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

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Letter

Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supersedes:
Compliance Policy for Natural Health Products (September 2008)
and Natural Health Products Compliance Guide (January 2007)

Date issued:
August 27, 2010

Date of implementation:
August 27, 2010

Disclaimer:

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Policy
  • 5.1 Policy Statement
  • 5.2 Guiding Principles
  • 5.3 Responsibilities
• 6.0 Identified Non-Compliance
  • 6.1 Higher Risk Non-Compliances
    • 6.1.1 Unlicensed products sold and/or imported for sale
    • 6.1.2 Unlicensed sites conducting licensable activities
    • 6.1.3 Licensed products subsequently labelled and/or advertised with an unauthorized Schedule A claim
    • 6.1.4 Licensed product does not meet its specifications or is adulterated
  • 6.2. Non-Compliances that may pose a risk to health
    • 6.2.1 Product is not labelled or packaged in accordance with Part 5 of the NHPR
    • 6.2.2 Product is sold and/or advertised in a false, misleading or deceptive manner
    • 6.2.3 Good Manufacturing Practices (GMP) non-compliances
  • 6.3 Lower Risk Non-Compliances
• 7.0 Compliance and Enforcement Approach
  • 7.1 Unlicensed products being sold
  • 7.2 Unlicensed products being imported
  • 7.3 Unlicensed Sites Conducting Licensable Activities
  • 7.4 Product labelling for the treatment or cure of any of the diseases, disorders or abnormal physical states referred to in Schedule A or in a manner that may pose a risk to health
  • 7.5 Product advertising for the treatment or cure of any of the diseases, disorders or abnormal physical states referred to in Schedule A
• 8.0 Additional Considerations
  • 8.1 Site information related to a product
  • 8.2 Post market surveillance, mandatory adverse reaction (AR) reporting and new scientific information
  • 8.3 Post market changes to licensed products
• 9.0 Complaint Reporting
• 10.0 Reference Material

1.0 Purpose

The purpose of this policy is to describe Health Canada’s approach to compliance and enforcement of Natural Health Products (NHPs) under the Natural Health Products Regulations (NHPR) and the Food and Drugs Act (FDA).

The main objective of this policy is to foster fairness, transparency and uniformity in the compliance and enforcement approach taken by Health Canada in instances of non-compliance.

This policy replaces and supersedes the Compliance Policy for Natural Health Products (implemented in 2004, and revised in September 2008).  It also replaces the Natural Health Products Compliance Guide (Version 2.1 Jan. 2008).  This policy is to be used in conjunction with Health Canada’s Compliance and Enforcement Policy (POL-0001) .

2.0 Background

The NHPRcame into force on January 1, 2004. These regulations fall under the 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 theyset out requirements for the manufacturing, packaging, labelling, importing, storing, distributing, selling and advertising of NHPs.

The NHPR are intended to ensure that all Canadians have ready access to NHPs that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity. Compliance with the FDA and NHPR helps ensure this mandate is being met and allows consumers to have greater confidence in the products they choose. It is essential that the NHP industry, Health Canada, health care practitioners and the public all work together to help maintain confidence that NHPs being made available for sale in Canada are safe, effective and of high quality.

Within Health Canada, the NHPR are administered by the Natural Health Products Program which is comprised of the Natural Health Products Directorate (NHPD), the Marketed Health Products Directorate (MHPD) and the Inspectorate (which has staff within the Health Products and Food Branch (HPFB) as well as the Regions and Programs Branch (RAPB)). Compliance and enforcement activities are primarily led by Health Canada inspectors situated within the Inspectorate.

3.0 Scope

This policy applies to instances of non-compliance with the FDA and/or the NHPR as they relate to NHPs, with the exception of NHPs used in clinical trials involving human subjects (Part 4 of the NHPR).

This policy describes Health Canada’s compliance and enforcement approach when instances of non-compliance with the FDA and/or NHPR are identified.

4.0 Definitions

The source of the definitions has been indicated in parenthesis as follows:

• Food and Drugs Act (FDA)
• Natural Health Products Regulations (NHPR)
• Compliance and Enforcement Policy (POL-0001)

Definitions may have been adjusted from their original source to fit the context of this policy.

Adverse Reaction:

(NHPR) 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:

(FDA) 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:

 (POL-0001) 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:

(POL-0001)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.

Distributor:

(NHPR) a person who sells an NHP to another person for the purpose of further sale by that other person.

