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Drugs and Health Products

Health Products and Food Branch Inspectorate - Natural Health Products Compliance and Enforcement Policy (POL-0044)

Health Product and Food Branch Inspectorate

The Inspectorate is responsible for branch-wide compliance and enforcement activities, enabling consistency of approach across the spectrum of regulated products. The Inspectorate core functions are compliance monitoring, and compliance verification and investigation, supported by establishment licensing of drugs and medical devices, and laboratory analysis.

  • Supersedes:
    Natural Health Products Compliance and Enforcement Policy (August 27, 2010)
  • Date issued:
    August 29, 2014
  • Date of implementation:
    September 1, 2014

Disclaimer

This document does not constitute part of the Food and Drugs Act (FDA) or its associated Regulations. In the event of any inconsistency or conflict between the FDA or its associated Regulations and this document, the FDA or its associated Regulations take precedence. This document is an administrative document intended to facilitate compliance by the regulated party with the FDA, its associated Regulations and the applicable administrative policies.

Table of Content

1.0 Purpose

The purpose of this Policy is to further describe to regulated parties the compliance approach outlined in the Inspectorate's Compliance and Enforcement Policy (POL-0001) as it relates to NHPs to support a transparent, consistent and predictable compliance and enforcement approach.

It is recommended that this document be consulted in conjunction with POL-0001.

2.0 Background

The Natural Health Products Regulations (NHPR) came into force on January 1, 2004 and provided a regulatory framework for NHP separate from biologic and pharmaceutical drugs. The NHPR fall under the Food and Drugs Act (FDA), and as such, NHPs are legally considered to be drugs in regards to the FDA. The FDA and the NHPR apply to all NHPs as defined in the NHPR and they set out requirements for the manufacturing, packaging, labelling, importing, storing, distributing, selling and advertising of NHPs.

Within Health Canada, the NHPR are administered by the Natural Health Products Program which is comprised of the Natural and Non-prescription Health Products Directorate (NNHPD), the Marketed Health Products Directorate (MHPD) and the Health Product and Food Branch Inspectorate (the Inspectorate).

3.0 Scope

This policy covers the Inspectorate's compliance and enforcement approach with respect to NHPs, excluding those used in clinical trials.

4.0 Policy

4.1 Policy Statement

Every person that conducts an activity subject to the FDA and/or the NHPR is expected to comply with the FDA and NHPR.

Any person that conducts an activity or sells an NHP in contravention of the FDA and/or NHPR may be subjected to compliance and enforcement actions.

4.2 Roles and Responsibilities

Regulated Party

Regulated parties that sell, manufacture, package, label, import, distribute or advertise NHPs in Canada are responsible for ensuring that the activities they conduct and the products they sell comply with the FDA and the NHPR. Regulated parties that market NHPs also have the primary responsibility for the safety of any NHP they sell.

In addition, product licence holders have the responsibility for the post market monitoring adverse reaction reports and complaints. This includes reporting all recalls to Health Canada as well as submitting a case report for each Canadian serious adverse reaction and foreign and Canadian unexpected serious adverse reaction.

Additional information about recall reporting can be found in the HPFBI Recall Policy (POL-0016) and additional information about reporting adverse reactions can be found in Health Canada's Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products.

The Inspectorate

The Inspectorate's mandate with respect to NHPs is to manage and deliver a national compliance and enforcement program for natural health products, collaborating with and across, all regions. The role of the Inspectorate is to:

  • Take appropriate action to encourage, monitor and induce compliance and
  • Inform Canadians of the risk posed by non-compliant products.

It is the Inspectorate's responsibility to conduct its compliance and enforcement activities in accordance with the law, policies and guidance documents and in a consistent manner.

4.3 Core Activities

In order to meet its mandate, the Inspectorate relies on 3 core activities for the compliance and enforcement of NHPs: Compliance Generation; Compliance Monitoring; and Risk Mitigation. The 3 core activities are complementary and may be used in combination for greater impact. The selection of compliance activities is made in accordance with this policy's guiding principles (section 4.4).

