Natural Health Product Compliance: What You Need to Know About Product Information Forms and Microbial Suitability Testing 

If you’re involved in the manufacturing, formulation, or site licensing of Natural Health Products (NHPs) in Canada, staying compliant with Health Canada’s evolving regulatory requirements is essential. One key requirement that has recently gained prominence is the Product Information Form, now considered a central component of the site licensing process. The PIF outlines the standards and specifications that must be met for compliance. 

This article provides a comprehensive overview of the Product Information Form, with a special focus on microbial suitability testing—a crucial but often overlooked step in ensuring compliance with Good Manufacturing Practices (GMP) for NHPs. 

What Is a Natural Health Product? 

Natural Health Products (NHPs) refer to a regulated category of products in Canada that provide health benefits through natural ingredients such as vitamins, minerals, herbs, amino acids, and probiotics. Similar products in other countries may be labeled as dietary supplements, but in Canada, NHPs are regulated under a unique framework governed by Health Canada. With recent changes in enforcement practices by Health Canada, a key document introduced in the site license application process is the “Product Information Form” detailing product specifications required to meet regulatory standards. 

Overview: Health Canada’s Product Information Form 

The Product Information Form is now one of the most important documents in Health Canada’s site license application and compliance processes. It collects detailed data on: 

• Product formulation 

• Finished product testing 

• Stability testing 

• Microbial testing requirements 

A comprehensive submission to Health Canada, including the Product Information Form, is crucial for demonstrating compliance with safety, effectiveness, and quality standards for natural health products. 

What Is Microbial Suitability or Preparatory Testing? 

Suitability Testing: 

Suitability testing is used to determine if a specific microbial testing method is appropriate for your product’s formulation, including the quantity of microbial contaminants. For example, USP (US Pharmacopeia) testing methods for microbial contamination include both suitability and preparatory testing protocols. In Canada, laboratories typically reference USP < 61> for this process. If the method proves unsuitable, it must be adjusted and re-validated. 

Preparatory Testing: 

Preparatory testing, guided by USP < 2021>, ensures that the raw materials are appropriately tested and that the product is ready for microbial evaluation. This ensures that the test method will yield accurate results for your unique product type. 

Which Microbial Tests Are Required by Health Canada for NHPs? 

For most NHPs, microbial testing of finished products must include the following: 

• Total Plate Count 

• Yeast and Mold 

• Salmonella spp. 

• Escherichia coli (E. coli) 

• Staphylococcus aureus 

• Pseudomonas aeruginosa*(for liquid products)* 

If a product fails method suitability, the testing procedure must be revised by the microbiology lab, and the suitability test must be re-executed until the method is deemed appropriate. When selecting laboratories for suitability and preparatory testing, USP <61> is typically referenced for suitability testing, while USP <2021> is applied for preparatory testing. 

These requirements apply specifically to NHPs, not to DIN (Drug Identification Number)-registered products, which are governed under a different regulatory pathway. 

Why Microbial Suitability Testing Matters 

With Health Canada placing greater scrutiny on microbial testing, manufacturers, importers, and site license holders must be prepared to demonstrate: 

• That appropriate microbial test methods are used in the manufacturing process 

• That testing procedures meet GMP standards 

• That lab documentation reflects current regulatory expectations 

Ensuring quality control throughout the entire production process is crucial. Applying Good Manufacturing Practice (GMP) helps maintain consistency and compliance from growth to processing stages. 

Failure to meet microbial suitability requirements may delay site license approvals or trigger compliance issues during inspections. 

Dell Tech Can Help  

At Dell Tech, we assist businesses in the Natural Health Product industry with full compliance support—from site license preparation to quality assurance. Whether you’re using an internal quality lab or need a third-party lab recommendation, we can guide you through: 

• Selecting the right testing methods 

• Reviewing and completing the Product Information Form 

• Ensuring documentation is inspection-ready 

📩 Contact us today for regulatory support or visit our website to learn more. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.