Enforcement:

(POL-0001) actions that may be taken to induce, encourage or compel compliance with the FDA and the NHPR.

Importer:

(NHPR)a person who imports an NHP into Canada for the purpose of sale.

Inspector:

(FDA) 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.

Label:

(FDA) includes any legend, word or mark attached to, included in, belonging to or accompanying any drug (including an NHP) or package.

Manufacturer:

(NHPR) 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. 

Market Authorization:

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 NHPD. 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:

(NHPR) 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 with a specific regulatory requirement of the FDA and/or the NHPR.

Package:

(FDA)includes any thing in which any drug (including an NHP) is wholly or partly contained, placed or packed.

Recommended conditions of use:

(NHPR) the recommended use or purpose; dosage form; recommended route of administration; recommended dose; recommended duration of use, if any; and its risk information, including any cautions, warnings, contra-indications or known adverse reactions of an NHP.

Sell:

(FDA) offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.

Specifications:

(NHPR) means a description of an NHP that contains the information described in subsection 44(2) of the NHPR.

5.0 Policy

5.1 Policy Statement

It is the responsibility of the regulated party to ensure that NHPs being sold, advertised, manufactured, packaged, labelled, imported, distributed or stored comply with the FDA and the NHPR. In accordance with Compliance and Enforcement Policy (POL-0001) , where non-compliance with the FDA and/or the NHPR is identified by the Inspectorate, it is brought to the attention of the regulated party (ie. the company or individual involved).  It is then the regulated party’s responsibility to take timely and appropriate action to comply with legislative and regulatory requirements. Compliance is normally achieved through a cooperative approach among the regulated party, the Inspectorate and other relevant organizations within Health Canada. However, a number of enforcement options are available if necessary, particularly when the regulated party is unable or unwilling to correct non-compliance. The Inspectorate’s role is to ensure that the regulated party complies with the regulatory decisions. The primary objective of the response strategy is to manage the risk to Canadians and use the most appropriate level of intervention to ensure that the responsible regulated party brings the product or activity into compliance. In identifying the appropriate enforcement action, many factors are considered including the risk to health, the likelihood of compliance by the regulated party (considering their history of compliance, intent and degree of cooperation being offered) and available resources.

5.2 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.

5.3 Responsibilities

As indicated in POL-0001, where non-compliance is brought to the attention of a regulated party it is the regulated party's responsibility to take timely and appropriate action to comply with regulatory requirements and to ensure that appropriate risk management actions are taken.

It is the responsibility of the Inspectorate to conduct compliance and enforcement activities related to NHPs. Where the Inspectorate identifies or is notified of a potential non-compliance, the primary objective of the response strategy is to manage the risk to Canadians and use the most appropriate level of intervention to help ensure that the regulated party brings the product or activity into compliance.

6.0 Identified Non-Compliance

The safety of Canadians is the highest priority for Health Canada. Generally, Health Canada becomes aware of instances of non-compliance of NHPs primarily through consumer or trade complaints, and/or referrals from internal and external partners. When a complaint is received, the Inspectorate aims to prioritize the potential non-compliance according to the possible level of risk it may pose in order to most effectively apply departmental resources on a risk based approach. Generally, non-compliances that Health Canada considers to be a higher risk are assigned the highest priority for Inspectorate compliance verification, and are expected to result in immediate risk management actions by the regulated party as needed.

This section is intended to provide guidance regarding the initial risk classification of various non-compliances with the NHPR or FDA. Several non-compliances with the FDA or NHPR have been classified according to their initial level of risk classification. For the purpose of this policy, these have been defined as:

• Higher risk non-compliances
• Non-compliances that may pose a risk to health and;
• Lower risk non-compliances

These initial classifications are intended to provide guidance only. The circumstances surrounding a situation could modify the risk and/or resulting compliance and enforcement actions from that outlined below. In some instances, the Inspectorate may request that a formal risk assessment be conducted by the NHPD or other partners, in order to make a determination on the risk to health of a particular non-compliance. The level of risk could increase or decrease at any time if new information emerges.

6.1 Higher Risk Non-Compliances

There are a number of instances of non-compliance which are initially considered by Health Canada to pose a higher risk to health. Immediate risk management actions are expected in these circumstances. This section outlines some of the situations in which Health Canada may consider as instance(s) of non compliance posing a higher risk to health. This list is not exhaustive and is in no particular order. Details regarding the enforcement approach for instances of higher risk non-compliances can be found in section 7 of this policy.

