Final Report - Online Consultation: Natural Health Products Regulatory Review

This content was archived on June 24, 2013.

November 2008

Cat. No.: H164-87/2008E (PDF Version)
ISBN: 978-1-100-10007-4 (PDF Version)

Table of Contents

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Foreword

On March 12, 2007 the Natural Health Products Directorate (NHPD) launched its Natural Health Products Regulatory Review (NHPRR) Initiative with the posting of its discussion paper entitled: Charting a Course: Refining Canada's Approach to Regulating Natural Health Products (http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/blueprint-plan/chart-course_tracer-voie-eng.php). The purpose of this document was to provide stakeholders with an opportunity to familiarize themselves with the NHPRR and with the regulatory and policy issues Health Canada proposed to address in this context. The accompanying e-consultation document was posted on March 30, 2007 and was open for comment for 60 days until May 30, 2007. Stakeholders were invited to provide feedback on currently identified issues, to identify any other issues that were not identified and to rank their top 5 priorities. This phase has now been completed.

This report provides a summary of the results of the e-consultation in the context of the NHPRR. This document consists of 4 sections. Section 1 is intended to provide background information on the NHPRR as well as general demographic information for the participating stakeholders. Section 2 provides a summary of the consultation feedback including general comments and perspectives on the NHPRR process. Section 3 provides a summary of the comments received on the issues outlined in the consultation document, on identified stakeholder priorities and additional issues raised by them which were not included in the consultation document. Finally Appendices A, B and C provide a list of participants, additional issues, and acronyms.

For additional information and/or copies of the document please contact:

Natural Health Products Directorate
Health Products and Food Branch
Address Locator: 3302A
Tel: 1-888-774-5555
Fax: (613) 948-6810
E-mail: nhpd_dpsn@hc-sc.gc.ca

The Review at a Glance

Vision

• Health Canada is committed to being a world class regulator. Health Canada has taken the international lead in establishing a regulatory regime that deals comprehensively with natural health products (NHPs) as a distinct class of products and will continue to be innovative in this regard,
• The Natural Health Products Directorate (NHPD) will aid Canadians in gaining access to NHPs while ensuring the safety, efficacy and quality of the products,
• The NHPD will implement a system that will regulate proportional to risk,
• The NHPD will implement a system that recognizes the cultural component of NHP use,
• The NHPD will reflect the broad range of products, as by their very nature NHPs have many variations in formulation and use.

Our Mandate

• To ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.

Objectives

• Respond to Health Canada's commitment to conduct a review of the regulations within three to five years of coming into force,
• Improve regulatory performance and ensure the sustainability of the NHP regulatory program in a way that maximizes safety and quality while minimizing health risks to Canadians,
• Align the Review with regulatory modernization initiatives within Health Canada and the Health Products and Food Branch (HPFB), in particular the Blueprint for Renewal Initiative,
• Respect the underlying principles/logic of the Food and Drug Act regarding the pre- and post-market review of product classes based on risk,
• Identify and attempt to address regulatory lessons learned from parallel models of regulatory health risk assessment from within Health Canada,
• From the Review, the desired outcome is a regulatory framework for NHPs that:
  • Protects the health of consumers,
  • Respects consumers' access to products,
  • Guarantees product safety and quality,
  • Ensures consumers can make informed choices,
  • Is proportional to the risk of the products.

Executive Summary

Background

The Natural Health Products Regulations (NHPR) came into force on January 1, 2004 following extensive consultations with stakeholders. At that time a commitment was made to undertake a review of the regulations within the first three (3) to five (5) years of their implementation. This review was launched to further that commitment and in consideration of challenges and issues which have been identified in the first three years of regulating natural health products (NHPs). The Natural Health Products Regulatory Review (NHPRR) is being carried out as part of the Health Products and Food Branch (HPFB)'s Blueprint for Renewal Initiative, which is Health Canada's plan to modernize its regulatory framework for health products and food.

On March 12, 2007 the Natural Health Products Directorate (NHPD) launched its NHPRR Initiative with the posting of its discussion paper entitled: Charting a Course: Refining Canada's Approach to Regulating Natural Health Products. The accompanying e-consultation document was posted on March 30, 2007 and was open for comment for 60 days until May 30, 2007. Stakeholders were invited to provide feedback on currently identified issues; identify any other issues that were not identified, and to rank their top five (5) priorities.

Participation

A total of seventy-seven (77) submissions were received prior to the deadline encompassing over seven-hundred (700) total comments. Seventy-two (72) of these submissions were submitted electronically using the e-consultation while the remaining five (5) were sent via regular mail. Beyond those issues identified in the review, eighty-seven (87) supplementary comments were made which highlighted additional issues.

Bar chart showing the distribution of participants by stakeholder group.

The largest group of participants came from within the NHP industry (40% of all submissions). The second and third largest participant groups were NHP industry associations (16%) and health professionals (14%) (See Figure 1). The rest of the submissions were distributed relatively evenly across the remaining thirteen (13) groups. The majority of submissions were received from participants in Ontario (57%) followed by British Columbia (14%) and Quebec (14%). The remaining submissions were received from across Canada as well as from international participants (see Figure 2).

Pie chart showing the demographic breakdown of participants.

Summary of Consultation Feedback

Participating stakeholders felt that the regulatory review process was a necessary component in efficient regulation and appreciated the opportunity to participate in the process. Strong support was articulated for the undertaking of a regulatory review, and Health Canada's (HC) commitment to refine, improve and update the NHPR. Various comments were received regarding the issues identified in Charting a Course; however, the most recurring theme expressed by stakeholders was that NHPs should be regulated proportional to their level of risk. Participating stakeholders generally felt that the regulatory requirements were too onerous for this product type given the low risk nature of these products and their history of safe use. Strong comments were made in support of several issues outlined in Charting a Course such as:

• The harmonization of Government policies/protocols
• The regulation of natural health products (NHPs) proportional to their risk level
• The inclusion of provisions for compounding in the NHPR
• The revision of requirements for the use of human tissue in NHPs

Mixed views were expressed regarding issues such as:

• The addition of a (GMP) inspection component to the Natural Health Products Regulations
• The harmonization of NHPR clinical trials (CT) requirements involving human subjects with the requirements set out in the Food and Drug Regulations (FDR)

Participating stakeholders generally were in disagreement with certain issues such as:

• The addition of advertising regulatory provisions in the Natural Health Products Regulations (NHPR)
• Additional labelling requirements for products carrying the "for professional use" claim

Stakeholder Priorities and Additional Issues Raised by Participating Stakeholders

Respondent's top priorities were: issue 1.3 (regulation of lowest risk products), issue 1.5 (regulation of personal care products) and issue 3.1 (good manufacturing practices) (see Figure 3).

