Understanding Natural Health Product Testing in Canada
When entering the Canadian market with a natural health product (NHP) or supplement, ensuring the product meets regulatory standards is essential. Proper supplement testing helps meet requirements with Health Canada’s regulations while maximizing product safety and efficacy.
This article explores the distinctions between natural health products and food products in Canada, the regulatory framework surrounding NHPs, and the importance of partnering with a reliable analytical testing lab.
Distinguishing Between Natural Health Products and Food Products
Natural health products and food products, while both regulated by Health Canada, fall under different categories with distinct safety, efficacy, and quality requirements.
An NHP is defined as a naturally occurring substance used to maintain or restore good health. These products can include…
- Vitamins
- Herbal remedies
- Essential fatty acids
- Homeopathic medicines
- Amino acids
- Probiotics
- Minerals
- Traditional medicines
The regulations also include non-prescription drugs such as over-the-counter analgesics, antacids, cough and cold remedies, birth control drugs, and disinfectants.
In contrast, food products primarily serve to nourish, provide energy, or satisfy hunger.
Understanding the difference is crucial for compliance, as misclassification can lead to regulatory issues. Before proceeding with production, it’s essential to determine under which category your product falls.
Health Canada’s Regulatory Framework
Health Canada regulates NHPs under the Natural Health Products Regulations (NHPR), a subset of the Food and Drugs Act (FDA). The Natural and Non-prescription Health Products Directorate (NNHPD) oversees the licensing, review, and approval of NHPs, ensuring they meet safety, efficacy, and labeling standards.
For an NHP to be sold in Canada, it must obtain a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). These numbers, found on the product label, indicate that the product has been authorized for sale in Canada and is considered safe and effective when used as directed.
Factors Determining NHP Classification
To determine whether a product is classified as an NHP, Health Canada outlines four key factors:
- Product Composition: The primary ingredients and their intended use are crucial. If the ingredients are primarily for nutrition or hydration, the product is likely a food. If the ingredient is known for medicinal purposes, it may be classified as an NHP. Health Canada maintains an NHP Ingredients Database to help determine acceptable ingredients.
- Product Representation: How a product is labeled, advertised, and packaged plays a significant role in classification. For example, terms like “cough tablets” suggest NHP classification. Claims outside traditional food use may also indicate that a product is an NHP.
- Product Format: If a product is packaged in conventional food formats, like ready-to-drink beverages, it is likely classified as a food. However, products designed for controlled dosages, such as capsules or tablets, are more likely to be NHPs.
- Public Perception & History of Use: The public’s perception of a product and its historical use can influence its classification. If a product is commonly used for health purposes, it may be classified as an NHP.
Correct classification is essential for compliance with Health Canada’s regulations and ensures that the product meets all necessary safety standards.
The Role of Analytical Testing in NHPs
Analytical testing is vital in ensuring the safety, efficacy, and quality of natural health products.
As Health Canada states: “The licence holder is ultimately responsible for product quality.”
While some tests are required by Health Canada, additional testing can enhance a product’s marketability. Testing helps ensure that consumers receive products that are safe, correctly labeled, and of the highest quality.
Health Canada’s Quality of Natural Health Products Guide provides helpful guidance not only on what tests to perform but proper methodologies and acceptable tolerances.
Common lab testing for NHPs and supplements include…
- Specifications testing, per section 44 of the Natural Health Products Regulations. This includes product purity and, for each medicinal ingredient, the quantity per dosage unit and its identity.
- Microbial testing for contamination, including yeast and mould; Salmonella spp.; Escherichia coli; Staphylococcus aureus; Pseudomonas aeruginosa; mycotoxins; aflatoxins; or other contaminants deemed necessary for you product.
- Elemental impurities testing for heavy metals, including arsenic, cadmium, lead, and mercury. Health Canada publishes acceptable limits in its Quality of Natural Health Products Guide.
- Residual solvents from the manufacturing process.
- Pesticide residues.
- Disintegration and dissolution testing (not required if the product is to be chewed).
- Analytical testing in support of label claims (e.g. “Gluten-Free”).
Consult the regulations and guidelines for your products. Tailor your quality program to your raw materials, finished products, and their inherent risks. Err on the side of caution and conduct as much testing as needed to verify product safety – don’t stop at just the testing required in the regulations!
Reach Out for Help with NHP and Supplements Testing
Labstat’s Edmonton location specializes in NHP and supplements testing. Our lab is ISO 17025-accredited, GMP-compliant, and holds a Health Canada GMP Drug Establishment Licence.
We offer validated methods to provide microbiology, analytical chemistry, and stability testing for a variety of NHP and supplement products.
As part of Certified Group, our laboratory network extends into the United States, with locations that specialize in supplement testing for U.S.-based customers.