Compliance generation activities are focused on generating compliance throughout the supply chain. When conducting compliance generation activities, the Inspectorate provides regulated parties with the necessary information they need to understand the regulatory requirements, their compliance status or other relevant compliance information they need in order to be compliant. Such activities could include:

  • The publication of standards, policies or guidance;
  • Awareness or education campaigns (e.g. Fact Sheet, Q&A);
  • Transparency initiatives (e.g. posting of compliance reports);
  • Issuance of compliance letters (e.g. letter informing regulated parties of their compliance status).

Compliance monitoring activities consist of any actions taken by the Inspectorate to record, gather, obtain or analyse compliance information. Such activities could include:

  • The receipt of consumer and trade complaints;
  • Compliance verification;
  • Product sampling and testing;
  • Compliance monitoring projects and compliance surveys (e.g. retailer survey);
  • Monitoring the implementation of risk mitigation or corrective actions;
  • Analysing trends in compliance information;
  • Triage.

Risks mitigation activities consist of any actions taken by the Inspectorate to evaluate and mitigate the risks posed by identified non-compliance and/or to achieve compliance with the regulations. Such activities could include:

  • Evaluating the regulated party's assessment of the risks, risk mitigation strategy and/or corrective actions;
  • Requesting corrective actions from the regulated party and/or risk mitigation measures including voluntary stop sale and/or recall;
  • Taking enforcement action to mitigate the risks and/or correct the non-compliance including regulatory stop-sale, public communications and seizure.

4.4 Guiding Principles

This policy is founded on the principles contained in the Inspectorate's Compliance and Enforcement Policy (POL-0001). Risk management principles are guided by Health Canada's Decision Making Framework. These include:

  • The health and safety of Canadians is the highest priority of Health Canada.
  • The level of risk generally determines the extensiveness and timeliness of the risk mitigation actions the regulated party is expected to take.
  • The Inspectorate works collaboratively with regulated parties, to the extent possible, to achieve compliance and to mitigate risks.
  • The Inspectorate uses the most appropriate level of intervention and compliance tools proportional to the risks posed and in consideration of other factors, including the likelihood of achieving compliance (e.g. compliance history, intent and degree of cooperation).
  • Compliance actions are generally targeted at the regulated party responsible for the non-compliance at the highest level of the supply chain for greatest impact and efficiency.

5.0 Approach to Non-compliance

The Inspectorate uses compliance monitoring activities to discover situations of non-compliance. These situations are then triaged based on risk and other factors such as compliance history. Triage determines compliance verification priorities in cases where compliance has not yet been confirmed as well as risk mitigation priorities for confirmed non-compliance. More detailed information regarding risk mitigation activities is available in section 6.0.

The Inspectorate records information gathered via compliance monitoring and risk mitigation activities, and uses trending and analysis to identify proactive compliance monitoring and compliance generation priorities.

Proactive compliance monitoring priorities may be determined based on various factors which may include: a high volume of complaints; an increase in occurrence of a non-compliance; the level of risk; the need to measure the outcome of compliance generation activities; or the need to better understand how to generate compliance.

Compliance generation priorities may be determined based on various factors which may include Departmental priorities, the spread and the risk posed by a particular issue or non-compliance. While compliance generation activities are not limited to low risk situations, low risk situations are generally more likely to be addressed via compliance generation activities rather than via risk mitigation activities.

6.0 Risk Mitigation Activities

To foster transparency, predictability and consistency, this section exclusively discusses the actions that can generally be expected from the Inspectorate when a situation is determined to require risk mitigation activities.

It is important to note that requesting a stop sale is usually the minimum action taken by the Inspectorate when conducting risk mitigation activities. As mentioned in the guiding principles of this policy, the health risk as well as other factors from POL-0001 such as the likelihood of achieving compliance, compliance history of the regulated party, intent and degree of cooperation offered may influence the actions taken by the Inspectorate and result in different actions than described below.

As described below, the most common tools used by the Inspectorate to mitigate health risks are requests to stop sale and/or recall and public communications. However, other tools and authorities are available to the Inspectorate when necessary. A list of compliance and enforcement tools and authorities available to the Inspectorate is available in POL-0001.