Non-Compliance with Licensing Requirements

6.1.1 Unlicensed products sold and/or imported for sale

As per section 4 of the NHPR, all NHPs require a product licence to be sold. A product licence demonstrates that a product has been assessed by Health Canada for its safety, efficacy and quality. NHPs that have not undergone this assessment are considered to pose a risk to health. For example, the product may not be labelled with adequate risk information, it may contain an ingredient unsuitable for vulnerable sub-populations such as children or pregnant women, it may contain levels of bacterial or chemical contaminants that do not conform to NHPD requirements and therefore the specifications for product testing may not be appropriate. The safety, efficacy and quality of an NHP are assessed through the product licensing process. Counterfeit products are considered to be unlicensed products and do not adhere to numerous requirements in the FDA and the NHPR. For more information refer to the Policy on Counterfeit Health Products (POL-0048). For more information regarding product licensing, refer to the Product Licensing Guidance Document.

6.1.2 Unlicensed sites conducting licensable activities

As per section 27 of the NHPR, manufacturers, packagers, labellers and importers are required to hold a valid site licence. A site licence demonstrates that Health Canada has assessed the application and determined that the applicant has provided the required documentation to be issued a site licence.  Applicants must 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. GMPs help ensure the consistent quality of an NHP. All NHPs must be manufactured, packaged, labelled, imported, distributed and stored in accordance with these GMPs as per section 43 of the NHPR. Products from unlicensed sites have not provided the evidence required through the site licensing process to demonstrate that they have been manufactured, packaged, labelled, or imported in accordance with GMPs and may thus pose a higher risk to health. GMP non-compliances for licensed sites are further outlined in section 6.2.3 of this policy. For more information on site licensing, refer to the Site Licensing Guidance Document .

Importation of NHPs from Foreign Sites

Canadian importers of NHPs must be licensed and the onus is on them to provide evidence that imported products come from sites that meet Canadian GMPs under Part 3 of the NHPR or equivalent standards. All foreign sites are listed on an importer’s site licence to demonstrate they are in compliance with the GMP requirements.

Non-Compliances that may be identified with licensed products:

6.1.3 Licensed products subsequently labelled and/or advertised with an unauthorized Schedule A claim

As per section 3 of the FDA, an NHP cannot be labelled or advertised to the general public for the prevention, treatment or cure of diseases listed in Schedule A of the FDA. On June 1, 2008 regulatory amendments were made to the Food and Drug Regulations (FDR) and the NHPRto allow the sale and advertising of NHPs that only make preventative claims for diseases listed in Schedule A, provided that the product has been reviewed and authorized by Health Canada. Claims of treatment or cure of a disease listed in Schedule A are still prohibited. For further information refer to the  Canada Gazette. 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.  The complete list of schedule A diseases can be found in the FDA. A product labelled and/or advertised with an unauthorized Schedule A claim is also considered to be non-compliant with additional parts of the FDA or NHPR as referenced in sections 6.2.1 and 6.2.2 of this policy.

6.1.4 Licensed product does not meet its specifications or is adulterated

Under section 44 of the NHPR, every NHP available for sale must comply with the specifications approved by the NHPD for the licensed product. Specification requirements include: product purity, quantity and identity of the medicinal ingredients, potency if applicable, and testing methods. Non-compliance with this section of the NHPR may result in a product posing a higher risk to health. For example, an NHP may be contaminated with bacteria and mold, toxic metals such as mercury, lead, cadmium and arsenic, and residues of pesticides, PCBs, dioxins, or solvents; it may be super-potent or sub-potent or contain misidentified ingredients.

While product specifications cannot speak to every possible substance that could be present in an NHP, paragraph 8(b) of the FDA generally prohibits the sale of an NHP that is adulterated. An NHP may be considered adulterated if it contains an extraneous, improper or inferior (sub-standard to the product specifications) ingredient or a substance not reasonably expected to be found in the NHP. An NHP may also be considered adulterated when its specifications speak to a substance being present up to a certain level and the substance is present at a level above that limit. Adulterated NHPs may pose a higher risk to health, depending on the nature of the adulterant

The sale of an NHP which contains an undeclared prescription drug will be considered an enforcement priority due to the nature of the risks involved with drugs containing Schedule F ingredients. Health Canada will consider the sale of these products to be in violation of section 8(b) of the FDA. It is the responsibility of the regulated party to ensure that every NHP meets its specifications and is not adulterated. Tolerance limits for some microbial and chemical contaminants are set out in the NHPD guidance document, Evidence for the Quality of Finished Natural Health Products.

