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Evaluation of the pilot natural health products good manufacturing practices inspection program

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Compliance monitoring

In Canada, companies must hold a site licence (SL) to manufacture, package, label or import natural health products (NHPs) for sale. In order to be issued an SL companies must follow good manufacturing practices (GMP) requirements as outlined in Part 3 of the Natural Health Products Regulations(NHPR).

Health Canada grants SLs to companies that submit all the required application documents referred to in Part 2 of the NHPR. It is a company's responsibility to comply with the applicable regulatory requirements. When we identify non-compliance, we take compliance and enforcement action based on several factors, including the risk to health.

Health Canada monitors compliance to help ensure that NHPs on the Canadian market are safe, effective and of high quality. From 2017 to 2019, we conducted 3 proactive compliance monitoring projects (CMPs) to assess how some companies followed certain NHP GMPs. The results showed varying levels of non-compliance within the NHP industry. About half of the companies had issues serious enough for us to take regulatory action:

Our findings played a key part in the development and implementation of a pilot NHP GMP inspection program. Through this pilot program, we assessed compliance, prevented non-compliance and conducted compliance promotion activities at 36 NHP sites in Canada.

Inspections are one of many tools that Health Canada uses as part of our compliance and enforcement approach. They are used to assess if companies are following the applicable requirements of the Food and Drugs Act(FDA) and its associated regulations. In established inspection programs they are carried out regularly, based on risk, to assess compliance and prevent non-compliance.

Why we conducted this pilot

The Commissioner of the Environment and Sustainable Development (CESD) conducted an audit of the NHP program in 2019/2020. In its report, it identified both strengths and areas for improvement, including 5 recommendations for the program.

Strengths included:

Areas for improvement included our oversight of:

Health Canada accepted all 5 recommendations, which included developing a risk-based monitoring and inspection program.

We developed the pilot as part of our continued proactive and risk-based approach to compliance monitoring as well as using lessons learned from the previous CMPs conducted. The pilot complements the current paper-based licensing process and complaint-based compliance verification process.

The pilot had 3 main objectives:

How we conducted this pilot

Health Canada verified compliance of the NHP industry by inspecting a selection of SL holders across Canada against regulatory requirements outlined in Part 3 of the NHPR.

During the pilot, we:

Impact of COVID-19 pandemic on pilot implementation

Due to the COVID-19 pandemic, physical distancing requirements were put in place across Canada. Thus, Health Canada identified new ways to ensure and monitor compliance and conduct inspections that would not require inspectors to go on-site.

We identified and developed procedures and tools for conducting inspections via telecommunication (completely off-site or "remotely").

As distancing restrictions eased, we developed procedures to allow inspectors to conduct inspections partially off-site and on-site ("hybrid"). To protect the safety of inspectors and company personnel, inspectors had to follow the federal and applicable provincial public health guidelines in place at the time of their inspections. They were also given personal protective equipment (such as masks and gloves) to use when on-site.

Of the 36 inspections conducted, 16 were remote and 20 were hybrid.

What we focused on

We focused on 2 types of higher-risk activities conducted by Canadian SL holders:

Manufacturing

Manufacturing processes and controls have a direct impact on the safety, quality and effectiveness of NHPs. Properly trained employees must use clean equipment and facilities to produce NHPs. Companies must test products to make sure what is listed on the label is what ends up in the package and to support the recommended expiry date of the product. They need to keep good records of their supply chain and have an effective process in place for recalling products.

Importation

Many products are made outside of Canada. Importers must take measures to ensure that the products they bring into Canada are made in facilities that follow Canadian NHP GMPs (or their equivalent). These include our country's requirements for safety, quality and effectiveness. One way to ensure this is to test NHPs in a qualified laboratory.

For information on the regulatory requirements for both the manufacturing and importation of NHPs, please consult:

How we selected sites

We chose companies to inspect based on the level of risk to people in Canada. This was determined by:

We also wanted to ensure there was an equal representation of SL holders across Canada.

What we did

Health Canada inspectors conducted inspections at 36 companies from March 2021 to March 2022. This represents about 4% of all companies with active NHP SLs in Canada.

There were:

The companies were located in:

Given the travel restrictions due to the COVID-19 pandemic, we chose companies in locations where an on-site visit could take place if required.

