsistent approach may cause confusion for consumers who are selecting products to care for themselves and their families.

The proposed amendments would also enhance Health Canada's regulatory alignment with the United States (U.S.), the European Union, and Australia. In these jurisdictions, facts tables containing important information are already required for similar products. For example, in the U.S., a product regulated as a food requires a Nutrition Facts table, a dietary supplement requires a Supplement Facts table, and a drug requires a Drug Facts table. What we consider an NHP in Canada could fall into any three of those situations, but in each case would have a facts table.

Over a 15-year period (2022 to 2036 inclusive), the proposed amendments would result in a total monetized benefit of $320 million present value (PV) and a total incremental cost of $159 million PV. This provides a total net benefit of $162 million PV or $18 million in net annualized benefits.

Issue

Labelling to improve self-selection and safe use of natural health products

In 2010-11, more than 70% of Canadians used natural health products (NHPs).footnote 1 Since then, use among Canadians has been increasing and this trend is expected to continue due to a number of 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 has caused an unprecedented increase in the use of certain NHPs, such as hand sanitizers.footnote 2

Considering the prevalent use of NHPs and an aging population in Canada, appropriate risk mitigation and prevention measures, including effective product labelling, play an increasingly critical role in ensuring the health and safety of Canadians. When key information is not presented in a clear and consistent format on product labels, it makes it difficult, if not impossible without magnification tools, for consumers and health professionals to locate, read, and compare important safety information, which can lead to preventable harms. Preventable harms include any preventable event that may cause or lead to harm through inappropriate NHP use. Preventable harms related to NHP labelling are known to occur when labelling inconsistencies exist between similar self-care products (i.e., cosmetics and NHPs) or when important information is not effectively communicated, thus leading to inappropriate selection, such as when:

Preventable harms not only negatively influence the health and safety of Canadians, but may also add burden to the health care system, and contribute to increased physical waste and economic loss based on inappropriate purchases. Additionally, preventable harms may negatively impact the Canadian economy through lost productivity.

Modernized contact information to reduce preventable harms

The current provisions of the NHPR do not allow for a manufacturer or importer to replace a postal address with modernized contact information, such as an e-mail address, telephone number, or website address on the label. This means the label is only required to have a postal address, and will not contain this modernized information unless it is provided voluntarily. A lack of modernized contact information limits consumers' ability to ask product-related questions or report adverse events in a timely manner. This poses challenges for Health Canada to effectively mitigate post-market risks and preventable harms.

Clarification of existing provisions of the Natural Health Products Regulations

Lastly, certain clarity and language inconsistency issues exist within the NHPR. Health Canada wishes to take this opportunity to bring forward amendments to address these issues.

Background

NHP labels communicate important information to consumers and health professionals about the products' safe and effective use. A “label” is an all-encompassing term that covers the affixed information on the actual health product package and other information that is made available to consumers and health professionals, including the product box and any inserts, tags, or leaflets. Important information should be clearly and consistently displayed so consumers can make comparisons between products, properly select and use NHPs, be fully informed of their benefits and harms, and be able to avoid preventable harms.

In 2014, the Food and Drug Regulations (FDR) were amended to introduce Plain Language Labelling (PLL) requirements for prescription drugs and NPDs.footnote 3 The principles of PLL are in line with the general principles of labelling beyond health products, such as those that supported the implementation of a Nutrition Facts table for food. These principles include the use of a design that is easy for the intended audience to see and understand. Design factors supporting PLL include typography, form, and communication,footnote 4 and relate to font type, size, and clarity. The use of such design and format criteria enables important information to be presented in a manner that ensures legibility and comprehension to mitigate and prevent harm. The standardized table format was modelled after the Drug Facts Label in the United States (U.S.).footnote 5 This approach has also been used to create similar rules for NPDs and prescription drugs in Australia.

In Canada and internationally, health literacy research has demonstrated that when information is presented in an unclear, confusing, or inadequate manner on health product labels, it can contribute to preventable harms. These harms may lead to time off work, visits to a physician, clinic, or emergency room, and/or hospitalization or a lack of resolution of the disease or condition from inefficacy. In extreme cases, preventable harms can lead to serious injury resulting in ongoing disability or death.

Studies analysing errors related to the selection or use of health products have generally been conducted on prescription drugs. Principles of design and the need for the effective communication of important information to minimize these errors are also appropriate for NPDs and NHPs. For example, a study specific to prescription drugs suggested that the use of white space on product labels improves legibility for seniors;footnote 6 this would also apply to the legibility of similar, important information presented on NHP labels.

Currently, an inequity exists between the NPD and NHP market. NPDs are required to meet improved PLL requirements to support their safe use, while NHPs, which may, in some instances, have similar risk profiles (e.g. ginko biloba, high-dose vitamin and mineral supplements) present information in a variety of formats. Similar to the policy objectives underlying the implementation of the Nutrition Facts table and Drug Facts table in Canada, improved labelling for NHPs is expected to lead to positive outcomes for NHP consumers, which represent a larger portion of the population than NPD consumers.

Through consultations with stakeholders, consumer groups provided feedback that type sizes on current NHP labels are too small for seniors who, in some cases, require the use of a magnifying glass to read important information. Displaying important information in a standardized table format would allow consumers to more easily:

For NHPs, the NHPR sets out rules for labels and packages. While Health Canada recommends a facts table and the principles of the PLL amendments for NHPs through guidance for industry,footnote 7 there is little to no evidence that the NHP industry has been adopting these best practices.

Natural health products and associated preventable harms

According to the Canadian Institute for Health Information (CIHI), Canadians made approximately 15.8 million trips to hospital emergency departments in 2011, with an estimated 1.9 million trips related to preventable medication errors. Separate international reports have indicated that about 33% of all medication errors are caused by issues related to product naming, packaging, and labelling.footnote 8 For example, from 2013 through 2017, the Ontario Poison Control Centre received 2,777 reports related to essential oils.footnote 9 A common theme throughout the reports was consumption in excess of the recommended dosage on the label and/or confusion with another medication (e.g. cough syrup), which in some cases led to hospitalization.

More recently, the increased use of hand sanitizers through the COVID-19 pandemic has highlighted the preventable harms associated with these products. In particular, data from the Canadian Poison Control Centres show that the number of reported incidents related to hand sanitizers has increased in 2020 compared to 2019, up to 4.5- fold higher on a month-to-month basis. High demand for hand sanitizers during the pandemic has led to shortages in both the product and standard packaging, resulting in the use of unconventional packaging such as food or beverage containers. The use of these containers without sufficient labelling may lead the consumer to believe that these products are consumable. As a result of the increase in reports received by poison control, Health Canada responded with a published health advisory in October, 2020.footnote 10

In addition, the potential for NHP-prescription drug interactions can be significant, highlighting the need for measures to reduce the likelihood of preventable harms associated with NHPs. Concurrent NHP and prescription drug use among Canadians is common. A pharmacy-level study of 1118 patients reported that 58% of participating patients took both NHPs and prescription drugs concurrently.footnote 11 Of the patients taking an NHP and a prescription drug concurrently, 7.3% reported one or more adverse events. This corresponded to a 6.4 times greater likelihood of experiencing an adverse event than those in the study who took prescription drugs alone. However, the indications on the labels of most of these products state that they are only for use amongst healthy adults for general health purposes (e.g., supports health and wellness).footnote 12 An additional study that examined children who were receiving care in a pediatric hospice found that almost half of all patients had potential NHP-drug interactions, while 22% had potential NHP-NHP interactions (i.e., interactions between different NHPs).footnote 13 For example, ginseng is known to reduce the effectiveness of antihypertensive agents and antidepressant drugs, and gingko biloba can interfere with antibiotic drugs, potentially leading to ineffective treatments.footnote 14,footnote 15 St. John's Wort can reduce the effectiveness of immunosuppressive drugs used to treat individuals living with Human Immunodeficiency Virus (HIV) and is contraindicated for use in patients taking anti-cancer medications, blood thinners, antidepressant medications, cardiovascular medications, and contraceptive medications.footnote 16,footnote 17,footnote 18 It has also been linked to transplant rejections due to its inhibitive effect on immunosuppressant drugs.footnote 19

NHPs have also been found to be used more frequently by women and certain vulnerable subpopulations (e.g., older adults and certain patient groups with chronic medical conditions such as HIV/AIDS, cardiovascular disease, and diabetes).footnote 20,footnote 21 The increasing use of NHPs and their concurrent use with other medications places additional importance on the timely and effective communication of key information in order to protect the health and safety of these Canadians.