High priority issues were flagged as important by stakeholders and are not necessarily an issue that was disagreed with. For instance, thirty-four (34) stakeholders flagged issue 3.1 (GMPs) as important. Half of those stakeholders agreed with the proposed additions to GMP requirements while half disagreed with adding an inspection component.

The most recurring themes not identified for comment in Charting a Course but added as additional issues by respondents, are as follows (see Appendix B for full listing):

• NHP/Food Interface
• Security packaging
• Overregulation in the areas ingredients disclosure, reporting of adverse events, and testing specifications
• Transitional Drug Identification Number (DIN) to Natural Product Number (NPN) review period
• Risk proportional product licensing process
• Small package labelling requirements
• Quality Assurance Person education requirements
• Veterinary NHPs
• Frequency of site licence renewals

Bar chart showing the rank-order of priority issues based on the number of votes for each issue.

For more information on stakeholder comments, priorities and additional issues, please refer to Appendix B.

Conclusions and Next Steps

The online consultation was successful in providing NHP stakeholders the opportunity to offer input on issues surrounding the NHPR.

Feedback from the consultation showed strong support for the interactive review process. By including NHP stakeholders in the process, NHPD has allowed stakeholders to be involved in the review process as well as to familiarize themselves with the Review and regulatory policy issues that Health Canada has proposed to address.

Health Canada is proceeding with the analysis of the comments received during the consultation and the input is being used to develop options and to draft a medium to long term action plan for issue resolution. Health Canada is confident that the Review will contribute to the continued growth and refinement of an appropriate framework that is flexible, effective, efficient and sustainable for the regulation of NHPs into the 21^st century.

Consultation Report

Section 1: Background and Participation

Section 1 consists of background information on the Natural Health Products Regulatory Review (NHPRR) as well as general demographic information for the participating stakeholders.

1.1 Background

The Natural Health Products Regulations (NHPR) came into force on January 1, 2004 following extensive consultations with stakeholders. At that time a commitment was made to undertake a review of the regulations within the first three to five years of their implementation. This review was launched to further that commitment and in consideration of challenges and issues which have been identified in the first three years of regulating natural health products (NHPs).

The Natural Health Products Regulatory Review (NHPRR) is being carried out as part of the Health Products and Food Branch (HPFB)'s Blueprint for Renewal Initiative which is Health Canada's plan to modernize its regulatory framework for health products and food. This process is consistent with and reflects the eight policy objectives of the Blueprint, in particular the following three:

• Applying interventions proportional to risk
• Moving to a system that makes the best use of all types of evidence; and
• Moving to a proactive and enabling system

This review process is intended to provide stakeholders with a sustainable and appropriate regulatory framework for NHPs and increase efficiency by improving and updating the NHPR and ensuring that the policy objectives relating to safe, effective and high quality products continue to be met.

1.2 Participation

On March 12, 2007, the Natural Health Products Directorate (NHPD) launched its NHPRR Initiative with the posting of its discussion paper entitled: Charting a Course: Refining Canada's Approach to Regulating Natural Health Products. The accompanying e-consultation document was posted on March 30, 2007 and was open for comment for 60 days until May 30, 2007. Stakeholders were invited to provide feedback on currently identified issues, to identify any other issues that were not identified and to rank their top 5 priorities.

A total of seventy-seven (77) submissions were received prior to the deadline, encompassing over seven-hundred (700) total comments. Seventy-two (72) of these submissions were provided electronically using the e-consultation while the remaining five (5) were sent via regular mail. Beyond those issues identified in the review, eighty-seven (87) supplementary comments were made which highlighted additional issues.

The largest group of participants came from within the NHP industry (40% of all submissions). The second and third largest participant groups were NHP industry associations (16%) and health professionals (14%) (See Figure 1 for a complete distribution of stakeholder groups who participated in the consultations) The rest of the submissions were distributed relatively evenly across the remaining thirteen (13) groups. It should be noted that stakeholders were able to identify themselves as a part of multiple groups (i.e. a stakeholder could be a consumer as well as a part of the general public).

The majority of submissions were received from participants in Ontario (57%) followed by British Columbia (14%) and Quebec (14%). The remaining submissions were received from across Canada as well as international participants (see Figure 2 for a complete breakdown of the demographic distribution of all stakeholders).

Section 2: Summary of Consultation Feedback

2.1 General Comments and Perspectives

Participating stakeholders felt that the regulatory review process was a necessary component in efficient regulation and appreciated the opportunity to participate in the process. Strong support was articulated for the undertaking of a regulatory review, and Health Canada's (HC) commitment to refine, improve and update the NHPR. Various comments were received regarding the issues identified in Charting a Course; however, the most recurring theme expressed by stakeholders was that NHPs should be regulated proportional to their level of risk. Participating stakeholders generally felt that the regulatory requirements were too onerous for this product type given the low risk nature of these products and their history of safe use. Strong comments were made in support of several issues outlined in Charting a Course such as:

• The harmonization of Government policies/protocols
• The regulation of natural health products (NHPs) proportional to their risk level
• The inclusion of provisions for compounding in the NHPR
• The revision of requirements for the use of human tissue in NHPs

Mixed views were expressed regarding issues such as:

• The addition of Good Manufacturing Practices (GMP) inspection component to the Natural Health Products Regulations (NHPR)
• The harmonization of NHPR clinical trials (CT) requirements involving human subjects with the requirements set out in the Food and Drug Regulations (FDR)
• Participating stakeholders generally were in disagreement with certain issues such as:
• The addition of advertising regulatory provisions in the Natural Health Products Regulations (NHPR)
• Additional labelling requirements for products carrying the "for professional use" claim

Many participants who agreed in principle with certain proposals also noted that the most effective change can often be made in implementing a set of regulations. However, these stakeholders felt that if NHPD executes its planned implementation approach in its entirety then the regulatory framework for natural health products (NHPs) would undoubtedly be improved.

Each stakeholder was also asked to provide input on the consultation format including the clarity and comprehensiveness of each issue outlined in Charting a Course. For each issue, stakeholders were asked if the topic was described adequately. Based on stakeholder feedback, it seems that the majority of the issues as well as the consultation format were developed effectively. Out of the thirteen (13) issues proposed by the Natural Health Products Directorate (NHPD), only two were seen by stakeholders as inadequately described. Due to this, many participants were not able to respond accordingly. These were issues 1.6 (Use of Human Tissue in NHPs) & 5.2 (NHPs Carrying a "for Professional use" Claim). Comments were received regarding the space restrictions that limited the feedback that participants could provide. With that being said, the general feedback received from stakeholders suggests that the consultation was useful and comprehensive.