6.2. Non-Compliances that may pose a risk to health

There may be other instances of non-compliance that could pose a risk to health. Upon assessment of the specific circumstances surrounding a non-compliance, the risk could increase or decrease at any time. This section outlines some of these instances of non-compliance, in no particular order.

6.2.1 Product is not labelled or packaged in accordance with Part 5 of the NHPR

Part 5 of the NHPR sets out the labelling and packaging requirements for NHPs available for sale to the public. This part does not apply to sale that is restricted to a manufacturer or distributor (Section 86 of the NHPR). Part 5 outlines requirements for information to be in accordance with the terms of the product licence (e.g., the recommended use, dose, risk information etc.), additional labelling requirements (e.g., expiry date, importer information etc.) as well as presentation of labelling information on NHPs (e.g., NPN on the principle display panel, bilingual labelling, security packaging etc.). A product that is not labelled in accordance with its product licence and Part 5 of the NHPR may not contain enough information to be used safely. For example, a product may contain incorrect or incomplete risk information. In accordance with section 9(2) of the FDA, an NHP that is not labelled or packaged in accordance with the NHPR is considered to be labelled or packaged contrary to subsection 9(1). Thus its sale may contravene s. 9(1) as being sold in a false, misleading or deceptive manner. See section 6.2.2 of this policy. Non-compliance with Part 5 of the NHPR may result in a product that is determined to pose a higher risk to health once assessed. For more information, refer to the Labelling Guidance Document .

6.2.2 Product is sold and/or advertised in a false, misleading or deceptive manner

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. In order to allow consumers to make an appropriate and informed choice, advertising of NHPs should clearly communicate the intended use of the product in a manner that is consistent with the product licence. A product that is being labelled, sold or advertised in a manner consistent with that product’s terms of market authorization, absent other factors, would not generally be false or misleading, or likely to create an erroneous impression with respect to its character, value, quantity, composition, merit or safety.  Unauthorized claims made in conjunction with authorized products may be misinterpreted by the consumer as being authorized claims, as such these claims may contravene section 9(1) of the FDA by misleading consumers to believe the products are authorized to be sold with those claims. Any products or advertising materials brought to the attention of Health Canada will be evaluated and may be subject to compliance and enforcement actions on the basis of section 9 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).

6.2.3 Good Manufacturing Practices (GMP) non-compliances

Part 3 of the NHPR sets out the requirements for GMPs. Compliance with this part is required for all those who manufacture, package, label, import, distribute or store NHPs. GMPs are ongoing practices designed to ensure 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. For example, setting out that premises and equipment must be clean to prevent contamination; that quality assurance people are present and have appropriate expertise to control the activities and approve release of products; that processes are in place for proper sanitation and operations such as the ability to conduct a product recall; and that products meet their specifications and appropriate records are maintained. GMP violations may adversely affect the quality of the products and may result in different levels of risk based on the specific violation. Violations of GMP provisions are to be assessed by the regulated party to determine if risk management actions are required with respect to the products or any processes related to the activities.  Further information can be found in the Good Manufacturing Practices Guidance Document.

6.3 Lower Risk Non-Compliances

Instances of non-compliance that do not result in a product or activity posing a risk to health and in which corrective actions can be taken in a timely manner by the regulated party may be considered a lower priority for Health Canada enforcement measures.

7.0 Compliance and Enforcement Approach

POL-0001 and the policy position stated in section 5.1 of this policy summarize the overall compliance and enforcement approach in relation to NHPs. As indicated, the risk to health, as well as a number of additional factors, such as the likelihood of compliance by the regulated party, are taken into consideration in determining the compliance and enforcement approach and risk management tools employed. Generally, as the risk to health increases, coupled with additional factors, such as a low likelihood of compliance by the regulated party, the likelihood that risk management tools will be used also increases.