While it is difficult to precisely identify the total number of preventable errors associated exclusively with NHPs, their widespread use and a growing demand increases the potential for preventable harms related to confusion or illegibility of label information.

Adverse event reporting related to natural health product use

Since the introduction of the NHPR in 2004, Health Canada has received reports of over 1500 serious adverse reactions in which NHP use had a suspected role. More recently, between January 2015 and December 2017, Health Canada received reports of 207 adverse reactions suspected to be related to NHP use, with six of these suspected to be directly related to labelling errors/confusion.footnote 22 For example, Health Canada has received adverse reaction reports related to label confusion where warnings have been missed and consumers experienced adverse reactions due to pre-existing conditions for which the product was contraindicated. Health Canada has also received serious adverse reaction reports for products containing green tea leaf extract, where suspected rare, but serious, cases of liver injury and hospitalization occurred. In this instance, Health Canada requested that companies responsible for these products strengthen their warning statements.footnote 23 By presenting warning statements in a clear, consistent, and legible format on NHP labels, it would further protect the Canadians that use these products.

It should be noted that the role that product labels play in adverse reactions is not always captured in the reports and the reports themselves only reflect a small proportion of the actual events that occur.

Research has shown that the reporting of adverse reactions is low; the rate of reporting for prescription drugs has been estimated to be between 1% and 10%,footnote 24 while studies specific to NHPs suggest the rate may be closer to 1% to 2%.footnote 25 Consumers frequently use NHPs with the assumption that because they are natural, they are without risk. Most Canadians, according to Health Canada's public opinion research, do not consider these products to be drugs. As such, they may not even think to identify the product as the reason for the adverse reaction.footnote 26 This misconception can contribute to underreporting of NHP adverse reactions.footnote 27 This underreporting is likely exacerbated by a lack of modernized contact information on most NHP labels that would enable consumers and health professionals to reach a Canadian representative in a timely manner to ask questions or report problems.

Additional evidence has demonstrated that consumers often have questions related to NHP use. In a study of 131 pharmacists, 89% reported spending more than 30 minutes per day counselling consumers on NHP use.footnote 28 While the ability to easily and readily discern key information is important in all settings, it is especially important when these products are sold outside of pharmacies. In the absence of a health professional, it is critical that there be accessible ways to contact a product representative to answer consumers' health-related questions.

Consumer perspectives and the Canadian context

It is important to consider risks associated with NHP use in the context of consumers' perceived knowledge of their safety and effectiveness. In 2016, 19% of Canadians surveyed by Health Canada reported being knowledgeable about NHPs.footnote 26 A majority of Canadian consumer health product users reported that it is important to have directions for use (70-77%), ingredients (66-72%), warnings (66-75%), and dosage information (71-78%), directly on product labels.footnote 29 Given that only 19% of Canadians reported being knowledgeable about NHPs, 81% of Canadian consumers could be better informed of the safety and effectiveness of NHPs. Clear and consistent (standardized) labels would help bridge this gap by more effectively providing key information prior to, and during, NHP use.

A 2015 focus group study by the Institute for Safe Medication Practices found that consumers felt the current formatting of consumer health product labels (such as type size and font type, for NHPs and NPDs) made important information challenging to access, understand, and use.footnote 30 This view was also supported by further research on self-care products (in this case, for NPDs) demonstrating that type size affected comprehension, especially for older adults.footnote 31 Another study, conducted specifically with NHPs, outlined that standardization (consistency of the format and presentation) is important to effectively convey important information.footnote 32

Through an online Health Canada public consultation conducted between September and October 2016, participants reported concerns about label clarity and the need for increased consumer education on how to read and use NHP labels.footnote 33 Participants attending Health Canada consumer engagement sessions in 2018 raised concerns related to the legibility and usefulness of current NHP labelling and expressed that text is often presented with poor contrast and in a type size that is too small or difficult to read.footnote 34 They supported labels that are accurate and complete, that clearly state all warnings (including allergen information), and noted that medicinal and non-medicinal ingredients should appear side-by-side.

Objectives

The objectives of this regulatory proposal are to:

Description

Introduction of improved natural health product labelling requirements

Health Canada is proposing to modify the NHP labelling requirements by amending the NHPR in the following manner:

Introduction of a Product Facts table

Important information already required by the NHPR on the label of an NHP in a non-standardized format, and newly required information specific to NHPs containing allergens, gluten, and/or aspartame, would be required in the format of a standardized Product Facts table. The following headings, and information under those headings, would be required to be placed in a bilingual table or two unilingual tables (one in French and one in English), titled “Product Facts/Info-Produit”, or alternatively, “Drug Facts/Info-Médicament”:

The Product Facts table must be displayed in either a vertical or horizontal orientation and may span one or more panels of the outer label or, if there is no outer label, the inner label. The title “Product Facts” must be larger than each heading, and each heading must be larger than the information contained under that heading. All text within the table must be in a regular, single type, except for the title “Product Facts”, and headings, and information found under “Warnings”, which must be in bold type. The title of the table must be separated from the headings by a solid black line, and each heading and information under that heading must be separated by a solid black line from the heading that follows. Characters within the table cannot be in contact with each other and no other information, other than the required information, may be shown in a Product Facts table.

On the same label as the Product Facts table, the NHP would have to show the following information:

Where the outer label of an NHP is required to display a Product Facts table, the inner label would have to show the following information that is currently required, in addition to newly required information specific to NHPs containing allergens, gluten, and/or aspartame:

If there is insufficient space on the NHP label to accommodate a Product Facts table and the information required to be contained within it, a series of graduated flexibilities would be permitted to enable the product to accommodate the proposed requirements. However, before accessing any of these flexibilities, information in a minimum condensed type size (i.e. 5 point condensed for non-medicinal ingredients and 5.5 point condensed for all other applicable information) must be shown in a single bilingual Product Facts table. If these conditions are met, the following flexibilities would be permitted:

If any of these flexible approaches are used, a statement must be displayed, under the respective Product Facts table heading, indicating where this information can be found. In addition, if any of these flexibilities are used and engage the use of a leaflet, insert, or website, the leaflet, insert, or website must display a full and complete Products Facts table.

Labelling requirements for NHPs exempt from the Product Facts table

An NHP would be exempt from the requirement for a Product Facts table if it meets any of the following criteria:

For these NHPs, the inner and outer labels would have to display the following information that is currently required, in addition to newly required information specific to NHPs containing allergens, gluten, and/or aspartame:

The outer label or, if there is no outer label, the inner label would have to show the following, currently required, information:

If there is insufficient space on the outer label or, if there is no outer label, the inner label to accommodate the required information, the following graduated flexibilities would be permitted to enable the product to accommodate this information:footnote 39

If one or both of these flexible approaches are used, the NHP's label must contain a statement indicating where this information can be found.