Note about Retail

When conducting risk mitigation activities at the distributor or retailer level, the Inspectorate may request that the distributor or retailer remove the non-compliant product from sale. However, the focus of the Inspectorate is to identify the responsible party at the highest level of the supply chain. To that end, the distributor or retailer may be requested, under the authority of FDA Section 23(3), to provide the inspector with the name and address of the supplier of the product. If the retailer directly imports the product for sale, the retailer is considered and is treated as the importer of the product.

6.1 Counterfeit Products

6.1.1 Regulatory requirement

Counterfeit NHPs are non-compliant products under the FDA and the NHPR. Specifically, the following section of NHPR or FDA may apply:

  • Section 4 of the NHPR prohibits the sale of any NHP without a valid product licence.
  • Section 9 (1) of the FDA prohibits the sale of any NHP in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

6.1.2 Risk Mitigation Strategy

When a product is confirmed to be counterfeit, the Inspectorate requests a stop sale and a recall of the product. Additional actions, including the issuance of a public communication and sharing information with other regulatory authorities, may also be taken.

For more information about the approach to counterfeit products refer to the Policy on Counterfeit Health Products (POL-0048).

6.2 Products labelled and/or advertised with a Schedule A claim

6.2.1 Regulatory requirement

As per section 3 of the FDA and section 103.2 of the NHPR, an NHP cannot be advertised for the treatment or cure of diseases listed in Schedule A of the FDA including on its label. Diseases listed in Schedule A of the FDA, such as cancer and diabetes, all require medical intervention. The use of products through self-medication for serious diseases may result in harm to the consumer. Next link will take you to another Web site The complete list of schedule A diseases can be found in the FDA.

Products with a statement for the treatment or cure of diseases listed in Schedule A on their label are deemed to be in contravention of section 3 (2) of the FDA.

6.2.2 Risk Mitigation Strategy

Schedule A: Label

When an NHP labelled with a statement for the treatment or cure of diseases listed in Schedule A is identified, the Inspectorate may request a stop sale and recall of the non-compliant NHP. Additional actions including the issuance of a public communication may also be taken.

Schedule A: Advertising

When NHP advertising with a statement for the treatment or cure of diseases listed in Schedule A is identified, the Inspectorate may request that the person responsible for the advertising immediately cease the advertising activities. Additional actions including the issuance of a public communication may also be taken.

6.3 Product does not meet its specifications, is contaminated or adulterated

6.3.1 Regulatory Requirements

Specification

As per section 43 and 44 of the NHPR, to be legally sold in Canada, every NHP available for sale must comply with the specifications approved by the NNHPD for the licensed product. Specification requirements include a list of tests to ensure the labelled ingredients are in the product at the amount indicated on the label. It also includes a list of tests to ensure that the level of various contaminants do not exceed acceptable limits. Products that do not comply with their approved specification may result in different levels of risk.

Contamination and/or Adulteration

Contaminated or adulterated NHPs cannot be legally sold in Canada. Specifically, the following section of the Food and Drug Regulations (FDR), NHPR or FDA may apply:

  • Section 13 of the NHPR prohibits the sale of any NHP containing any amount of a medicinal ingredient that was not authorised under section 7a) of the NHPR.
  • Products contaminated or adulterated with a non-NHP ingredient, such as any ingredient listed on Schedule 2 of the NHPR, a prescription drug or other, are not considered NHPs. In most cases these products will meet the definition of a drug and require a DIN to be legally sold in Canada as per section C.01.014 of the FDR.
  • Section 8 of the FDA prohibits the sale of an NHP that is either adulterated or was exposed to conditions that might contaminate it with dirt or filth, or rendered it injurious to health.

6.3.2 Risk Mitigation Strategy

Specification

When an NHP that does not meet its specification is identified, the Inspectorate may issue a request to stop the sale of the affected products. Additional actions including a request to recall the product and the issuance of public communications may also be taken.