Inspectors conducted inspections under the authority of their powers. These are outlined in section 23 of the FDA.

Inspectors spent an average of 7 days inspecting each site. They verified that:

They also verified if there were:

In some cases, inspectors took samples of products and tested them in Health Canada laboratories to determine if there were any issues with a company's processes or test results. The types of tests conducted depended on the inspector's findings and if there were specific quality or safety concerns.

If inspectors identified issues during the inspection that affected a product's safety, quality or effectiveness, they:

The inspector discussed the findings (regulatory deficiencies) with site personnel during each inspection. After completing an inspection, they summarized their findings in an inspection report (called an" inspection exit notice") and classified the risks.

For the risk classifications, please consult:

Draft inspection reports were reviewed internally before they were shared with the companies. Each inspector set up a meeting with the company ("exit notice meeting") to review the report. Then a final report was sent to the company.

Where compliance and enforcement action had to be taken with licences, Health Canada issued notices on:

Where no compliance and enforcement action was necessary, the company maintained their SL and PL, if applicable.

In all cases, companies were asked to submit a corrective and preventive action (CAPA) plan to address the regulatory deficiencies identified by the inspector in the inspection report. Inspectors reviewed the CAPAs for adequacy. If compliance and enforcement actions were taken with a company, an adequate CAPA could reverse those actions (for example, a suspended licence could be re-instated). An inadequate CAPA could lead to additional actions (for example, a suspended SL could be cancelled).

What we found

We found similar issues to those observed in the CMPs conducted from 2017 to 2019. Compliance issues ranging in severity were found at all the companies we inspected (Table 1).

Table 1: Inspection findings during the pilot
Topic Section of NHPR Section of the Good manufacturing practices guidance document What we found Why this matters
Specifications 44 2.4.1 Deficiencies were noted with the specifications pertaining to the NHPs handled at the site

A product's specifications are the criteria that ensure a finished NHP is acceptable for its intended use.

There are 2 important aspects:

  • product specifications are established and relevant for the product
  • manufacturers have a quality system in place that ensures the product consistently meets the established specifications

Testing of finished products complements the controls employed during the manufacturing and importing processes. Each manufacturer and importer must have:

  • accurate specifications
  • adequate quality systems
  • the right test methods

Where the medicinal ingredient is a whole herb, a complex extract or the mixture of the NHP is so complex that no test method is available, quantification by input may be acceptable.

The SL holder is responsible for ensuring that quantification by input is appropriate for the medicinal ingredients within the product.

Learn more about quantification by input in the Quality of natural health products guide.
Premises 45 2.1.1 Deficiencies were noted with the premises resulting in conditions that may not maintain safety and quality of the NHP

Buildings where NHP processes take place must be designed and constructed in a way that permit cleanliness and orderliness and prevent contamination. Regular upkeep is required to prevent deterioration of the premises.

Products must not become contaminated through unsanitary conditions.

A clearly marked segregated area should be in place for NHPs and materials that is only accessible to authorized employees. This is important to restrict the availability of materials and products until their release by the quality assurance person.
Equipment 46 2.1.2 Deficiencies were noted with the design, construction, maintenance, operation and/or arrangement of equipment used

Contamination of NHPs by other products, dust, cleaning agents or foreign materials, such as rust, lubricant and particles coming from equipment, must be prevented.

Contamination problems may arise from inadequate cleaning practices, poor upkeep, misuse of equipment, exceeding the capacity of equipment and use of worn-out equipment.

Equipment arranged in an orderly manner permits effective cleaning and does not interfere with other processing operations. It also minimizes the circulation of personnel and optimizes the flow of materials.
Personnel 47 2.2.1 Deficiencies were noted with the qualifications of personnel to carry out their respective tasks

Appropriate personnel with sufficient training are necessary to process NHPs of high quality.

Qualified personnel must be employed to supervise NHP processes.

NHP processing operations require constant monitoring, attention to detail and a high degree of competence from employees.

Personnel handling NHPs who have inadequate qualifications or training could contribute to the failure of the NHP to meet specification and quality requirements.
Sanitation program 48 2.3.1 Deficiencies were noted with the sanitation program

Sanitation of a building and employee hygiene can affect the quality of NHPs.