In response to instances of non compliance, the Inspectorate has a number of compliance measures available to address the situation. The Inspectorate may request that the regulated party take certain voluntary measures in response to an identified non-compliance. There are also a number of powers that can be used by the Inspectorate, where intervention is warranted, which are further detailed in POL-0001. Voluntary measures by the regulated party may include but are not limited to: corrective actions to prevent recurrence, a product stop sale, recall or public communications pieces. Measures available to the Inspectorate may include but are not limited to: warning letters, public communications pieces, product seizures, and importation refusals or the issuance of import alerts. The NHPR contain additional post-licensing tools that may be used to address non-compliance. These tools include:

• a request for additional safety information under section 16 or 24 of the NHPR,
• a direction to stop sale under section 17 of the NHPR, and;
• a suspension or cancellation of a product or site licence under sections 18 or 19 and sections 39 or 40 respectively.

Further information can be found in the NHP Post Licensing Guidance Document.

The Inspectorate and regulated parties have a shared responsibility for monitoring compliance with the FDA and its Regulations.  Where the non-compliance identified might impact the safety, efficacy or quality of the NHP, the Inspectorate expects that the regulated party will immediately stop the sale and/or importation of the product or the activity being conducted. The Inspectorate expects that the regulated party will take immediate action to assess the risk associated with the non-compliance to determine the risk management actions required as well as take preventative action to achieve and maintain compliance. The stop sale should not be lifted until such a time that compliance is achieved and appropriate risk management actions have been taken. The Inspectorate expects that the regulated party will take full responsibility for product recalls. Further compliance and enforcement actions in accordance with POL-0001 may be taken if a regulated party fails to voluntarily recall a product. Any recall initiated must be reported to the Inspectorate within 3 days after the day on which the recall is commenced along with the necessary recall information as per section 62 of the NHPR in accordance with the Inspectorate’s Recall Policy (POL-0016) .

In general, the Inspectorate will work with the regulated party using the appropriate level of oversight based on the level of risk in accordance with POL-0001. Enforcement actions may be taken at any time where warranted by circumstances such as lack of cooperation or an inability to address the noncompliance. Failure of companies to respond to written notices or letters advising of recommended compliance actions are interpreted as an indication that the company does not intend to voluntarily comply and that enforcement action is required. Companies with a history of failure to provide adequate response to noncompliance(s) may be subject to immediate enforcement action.

When an issue of non-compliance is identified that does not impact the safety, efficacy or quality of an NHP, the company should ensure that appropriate corrective actions have been taken to resolve the non-compliance in a timely and effective manner and to prevent future recurrence. When identified to the Inspectorate, the Inspectorate may work with the regulated party using a lower level of enforcement oversight. If it is determined at any time that the non-compliance may pose a higher risk to health, further risk management actions may be required.

Continued non-compliance may result in the recommendation by the Inspectorate to the NHPD for actions such as requests for safety information under section 16 of the NHPR related to the product and/or the recommendation to issue an intent to suspend for a product or site licence under sections 18 or 39 of the NHPR respectively, or in cases where there is a risk to health, an immediate suspension of a product or site licence under section 19 or 40 of the NHPR.

Outlined below are some examples of how the compliance and enforcement approach may be applied in some instances of non-compliance, in accordance with POL-0001. The examples provided are intended to serve as a general guide and do not include all instances of non-compliance. Circumstances surrounding the non-compliance may result in variance from the examples provided.

7.1 Unlicensed products being sold

When the Inspectorate has reasonable grounds to believe that an NHP is being sold without a product licence in contravention of section 4 of the NHPR, the Inspectorate may issue a direction to stop sale to the manufacturer, distributor or importer of the unlicensed product. In addition, the Inspectorate may request that the manufacturer, distributor or importer initiate a product recall to the retail level in accordance with the Inspectorate Recall Policy. Recall information as required by section 62 of the NHPR must be provided to the Inspectorate within 3 calendar days of recall initiation. For licenses which have been suspended or cancelled under the NHPR, the stop sale and recall of any products available for sale should be initiated immediately upon the cancellation or suspension date. For more information refer to the Inspectorate’s Recall Policy (POL-0016) .

If it comes to Health Canada’s attention that an unlicensed NHP is being sold at retail, the retailer may be asked to remove the unlicensed product from sale. In addition, the retailer may be requested to provide the name and address of the supplier of the product. If successful in obtaining the information, the inspector may follow up with the manufacturer, distributor or importer of the product and proceed as indicated above. If the retailer directly imports the product for sale, or in the case where the retailer does not offer the necessary cooperation to remove the product or provide information on the supplier, the retailer may be treated as the distributor or importer of the unlicensed product.