Improved labelling requirements for all NHPs

Clearly and prominently displayed label text

The NHPR would be amended to require statements, information, or declarations required by the NHPR, both within and outside of a Product Facts table, to be shown in a type size of at least 6 points or 5.5 points, if condensed (except for non-medicinal ingredients, which would have to be shown in a type size of at least 5.5 points or 5 points, if condensed). In addition, such text would have to be displayed in a single colour, visually equivalent to 100% solid black (i.e., dark blue, green, brown, or purple) and be contrasted with a white or uniform neutral background with maximum 5% tint of colour. Exceptions to these requirements would include:

In addition, these legibility requirements, would not apply to specific information, such as lot numbers, product numbers, and brand names, and other such advertising information.

“Point” would be defined in the NHPR as a unit of measurement for type size that is equal to 0.3527777778 mm.

Labelling of food allergens, gluten and aspartame

In order to implement the new statements for allergens, gluten, and aspartame, the NHPR would be amended to include definitions for “food allergen” and “gluten”; they would have the same meaning as in B.01.010.1(1) of the FDR. This would be consistent with food labelling, as these ingredients are the most likely to cause a serious risk or reaction, such as anaphylaxis or other reactions related to the unintended consumption of gluten. Currently allergens must be listed in the medicinal ingredient or the non-medicinal ingredient sections of the product label. However, no standardization in the location or naming is required. For example, pollen can be listed with the non-medicinal ingredients, or bee propolis can be listed with the medicinal ingredients, both of which would cause a reaction in individuals with an allergy to this ingredient. The proposed amendments require manufacturers or importers to include a statement such as “Contains pollen” in the “Warnings” section on product labels.

Modernized contact information

The NHPR would be amended to enable a manufacturer or importer to display an e-mail address, telephone number, or web address within an NHP's Product Facts table (or elsewhere on the label if the NHP is exempt from the facts table requirement), instead of a postal address. Currently, a postal address cannot be replaced with modernized contact information, and it may be challenging to display both. Postal addresses are antiquated and infrequently used by most Canadians to contact a company. In addition, feedback received through consultations indicated that more product-related feedback is received through companies' websites.

International Nomenclature Cosmetic Ingredient (INCI) names for NHPs

The NHPR would be amended to allow an NHP's non-medicinal ingredients to be shown on the label using their INCI name, instead of being displayed in both English and French, or any other language if there is no French or English equivalent. INCI is an internationally developed and accepted nomenclature that can be used in any language to identify common ingredients/properties, most notably used for cosmetic ingredients, but also is used for NHPs and OTCs.

Current NHPR labelling provisions that would continue to apply

Current requirements under the NHPR in relation to information required on the principal display panel of an NHP's inner label and, if any, outer label would still apply. In addition, the requirements under section 94 (Small Package Labelling) would continue to apply to NHPs where the immediate container is not large enough to accommodate an inner label that complies with the proposed amendments.

Amendments to the Natural Health Products Regulations for clarification

In addition to the proposed changes for the improved labelling of NHPs under the NHPR, Health Canada wishes to take this opportunity to bring forward amendments for clarification purposes. These amendments do not set out new requirements nor remove existing requirements and are expected to be cost neutral to both government and regulated parties. The following proposed amendments would come into force on the date that they are registered:

Coming into force and transitional provisions

With the exception of the amendments to the NHPR to clarify existing rules, which would come into force upon registration, these regulations would come into force three years following registration. At this point, all new products entering the market would have to meet the proposed labelling requirements. A three-year coming into force following registration would prevent businesses from having to redesign and relabel products for which product licence applications will soon be submitted, or that have already been submitted to the Minister and are awaiting a decision.

NHPs licensed and labelled in Canada prior to the day the proposed regulations come into force would be 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. This period would provide sufficient time for companies to redesign product labels to comply with the proposed requirements and would provide an opportunity for stocks of existing products to be sold without having to be destroyed and relabelled. This would reduce relabelling and removal costs, especially for small to medium size enterprises, and reduce environmental impacts by allowing products to reach the end of their normal lifecycle.

As noted by stakeholders during Health Canada's technical consultations and through the CBA survey, a coming into force and transition period of this length reduces the risk of supply chain bottlenecks with third party designers, labellers, and packagers. In addition, stakeholder feedback indicated that within a six-year timeframe, most companies would engage in some form of relabelling, at a time most convenient for their business, regardless of the new requirements. However, in order to balance the objectives of this proposal with these important implementation considerations, Health Canada would encourage the earliest adoption of the proposed requirements, where possible.

In addition, if a licensee modifies any risk information on the label of an NHP to support the implementation of the proposed regulations during the three-year transition period, they will be required to submit a notification to the Minister instead of an application for amendment, which is currently required. These modifications may include changes to a caution statement, warning, contraindication, or known adverse reaction associated with its use in order to comply with any changes in the labelling requirements mandated by Health Canada. The notification must include the label text and occur within 60 days after the day on which the change is made. This would only apply to products to which the transition period of three years applies, and therefore, the licensee would be able to notify the Minister of such a modification and provide the amended label text between the day the regulations come into force and the 60th day after the three-year transition period, depending on when the change is made. Health Canada recognizes that in order to accommodate a Product Facts table, the Compendium of Monographs would need to be amended in order to make the warning statements more concise, understandable, and assure that they are necessary.

Regulatory Development

Consultations

Consultation on this proposal was undertaken as part of the proposed Self-Care Framework, which began in April 2016. Feedback was obtained from over 2,500 Canadians, providing baseline information on how Canadian consumers perceive and use self-care products.footnote 40 Together with previously provided consultation feedback for the Consumer Health Products Framework,footnote 41 the public opinion research informed material for an online consultation that took place from September 2016 to October 2016. Through online consultation, Health Canada heard from over 3,500 people, of which more than 2,500 self-identified as consumers. Some Canadians strongly supported the ideas in the proposed approach, and others communicated their concerns about their impact. However, it was clear that Canadians wanted more clarity and details on the proposed approach, specifically about how Health Canada would define risk and the classification of products.footnote 42 In response, the Department made changes to the proposal and committed to host in-person and online consultation sessions throughout 2017, to further refine the proposal with Canadians.

Health Canada held a total of 17 in-person consultations between April and June 2017, as well as a number of additional bilateral and multilateral meetings with key associations. These took place across the country including Vancouver, Edmonton, Montreal, Toronto, Halifax, Yellowknife, and Saskatoon. In addition, there were a number of online webinars held for those who could not attend the in-person sessions.

As the proposal became more refined, technical aspects specific to improved labelling for NHPs were discussed with stakeholders. The first technical discussion with potentially impacted stakeholder associations was held in Ottawa in February 2018, and was dedicated to the topic of labelling. Further consultation sessions were held with members of industry in February, March, and April 2018, in Vancouver, Toronto, and Montreal, respectively.

As a preamble to the CBA survey, an even further detailed NHP labelling policy proposal was sent to stakeholder associations as well as the list of all previously engaged stakeholders. The detailed policy proposal elicited feedback from stakeholders; in response, two public webinars were held in March 2018, to answer questions concerning the proposed approach and the CBA survey itself.

