Shilajit, known for its numerous health benefits, is becoming increasingly popular as a dietary supplement in Canada. However, to legally market and sell shilajit in Canada, you must ensure it meets Health Canada’s regulatory standards. This process involves obtaining approval as a Natural Health Product (NHP) and obtaining a Natural Product Number (NPN). In this guide, we’ll walk you through the essential steps to get Health Canada approval for your shilajit supplement.
1. Determine if Your Shilajit Product Qualifies as a Natural Health Product (NHP)
The first step to getting Health Canada approval for shilajit is determining whether your product qualifies as a Natural Health Product (NHP). Shilajit is a mineral-based supplement and generally falls under the NHP category. NHPs are defined by Health Canada as products made from natural sources, such as plants, minerals, or algae, and intended to maintain or restore health or prevent disease.
Before proceeding with the approval process, ensure your product fits the NHP definition. If it does not meet the criteria, it may need to go through a different regulatory process.
2. Submit a Product License Application
To market your shilajit supplement as an NHP in Canada, you need to submit a Product License Application to Health Canada. This application includes comprehensive details about your product’s ingredients, intended use, manufacturing process, and any health claims made. The application also requires scientific evidence to support the health claims.
Once the application is reviewed and approved, you will receive a Natural Product Number (NPN). The NPN verifies that Health Canada has authorized the product for sale in Canada. This number must be displayed on your product label, confirming that your shilajit has passed regulatory scrutiny.
3. Ensure Compliance with Good Manufacturing Practices (GMP)
Health Canada mandates that all NHPs, including shilajit, be manufactured under Good Manufacturing Practices (GMP). These standards ensure that the product is consistently produced to meet quality and safety standards. Manufacturers must implement GMP at every stage, including raw material sourcing, production, packaging, and labeling.
To meet these standards, ensure that your manufacturing facility is GMP-compliant. Health Canada may inspect the facility to confirm that all production processes adhere to these strict guidelines.
4. Provide Supporting Evidence for Health Claims
If your shilajit product makes health claims, you must provide scientific evidence supporting those claims. Health Canada requires that all claims made about the product’s effectiveness be backed by credible data, such as clinical trials, traditional use data, or scientific studies.
The application you submit for approval will need to include this evidence. Health Canada reviews the evidence to ensure that the claims are not misleading and that the product is safe for consumer use. If you cannot provide sufficient evidence, you may need to revise or remove certain claims from the product label.
5. Labeling Requirements and Displaying the NPN
Once your shilajit product is approved, Health Canada requires that your product label be fully compliant with NHP regulations. The label must include the Natural Product Number (NPN), product name, list of ingredients, dosage instructions, and any necessary warnings or cautions. Additionally, the label should reflect any approved health claims and provide risk information where applicable.
Ensure that the labeling is clear, accurate, and consistent with Health Canada’s requirements. Misleading labels or failure to include required information can result in delays or complications in getting your product to market.
Ready to Get Your Shilajit Approved by Health Canada?
By following these steps and ensuring compliance with Health Canada’s NHP regulations, you can bring your shilajit supplement to market with confidence. Whether you’re submitting a Product License Application, adhering to GMP, or providing supporting evidence for health claims, each step is crucial to ensuring your product’s success.
If you need assistance with the Health Canada approval process, contact us today. Our team is here to help guide you through the regulatory steps and ensure your shilajit product meets Canadian standards.
For more detailed information on NHP regulations, visit Health Canada’s NHP page.
