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Natural health products - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 164794
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Regulating Natural and Non-prescription Health Products: The Path Forward - Canada.ca
Jan 1, 2026
hc-20260101
ID 404473
High-noise change
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updated1 sections changed; 7 added; 9 removed (high-noise change)
1 sections changed7 added9 removed+54 / -85 linesChange ratio: 96%
--- +++ @@ -1,88 +1,57 @@-Natural health products-Quick Facts-Health Canada regulates natural health products (NHPs) so that Canadians can have confidence that the products they use are safe, effective and of high quality.-Labels are an important tool to assist Canadians in making informed health choices when selecting and using NHPs.-Health Canada has amended the+Regulating Natural and Non-prescription Health Products: The Path Forward+On this page+Background+Red Tape Review+Natural health product regulatory modernization+Non-prescription drug regulatory modernization+Background+The Natural and Non-prescription Health Products Directorate is the Canadian regulatory authority for natural health products (NHPs) and non-prescription drugs (NPDs). We authorize NHPs and NPDs for sale in Canada and ensure that Canadians have ready access to a wide range of products for which safety, efficacy and quality standards are in place.+Health Canada introduced the Natural Health Products Regulations-, to make NHP product labels easier to read and understand. These changes support consumers in selecting and safely using NHPs. For more information and to access the supporting Labelling of Natural Health Products guidance document, visit-What's new: Natural and non-prescription health products-For industry information about COVID-19, visit our-COVID-19 Disinfectants, sanitizers, cleaners and soaps-section.-Natural Health Products-Under the-Natural Health Products Regulations-, which came into effect on January 1, 2004, natural health products (-NHPs-) are defined as:-Probiotics-Herbal remedies-Vitamins and minerals-Homeopathic medicines-Traditional medicines such as traditional Chinese medicines-Other products like amino acids and essential fatty acids-What's New-Hard surface disinfectants and hand sanitizers (COVID-19)-Natural Health Products Online System-Licensed Natural Health Products Database-List of Site Licence Holders-Commissioner of the Environment and Sustainable Development Report 2 – Natural Health Products-Health Canada responds to the Spring 2021 Report of the Commissioner of the Environment and Sustainable Development-Features-What's new: Natural and non-prescription health products-Hard surface disinfectants and hand sanitizers (COVID-19)-Natural Health Products Online System-Licensed Natural Health Products Database-List of Site Licence Holders-Commissioner of the Environment and Sustainable Development Report 2 – Natural Health Products-Health Canada responds to the Spring 2021 Report of the Commissioner of the Environment and Sustainable Development-Natural health products must be safe to use and sold without a prescription. Products requiring a prescription are regulated under the+(NHPR) under the+Food and Drugs Act+on January 1, 2004. The NHPR created a distinct category for NHPs with tailored rules. The goal of the regulations is to ensure safety, efficacy, and quality, while enabling consumer access to these products.+Health Canada has heard from some industry stakeholders that recent initiatives aimed at strengthening oversight of NHPs have increased regulatory burden, and do not align the level of regulatory oversight with the level of risk that the products represent.+Health Canada regulates NPDs under the Food and Drug Regulations-.-For Consumers-Caffeinated energy shots-About Natural Health Products-About Natural Health Product Regulation in Canada-Report a Side Effect (Adverse Reaction)-Licensed Natural Health Products Database-Natural Health Products Ingredients Database-Contact the Natural and Non-prescription Health Products Directorate-Stay Connected-For Industry-Forms, templates and guidance documents-Natural Health Products Online System-– natural health product-application forms-and guidelines-Natural Health Product Licensing-–-Forms and templates-Natural Health Products Site Licensing-–-Forms-Clinical Trials-–-Forms and templates-Guidance Documents-- on all aspects of regulatory requirements for natural health products-Guidance for Industry on Third-Party Issuance of international Trade Certificates-Information-Natural Health Product Licensing Bulletin-The Natural Health Product Site Licensing Bulletin and Good Manufacturing Practices Inspection Bulletin-Fact Sheet-on Schedule A Health Claims for Natural Health Products-Licensed Natural Health Products Database-NNHPD-monographs-Self-care products regulation-How self-care products, including natural heath products, cosmetics and over-the-counter drugs, are regulated in Canada.-Classification of Products under the Food and Drugs Act (F&DA)-Contact the Natural and Non-prescription Health Products Directorate-Lists incorporated by reference-Health Canada's Role-The Program assesses all NHPs before allowing their sale in Canada. It also verifies that NHPs are properly manufactured (without contamination or incorrect ingredients). The Program monitors companies involved in NHPs to make sure they respect the-Natural Health Products Regulations-.+(FDR), to ensure NPDs are safe to use and the benefits outweigh the risks to people in Canada. The FDR define how NPDs are regulated, including their:+safety+efficacy+quality+labelling, and+entry into the Canadian market.+The requirements set out in the FDR for NPDs are outdated and inflexible, with the same rules for both prescription and non-prescription drugs. These regulations may pose barriers to innovation and may be challenging for regulated parties to navigate.+Red Tape Review+In July 2025, the government launched a+Red Tape Review+that called on departments and agencies to review their regulations, including how they are administered, and develop reports detailing their progress.+On September 8, 2025, Health Canada and the Public Health Agency of Canada published a+report on red tape reduction+that outlines the actions Health Canada is committed to taking for both NHPs and NPDs.+The changes will simplify both application requirements and post-authorization obligations for NHPs and NPDs. Industry will have more flexibility to meet their regulatory obligations. This approach will also encourage more products to be brought to the Canadian market and support flexible, risk-based post-authorization vigilance.+Ultimately the goals are to reduce barriers for businesses, foster innovation, and protect the health and safety of people in Canada.+We are focusing on advancing the policy and regulatory changes highlighted in the report and in the+Forward Regulatory Plan+so that we can:+increase flexibility in requirements+ensure proportionate oversight+facilitate easier market access+reduce burden for industry and government+Natural health product regulatory modernization+We plan to amend the NHPR to reduce regulatory burden for both industry and government, while maintaining a level of oversight that is proportionate to both risk and uncertainty.+Specifically we are:+introducing a simple registration process for certain NHPs+reducing pre-market requirements where post-market oversight is more appropriate+introducing flexible risk-based vigilance requirements for all NHPs+amending labelling requirements to allow more flexibility+Non-prescription drug regulatory modernization+We plan to amend the FDR to introduce modern, flexible regulations for NPDs to fast-track their approval.+Specifically we are:+introducing simplified requirements introducing a simple registration process for certain NPDs+introducing flexible risk-based vigilance requirements+Related links+What's new+NHP applications and submissions+Natural health product licensing bulletin Page details-Date modified:-2025-03-05+2025-12-30