An additional technical consultation was held in June 2018, to engage industry associations and consumer safety groups on the regulatory proposal. This included reviewing early costing information, a draft of the proposed regulatory text, and an advanced policy document that described the changes to the proposal. The obtained feedback helped Health Canada to better understand consumer needs as they relate to the information on the label. Health Canada has continued to hold consultations, including targeted sessions with industry and consumer safety groups through 2019 and the first part of 2020.

Health Canada also conducted consumer focus group sessions to engage Canadians on the proposed approach for NHP labelling from May to July 2018. Findings from the sessions were published in a “What We Heard Report” that is posted on the Department's website.footnote 43

Three key themes were present throughout these discussions with Canadians. Firstly, all participants read labels of self-care products, whether regularly or occasionally, to learn more about the product they were using or choosing to buy. The labels were most frequently read at the point of purchase and participants were most likely to read labels of products they had not used before, or had not used recently. In addition, labels were read for a variety of reasons, depending on the circumstance, need, product, product type, or individual interest.

Secondly, participants deemed certain key information on the label as most important, such as warnings, ingredients, and dosage information; however, there was no support for removing other information (that may be of secondary importance) from the label, such as non-medicinal ingredients, especially for participants with allergies. Participants supported the use of online product information, but they preferred it to be used as a supplement to, rather than a replacement for, on-label information.

Thirdly, participants communicated that current labels are not always easy to read, mainly due to type size being too small, poor contrast (black text on a white background was preferred), and non-standardized presentation of information. Following the session, participants said they would be more likely to read self-care product labels or to read them more carefully in the future.

Throughout these consultations, Health Canada listened to stakeholder feedback and continually refined the policy approach, while ensuring the objectives of the proposal were maintained and achievable. Based on stakeholder feedback, the Department incorporated flexible approaches for the Product Facts table, an exemption from the Product Facts table for certain low-risk products, additional flexibilities and exceptions for very small packages, and an extended period for existing products to come into compliance with the new requirements (i.e., six years).

The flexibilities, including the risk-based exceptions, would significantly reduce the burden on small businesses in complying with the proposed requirements and reduce the environmental impact. To reduce burden further, while achieving the same policy objectives, Health Canada proposes to extend these flexibilities to all products, regardless of the size of the business.

Instrument choice

Non-regulatory options – status quo

The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), and accompanying Guide (Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products), set out the requirements and implementation approach for a Canadian Drug Facts table for NPDs. For consistency and good practice, this Guide also outlined a voluntary, standardized labelling format (which includes a Product Facts table recommendation) for NHPs. Through discussions with industry, Health Canada has determined the adoption of this voluntary labelling approach has been low. Based on this feedback, and industry's concerns related to the costs versus the perceived benefit of this proposal, the Department does not anticipate a significant increase in the voluntary adoption of improved NHP labelling. Continuing with this approach would not address the issue of dissimilar, unclear, confusing, and illegible NHP labels in the marketplace leading to medication errors and selection of the wrong product.

Regulatory options

1. Standardized labelling format, with no exceptions, flexibilities, or exemptions, with a one-year coming into force and a three-year transition period

Health Canada originally considered a proposal that would require NHPs to display on the label a full Products Facts table and all of its required information, statements, and declarations, to be in a minimum type size and with specific contrast requirements. While this approach would enable the intended policy objectives to be achieved, the original proposal's re-labelling and re-packaging burden on the NHP industry, especially for small businesses, would have been significant. In addition, the proposed requirements would not necessarily have been appropriate for all products from a risk-based perspective. While some NHPs have risk profiles similar to those of NPDs, there are certain NHPs that have lower risk profiles (i.e. those with a duration of use of one day or less, or those with a localized effect), such that a Product Facts table would not significantly impact preventable harms.

In addition, the burden on manufacturers, importers, labellers, packagers, distributors, and retailers of small packages would have been significant and, as originally considered, a coming into force period of one year following registration would not likely have provided enough time for products under development to implement the new labelling requirements. As such, Health Canada did not choose this approach.

When compared with the other regulatory options, this option would have the most significant environmental impact, as the short implementation period could have resulted in a number of marketed products requiring re-labelling or re-packaging. In addition, having no exemptions for small packages may have also resulted in those products requiring larger packages, thus creating additional environmental impacts.

2. Standardized labelling format with exemptions, but without flexibilities or exceptions, with a one-year coming into force and a three-year transition period

After further analysis and consultation with stakeholders, it became clear that certain products have risk profiles such that a Product Facts table format would not likely further mitigate potential harms. Therefore, Health Canada amended the proposal to exempt certain low-risk products from the Product Facts table requirement (e.g., toothpastes, mouthwashes, throat lozenges, certain inhaled products, and cosmetic-like skin care products). This option was preferable to Option 1 in terms of considering the risk profile of the product; however, it did not go far enough to address the burden the proposal would have imposed on manufacturers, importers, labellers, packagers, distributors, and retailers to re-package products. As a result, the Department made further changes to the proposal.

By exempting certain low-risk products from having to carry the Product Facts table and expanding the transition period, this option would have reduced the environmental impact outlined in Option 1, given that fewer products would require re-labelling or re-packaging. This option would require the Product Facts table to be on small packages that do not have a low-risk exemption; therefore, it could have a more significant environmental impact than Option 3, as the size of some packages may need to be increased to fit the required information.

3. Standardized labelling format with exemptions, flexibilities, exceptions, a three-year coming into force and a three-year transition period

In addition to the proposed Product Facts table exemptions, Health Canada amended the proposal to incorporate a number of other changes that would be expected to further reduce burden on industry, while maintaining the achievability of the policy objectives. The proposal was amended to accommodate, through a risk-based approach, very small packages (having an available outermost surface area for a label of less than or equal to 77.5cm²), NHPs with a duration of use of one day or less, and NHPs that contain three or fewer dosage units. These products would be exempt from the Product Facts table requirement and would also be exempt from the proposed minimum type size and contrast requirements. These proposed changes would avoid the need to repackage these NHPs and mitigate an increase in package sizes throughout the distribution chain. This would also significantly reduce burden on manufacturers, importers, labellers, packagers, distributors, and retailers.

In addition, flexible approaches to accommodate a Product Facts table were incorporated into the regulatory proposal. These include moving certain information outside of the Product Facts table (i.e., elsewhere on the label), or to a leaflet, an insert, or website. This would further avoid the need to repackage NHPs due to the proposed amendments. However, in aligning with a risk-based approach, these proposed flexibilities were extended to all products, regardless of the size of the business/product licence holder.

The coming into force of the regulations, following registration, was extended from one year to three years. This extended coming into force period would provide industry with sufficient time to develop product labels that would meet the proposed requirements before submitting a product licence application. It would also provide sufficient time for any products currently under development or under review to potentially become marketed products before the coming into force. These now-marketed products could then take advantage of the transition period, during which existing products could continue to be sold without complying with the proposed amendments.

Furthermore, an additional three-year transition period would be provided for existing products (i.e., already licensed, marketed NHPs) following the coming into force of the proposed regulations. This proposed three-year transition period, combined with the three-year coming into force (i.e., six years in total), would provide manufacturers, importers, and labellers with sufficient time to relabel NHPs within their normal cycle of business. This would minimize the proposal's incremental costs on industry and avoid the risk of supply chain bottlenecks with third party designers, labellers, and packagers. This extended period would also avoid the need to discard any unused or unsold NHPs throughout the distribution chain as well as costs related to potential voluntary recalls, as product labels could have otherwise been noncompliant (in which case a retailer may charge the manufacturer a fee). In addition, this extended coming into force and transition period provides time for Health Canada to revise current labelling monographs and guidance to make them more concise and understandable and assure that they are necessary.

