The Importance of Taking a Proactive and Anticipatory Approach Towards Quality and Regulatory Compliance of Natural Health Products (NHPs)

The Importance of Taking a Proactive and Anticipatory Approach Towards Quality and Regulatory Compliance of Natural Health Products (NHPs)

November 11, 2019 By

Natural Health Products (NHPs) are widely purchased and used by many Canadians. Consumers have the expectation that natural health products are fit for their purpose and there is a reasonable expectation that the product contains the ingredients listed on the label and that these ingredients support the label claims. However, conflicting evidence was found during the Heath Canada Compliance Monitoring Program (CMP) between 2017 and early 2019, when randomly selected establishments were assessed on their compliance with key aspects of Natural Health Products Good Manufacturing Practices (“NHPs GMPs”). Of the random selection, many companies had poor quality in their manufacturing processes and is an ongoing concern for regulatory authorities.

During these visits, it was found that companies incorrectly attested to compliance issues. Critical observations were noted in the following areas:

  • Quality Assurance
  • Stability
  • Premises
  • Operations

The observations resulted in regulatory actions such as:

  • Stop sales
  • Recalls
  • Laboratory Testing

In addition, the findings in some cases were significant enough for Health Canada to consider and issue Site License suspensions. Health Canada stated, “companies need to put measures in place to ensure that they meet the regulatory requirements and are responsible for taking action to fix problems when they occur.”

What are the risks associated with the sale of non-compliant or unregulated Health Products? Failure to comply with the following may result in stop sales and recalls of certain products:

  • Absence of active ingredients
  • Presence of toxic agents
  • Manufacturing problems (e.g. contamination, incorrect ingredients or dosage)
  • Unproven claims, which can lead people to use the wrong products for serious conditions or to delay proper treatment
  • Lack of information for people to make an informed choice (e.g. incorrect instructions or no warnings that a product may not be suitable for certain groups)
  • Interaction with prescription drugs or other natural health products
  • Unwanted side effects such as allergic reactions

To evaluate and mitigate these risks and achieve compliance with regulations, Health Canada has announced that it will soon begin to carry out their planned proactive risk management projects for 2019-2020 which will include planned reviews in the following areas:

1. Natural Health Products Good Manufacturing Practices: Follow-up visits with license holders visited during the previous monitoring projects to verify implemented corrective actions to inspection findings.

2. Performance of Natural Health Products: Testing of Natural Health Products licensed as workout supplements to screen for the presence of undeclared ingredients or contamination.

3. Advance Notice of Importation: Site visits to verify the labelling of products imported via the Advance Notice of importation (A.01.044 of the Food and Drug Regulations (FDR)). 

As Health Canada continues to take a more proactive approach in verifying industry compliance, it’s extremely important that manufacturers, packager, labellers and importers of Natural Health Products take a similar and anticipatory approach towards verifying and ensuring facilities and product compliance and identify and address any potential problem before being required by regulatory agencies. This will allow to mitigate risks, protect their business and their customers.

Companies need to ensure that they are meeting GMP requirements not only to avoid revoked site licence but for the health and safety of consumers. The first step in achieving this goal is to ensure that the facility is equipped with qualified staff, particularly in the important, but often neglected, the role of Quality Assurance. For this reason, many companies will choose to contract out certain QA activities to a qualified third-party consulting firm. Be proactive and learn how your company can ensure compliance with Health Canada. Contact us for assistance with your Natural Health Product or Dietary Supplement to ensure your product stays competitive in the market.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.