Section 3: Issue Feedback Briefs

The information detailed in this section was gathered through statistical analysis of stakeholder feedback from the e-consultation.

As noted above, participants of the consultation process had the opportunity to provide feedback on the issues presented in this section, and the opportunity to raise additional issues which were not incorporated in Charting a Course. Further, stakeholders were asked to prioritize and rank issues.

3.1 Feedback Summary

Comments were received for each of the following issues. These issues were categorized into five (5) parts.

Part 1 - Definitions and Product Licences

• Issue 1.1: Compounding of Natural Health Products
• Issue 1.2: Definition of Homeopathic Medicines
• Issue 1.3: Lowest Risk Products
• Issue 1.4: Regulation of Natural Health Products Derived from Fish
• Issue 1.5: Regulation of Personal Care Products
• Issue 1.6: Use of Human Tissue in Natural Health Products

Part 2 - Site Licensing

Part 3 - Good Manufacturing Practices

• Issue 3.1: Inspections for Good Manufacturing Practices

Part 4 - Clinical Trials Involving Human Subjects

• Issue 4.1: Harmonizing Natural Health Product Clinical Trial Requirements with Changes to the Food and Drug Regulations

Part 5- General

• Issue 5.1: Lack of Advertising Regulatory Provisions in the Natural Health Products Regulations
• Issue 5.2: Natural Health Products Carrying a "for professional use" Claim
• Issue 5.3: Clarification of the Extent of the Application of the Natural Health Products Regulations for Types of Natural Health Products Intended for "Self-Care"
• Issue 5.4: Sampling of Natural Health Products to Health Professionals

Part 1 - Definitions and Product Licences

Issue 1.1: Compounding of Natural Health Products

Issue Introduction and Background

Compounding is an activity in which a practitioner mixes or prepares health products (natural, medicinal, etc.) to an exact specification tailored to a patient's needs, and in a desired medium (cream, lotion, gel, drops, capsules, pellets, etc.). Compounding is excluded from the Natural Health Products Regulations (NHPR) by means of the manufacturer definition.

On October 26, 2006, the Natural Health Products Directorate (NHPD) released its newly developed Natural Health Product Compounding Policy to clarify the distinction between the manufacturing and compounding of natural health products (NHPs).

The Aboriginal community has asked for an express exemption in law for Traditional Aboriginal Medicines (TAMs). In keeping with the commitment made in the Regulatory Impact Analysis Statement (RIAS) to the regulations, NHPD will examine the issue of compounding of NHPs.

What We Heard - Part 1, Issue 1.1

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, thirty-nine (39) provided a comment regarding the issue of compounding of NHPs.

Many respondents stated that they were not directly affected by the practice of compounding as it is described in the NHP Compounding Policy.

A majority (59%) of comments expressed concern with some aspects of compounding. The issue most often raised was that compounding should not be excluded from the NHPR. The current exclusion of compounding from the NHPR was cited as a concern by 39% of stakeholders. Although comments varied in content, the basis of most of the arguments was public safety and awareness. In general, comments provided by NHP stakeholders speak to the fact that Health Canada, as the federal body responsible for helping Canadians maintain and improve their health, should regulate all (without exclusion) those who are undertaking the practice of compounding.

Roughly half (51%) of submissions regarding this topic came from within the NHP industry. Also, the majority of comments received from this issue came from Ontario due to the overwhelming proportion of participants from this region. However, it is of note that roughly three quarters (73%) of entries from British Columbia commented on this issue

Those respondents who spoke specifically of Traditional Aboriginal Medicines (TAMs) expressed that Health Canada would have no valid reason to exclude, in law, compounding by practitioners of TAMs without granting the same privilege to practitioners of Traditional Chinese Medicines (TCMs) as well as other groups. Respondents expressed the view that potentially, if Health Canada were to make these exclusions, there would be the possibility that these alternative practitioners may not be regulated within their respective provinces and that the onus of public safety and accountability could fall on NHPD even though Health Canada does not regulate compounding.

Certain respondents feel that the practice of compounding should not be excluded from the NHPR. Also, certain stakeholders advised NHPD to be cautious when considering regulatory exemptions for certain groups.

Issue 1.2: Definition of Homeopathic Medicines

Issue Introduction and Background

The Natural Health Products Directorate (NHPD) has defined homeopathic medicines (HM) in the Evidence for Homeopathic Medicines Guidance Document (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/ehmg-nprh-eng.php). However, the Natural Health Products Regulations (NHPR) do not incorporate this definition.

Concern was expressed regarding the current definition of HM, saying that it is too restrictive, being limited only to those ingredients which are listed in certain recognized pharmacopeias. The NHPD has agreed to review this definition of HM as part of the Natural Health Products Regulatory Review (NHPRR).

What We Heard - Part 1, Issue 1.2

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, thirty-seven (37) provided a comment on the issue relating to homeopathic medicines.

The majority (65%) of the thirty-seven (37) comments provided stated that ingredients which may not be included in the pharmacopeias should be recognized as homeopathic medicines (HMs). However, many participants were in disagreement with expanding the scope of the homeopathic definition to include ingredients not currently listed in recognized pharmacopeias. They pointed out that without proper standards almost anything could be deemed a homeopathic. These stakeholders also expressed their concerns that this poses an efficacy and safety risk for Canadians.

Alternatively, it was suggested by some respondents (37%) that products be deemed homeopathic based on the extent to which they follow the homeopathic procedures for preparation and/or manufacturing as outlined in the pharmacopeias.

The majority of those stakeholders who were in agreement with broadening the definition of homeopathic medicines (HMs) were either health care practitioners (complementary and alternative health care practitioner or other), part of the NHP industry, or an industry association. Conversely, those who disagreed belonged predominantly to the Natural Health Product (NHP) industry.

For the most part stakeholders agreed that Health Canada's current definition of homeopathic medicines (HMs) is too restrictive and that pharmacopeias may not be up to date with today's more advanced or newly developed homeopathic remedies. However, safety issues related to a broader definition of homeopathic medicines was the most frequently discussed concern among stakeholders who were against amending the current definition.

Issue 1.3: Lowest Risk Products

Issue Introduction and Background

The natural health products (NHPs) definition encompasses a broad spectrum of products such as homeopathics and traditional medicines with varying levels of risk.