This option minimizes the environmental impact of the proposed changes in comparison to the first two options. Given the shelf life of most NHPs and the relabelling cycle of most business, it is not anticipated that any products under this option would need to be removed from the market prior to their expiry to be re-labelled or re-packaged. In addition, small packages are exempt from requiring the Product Facts table, meaning there would be no requirement to increase package sizes.

This option would significantly reduce the burden and impact of the proposed regulatory amendments on manufacturers, importers, labellers, packagers, distributors, retailers and the environment, while still allowing the policy objectives to be met. Therefore, Health Canada decided to proceed with this proposed option.

Regulatory Analysis

Benefits and Costs

This cost-benefit analysis (CBA) focuses on both qualitative and quantitative costs and benefits of the proposed amendments. Data related to costs were collected using a questionnaire distributed to stakeholders that would be most affected by the proposal, namely manufacturers, importers, packagers, labellers, retailers, wholesalers, and associations.footnote 44

Published literature and focus group discussions were also used to gather relevant information and expert opinions on impacts such as downstream logistic support (e.g., warehousing), availability of shelf-space in retail outlets, and time spent by pharmacists answering consumers' product use-related questions. All incremental costs and benefits are in 2018 constant dollars, estimated over 15 years, expressed in present value (PV) using 2022 as the present value base year, and discounted at 7% as recommended in the Treasury Board Secretariat's Canadian Cost-Benefit Analysis Guide.footnote 45 It is assumed that all existing product will be fully compliant with the proposed amendments by January 1, 2028, therefore, this analysis assumes that the compliance costs and benefits will start accruing in 2027.

Due to the high uncertainty and lack of reliable information on the actual number of NHPs being sold in the Canadian market at any one time versus the number of products that have been licensed, this analysis used 50,000 stock keeping units (SKUs) to estimate the impacts to the industry.footnote 46

The full cost-benefit analysis report is available upon request.

Benefits

The following analysis outlines two expected incremental benefits with reliable and sufficient data to be evaluated quantitatively, and other expected benefits described qualitatively. Total quantified benefits are estimated at $320.4 million PV over 15 years.

The first quantified benefit measures the savings to consumers from avoided incorrect purchases. The proposed amendments are expected to improve consumers' access to, and understanding of important information on NHP labels, which is expected to reduce inappropriate product selections by 50%. Overall, it is estimated that incorrect purchases represent 1.2% of NHP sales.footnote 46 The benefit of reduced incorrect purchases of NHPs is calculated as:

Benefit ($) of reduced incorrect NHP purchases

=

Total adjusted NHP sales
($5.1 billion)footnote 62

x

Purchase error percentage (1.2%)

x

Purchase errors avoided (50%)

Based on the above formula, it is expected that the proposed amendments would provide an estimated monetized benefit to Canadians of $167.7 million PV over 15 years through avoided incorrect purchases.

The second quantified benefit relates to the inclusion of food allergen information on the front of the package of NHP labels, as measured by the willingness-to-pay (WTP) by Canadian consumers to include the safety statement on the NHP. This is measured as:

Value ($) NHP consumers place on allergen information

=

Total adjusted NHP sales
($5.1 billion)footnote 62

x

Percentage of NHP users who read labels (69%)footnote 63

x

WTP as a % of expenses on NHPs (0.8%)footnote 64

The WTP is calculated as 0.8 cents for every dollar spent on NHPs. Based on the above formula, the value that consumers gain based on their WTP for a food allergen safety statement on product labels is estimated at $152.7 million PV over 15 years.

It is anticipated that Canadians would benefit from the proposed amendments in other ways. For instance, it is expected that incorrect use of NHPs would decrease which may reduce the incidence of adverse reactions or adverse events, particularly with concurrent NHP-prescription drug or NHP-NPD use. This should result in cost savings to consumers and the health care system. This benefit was not quantified in the CBA model as Health Canada was unable to sufficiently estimate the probability that consumers would change their behaviour and avoid harm.footnote 47 Other qualitative benefits include reduced purchasing time for consumers when understanding and comparing products, and an increased ability for consumers to make more informed decisions.

The proposed amendments to include modernized contact information may provide consumers with an improved means of contacting product manufacturers or importers to pose questions, or to report harms. This is also expected to help consumers avoid incorrect purchases and to help prevent adverse drug reactions (ADRs) through better consumer access to the most up-to-date NHP-related health and safety information.

Costs to Businesses

Label redesign is a common practice in the NHP industry for various reasons, including as part of their business and marketing strategy. Consultations with stakeholders revealed that, on average, businesses relabelled their products every five years regardless of company size. Therefore, it is anticipated that businesses would already incur relabelling costs in the baseline scenario (i.e., in the absence of the proposed amendments). As the proposed amendments would also provide existing products with a transition period of three years, after the three-year coming into force period, to comply with the requirements, it is reasonable to assume that most businesses would relabel their products within this six-year timeframe. This suggests that businesses would incur at least a portion of the estimated compliance costs under the baseline scenario.footnote 48 This analysis assumed that businesses would incur 20% of relabelling costs under the baseline scenario.

In this analysis, businesses are assumed to either stop producing; continue with existing labelling configurations;footnote 49 or change to innovative labelling configurations, such as peel-back, or leaflets. It is assumed that discontinuation of product SKUs does not result in incremental costs for the CBA because the proposed amendments do not require that products stop being produced, but rather it is a business decision to discontinue.footnote 50 The survey of businesses and consultation with major stakeholders also revealed that it is likely that businesses could continue using existing labelling configurations (87.5% of total SKUs). These products would incur a one-time compliance cost only. It is also assumed that 7.5% of SKUs would use innovative labelling options and would incur both one-time and ongoing costs.footnote 51

Distribution of product SKUs based on product labelling configurations to comply with new requirements
  Category of Products
(in SKUs)		 Per cent of total SKUs In number of SKUs
1 Products continuing with
existing labelling configurations		 87.5% 43,750
2 Products using innovative labelling configurations
(such as peel-back,
leaflet, etc.)		 7.5% 3,750

Through a survey of businesses, respondents indicated that the average incremental cost to redesign product labels is estimated at $5,333 per SKU. Taking into account the various labelling requirements products will have to comply with (some will require an allergen statement, others will have to meet all of the new labelling requirements, while some will require all changes with the exception of a Product Facts table), the net compliance cost for the 43,750 SKUs that will maintain their existing labelling configurations (87.5%) is estimated at $120.2 million PV.

Estimated one-time compliance costs for products that will continue with their existing labelling configurations
Labelling Configuration Distribution % Number of SKUs Net Incremental
One-Time Cost*
Small packages that only need to include allergens 7.00% 3,500 $ 1,067
Products that do not need a Product Facts table 13.00% 6,500 $ 3,200
All new requirements on existing labelling configuration 67.50% 33,750 $ 4,266

* After deducting 20% of label redesigning cost to be incurred in the baseline scenario.

The survey of businesses and consultation with major stakeholders also revealed that 3,750 SKUs (7.5%) would require more expensive labelling configurations to comply with the proposed amendments. A major industry association estimated the incremental one-time cost for innovative labelling options by expressing it as a factor of $5,333 (the incremental one-time cost of products continue with existing labelling configurations). The association used factors ranging between 1.28 and 1.77, which were used in this analysis. This analysis also anticipated that businesses adopting innovative labelling options such as the use of a leaflet, peel-back label, or fifth panel would incur ongoing costs due to the more expensive labelling options (which would be associated with every unit of product). Based on the assumed distribution of the innovative labelling in the below table, the net compliance cost for the 3,750 SKUs that would require the innovative labelling option is estimated at $38.6 million PV.