The company and its employees must perform NHP activities in areas that are free from:

  • environmental contamination
  • contamination from other products

A written sanitation program must be in place to inform employees of the expectations and necessary steps to take to ensure sanitation requirements are met. This assures the cleanliness of the building.
Operations 49 2.3.2 Deficiencies were noted with written processes required to ensure activities pertaining to NHPs are conducted as required

Measures must be in place to maintain the integrity of a NHP from when raw materials enter the building to the time the finished dosage form is released and distributed for sale.

Companies must ensure, where applicable, that practices and procedures are in place for:

  • material control
  • process control
  • the inspection program for contractors
Operations 50 2.3.2 Deficiencies were noted with implementation and/or maintenance of the system of control which permits the rapid and complete recall of NHPs

A recall removes from the market a NHP that:

  • does not conform to the Act or Regulations or
  • presents a risk to consumer health

NHPs that have left the premises of a company may end up in a number of locations.

Depending on the non-compliance or how serious the health risk, a NHP may need to be recalled from the market. There must be the ability to recall at the consumer level if necessary. More information on recalls can be found in the Recall policy for health products (POL-0016).
Quality assurance 51 2.2.2 Deficiencies were noted with the qualifications, responsibilities, and/or activities performed by the quality assurance person

Quality assurance is the area concerned with sampling, specifications and testing, including documentation and release procedures.

Before releasing a product for sale, the quality assurance person must ensure each product:

  • meets product specifications
  • has necessary and relevant tests done
Stability period 52 2.4.2 Deficiencies were noted with the program established to determine the period of time that an NHP will stay within its specifications under recommended storage conditions

The stability program determines how long the NHP will stay within its specifications under recommended storage conditions.

Companies must have data to prove that an NHP meets its label claims and the expiry date.
Records - manufacturers 53 2.4.4 Deficiencies were noted with the maintenance and/or location of records required for the activity of manufacturing

Records are evidence of product production and quality should an investigation be launched for reasons such as:

  • a customer complaint or
  • product recall

Manufacturers, packagers, labellers, importers and distributors must meet the minimum record-keeping requirements for NHPs set out in Appendix 2 of the Good manufacturing practices guidance document.
Records - importers 56 Deficiencies were noted with the maintenance of records required for the activity of importation
Record maintenance 58 Deficiencies were noted with the period of time established for record retention
Lot or batch samples 61 2.4.3 Deficiencies were noted in the retention, quantity and/or availability of samples of NHPs handled by the site

NHP samples, in their final packaging, must be kept as evidence of quality should an investigation be launched for reasons such as:

  • a customer complaint or
  • product recall

Samples must be maintained in an environment that mimics regular storage requirements to ensure the sample is equivalent to products available for sale.

Health Canada may ask a manufacturer, importer or distributor to submit samples of a lot or batch of a product if there is a concern about product safety or quality.
Recall reporting 62 2.4.5 Deficiencies were noted in the reporting of NHP recalls initiated by the site

Manufacturers, importers and distributors who initiate a recall of a NHP are required to provide specific information to Health Canada about the recall within 3 days of initiation.

What enforcement actions we took

Health Canada reviewed all of the information collected from the inspection pilot. We considered the nature and extent of all issues found and took necessary compliance and enforcement actions in line with Policy-0001.

Our compliance and enforcement actions included asking some companies to:

In 15 of the 36 inspections we conducted, we found issues that were serious enough to warrant sending notices to the respective companies. The notices indicated that Health Canada was:

Twelve companies submitted adequate CAPAs to address the issues noted during their inspection. Thus, they were able to maintain their SL and PL(s), if applicable. One of the 12 companies allowed their SL to expire and confirmed they were no longer conducting licensable activities.

Of the 3 remaining inspections, the notices of consideration to suspend the SL and 9 of 10 PLs of 1 company were closed. However, 1 notice of consideration to suspend a PL progressed to a notice of suspension. The company decided to discontinue the product. The notices of consideration to suspend the SL and the PLs of 2 companies progressed to notices of suspension. One company submitted an adequate CAPA and their SL and PLs were re-instated. The outcome for the last company is still pending. This company has submitted a CAPA in response to the notices of suspension. Their submissions are being reviewed and, thus, some results are not yet available.

Further details on the issues identified and actions taken for each company are listed in Tables 2 and 3. All companies that still hold a SL and PL(s), if applicable, have adequately addressed the issues identified during inspection.