The Natural Health Products Directorate (NHPD) has developed and implemented measures to facilitate and fast-track the issuance of product licences in recognition of the fact that different levels of evidence are required, depending on the risk profile of the product in question. The NHPD recognizes that certain lowest risk products may not need the level of scrutiny that is currently being applied. Thus, the NHPD is reviewing other models within Health Canada for the evaluation of lowest risk products in order to put forward an appropriate model for Natural Health Products (NHPs). Such a model may entail lowest risk products not requiring pre-market assessment. Regardless, NHPD intends to continue to ensure that the level of scrutiny/oversight of all products is proportional to the risks they pose to the health and safety of Canadians.

What We Heard - Part 1, Issue 1.3

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, sixty-three (63) provided a comment on the issue of lowest risk products.

Of the sixty-three (63) respondents, (55%) stated that lowest risk products are over-regulated in proportion to their risk, or should not require pre-market assessment

Some stakeholders (37%) believe that lowest risk products are not over-regulated and should undergo a pre-market assessment. The majority of participants' comments can be grouped into one (1) of three (3) general categories.

The first category involves the development of the NHPD Compendium of Monographs which allows the NHPD to fast track the review of lowest risk products through the compendial stream. Of the sixty-three (63) stakeholder submissions, fourteen (14) submissions commented specifically on this issue. Eleven (11) comments were received in favour of developing monographs. However, three (3) comments were also received that disagreed with the implementation of the NHPD Compendium of Monographs.

The second category involves the possibility of lowest risk products not requiring pre-market assessment. This specific issue was addressed by twenty-six (26) respondents. Of these respondents, (38%) held the view that lowest risk products should require pre-market assessment, while, (62%) stated that they did not think lowest risk products should be required to undergo pre-market assessment. Within the group that did not think pre-market assessment was needed, some held the position that the pre-market assessment should only be forgone for products that comply with the monographs, while others thought it was not necessary for any low risk products. Of this group, (69%) came from the NHP industry or an NHP industry association.

The third category raised asked whether the level of regulation should be proportional to the risk of a product. This issue was commented on by twenty (20) respondents. From this group of respondents, almost all (95%) held the view that lowest risk products should be regulated according to their risk profile so that the level of scrutiny is proportional to risk. These responses came predominantly from within the NHP industry, NHP industry associations and health care professionals.

In sum, a majority of respondents feel that NHPs are, in some manner, overregulated in proportion to their risk level.

Issue 1.4: Regulation of Natural Health Products Derived from Fish

Issue Introduction and Background

Since Health Canada and the Canadian Food Inspection Agency (CFIA) are both involved in regulating fish-containing materials, the duplicate and often conflicting policies designed by these two organizations have resulted in licensing related challenges for stakeholders. Since Health Canada's Natural Health Products Regulations (NHPR) do not have an inspection component, the Natural Health Products Directorate (NHPD)'s export certificates are not acceptable to many importing countries. This poses a problem for those stakeholders aiming to export fish-containing natural health products, as they often cannot obtain appropriate certification in order to easily export their product.

What We Heard - Part 1, Issue 1.4

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, thirty-six (36) provided a comment on the issue of NHPs derived from fish.

The majority (72%) of the comments stated that stakeholders agreed with amending or harmonizing the CFIA's and the NHPD's protocols in order to eliminate conflicting policies and requirements. This would allow those companies that manufacture fish-based foods and NHPs containing fish by-products to become licensed with minimal difficulty.

Over half (58%) of these respondents suggested creating a joint document for the CFIA and NHPD policies. It was also suggested that the NHPD hand over its inspection processes to CFIA to carry out, at least until such time as the NHPR include an inspection component in order to make NHPD's export certificates acceptable to the importing countries. Another item that was mentioned was that the CFIA should be the official regulating body for all products, whether food or NHP and whether they contain animal or fish materials.

Other suggestions included the following: Health Canada should better harmonize with international governing bodies, such as the European Union (EU), in order to maintain its competitiveness in the global marketplace (8% of comments received), there should be only one export certificate for all countries (4% of comments received), all products carrying a health claim be handled as an NHP by NHPD, while those products not carrying a health claim be classed as a food product and regulated by the CFIA since it has more stringent, internationally recognized guidelines (4% of comments received).

Conversely, (28%) of the responses disagreed with the harmonization of policies, saying that manufacturers should deal with the different policies of the CFIA and NHPD if they intend to export. Within this group of responses, some stakeholders stated that the onus is on companies to decide who they are selling to, and access the appropriate regulatory bodies. Others agreed that the stringent, if somewhat conflicting guidelines would ensure greater product safety; make manufacturers' products more competitive, are satisfactory in their current state; and cannot be altered simply because the NHPD lacks an inspection component.

Stakeholders who were part of an industry association or who were an alternative health practitioner were more likely to agree with amending and minimizing conflict between departmental policies, while those who were consultants, consumers, or health professionals, were more likely to disagree with these proposed changes to the policies.

In general, participating stakeholders are support harmonization between CFIA and NHPD policies and protocols with respect to the regulation of NHPs derived from fish in order to eliminate licensing related challenges.

Issue 1.5: Regulation of Personal Care Products

Issue Introduction and Background

While there is no formal definition for personal care products (PCPs) in the regulations they are generally defined by the cosmetic industry as products which are applied to the surface of the body, hair, nails, teeth and mucosa for the purposes of cleansing, moisturizing, lubricating, beautifying and/or perfuming. Examples of PCPs include, but are not limited to, sunburn protectants, antiperspirants, acne products, toothpastes and medicated skin care products.

In Canada, PCPs can fall under three (3) different regulatory frameworks under the Food and Drugs Act (FDA): the Cosmetic Regulations, the Food and Drug Regulations (FDR), or the Natural Health Products Regulations (NHPR). A product's classification under one of these frameworks is based on its function, purpose, representation for use outlined in the FDA.

Currently, the vast majority (90%) of PCPs sold in Canada are regulated as cosmetics. This issue is of interest to the Natural Health Products Directorate (NHPD) because many of the remaining 10% of products are regulated as natural health products (NHPs). Although these products may resemble cosmetics, products containing natural therapeutic ingredients permitted on Schedule 1 of the NHPR (and not excluded by Schedule 2) which make acceptable therapeutic claims are classified as NHPs.

In response to requests from stakeholders, Health Canada has committed to consider policy and administrative solutions in the short term to the regulation of PCPs to ensure that they are regulated in a consistent manner.

What We Heard - Part 1, Issue 1.5

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, fifty-four (54) provided a comment on the issue of the regulation of personal care products.

A majority (79%) of the comments received agreed that, at the very least, alternative measures for the regulation of PCPs should be jointly discussed by NHPD, the Therapeutic Products Directorate (TPD) and the Healthy Environments and Consumer Safety Branch (HECSB). Only two (2) stakeholders stated that the current regulatory framework affecting PCPs was proving to be adequate. The remaining comments dealt with issues not directly related to the regulation of PCPs. Nearly half (47%) of the comments received for this issue came from within the NHP industry.