Number of SKUs and one-time compliance cost factors by innovative labelling configurations
Labelling Configuration Distribution % Number of SKUs Incremental
One-Time Cost		 Annual On-Going Cost
Peel back 3.75% 1,875 $5,770 $ 1,129
5th panel 1.88% 940 $8,095 $ 1,129
Leaflet 1.50% 750 $8,357 $ 1,129
Outer Box 0.38% 190 $8,357 $1,327

Costs to Consumers and the Government

Costs to consumers are expected to be negligible since NHPs are sold in a competitive market and thus the analysis assumes manufacturers and importers are likely to absorb costs to maintain existing market shares rather than increase product prices. However, some consumers might experience inconvenience due to some businesses deciding to discontinue their preferred products. Similarly, costs to government are not expected to be significant since the requirements of the proposed amendments would be incorporated into the existing compliance and enforcement activities of the personal care products managed by Health Canada. There may be a minimal incremental cost associated with consultation and engagement activities to inform and educate regulated parties on how to appropriately comply with the new requirements. However, Health Canada engages with NHP stakeholders on an ongoing basis and these types of activities fall within the normal day-to-day business of the Department.

Distributional Impacts

A review of the literature indicated that Canadian NHP users that are more likely to read product labels are those with higher levels of education.footnote 52 It is expected that these NHP consumers would benefit most from the proposed amendments. Although the literature revealed that females are more likely to use NHPs,footnote 53 the anticipated impacts of the proposed amendments are expected to equally benefit consumers, independent of sex or gender.

Other distributional impacts may be based on ethnicity. Certain cultural communities (e.g., users of traditional Chinese medicines and Ayurvedic medicine) could be more likely than others to benefit from the proposed amendments.

Environmental Impacts

The environmental costs associated with the proposed amendments would depend on the extent of changes to labelling configurations. Based on stakeholder feedback, NHP manufacturers and importers would likely maintain most of their current labelling configurations. There would be some exceptions for a small number of products where new labelling configurations (such as the use of a leaflet, insert, peel-back label, or fifth panel) would be necessary to comply with the proposed amendments. However, the incremental environmental impact of these changes to labelling configurations would be minimal.

Due to warehousing and distribution constraints, there is little to no capacity to accommodate new labelling configurations that result in additional packaging material or overall product size, as the pallet size(s) remain fixed and there is no willingness to increase the capacity based on the feedback from the wholesale industry. As such, this analysis assumed the majority of stakeholders would choose peel-back labels, inserts, or leaflets to avoid increases in package size. However, it is also common that businesses would choose the lowest cost approach when reconfiguring product packages and labels to comply with the new requirements (i.e., a leaflet or a peel back). The proposed amendments provide a transition period of three years, after the three-year coming into force period, to prevent waste from unsold stock.

Table 1: Cost-benefit statement

Monetized costs (in millions)
Impacted stakeholder Description of cost Base Year
(2022)		 Year before CIE
(2027)		 Final Year
(2036)		 Total
(PV)		 Annualized Average
Industry One-time compliance costs with existing labelling configurations $0.00 $168.52 $0.00 $120.15 $13.19
Industry One-time and on-going compliance costs with innovative labelling configurations $0.00 $26.24 $4.27 $38.55 $4.23
All stakeholders Total costs $0.00 $194.76 $4.27 $158.70 $17.42
Monetized benefits (in millions)
Impacted stakeholder Description of benefit Base Year (2022) Year before CIE
(2027)		 Final Year
(2036)		 Total
(PV)		 Annualized Average
Canadians Benefits from reduced incorrect purchases $0.00 $31.30 $31.30 $167.73 $18.42
Canadians Benefits from the value of allergen information $0.00 $28.49 $28.49 $152.67 $16.76
All stakeholders Total benefits $0.00 $59.80 $59.80 $320.40 $35.18
Summary of monetized costs and benefits (in millions)
Impacts Base Year
(2022)		 Year before CIE
(2027)		 Final Year
(2036)		 Total
(PV)		 Annualized
Average
Total costs $0.00 $194.76 $4.27 $158.70 $17.42
Total benefits $0.00 $59.80 $59.80 $320.40 $35.18
Net impact $0.00 $134.97 $55.52 $161.70 $17.75

Qualitative impacts

Positive impacts:

Negative impacts:

Small Business Lens

The small business lens applies as there are impacts on small businesses associated with the proposal.

Based on the 2011 Functional Food and Natural Health Products Survey, there were 750 establishments operating in the functional food and NHP space, of which 566 establishments (including 144 establishments actively involved in both functional food and NHPs) were active in the NHP market.footnote 54,footnote 55

The functional food and NHP sectors experience a high rate of new product failures in the current market; the sectors' success are highly influenced by the wide range of products as well as market segments and economic conditions.footnote 55 The latest database maintained by Health Canada indicates there are slightly more than 4,000 entities,footnote 56 including fewer than 2,800 Canadian entities that have applied for authorizations to market NHPs in Canada, although historical records showed that not all products issued with product licenses were actively marketed.

It is believed that small businesses are more vulnerable to any external challenges, including compliance with new regulatory requirements. This is due to lower profit margins, lower business volumes over which to spread fixed costs, and reduced access to capital or disadvantaged cash flow conditions. However, Health Canada's survey of businesses revealed that medium and large business owned more product SKUs overall than small businesses.footnote 57 The number of SKUs owned per small business is also fewer than the number owned per medium and large business.footnote 58 Small businesses also reported a shorter period for their label redesign lifecycle, averaging 4.3 years,footnote 59 compared to an average of 5.1 years for all businesses who responded to the survey. The small business redesign lifecycle period is shorter than the six-year compliance period of the proposed amendments. This suggests that most, if not all, small businesses would have gone through at least one label redesign cycle during this time, even without the proposed regulations, thus limiting the incremental cost of the proposed regulations.

Stakeholder consultations revealed that more than half of the impacted manufacturers and importers of NHPs in Canada are small businesses.footnote 60 Assuming that the sector impacted by the proposed amendments is comprised of 70% (2,847) small businesses, and 20% (813) and 10% (407) medium and large businesses,footnote 61 approximately 14,954 SKUs impacted (31.5%) by the proposed amendments would be owned by small businesses. This suggests that small businesses would be impacted with approximately $50.0 million (PV) of the total compliance costs, including 1,122 SKUs that would require innovative labelling options. This means that on average, each small business would be impacted with $17,550 (PV) of compliance cost over the 15-year period. Medium and large businesses would be impacted with $69,009 and $129,348 respectively, per business, over the 15-year period.

In order to minimize impacts to all businesses (including small businesses) while maintaining the achievability of the policy objectives, the proposal was, after various stakeholder consultations, amended to incorporate a number of flexibilities, namely:

Table 2: Small business lens summary

Compliance costs
Activity Annualized value Present value
Low risk products $0.51 M $4.67 M
Small packages $0.09 M $0.84 M
Full compliance using existing labelling configurations $3.55 M $32.32 M
Full compliance using innovative options $1.33 M $12.14 M
Total compliance cost $5.49 M $49.96 M
Administrative costs
Activity Annualized value Present value
Total administrative cost $0 $0
Total compliance and administrative costs
Totals Annualized value Present value
Total cost (all impacted small businesses) $5.49 M $49.96 M
Cost per impacted small business $2,007 $17,550

One-For-One Rule

The One-for-One Rule does not apply to this proposal, as the regulatory amendments are not expected to increase administrative burden on businesses.