Contamination and/or Adulteration

The Inspectorate will address contamination and adulteration situations on a case by case basis as the risk profile of the various contaminants or adulterants that may be found in an NHP may vary. The Inspectorate may request that the manufacturer and/or importer stop selling the product and additional actions including a request to recall the product and the issuance of a public communication may also be taken.

Products either represented or licensed as NHPs that are contaminated or adulterated with a non-NHP ingredient, and meeting the definition of a drug will be subject to the Drug Identification Number (DIN) Enforcement Policy (POL-0040) and will be treated as unauthorised drugs.

In accordance with the precautionary principle approach, when a contaminant or adulterant in an NHP is confirmed, but information with respect to the contaminant quantity or concentration is not yet available, the actions taken by the Inspectorate will be proportional with the potential risk posed by the product. To that end, if a contaminant or adulterant poses a low risk at a low dose but could cause significant adverse health effects at a higher dose, the lack of certainty surrounding the quantity of the contaminant or adulterant will not be used as a reason to delay preventive precautionary risk mitigation measures.

6.4 Unlicensed products sold and/or imported for sale

6.4.1 Regulatory requirement

As per section 4 of the NHPR, all NHPs require a product licence to be legally sold in Canada. A product licence demonstrates that required information has been submitted to Health Canada and has been assessed and deemed sufficient to support the safety, efficacy and quality of the product and that the issuance of the licence is not likely to result in injury to the health of the consumer.

For more information regarding product licensing, refer to the Product Licensing Guidance Document.

6.4.2 Risk Mitigation Strategy

When an NHP that is being sold without a product licence is identified, the Inspectorate may request that the manufacturer and/or importer stop selling the unlicensed product. Additional actions including a request to recall the product and the issuance of a public communication may also be taken.

In cases where an NHP is being represented as a non-NHP and an Inspector finds reason to believe that the product is an NHP, the responsible party may be notified and made aware of the applicable Regulations. Compliance actions including the issuance of a request to stop sale and/or recall the products and the issuance of a public communication may also be taken.

Compliance and enforcement activities related to the importation of NHPs are administered in accordance with the Import and Export Policy for Health Products (POL-0060). Commercial shipments of NHPs imported into Canada without a product licence will be recommended for refusal at the border when identified.

6.5 GMP Violations and Unlicensed sites conducting licensable activities

6.5.1 Regulatory requirement

Site Licencing

As per section 27 of the NHPR, manufacturers, packagers, labellers and importers are required to hold a valid site licence. A site licence indicates that the required documentation was submitted to Health Canada in a site licence application to demonstrate that the activities being conducted at the site are being conducted in accordance with Good Manufacturing Practices (GMPs), as outlined in Part 3 of the NHPR.

For more information on site licensing, refer to the Site Licensing Guidance Document.

Good Manufacturing Practices

Part 3 of the NHPR sets out the requirements for GMPs. As per section 43 of the NHPR, all NHPs must be manufactured, packaged, labelled, imported, distributed and stored in accordance with GMPs. GMPs are designed to support an effective overall approach to product quality control and risk management. They do so by setting appropriate standards and practices for places, people, processes and products. GMP violations may adversely affect the quality of the products and may result in different levels of risk. Further information can be found in the Good Manufacturing Practices Guidance Document.

6.5.2 Risk Mitigation Strategy

Site Licencing

When a site conducting licensable activities without a site licence is identified, the Inspectorate may request that the licensable activity cease until such a time that a site licence is obtained or updated.

Compliance and enforcement activities related to the importation of NHPs are administered in accordance with the Import and Export Policy for Health Products(POL-0060). Commercial shipments of NHPs imported into Canada where the importer is without the required site licence or where the foreign manufacturing site is not listed on the Importer's site licence will be recommended for refusal at the border when identified.

Good Manufacturing Practices

The Inspectorate will address products manufactured pursuant to GMP non-compliance, including the lack of a site licence, on a case by case basis as the level of risk will vary based on the specifics of each situation. Therefore, the Inspectorate may request that the manufacturer, importer, packager and/or labeller stop selling the affected product and additional actions including a request to recall the product and the issuance of a public communication may also be taken.