For the most part, respondents who felt that there should be joint discussion also had suggestions as to the nature of this alternate framework. The most recurring suggestion was that all cosmetic-like natural health/drug products should be regulated as cosmetics. Half of those suggestions came from NHP industry stakeholders.

Some participants suggested that the framework could be developed in accordance with the model utilized in the European Union (EU), given that Canada is seemingly the only place that regulates PCPs under three regulatory frameworks.

It is of note that not all respondents were in favour of regulatory reform. It was stated by certain stakeholders that the regulations should not be amended simply to be less onerous; and that a common safety standard for NHPs was needed in order to protect Canadians. However, again, the majority of participants agreed that, at the very least, alternative solutions to the issues should be considered.

Issue 1.6: Use of Human Tissue in Natural Health Products

Issue Introduction and Background

According to the Natural Health Products Regulations (NHPR) a natural health product (NHP) that is a homeopathic medicine (HM) or a traditional medicine (TM) may contain human tissue. All other NHPs may contain "non-human animal material." For the purposes of the NHPR, a substance or combination of substances or a traditional medicine is not considered to be an NHP if its sale, under the Food and Drug Regulations (FDR), is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations.

What We Heard - Part 1 - Issue 1.6

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, thirty-five (35) provided a comment on the issue regarding the use of human tissue in NHPs.

The issue can be divided into two (2) sub-issues. The first issue asks whether an NHP that is a homeopathic or a traditional medicine (TM) may contain human tissue. The second sub-issue deals with what substances should be considered NHPs. Fifteen (15) stakeholders responded with comments related to the first issue. The majority (67%) of these stakeholders agreed that human tissue can or should be used for traditional medicines (TMs). The remaining (33%) disagreed.

The second issue deals with whether for the purposes of the NHPR, a substance, combination of substances or a traditional medicine (TM) should be considered an NHP, if its sale, under the FDR, is requires a prescription when it is sold other than in accordance with section C.01.043 of the FDR. Nine (9) stakeholders responded to this particular sub-issue. Of these responses, (67%) agreed that some substances should be required to be sold pursuant to a prescription, while (33%) disagreed.

The majority (55%) of participants either did not comment on the issue or found that the issue did not apply to them. Some (37%) of the respondents commented on the level of clarity on this issue.

Those who did have an interest in the issue generally agreed with the proposition of allowing traditional medicines (TMs) to contain human tissue and that such a product not be considered an NHP if the substance requires a prescription for sale.

Part 2 - Site Licensing

No comments were received on the issue of site licensing.

Part 3 - Good Manufacturing Practices

Issue 3.1: Inspection for Good Manufacturing Practices

Issue Introduction and Background

Good manufacturing practices (GMPs) ensure that natural health products (NHPs) are safe, of high quality and are manufactured, packaged and labelled in a proper manner. Part 3 of the Natural Health Products Regulations (NHPR) sets out the good manufacturing practices that manufacturers, packagers, labellers and importers must meet before the Natural Health Products Directorate (NHPD) will issue a site licence. Manufacturers, packagers, labellers and importers must demonstrate that they adhere to these practices by submitting a quality assurance report (QAR) as evidence of good manufacturing practice (GMP) compliance. The NHPR currently do not require on-site inspections to assess GMP compliance. NHP stakeholders provided feedback on the current GMP provisions as well as the possibility of extending the requirements to include inspections conducted by third party auditors or Health Canada inspectors.

What we Heard - Part 3, Issue 3.1

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, fifty-eight (58) provided a comment on the issue of good manufacturing practices.

The majority (69%) of respondents (predominantly from within NHP industry) disagreed with the idea of adding a GMP inspection component regardless of whether these inspections would be conducted by third party auditors or Health Canada inspectors. Those who did agree, however, were generally from other industries or were health professionals (complementary/alternative health care practitioner or otherwise).

Respondents in favour of third party/Health Canada inspections most frequently cited public safety as the foundation for implementing inspections.

Of those against GMP inspections, opinions varied as to why no additional GMP provisions were required. The most cited argument was simply that the current GMP provisions in the NHPR are adequate and effective. Many of these comments included references to the quality assurance person's (QAP) qualifications, stating that if Health Canada wishes to improve GMP guidelines it should be done by ensuring QAPs are sufficiently qualified. On the other hand, many individuals also stated that the GMP model is adequate as it stands.

The second most recurring theme was in relation to personal care products (PCPs). NHP stakeholders question the fact that PCPs are not regulated as NHPs anywhere else in the world. Comments declared that for the PCP sector, which is international in scope, consistency in GMP requirements between cosmetics and NHPs is essential.

One other frequently raised issue is the financial impact that could potentially follow the implementation of inspections. The perceived cost of adding third party or Health Canada inspections to the regime was noted as a concern by many in the NHP industry. Additionally, many complementary and alternative health professionals expressed concern that the business of traditional medicine would be prohibitively expensive if every herbal medicine had to go through costly GMP analyses.

In general, the majority of participants would not be in favour of adding an inspection component to the NHPR. Reasons range from cost issues to the concern that it is an added regulatory burden.

Part 4 - Clinical Trials Involving Human Subjects

Issue 4.1: Harmonizing Natural Health Product Clinical Trial Requirements with change to the Food and Drug Regulations

Issue Introduction and Background

Sections in the Natural Health Products Regulations (NHPR) addressing clinical trials are not consistent with Division 5 (clinical trial provisions) in the Food and Drug Regulations (FDR). This may cause confusion for applicants who are trying to meet standards of both regimes. Division 5 of the FDR is currently under regulatory review and some of the changes to Division 5 of the FDR may be driven by the progressive licensing framework (PLF). Changes resulting from the regulatory review, once finalized, may need to be applied to Part 4 of the NHPR, where appropriate, to ensure consistency. Consequently, it may not be appropriate to apply all current Division 5 requirements to Part 4 of the NHPR until the two reviews are complete.

What we Heard - Part 4 - Issue 4.1

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, forty-five (45) provided a comment on the issue of harmonizing the Natural Health Products Regulation's (NHPR)'s clinical trial (CT) requirements with the changes to the FDR.

The comments received can be generally broken down as (53%) who agreed with harmonizing, (27%) who disagreed, and (20%) who felt that the reviews of the CT and the Progressive Licensing Framework (PLF) must be completed before requirements are given.