Regulatory Cooperation and Alignment

In Canada, NHPs are regulated as a unique subset of drugs. In the U.S., some NHPs are regulated as NPDs while most are regulated as dietary supplements. The U.S. Food and Drug Administration requires NPD labels to contain a Drug Facts Label, which is very similar to the requirements of this proposal. In addition, the U.S. requires labels of dietary supplements to contain a Supplement Facts Table, which has similarities to the requirements of this proposal (e.g., contrast, font size, and standardization). As such, all products in the U.S. that would be considered NHPs in Canada would have a standardized table on their label containing important information. Overall, the proposed amendments would improve international label alignment with the U.S., especially from a consumer perspective.

In addition, the Australian Therapeutic Goods Administration (TGA) introduced new drug labelling standards in 2016. These standards included font, type, and format requirements (similar to those contained in this regulatory proposal) for all therapeutic goods in Australia, including NHP-equivalent products (i.e., listed medicines). The proposed amendments to the NHPR would improve regulatory alignment with the Australian TGA.

Canada's bilingual labelling requirements apply to manufacturers importing products into Canada. U.S. manufacturers cannot use a nearly identical label for an NHP intended to be marketed in Canada; Canadian labels will always be unique to accommodate both official languages.

Strategic Environmental Assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan did not identify important environmental impacts and concluded that a detailed strategic environmental assessment is not required.

The additional environmental impact of this initiative over and above the normal labelling process is expected to be minimal. Though it is anticipated that a small number of products will require a new or modified labelling configuration or resizing, it is not expected to have a significant additional impact on waste or greenhouse gas emissions. Further, a three-year coming into force period followed by a three-year transition period for already marketed products will provide companies with ample time to incorporate new labelling requirements without having to relabel or dispose of products currently on store shelves.

Gender-based Analysis Plus (GBA+)

This proposal is expected to protect the health and safety of all Canadians, rather than specific population sub-groups, who use, or are considering using NHPs by ensuring important information on the label is displayed in a standardized, easy-to-read and understand format that supports their safe and effective use. However, there are certain gender and diversity considerations related to this proposal. A review of literature indicated that there are three categories of consumers most likely to benefit from the proposal:

In partnership with researchers at the University of McGill, Health Canada assessed the sex and gender considerations of these proposed amendments by conducting a sex-and gender-based analysis of the April 2016 feedback received from over 2,500 Canadians through public opinion research. This analysis found that labels are one of the most common methods for both male and female frequent users to access critical information about an NHP. This includes safety information, intended uses, and dosage. Males who frequently use NHPs reported reading product labels more often than female frequent users; however, the overall reading of product labels for information did not differ greatly and in some specific cases (e.g., for sunscreens, vitamins, and homeopathic products), female frequent users reported relying on product labels more often than male consumers. Improved NHP labelling should positively impact all Canadian consumers regardless of sex or gender, by helping them more easily access and understand the important safety and usage information on NHP labels.

Implementation, Enforcement and Service Standards

The proposed regulations would come into force three years following registration, with the exception of the amendments to the NHPR to clarify existing rules, which would come into force upon registration. Once in force, all new products (i.e., those not yet licensed) would have to comply with the proposed amendments. All marketed NHPs (i.e., those which are licensed and labelled) at the time of the coming into force of this proposal would be provided an additional three year period before their labels would have to comply with the proposed amendments.

Guidance would provide greater detail on how to comply with the proposed labelling requirements. Health Canada has made draft guidance available for comment in parallel with the pre-publication of this proposal in Part I of the Canada Gazette.footnote 65 For submission-related processes, the Department will adhere to existing service standards as provided in its Natural Health Products Management of Applications Policy.footnote 66 Furthermore, Health Canada will revise the current Compendium of Monographs to make them more concise and understandable and assure that they are necessary.

Compliance and enforcement

Compliance and enforcement of the regulations would be in accordance with a risk-based approach, aligned with Departmental policies.

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 14, 11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
E-mail: hc.lrm.consultations-mlr.sc@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Administrator in Council, pursuant to subsection 30(1)footnote a of the Food and Drugs Actfootnote b, proposes to make the annexed Regulations Amending the Natural Health Products Regulations.

Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario K1A 0K9 (email: hc.lrm.consultations-mlr.sc@canada.ca).

Ottawa, June 10, 2021

Julie Adair
Assistant Clerk of the Privy Council

Regulations Amending the Natural Health Products Regulations

Amendments

1 (1) Paragraph (c) of the definition natural health product in subsection 1(1) of the Natural Health Products Regulationsfootnote 67 is replaced by the following:

(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

food allergen
has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations. (allergène alimentaire)
gluten
has the same meaning as in subsection B.01.010.1(1) of the Food and Drug Regulations. (gluten)
point
means the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. (point)

2 Subsection 9(2) of the Regulations is replaced by the following:

(2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, request that the Minister reconsider the application.

3 The portion of section 13 of the English version of the Regulations before paragraph (a) is replaced by the following:

13 For greater certainty, if the licensee makes any of the following fundamental changes in respect of the natural health product, the licensee shall not sell the natural health product affected by the change unless a product licence is issued in accordance with section 7 for the natural health product as changed:

4 The portion of paragraph 18(2)(b) of the Regulations before subparagraph (i) is replaced by the following:

5 Subsection 27(2) of the Regulations is replaced by the following:

(2) No person who holds a site licence shall manufacture, package, label or import a natural health product for sale during the period of any suspension of the licence under section 39 or 40.

6 Subsection 30(2) of the Regulations is replaced by the following:

(2) The notice shall indicate that the applicant may, within 30 days after the date of the notice, request that the Minister reconsider the application.

7 The portion of paragraph 39(2)(b) of the Regulations before subparagraph (i) is replaced by the following:

8 Subsection 51(5) of the English version of the Regulations is replaced by the following:

(5) Every natural health product that is sold and subsequently returned to its manufacturer, packager, labeller, importer or distributor, as the case may be, shall be approved by a quality assurance person before that natural health product is made available for further sale.

9 Paragraph 53(d) of the Regulations is replaced by the following:

10 Paragraph 54(a) of the Regulations is replaced by the following:

11 Paragraph 56(c) of the Regulations is replaced by the following:

12 (1) The portion of section 62 of the Regulations before paragraph (a) is replaced by the following:

62 Every manufacturer, importer or distributor who commences a recall of a natural health product shall, within three days after the day on which the recall is commenced, provide the Minister with the following information in respect of the natural health product:

(2) Paragraph 62(e) of the Regulations is replaced by the following:

(3) Paragraphs 62(g) to (j) of the Regulations are replaced by the following:

13 The portion of subsection 71(1) of the English version of the Regulations before paragraph (a) is replaced by the following:

71 (1) Subject to subsection (2), if the sale or importation of a natural health product for the purposes of a clinical trial is authorized under this Part, the sponsor shall not make any of the following amendments unless the authorization is amended accordingly:

14 Section 72 of the Regulations is replaced by the following:

72 If an authorization to sell or import a natural health product for the purposes of a clinical trial is amended in accordance with subsection 71(5), the sponsor shall sell or import the natural health product and conduct the clinical trial in accordance with the amended authorization.