Table 2: Findings and enforcement actions at manufacturers
Site name Province Name and section of regulations where issues were identified Measures we took
Gelda Scientific and Industrial Development Corporation Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
51. Quality assurance
52. Stability period
GFR Pharma Ltd. British Columbia 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
48. Sanitation program
49. Operations
51. Quality assurance
Laboratoire Riva Inc. Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
Estee Lauder Distribution Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
49. Operations
51. Quality assurance
Rhema Health Products Limited British Columbia 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
Les Emballages Façotek Quebec 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.

The company was asked to stop selling the following products because it had not demonstrated that the foreign supplier was conducting NHP activities in accordance with Part 3 of the NHPR:

  • Life Brand Spectrum Performa (NPN 80105471)
  • Life Brand Spectrum Adults (NPN 80095982)
  • Life Brand Spectrum Forte (NPN 80103288)
  • Life Brand Spectrum (NPN 80095857)

The company complied with the request, but was unable to correct the issue with the foreign supplier. The company decided to destroy remaining inventory.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
58. Record maintenance
ODF Nutra Inc. Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
46. Equipment
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
Viva Pharmaceutical Inc. British Columbia 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability
53. Records manufacturers
Nutralab Canada Corp. Ontario 50. Operations

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
51. Quality assurance
53. Records -manufacturers
Jaapharm Canada Inc. Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
Sante Naturelle (A.G.) Ltee Quebec 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.
45. Premises
46. Equipment
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
58. Record maintenance
Canadian Phytopharmaceuticals Corporation British Columbia 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.

Inspector took samples of the following products for testing at our laboratories due to concerns with test methods:

  • Ancient Keto Apple Cider Vinegar (NPN 80060175)
  • Vitality Glow Marine Collagen + Biotin (NPN 80103566)

Test results showed the products were within specifications for the specific tests conducted.
45. Premises
46. Equipment
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
62. Recall reporting
Akuna Health Products Inc. Ontario 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.
47. Personnel
49. Operations
51. Quality assurance
52. Stability period
Rafa River Naturals Canada Inc. British Columbia 44. Specifications

Intent to suspend SL issued.

Decision to close the "intent to suspend SL" because the CAPA adequately addressed the major issues noted during the inspection.
45. Premises
46. Equipment
48. Sanitation program
49. Operations
51. Quality assurance
52. Stability period
BioAmicus Laboratories Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
47. Personnel
48. Sanitation program
50. Operations
51. Quality assurance
53. Records -manufacturers
61. Lot or batch samples
Kefiplant Inc. Quebec 44. Specifications

Intent to suspend SL and PLs issued.

Decision to suspend the SL (Section 39(2)(b) of the NHPR) and PLs (Section 18(2)(b) of the NHPR) because the CAPA did not adequately address the major issues noted during inspection.

A final decision on the licences is pending.

There were concerns with test results and the expiry date assigned for KefiNutra Chardon Marie (NPN 80043219). The company confirmed there was none of this product on the Canadian market and is addressing our concerns.
45. Premises
46. Equipment
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
58. Record maintenance
61. Lot or batch samples
Absorb Science Inc. British Columbia 44. Specifications

Intent to suspend SL and PLs issued.

Decision to suspend the SL (Section 39(2)(b) of the NHPR) and PLs (Section 18(2)(b) of the NHPR) because the CAPA did not adequately address the major issues noted during inspection.

Decision to reinstate the SL and PLs because the CAPA adequately addressed the major issues noted during the inspection.

The inspector sent a sample of Viagreat-SX (NPN 80040741) for testing at our laboratories due to concerns with GMP deficiencies and information on the product label. Test results showed the products were within specifications for the tests conducted.

The company was asked to stop selling Grape Seed Extract (NPN 80063001) because it did not meet the requirements of the applicable product monograph. The company discontinued the product and destroyed the remaining inventory.
45. Premises
46. Equipment
47. Personnel
48. Sanitation program
49. Operations
51. Quality assurance
52. Stability period
53. Records -manufacturers
Laboratoires MSP Inc. Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.

There were concerns with finished product testing and stability data for Gel Buvable – Aloès (NPN 80019050), which are being addressed by the PL holder (Santrel International Inc.). The outcome is pending.