Of the (53%) that favoured the harmonization of the CT requirements, the majority did so with certain conditions and qualifications. The caveats included the recognition of the different nature of NHPs and drugs and that these differences need to be reflected in the regulations, that a rigorous scientific process be used, and that the harmonization should not result in a reduction of current standards. Many of the respondents felt that they had to reserve judgement until the reviews for both branch wide initiatives (the Clinical Trial Regulatory Review and PLF) were complete or until additional information, such as the impact of changes and why changes are necessary, is available.

A few four (4) of the forty-five (45) respondents argued that the cost of CT would be a problem for the NHP industry given their inability to patent their products due to the lack of exclusivity or patent protection for NHPs. Suggestions on dealing with this problem included phasing in the CT requirements for NHPs or Health Canada providing the NHP industry with more institutional and financial support.

Of the respondents that showed disapproval of harmonizing the NHPR CT requirements with those set out in the FDR, (92%) of the respondents did so for reasons relating to the difference between the nature and risk of drugs and NHPs. A recurring comment was that the regulations should be proportional to the risk of the product, and since drugs pose greater risk than NHP, the latter should not have to conform to the same CT standards. Half of respondents who held this opinion came from the NHP industry.

Overall, the vast majority of respondents believe that there should be consistency between NHPR CT requirements and the changes made to the FDR, but that harmonization should be done taking into account the unique regulatory nature of NHPs and be proportional to their level of risk.

Part 5 - General

Issue 5.1: Lack of Advertising Regulatory Provisions in the Natural Health Products Regulations

Issue Introduction and Background

Although the Food and Drugs Regulations (FDR) contains specific provisions with respect to the advertising of drugs, the Natural Health Products Regulations (NHPR) do not contain any specific advertising provisions. For example, the FDR states that only products for which the terms of market authorization have been established can be advertised in Canada; however, the NHPR does not explicitly state that the advertising of Natural Health Products (NHPs) cannot occur until a product licence has been issued.

What We Heard - Part 5, Issue 5.1

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, forty-four (44) provided a comment on the issue of advertising provisions in the NHPR.

The participating stakeholders were divided on this issue, (51%) agreed that the NHPR should prohibit advertising of products that are not yet licensed. The most frequently cited reason was the necessary elimination of products with unfounded health claims from the market (38% of those who agreed with prohibiting advertising).These respondents also commented on the NHPR's current level of comprehensiveness in regards to advertising. The feedback from respondents suggests that there is a consensus among respondents that the issue of advertising of NHPs was unclear and required revision.

Some suggestions on this matter included: clarifying the advertising conditions in the NHPR, explicitly prohibiting direct-to-consumer advertisements as is the current policy regarding the advertisement of drugs, clarifying the definition of 'advertising' in the NHPR, and explicitly stating that the advertising of NHPs that are already holding a licence is permitted.

The other (49%) of respondents disagreed. These stakeholders stated that they felt that the current regulations do not need alteration and that the NHPR should not include provisions for advertising.

Of those who commented on this issue, (25%) believed that until the product licensing backlog is resolved, companies awaiting a product licence should be allowed to advertise. This argument was supported by two separate rationales: (a) most businesses cannot wait for a natural product number (NPN) before they start advertising a product, and (b) there should not be any safety issues with advertising the product prior to market authorization since the product is not yet available to the public.

Of the (49%) of comments that responded negatively towards adding advertising provisions in the NHPR, half were complementary health care practitioners, or were from NHP industry or industry associations.

In sum, respondents were nearly equally divided on the issue of advertising. (51%) of responses stated that the NHPR should prohibit advertising of unlicensed products while (49%) of responses directly disagreed with this argument.

Issue 5.2: Natural Health Products Carrying a "for Professional use" Claim

Issue Introduction and Background

Since adopting all of the Therapeutic Products Directorate (TPD) labelling standards and Category IV Monographs for products that meet the definition of a natural health product (NHP), the Natural Health Products Directorate (NHPD) has encountered products bearing a "for professional use" claim on their labels. It must now be determined whether the NHPD should be responsible for licensing NHPs carrying the "for professional use" indication.

What We Heard - Part 5, Issue 5.2

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, twenty-seven (27) provided a comment on the issue of NHPs carrying a "for professional use" claim.

Some stakeholders expressed some extent of confusion with this issue. These stakeholders felt that the issue was not adequately comprehensive and they could not think of any context other than toothpaste that the "for professional use" claim would be an issue. Otherwise, the general consensus was that the Natural Health Products Regulations (NHPR) are designed to regulate NHPs intended both for self-care and general use.

Respondents generally stated the following regarding the "for professional use" indication (percentages are taken from those who responded to this issue):

• a trained health professional would be required for administration of the product (15%),
• products carrying a "for professional use" claim should not be used for self-care (22%),
• those products intended for self-care should not carry the "for professional use" claim (19%),
• labelling should be more detailed in order to explain the risks of use and how to use the product safely (15%),
• the NHPD should maintain TPD's labelling standards if those standards had previously been effective in regulating these same products before their transfer over to the NHPR (19%).

Furthermore, it was suggested that if products labelled "for professional use" can be used safely both by consumers and professionals then the NHPR should not prescribe additional labelling requirements as this would only create concern and confusion for the general public.

Most stakeholders either did not feel that this issue was relevant to them or did not comprehend the issue sufficiently. The majority of stakeholders who responded however seem to feel that products deemed "for professional use" should not be used for self-care but by a trained health professional.

Issue 5.3: Clarification of the Extent of the Application of the Natural Health Products Regulations for Types of Natural Health Products Intended for "Self-Care"

Issue Introduction and Background

There is a need to clarify the scope of the Natural Health Products Regulations (NHPR) for the treatment of natural health products (NHPs). Although the NHPR was intended to regulate products deemed suitable for self-selection and "self-care", this policy intent has not been captured or stated explicitly in the provisions of the NHPR. It has been proposed that the NHPR be amended to clarify that they only address those NHPs which are suitable for self-selection and self-care, thereby excluding those products which require the intervention of a health care provider.

What We Heard - Part 5, Issue 5.3

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, forty-one (41) provided a comment on the issue of self-care.

Of those who responded, (59%) stated that the NHPR should explicitly state that it only regulates natural health products intended for self-care, not those intended for use under the guidance or supervision of a trained health professional.

(36%) of those who commented disagreed with the proposal to explicitly limit the scope of the NHPR to self-care products. Many of these stakeholders felt that "self-care" should not be the defining criterion in determining what is regulated under the NHPR. Also, stakeholders were unsure how non-self-care products would be regulated, if not under the NHPR.