Follow Up Expectations

The manufacturer, importer or distributor should respond to the Inspectorate in writing within the requested timeframe indicating that they have complied. If a satisfactory response is not received within the requested timeframe, the Inspectorate may take further enforcement actions in accordance with POL-0001. These activities may include product seizures under the authority of section 23 of the FDA. Further risk management actions may be required, including public a communications piece initiated by the company or Health Canada.

7.2 Unlicensed products being imported

Unlicensed NHPs being imported into Canada and brought to the attention of the Inspectorate may be recommended for refusal of entry into Canada. Health Canada may also issue an import alert for an identified importer, or a lookout for the product, in order to monitor future importations. Further information can be found in the Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060) and the Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084).

7.3 Unlicensed Sites Conducting Licensable Activities

When the Inspectorate has reasonable grounds to believe that a site is conducting licensable activities without a site licence in contravention of section 27 of the NHPR, the Inspectorate may issue a notice to the site to cease the licensable activity until such a time that a site licence is obtained. The site may be requested to stop the sale of all products associated with the unlicensed activity under section 17 of the NHPR, as they may not be in compliance with Part 3 of the NHPR. In addition, the site should conduct a thorough assessment of each product to determine if further risk management actions are required, such as product recalls. In the case of an importer, products being imported into Canada and brought to the attention of the Inspectorate may be recommended for refusal of entry into Canada. For more information, refer to the Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060) and the Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084) .

Follow Up Expectations

The site should respond to the Inspectorate within the requested timeframe indicating they have complied with the request to cease activities and stop sale of all products associated with the unlicensed activity. In addition, the site should provide an assessment of all products associated with the activity and any further risk management actions to be taken, such as product recalls. If a satisfactory response is not received within the timeframes, the Inspectorate may take further enforcement actions in accordance with POL-0001. These activities may include product and/or equipment seizures under the authority of section 23 of the FDA. Health Canada may also directly contact the product licence holders or distributors of the products associated with the unlicensed activity and take further compliance and enforcement actions. In the case of an importer, Health Canada may issue an import target to review future importations. If additional non-compliances with the FDA and NHPR are identified through the product assessment that could indicate a potential further risk to health, further risk management actions may be required including product recalls and a public communications piece initiated by the company or Health Canada.

7.4 Product labelling for the treatment or cure of any of the diseases, disorders or abnormal physical states referred to in Schedule A or in a manner that may pose a risk to health

When the Inspectorate identifies an NHP that may be labelled for the treatment or cure of a Schedule A disease in contravention of section 3 of the FDA, the Inspectorate may issue a notice to the manufacturer, distributor or importer of the product to stop sale of the non-compliant NHP.   In addition, the Inspectorate may request that the manufacturer, distributor or importer initiate a product recall to the retail level in accordance with the Inspectorate Recall Policy. Recall information as required by section 62 of the NHPR must be provided to the Inspectorate within 3 calendar days of recall initiation. The stop sale should not be lifted until such a time that compliance is achieved and appropriate risk management actions have been taken.

Follow Up Expectations

The manufacturer, importer or distributor should respond to the Inspectorate in writing within the requested timeframe indicating they have complied. If a satisfactory response is not received within the requested timeframe, the Inspectorate may take further enforcement actions in accordance with POL-0001. These activities may include product seizures under the authority of section 23 of the FDA or public communications pieces.

7.5 Product advertising for the treatment or cure of any of the diseases, disorders or abnormal physical states referred to in Schedule A

When the Inspectorate identifies advertising materials for the treatment or cure of a Schedule A disease in contravention of section 3 of the FDA, the Inspectorate may issue a notice to the person responsible for the advertising to immediately cease the advertising activities. If the person responsible for the advertising is not the product licence holder, the Inspectorate may request that the person provide written notification to the product license holder of the advertising non-compliance.

Follow Up Expectations

The person responsible for the advertising activities should respond to the Inspectorate in writing within the requested timeframe indicating that they have complied with the request. If a satisfactory response is not received within the requested timeframe, the Inspectorate may take further enforcement actions in accordance with POL-0001. These activities may include seizure of advertising materials, further contacting the product licence holder to inform them of the non-compliance and/or the issuance of a public communications piece.

8.0 Additional Considerations

Additional compliance and enforcement considerations for regulated parties are outlined below:

8.1 Site information related to a product

As per section 22 of the NHPR, every product licensee is required to provide the NHPD with all site information prior to commencing the sale of the NHP. This information is to be submitted to the NHPD through the notification process outlined in the Post Licensing Guidance Document. This information may be verified at any time by the Inspectorate or NHPD. The regulated party should keep this information readily available to provide to Health Canada upon request.