6.6 Labelling, Packaging, Advertising

6.6.1 Regulatory requirement

Labelling and Packaging

Part 5 of the NHPR and section 9 of the FDA set out the labelling and packaging requirements for NHPs available for sale to the public, including the requirement for the information on the label to be in accordance with the terms of the product licence (e.g. recommended use, dose, risk information etc.). Non-compliance with Part 5 of the NHPR may result in different levels of risk. For more information, refer to the Labelling Guidance Document.

Misleading Labelling, Packaging and Advertising

Section 9(1) of the FDA sets out that no person shall label, package, treat, process, sell or advertise any health product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. A product that is labelled, sold or advertised in a manner that is not consistent with that product's terms of market authorization (e.g. unauthorised claims) is not compliant with section 9(1) of the FDA.

The Inspectorate and the MHPD work closely on advertising complaints with the Advertising Preclearance Agencies. Further information can be found in the document Regulatory Requirements for Advertising. Of particular interest is the Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products).

6.6.2 Risk Mitigation Strategy

The Inspectorate will address situations of non-compliance related to labelling, packaging, or advertising on a case by case basis.

7.0 Complaints and Adverse Reaction Reporting

Product Complaint
Complaints regarding potential non-compliance with the FDA, FDR and/or NHPR can be reported to the Inspectorate using the Health Product Complaint Form (FRM-0317)
Advertising Compliant
Complaint regarding the advertising of an authorized NHP should be submitted to the advertising preclearance agencies. For further information, refer to the List of Canadian Advertising Preclearance Agencies. Complaints regarding advertising of an unauthorized NHP should be submitted to the Inspectorate as above.
Adverse Reactions
Any suspected adverse reactions should be submitted to Canada Vigilance, and may be reported by phone to the Canada Vigilance regional offices at 1-866-678-6789, online, or by fax/mail. Electronic and hard copy forms are available through the MedEffect website.

8.0 Reference Material

Below is a list of weblinks to related materials referenced in this policy. The list is not exhaustive. Most reference materials can be found on the NNHPD website.

Policies

Guidance

Forms

Misc

Appendix 1 - Definitions

Adverse Reaction
means a noxious and unintended response to an NHP that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function.
Advertisement
includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a drug (including an NHP) under the FDA or the NHPR.
Compliance
the state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or an NHP with the FDA or the NHPR.
Compliance Verification
actions taken by the Inspectorate to verify compliance in response to information regarding a known or suspected non-compliance with the FDA and/or NHPR.
Importer
a person who imports an NHP into Canada for the purpose of sale.
Inspector
any person designated as an inspector for the purpose of the enforcement of the FDA and the NHPR under subsection 22(1) of the FDA.
Manufacturer
means a person who fabricates or processes an NHP for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds an NHP for the purpose of sale to that patient.
Product licence
a product licence issued by Health Canada, authorizing the sale of an NHP, issued pursuant to section 7 of the NHPR on the basis of information submitted in a licence application to the NNHPD. The market authorization is in the form of an eight (8) digit numerical code following the acronym NPN (Natural Product Number) or DIN-HM (Homeopathic Medicine Number).
Natural Health Product
a substance set out in Schedule 1 to the NHPR or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in:
  • the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  • restoring or correcting organic functions in humans; or
  • modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However, a natural health product does not include a substance set out in Schedule 2 to the NHPR, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2. Also, in accordance with subsection 2(2) of the NHPR, a substance or combination of substances or a traditional medicine is not considered to be a natural health product 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 the FDR.
Non-Compliance
a state of nonconformity conformity of a regulated party (including a corporation, institution, individual or other legal entity) or an NHP with the FDA or the NHPR.
Package
includes anything in which any drug (including an NHP) is wholly or partly contained, placed or packed.
Sell
offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.
Serious Adverse Reaction
for the purpose of this guidance document means a noxious and unintended response to a marketed health product covered by this document that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
Serious Unexpected Adverse Reaction
A serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the natural health product.
Specifications
means a description of an NHP that contains the information described in subsection 44(2) of the NHPR.