Of the respondents belonging to the NHP Industry, (80%) agreed with amending current regulations to more explicitly state its intent to regulate only products intended for self-care. No consumers, consultants or members of industry associations expressed concern over limiting the scope of the NHPR to self-care products exclusively.

Generally, stakeholders showed support for the NHPR explicitly stating that it only regulates products intended for self-care.

Issue 5.4: Sampling of Natural Health Products to Health Professionals

Issue Introduction and Background

Currently, the Natural Health Products Regulations (NHPR) do not include any guidelines for the distribution of natural health product (NHP) samples. Section 14(1) of the Food and Drugs Act (FDA) prohibits sampling, while Section 14(2) creates an exemption to the prohibition in Section 14(1) which essentially permits sampling to certain health professionals under prescribed conditions, which are defined in the FDR. No similar conditions exist within the NHPR and it has been proposed that provisions consistent with the FDR be included in the NHPR.

This issue contains two key questions:

• Should the NHPR be revised to include provisions that allow sampling of NHPs to health professionals in general?
• Should these changes to the NHPR be consistent with FDA provisions that permit sampling of prescription and non-prescription drugs to certain health professionals under prescribed conditions?

What We Heard - Part 5, Issue 5.4

The following feedback was received during the Natural Health Products Regulatory Review (NHPRR) e-consultation.

Of the seventy-seven (77) consultation participants, thirty-four (34) provided a comment on the issue of sampling.

Regarding whether or not the NHPR should contain provisions that permit sampling of NHPs to health professionals, (80%) of the thirty-four (34) comments received commented specifically on this point, with almost all (98%) indicating that sampling of NHPs to health professionals should be allowed.

With respect to amending the NHPR to make it consistent with the FDR's provisions on sampling of prescription and non-prescription drugs to health professionals, (56%) of the thirty-four (34) participants responded to this issue, with a majority (80%) suggesting that the NHPR should be made consistent with the sampling provisions of the FDR.

A third issue which arose in the responses, but which was not actually in the Issue Summary, was extending the provisions that permit sampling to include direct-to-consumers sampling.

Overall, it appears that the vast majority of respondents believe that the NHPR should contain provisions that allow the distribution of NHP samples to health professionals.

3.2 Issue Priority Rankings

Respondents were given the opportunity to prioritize the issues presented in Charting a Course by listing their top five (5) priorities (see Figure 3). The top three (3) priorities listed by participants (in order) were Issue 1.3 - Regulation of lowest risk products, Issue 1.5 - Regulation of personal care products and Issue 3.1 -Good Manufacturing Practices.

High priority ranking did not necessarily imply disagreement with an issue. For instance, thirty-four (34) stakeholders flagged Issue 3.1 (GMPs) as important. Half of those stakeholders agreed with the proposed additions to GMP requirements while half disagreed with adding an inspection component.

Highest ranked priorities for participants

1) Lowest Risk Products

Of the thirteen (13) issues that stakeholders were asked to rank, the issue most frequently cited as highest priority was 'lowest risk products'. Stakeholders commented that natural health products (NHPs) are generally of low risk to the consumer and that regulations surrounding lowest risk products should be proportional to their risk levels. The most common rationale participants provided for ranking this issue as their top priority was that they deemed it important to resolve applications for low risk products quickly in order to minimize the time required to issue product licences. It was also suggested that regulating NHPs in proportion to the level of risk they present would be a means of focusing on the higher risk products and thereby aiding in alleviating the pressure on the NHPD backlog.

2) Personal Care Products

Ranked by NHP stakeholders as the second highest priority overall was Issue 1.5, the regulations applicability to personal care products (PCP). The regulations, with regards to PCPs, were said to be unclear, inconsistent and in need of revision. Some respondents suggested that one set of regulations should be administered under a single Health Canada Directorate for cosmetics, cosmetic-like drugs and cosmetic-like NHPs. The rationale provided for this feedback was that the different regulatory frameworks used in Canada for cosmetic-like products compared to the regime in the European Union (EU) pose significant challenges on the industry's ability to market products in Canada.

3) Good Manufacturing Practices

Many respondents ranked Issue 3.1, Good Manufacturing Practices (GMP), as a high priority on the basis that it affects all stakeholders. It was also stated that there is currently a greater regulatory burden for NHPs than some Category 4 drugs regulated under the Food and Drug Regulations (FDR) which shows that NHPs are not currently being regulated in proportion to the level of risk they present.

Figure 3 describes the frequency of priority votes for each issue.

3.3 Comments on Various Additionally Raised Issues (see Appendix B for full listing)

In this section the three (3) most recurring themes that were not identified in Charting a Course but subsequently cited as additional issues by respondents are discussed.

Overregulation of Product Licensing

There were numerous issues raised by participants regarding product licensing. These comments focused more on the implementation of the NHPR than on the regulations themselves. Primarily, the most repeated argument was that the regulatory requirements surrounding product licensing should be proportionate to the risk of the product. Also, it seems that the majority of respondents feel that the product licence application (PLA) process is simply too extensive. Certain participants provided suggestions as to how this process could be shortened. More then one participant suggested that the NHPD remove the finished product testing specifications for the PLA process entirely. They are also seeking a change with regard to products that already have a Drug Identification Number (DIN) that are applying for a NHP product licence. Different respondents cited the "grandfathering of DIN products" as a high priority reform. With regard to time, stakeholders suggested a transitional DIN review period that would cover no longer then 60 days (for products looking to obtain a product licence).

Natural Health Product/Food Interface

This issue was identified under Chapter 4 (Short Term Action Plan) of the Charting a Course paper and was not one for which stakeholder feedback was explicitly sought. The nature of the feedback from participants was that the overlap is unclear and causes licensing issues among other problems. It is generally felt that similar (or identical) products should be regulated in the same way and under the same regime. Respondents who did not have specific arguments cited that it only makes sense to have similar products regulated in a similar fashion. Certain stakeholders would not support regulations that did not allow food-like NHPs that are now classified as NHPs to retain this designation. The argument here was that if a product has beneficial effects on the human body then it should be able to advertise itself as such because of its safety and efficacy.

Security Packaging

Several respondents believe that current security packaging requirements are not proportional to risk. The participants who made note of this issue expressed the opinion that the extensive security packing requirements are inappropriate due to the quality control testing that already deems NHP product to be safe.

Conclusions and Next Steps

The online consultation was successful in providing natural health product stakeholders with the opportunity to offer input on issues surrounding the Natural Health Products Regulations.

Overall, there were seventy-seven (77) respondents to the consultation with seven hundred (700) individual comments. Respondents included professional associations, consumer advocacy groups, industry representatives and individual natural health product consumers. Twenty-three (23) of these responses were from associations representing the interests of over three thousand (3000) members including: individual members of industry, other associations, practitioners, scientific interest groups and patient groups.