8.2 Post market surveillance, mandatory adverse reaction (AR) reporting and new scientific information

Scientific information is continuously evolving. As such, there may be new scientific information that modifies the safety, efficacy or quality profile of a marketed NHP. It is the responsibility of the product licence holder to ensure the continued safety, efficacy and quality of the licensed NHP.  Adverse Reaction (AR) reporting is an integral part of the post-market surveillance of NHPs and is a regulatory requirement for all product license holders, as set out in Section 24 of the NHPR. This includes the expedited reporting of all serious adverse reactions occurring within Canada and all serious unexpected adverse reactions occurring outside of Canada, and the preparation of a summary report of all adverse reactions to a licensed NHP on an annual basis. Regulated parties should have systems in place to monitor and assess adverse reactions received and take appropriate risk management actions. Failure to comply with post market requirements may present a potential risk to health and as such, may be subject to compliance and enforcement activities. It is important to highlight that adverse reactions may also signify other non-compliances, including possible counterfeit products, labelling non-compliances, as well as GMP or product specification non-compliances (e.g. adulteration, contamination). Further information on mandatory expedited reporting of serious adverse reaction(s) and preparation of annual summary reports can be found in Health Canada's Guidance Document for Industry – Reporting Adverse Reactions to Marketed Health Products.

Should Health Canada become aware of new scientific evidence that could modify the safety, efficacy or quality profile of the product, Health Canada may contact the affected licensee(s) and request additional safety information under section 16 of the NHPR or section 24 of the NHPR (annual summary report and/or interim summary report). If there are reasonable grounds to believe that there may be an immediate risk to health, the product licence may be suspended under section 19 of the NHPR and compliance and enforcement actions may be taken.

8.3 Post market changes to licensed products

NHPD must be informed of all post market changes made to licensed products. Under the NHPR, these are considered to be either amendments or notifications. Notifications are defined under section 12 of the NHPR and are considered to include changes which do not have a significant impact the safety, efficacy and/or quality of the product such as a change to the company information, site information, the addition or substitution of a non-medicinal ingredient that does not affect the safety or efficacy of the product, the brand name of the product, the common or proper name of any of the medicinal ingredients or the addition of risk information. Notifications should be submitted to the NHPD as soon as possible, but are required within 60 days of making the change to a marketed NHP.

Changes considered to be amendments as per section 11 of the NHPR require approval by the NHPD prior to making the change to the marketed product. These include but are not limited to: changes to the recommended dose, duration or recommended use or purpose, deletion or modification of risk information, a change to the source material or potency of any medicinal ingredient, certain changes to product specifications, among others.  These changes may have an impact on the safety, efficacy or quality profile of the NHP and may significantly impact the assessment of information for which the product licence has been granted.  Further information can be found in the Post Licensing Guidance Document.

9.0 Complaint Reporting

The Inspectorate is committed to verifying complaints regarding the quality or safety of health products.

Complaints regarding potential non-compliance with the FDA and/or NHPR can be reported to the nearest regional Operational Center using the following guidelines:

• How to submit a consumer complaint (GUI-044) or
• How to submit a trade complaint (GUI-038)

Advertising:

If a complaint is regarding the advertising of an authorized NHP, the first route of adjudication of complaints should be through the advertising preclearance agencies. For further information, refer to the List of Canadian Advertising Preclearance Agencies

Adverse Reactions:

In certain instances, a complaint may be related to an adverse reaction associated with the use of a particular NHP. 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.

10.0 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 from the NHPD website.

Policies:

• Compliance and Enforcement (POL-0001)
• The Inspectorate Recall Policy (POL-0016)
• Import and Export Policy for Health Products Under the Food and Drugs Act and its Regulations (POL-0060)
• Policy on Counterfeit Health Products (POL-0048)

Guidance Documents:

• Post Licensing Guidance Document
• Issuance of the final Consumer Advertising Guidelines for Marketed Health Products (for Non Prescription Drugs including Natural Health Products)
• Health Canada's Guidance Document for Industry – Reporting Adverse Reactions to Marketed Health Products
• Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084)

Misc:

• Drug and Medical Device Recall Listings
• Licensed Natural Health Products Database