There were concerns with stability data for Osépia (NPN 80033598). The concerns were adequately addressed by the PL holder (Laboratoire Holizen Inc.) so no further actions were required.
45. Premises
46. Equipment
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
53. Records - manufacturers
58. Record maintenance
Table 3: Findings and enforcement actions at importers
Site name Province Section and name of regulations where issues were identified Measures we took
Lifeagen Biosciences of Florida, Inc. Ontario 44. Specifications

SL was maintained.

The CAPA for this inspection was submitted after the deadline. It will be reviewed for adequacy during the 2022 SL renewal.
49. Operations
51. Quality assurance
52. Stability
56. Records - importers
Royal Natural Holdings Corp. Ontario 44. Specifications

SL was immediately suspended (Section 40 of the NHPR).

Intent to suspend PLs issued.

Decision to reinstate the SL because the CAPA adequately addressed the major issues noted during the inspection.

Decision to close the "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.

The company was asked to stop selling Apiario Silvestre Propolis (NPN 80006418) due to concerns with finished product testing.

Company allowed to sell the product again because our concerns were addressed.
45. Premises
47. Personnel
48. Sanitation program
50. Operations
51. Quality assurance
52. Stability period
56. Records -importers
Masson Ltd. Quebec 44. Specifications

Intent to suspend SL issued.

Decision to close the "intent to suspend SL" because the CAPA adequately addressed the major issues noted during the inspection.

The company was asked to correct the label for Mustela Crème Change 123 (NPN 80066962). The company volunteered to stop sale and destroy affected product. Sale can resume when the label is corrected.

The company volunteered to test this product due to concerns with finished product testing. The test results showed the product met specifications, so no further actions were required.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
56. Records - importer
United Herbal Trading Co. Ltd. British Columbia 44. Specifications

SL was immediately suspended (Section 40 of the NHPR).

Intent to suspend PLs issued.

The SL expired (Section 35 of the NHPR).

Decision to suspend the PLs (Section 18(2)(b) of the NHPR) because the CAPA did not adequately address the major issues noted during inspection.

Decision to re-instate the PLs because the CAPA adequately addressed the major issues noted during the inspection.
45. Premises
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
56. Records - importer
61. Lot or batch samples
Mayaka International Inc. Quebec 44. Specifications

Intent to suspend SL issued.

Decision to close the "intent to suspend SL" because the CAPA adequately addressed the major issues noted during the inspection.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
56. Records - importers
58. Record maintenance
Medexus Inc. Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
49. Operations
52. Stability period
56. Records - importers
i to i Logistics Inc. British Columbia 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
47. Personnel
48. Sanitation program
51. Quality assurance
52. Stability period
56. Records - importers
Shiseido Canada Inc. Ontario 48. Sanitation program

CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
49. Operations
50. Operations
52. Stability period
56. Records - importers
Baronesse Cosmetiques Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability period
56. Records - importers
Laboratoires Dermo-Cosmetik Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
47. Personnel
48. Sanitation program
50. Operations
51. Quality assurance
52. Stability
56. Records - importers
58. Record maintenance
Seaford Pharmaceuticals Ontario 48. Sanitation program

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.

The company was asked to correct the label and web advertisement for Drysol Mild (NPN 00461555). It complied with the request and was able to continue selling the product.
49. Operations
51. Quality assurance
52. Stability period
Biomed International Products Corp. British Columbia 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.
45. Premises
47. Personnel
49. Operations
51. Quality assurance
52. Stability period
56. Records - importers
Links Warehousing & Fulfillment Ontario 44. Specifications

Intent to suspend SL issued.

Decision to close the "intent to suspend SL" because the CAPA adequately addressed the major issues noted during the inspection.

The company volunteered to stop importing and selling 16 products because it had not shown that the foreign supplier was conducting NHP activities in accordance with Part 3 of the NHPR. The company corrected the issues and was able to resume importation and sale.

The company also volunteered to stop importing and selling Colic Calm (NPN 80042317) because of concerns with the product's label and ingredients. The product was returned to the supplier and the company is no longer importing it.
45. Premises
48. Sanitation program
47. Personnel
49. Operations
51. Quality assurance
52. Stability period
56. Records - importers
Yves Rocher Amerique du Nord Inc. Quebec 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability
56. Records -importers
58. Record maintenance
Fraser Direct Distribution Services Ltd. Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
45. Premises
52. Stability
56. Records - importers
Shaklee Canada Inc. Ontario 44. Specifications

The CAPA adequately addressed the issues noted during the inspection.