Feedback from the consultation showed strong support for the interactive review process. By including stakeholders in the process, the Natural Health Products Directorate (NHPD) has welcomed and encouraged stakeholders to be involved in the review process as well as to familiarize themselves with the review and regulatory policy issues that Health Canada has proposed to address.

Health Canada is proceeding with the analysis of the comments received during the consultation and the input is being used to develop options. Health Canada is confident that the Review will contribute to the continued growth and refinement of an appropriate framework that is flexible, effective and sustainable for the regulation of these products into the 21st century.

The NHPD is presently working to address many of the issues raised during the consultation through a combination of operational, policy and regulatory program adjustments. The single largest issue raised by stakeholders concerned regulating natural health products proportional to their risks and addressing the NHPD's review backlog.

Many of the issues raised by stakeholders are being addressed through the NHPD's new Risk Based Approach (RBA). This approach is intended to better leverage existing information regarding product risks and efficacy in a manner that will allow products that have long established histories of safe use to undergo quicker review processes. This will enable review resources to focus upon products of higher relative risk or where little information is known. This approach is intended to refine the natural health product regulatory program to better reflect the unique risk profile of the products while at the same time addressing the majority of the specific issues raised during the consultation. Likewise, the NHPD has begun examining its approach to site licensing and good manufacturing practices (GMPs) to better meet the needs of Canadians and stakeholders.

Under the RBA, the NHPD will be examining modifications to both product licensing and site licensing requirements to better account for the relative level of risk. Likewise, compliance and enforcement activities and adverse event reporting will be addressed to better concentrate on higher risk products and those non-compliant products which pose the greatest relative risk to the health of Canadians.

While it is anticipated that the majority of the issues raised during the consultation will be dealt with through the RBA, the NHPD is also working to address additional issues raised during the review.

Appendix A - List of Participant Organizations

Note: Only those who disclosed their organization are included in this list

• A. Lassonde Inc.
• Ag-West Bio Inc.
• Alberta Association of Naturopathic Practitioners
• Avon Canada
• Bio Lonreco Inc.
• BioMedEx
• Canadian Association of Naturopathic Doctors
• Canadian Cosmetic, Toiletry and Fragrance Association
• Canadian Diabetes Association
• Canadian Health Food Association
• Centre for Science in the Public Interest
• Colgate-Palmolive
• Consumer Healthcare Products Association
• Cover FX Skin Care Inc
• Dairy Processors Association of Canada
• Dicentra Inc
• Direct Sellers Association
• Ecolab
• Estée Lauder Companies
• Food & Consumer Products of Canada
• ICS Inc.
• International Chewing Gum Association
• IRI Separation Technologies Inc.
• Jamieson Laboratories
• JAS Consulting
• Lise Watier Cosmetics
• Manitoba Pharmaceutical Association
• Marmaved Inc.
• National Association of Pharmacy Regulatory Authorities
• Non-prescription Drug Manufacturer Association of Canada
• Nova Scotia College of Pharmacists
• Pepsi-QTG Canada
• Procter & Gamble Inc.
• Provincial Government Of British Columbia
• Puresource Inc.
• Québec Association of Rheumatologists
• Quixtar Canada Corp
• Refreshments Canada
• Shaklee Canada Inc.
• Siebert Consulting
• SPACEPOL Government Policy Consulting
• Spectrum MMC
• TallGrass
• The Herb Works
• Whitefish Group

Appendix B - Additional Issues: Stakeholder Identified Issues

Reoccurring themes stated by stakeholders (with number of comments):

• NHP/Food Interface (13): Simply, stakeholders stated that the overlap is unclear and causes licensing issues among other problems.
• Security packaging (8): Stakeholders stated that the extensive security packing requirements are inappropriate due to the quality control testing that already deems the product to be safe.
• Overregulation of ingredient disclosure, reporting of adverse effects, and testing specifications (6): Some stakeholders feel that there is overregulation in these areas.
• Transitional DIN review (5): Transitional DIN to NHP submissions should have a review default period of 60 days.
• Risk proportion product licensing (4): stakeholders argued that the regulatory requirements surrounding product licensing should be proportionate to the risk of the product
• Small package labelling (3): Small package labelling requirements are too onerous.
• Quality assurance (QA) person's education requirements (3): The internal QA person should be qualified by NHPD as having adequate authority to write a quality audit report by showing proof of training and/or qualification.
• Veterinary NHPs (2): Veterinary NHPs should be included in the NHPR.
• Frequency of site licence renewals (2): The initial frequency of SL renewals is too much.
• Additional issues referred to once:
• Market exclusivity and data protection for 3 years
• NHP advertising claims inconsistent with Schedule A of FDA
• Product licence application process to lengthy
• NHP definition too broad
• Importing product policy unclear
• Evidence for safety and efficacy claims list update
• Ensure consistent amounts of active ingredients
• Coordination of best practices internationally (emphasis on Canada-EU cooperation)
• Government must ensure availability of NHP practitioners in heath care system
• Add NHPs National Formulary and implement structure to allow access of free/discounted NHPs to low-income individuals)
• Sterile-injectible Homeopathic Medicines should be eligible for product licensing
• Biologics should only be regulated by Biologics and Genetics Therapies Directorate (BGTD)
• NHPD should commence GMP training Certification Program
• Remove requirement for pre-approval of compendial product licence applications and change notification procedure.
• Need for evidence of efficacy before advertising
• Update non-medicinal ingredient list
• Remove section 22 of NHPR (Site information requirements)
• Do not eliminate sale of bulk NHPs

Appendix C - Acronyms

BGTD: Biologics and Genetics Therapies Directorate
CFIA: Canadian Food Inspection Agency

CT: Clinical Trial

DIN: Drug Identification Number
EU: European Union
FDA: Food and Drugs Act
FDR: Food and Drug Regulations
GMP: Good Manufacturing Practices
HECSB: Healthy Environments and Consumer Safety Branch
HM: Homeopathic Medicine
HPFB: Health Products and Food Branch
NHP: Natural Health Product
NHPD: Natural Health Products Directorate
NHPR: Natural Health Products Regulations
NHPRR: Natural Health Products Regulatory Review
NPN: Natural Product Number

PCP: Personal Care Products

PL: Product Licence
PLA: Product Licence Application
PLF: Progressive Licensing Framework
QAP: Quality Assurance Personnel

RIAS: Regulatory Impact Analysis Statement
TAM: Traditional Aboriginal Medicine
TCM: Traditional Chinese Medicine
TPD: Therapeutic Products Directorate