15 Subsection 76(3) of the Regulations is amended by striking out “and” at the end of paragraph (g), by adding “and” at the end of paragraph (h) and by adding the following after paragraph (h):

16 The portion of paragraph 80(2)(b) of the Regulations before subparagraph (i) is replaced by the following:

17 (1) The portion of subsection 87(1) of the Regulations before paragraph (a) is replaced the following:

87 (1) If any of the following information is required by these Regulations to be shown on the label of a natural health product, it shall be shown in both English and French:

(2) Subsection 87(2) of the Regulations is replaced by the following:

(2) Despite subsection (1), in the case where the common name or proper name of a medicinal ingredient or the common name of a non-medicinal ingredient does not have an English or French equivalent, if there is an equivalent name in another language, that equivalent name shall be shown.

(3) Despite subsections (1) and (2), the common name of a non-medicinal ingredient may be replaced by the International Nomenclature Cosmetic Ingredient name assigned to it in the International Cosmetic Ingredient Dictionary and Handbook, published in Washington, D.C., U.S.A., by the Personal Care Products Council, as amended from time to time.

18 (1) Section 88 of the Regulations is amended by striking out “and” at the end of paragraph (a) and by adding the following after paragraph (b):

(2) Section 88 of the Regulations is renumbered as subsection 88(1) and is amended by adding the following:

(2) Paragraphs (1)(c) to (g) do not apply to the lot number, product number or brand name.

(3) Paragraphs (1)(c) to (g) do not apply if

19 Section 89 of the Regulations is repealed.

20 Section 93 of the Regulations is replaced by the following:

93 The following information in respect of a natural health product shall be shown on the principal display panel of the inner label and, if there is an outer label, on the principal display panel of the outer label:

93.1 (1) The following information in respect of a natural health product shall be shown on the outer label or, if there is no outer label, on the inner label:

(2) Any table that is referred to in paragraph (1)(f) shall be shown on the label vertically or horizontally.

(3) Despite paragraph (1)(f) and subsection (4), the order of the languages in a bilingual table may be reversed.

(4) A bilingual table shall contain only the following headings in the following order:

(5) A table in English shall contain only the following headings in the following order:

(6) A table in French shall contain only the following headings in the following order:

(7) The following information shall be shown under the heading “Medicinal ingredients / Ingrédients médicinaux” or under the headings “Medicinal ingredients” and “Ingrédients médicinaux”:

(8) The recommended use or purpose of the natural health product shall be shown under the heading “Uses / Usages” or under the headings “Uses” and “Usages”.

(9) Despite subsections (4), (5), (6) and (8), the recommended use or purpose may be omitted from the table if that information is shown elsewhere on the same label, and, if it is omitted, the heading “Uses / Usages” or the headings “Uses” and “Usages” shall also be omitted.

(10) The risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of the natural health product, shall be shown under the heading “Warnings / Mises en garde” or under the headings “Warnings” and “Mises en garde” and, subject to paragraphs (11)(a) and (12)(a), may be shown in bold type.

(11) If the natural health product contains a food allergen or gluten,

(12) If the natural health product contains aspartame,

(13) Despite subsections (4), (5) and (6), if there is no risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of the natural health product, the heading “Warnings / Mises en garde” or the headings “Warnings” and “Mises en garde” shall be omitted from the table.

(14) The following information in respect of the natural health product shall be shown under the headings “Directions / Mode d'emploi” or under the headings “Directions” and “Mode d'emploi”:

(15) The recommended storage conditions of the natural health product shall be shown under the heading “Other information / Autres renseignements” or under the headings “Other information” and “Autres renseignements”.

(16) Despite subsections (4), (5), (6) and (15), the recommended storage conditions may be omitted from the table if they are shown elsewhere on the same label, and, if they are omitted and no other information is to be included under the heading “Other information / Autres renseignements” or the headings “Other information” and “Autres renseignements”, the heading or headings shall also be omitted.

(17) The following information shall be shown under the heading “Non-medicinal ingredients / Ingrédients non médicinaux” or under the headings “Non-medicinal ingredients” and “Ingrédients non médicinaux”:

(18) The address, telephone number, email address or website address of a person who represents the product licence holder of the natural health product shall be shown under the heading “Questions?”.

93.2 The following requirements apply in respect of a table referred to in paragraph 93.1(1)(f):

93.3 (1) If, despite the following measures, the available surface area for a label is insufficient to accommodate all of the information that is required to be shown in a table under section 93.1, the information referred to in subsection 93.1(17) shall instead be shown elsewhere on the same label:

(2) If, despite the application of subsection (1), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information referred to in subsection 93.1(17) shall instead be shown

(3) If, despite the application of subsection (2), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information referred to in paragraph 93.1(7)(b) shall instead be shown in the leaflet or package insert, or on the website, that contains the information referred to in subsection 93.1(17).

(4) For the purposes of subsections (1), (2) and (3), the table shall include a statement under the appropriate heading that indicates where the information referred to in subsection 93.1(17), and, if applicable, paragraph 93.1(7)(b), can be found.

(5) The information that is required to be shown in a leaflet or package insert or on a website shall appear in a table that complies with the requirements of sections 93.1 and 93.2.

93.4 If a natural health product has both an inner and outer label, the following information in respect of the product shall be shown on the inner label:

93.5 Sections 93.1 to 93.4 do not apply in respect of a natural health product if

93.6 (1) If any of the conditions set out in section 93.5 is met, the following information in respect of the natural health product shall be shown on the inner label and, if there is an outer label, on the outer label:

(2) Subject to subsections (3) and (4), if any of the conditions set out in section 93.5 is met, the following information in respect of the natural health product shall be shown on the outer label or, if there is no outer label, on the inner label:

(3) The information referred to in paragraphs (2)(a) and (b) shall instead be shown in a leaflet that is affixed or attached to the immediate container of the natural health product, in a package insert or on a website if

(4) If, despite the application of subsection (3), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown under subsections (1) and (2), the information referred to in paragraph (2)(c) shall instead be shown in the leaflet or package insert, or on the website, that contains the information referred to in paragraphs (2)(a) and (b).

(5) For the purposes of subsections (3) and (4), the label shall include a statement that indicates where the information referred to in paragraphs (2)(a) and (b), and, if applicable, paragraph (2)(c), can be found.

21 (1) The portion of subsection 94(1) of the Regulations before paragraph (a) is replaced by the following:

94 (1) If the immediate container of a natural health product is not large enough to accommodate an inner label that complies with the relevant requirements of sections 93 to 93.6, the product shall be labelled as follows instead:

(2) Subparagraph 94(1)(a)(ii) of the Regulations is replaced by the following:

(3) Paragraph 94(1)(b) of the Regulations is replaced by the following:

(4) Subsection 94(2) of the Regulations is replaced by the following:

(2) If the natural health product does not have an outer label,

Transitional Provisions

22 (1) In this section, natural health product has the same meaning as in subsection 1(1) of the Natural Health Products Regulations.

(2) A natural health product for which a product licence has been issued, before the day on which sections 17 to 21 come into force, under section 7 of the Natural Health Products Regulations is not required, during the three-year period that begins on that day, to be labelled in accordance with those Regulations, as they read on that day, if the product is labelled in accordance with those Regulations as they read immediately before that day.

(3) If, during the three-year period referred to in subsection (2), a person that holds a product licence under the Natural Health Products Regulations in respect of a natural health product referred to in that subsection makes any modification of risk information referred to in paragraph 11(1)(c) of those Regulations in respect of the product for the purpose of complying with those Regulations, as amended by sections 17 to 21,

Coming into Force

23 (1) These Regulations, except sections 17 to 21, come into force on the day on which these Regulations are registered.

(2) Sections 17 to 21 come into force on the third anniversary of the day on which these Regulations are registered.