SL was maintained.
47. Personnel
48. Sanitation program
49. Operations
50. Operations
51. Quality assurance
52. Stability
Ecotrend Ecologics Ltd. British Columbia 44. Specifications

Intent to suspend SL and PLS issued.

Decision to close the "intent to suspend SL" and "intent to suspend PLs" because the CAPA adequately addressed the major issues noted during the inspection.

The company was asked to stop importing and selling Oxy-Health (NPN 80041070) because it had not shown that the foreign supplier was conducting NHP activities in accordance with Part 3 of the NHPR. The company returned the product to the supplier and is addressing our concerns.
45. Premises
47. Personnel
48. Sanitation program
49. Operations
51. Quality assurance
52. Stability period
56. Records - importers
Senzo Nutrition Quebec 44. Specifications

Intent to suspend SL and PLs issued.

Decision to close the "intent to suspend SL" because the CAPA adequately addressed the major issues noted during the inspection.

Decision to suspend the PL for Baby Boom (NPN 80103856) (Section 18(2)(b) of the NHPR) because the CAPA did not adequately address the major issues noted during inspection. The company decided to discontinue the product and destroy the remaining inventory.

Decision to close the "intent to suspend PL" for other products because the CAPA adequately addressed the major issues noted during the inspection.

45. Premises

48. Sanitation program

49. Operations

50. Operations

51. Quality assurance

52. Stability period

56. Records - importers

58. Record maintenance

Stakeholder feedback on the pilot

Health Canada sent surveys to NHP stakeholder associations and those companies involved in the pilot. Through the survey, we asked for feedback on:

We also gave stakeholders the opportunity to provide their ideas or suggestions for implementing a permanent inspection program. We will be considering these during permanent program development.

NHP associations

A survey was sent to 4 associations. The 2 associations that completed the survey were satisfied with how we communicated the development and implementation of the pilot.

The NHP associations also said that challenges with the pilot included:

The NHP associations also indicated it would be helpful to:

Companies inspected in the pilot

A survey was sent to the 36 companies that were involved in the pilot. The 24 companies that completed the survey were satisfied with:

The companies also said their knowledge of their regulatory responsibilities and NHP GMPs increased as a result of being inspected.

Challenges with the pilot included the following:

We also received comments on how to improve the inspection process, such as:

What we will do with the results of this pilot

In its report, the CESD recommended that Health Canada develop a risk-based monitoring and inspection program. In response, we committed to implementing a pilot inspection program for inspecting NHP GMPs and for promoting and verifying compliance of the NHP industry.

We are also committed to taking actions based on the outcomes of this pilot.

The pilot allowed us to collect information on:

Health Canada will use these findings to:

Health Canada implemented an interim inspection program in October 2022 in response to the CESD report and its recommendations as well as our findings from the inspection pilot. This program will help us maintain momentum with industry and will serve as an initial step to creating a permanent program.

The interim inspection program will allow us to:

Who is responsible for the safety of NHPs

Any company that manufactures, packages, labels, imports, stores and distributes NHPs in Canada is responsible for the safety of their NHPs. They must follow the requirements set out in the NHPR. This includes having a valid SL before manufacturing, importing, packaging and/or labelling.

For the companies that hold a valid Health Canada SL, please refer to the List of site licence holders.

To sell an NHP in Canada and become a PL holder, a person must:

Retailers

Retailers must only sell NHPs with a valid 8-digit natural product number (NPN) or drug identification number-homeopathic medicine (DIN-HM).

Use the Licensed natural health products database to check if the NHP you are selling has a valid NPN or DIN-HM.

Consumers

Consumers should only:

Use the Licensed natural health products database to check if the NHP you are buying is authorized for sale in Canada by Health Canada.

If you have questions about health products, speak with your health care provider. This will help you avoid taking a product that may interact with medications or other products you are already taking.

How to report a complaint about an NHP or NHP facility

We want to know if you have a complaint about:

For more information on how to report health product complaints, refer to the:

Examples of complaints:

For general questions on the safety of health products, contact us toll-free 1-800-267-9675 or by email at info@hc-sc.gc.ca.

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