The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to ensure the safety and quality of NHPs sold in the country. If you’re planning on selling NHPs in Canada, it’s important to be aware of these regulations.
Note: The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) after expanding its mandate to encompass non-prescription and disinfection medications (NHPs).
In this blog post, we will go over the top natural health product regulations in Canada. We’ll also provide some tips on how to comply with these regulations.
What is a Natural Health Product?
A natural health product (NHP) is a product that has been specifically designed to support and promote human health. They are often made from natural ingredients and can include vitamins, minerals, herbs, and other botanicals. NHPs are regulated by Health Canada and must meet specific safety and quality standards before they can be sold in Canada.
Natural health products have been used for centuries to support overall health and well-being. Today, they are an important part of many people’s lives and are used to treat a variety of conditions. Natural health products can be found in a variety of forms including tablets, capsules, tinctures, creams, and teas.
If you are considering taking a natural health product, it is important to speak with your healthcare provider first. This is especially important if you have any underlying health conditions or take any medications as NHPs can interact with these. Once you have decided that an NHP is right for you, be sure to purchase it from a reputable source and look for the Natural Product Number (NPN) on the front panel of the product label. This ensures that the product has been through Health Canada’s approval process and meets all safety and quality standards.
About the Regulations
Following extensive consultation with industry stakeholders, health care professionals, academics, and consumers in Canada, the Natural Health Products Regulations were drafted. They address the concerns of Canadians regarding the availability and safety of natural health products (NHPs), as well as the 53 recommendations made by the House of Commons Standing Committee on Health regarding the regulation of NHPs in Canada.
Every non-prescription health product (NHP) that is sold in Canada is required to have a product licence, and the facilities in Canada that produce, package, label, and import NHPs are also required to have site licences.
In order to get product and site licences, certain labelling and packaging standards need to be satisfied. Additionally, acceptable manufacturing procedures need to be adhered to, and appropriate evidence of safety and efficacy needs to be presented.
What are the top natural health product regulations in Canada?
There are many different regulations that govern the production and sale of natural health products in Canada. The following is a brief overview of the main regulations governing these products:
Health Canada regulates the safety, quality, and labeling of natural health products. This includes ensuring that products meet safety standards set out in the Food and Drugs Act and Health Canada’s Regulations. Health Canada also reserves the right to refuse to register a product’s registration. It is done in the case if it believes that it is unsafe or not in compliance with applicable regulations.
The Natural Product Association of Canada (NPA) is a voluntary association of manufacturers, distributors, retailers, and consumers of natural health products. NPA operates an online marketplace where members can buy, sell and trade natural health products.
The Canadian Food Inspection Agency (CFIA) is responsible for regulating the food industry in Canada. Among other things, the CFIA oversees product safety, working with provincial/territorial agricultural regulators to ensure that food sold in Canada is safe to eat. The CFIA also regulates natural health products under its jurisdiction, including through its Registration and Approval Program for herbal medications and dietary supplements.
How to Obtain a Natural Health Product License
In order to obtain a natural health product (NHP) license in Canada, you must submit a complete application to Health Canada. This application must include:
- A description of the product
- Information on the ingredients, including a list of all medicinal ingredients and their amounts
- The intended use(s) of the product
- Any safety information, including any warnings or precautions
- Any clinical information supporting the safety and efficacy of the product
After your application is received, it will be reviewed by Health Canada to determine whether the product meets the requirements for licensing. If your product is approved for licensing, you will be issued a Natural Product Number (NPN) which must be included on all labelling and advertising for your product.
Health Canada’s Regulatory Framework
In order to ensure the safety and efficacy of natural health products (NHPs) in Canada, Health Canada has established a comprehensive regulatory framework.
This framework includes:
- The Natural Health Products Regulations
- The Food and Drugs Act
- The Controlled Substances Act
- The Pest Control Products Act
- The Radiation Emitting Devices Act
The Natural Health Products Regulations (NHPR) are the primary piece of legislation governing NHPs in Canada. The NHPR sets out requirements for products that are to be sold as NHPs, including Good Manufacturing Practices (GMPs), labelling requirements, and product licensing.
Products that fall under the scope of the NHPR must obtain a product licence from Health Canada before they can be marketed in Canada. To obtain a licence, manufacturers must provide evidence that their products meet the requirements of the NHPR. Once licensed, manufacturers must comply with all applicable provisions of the NHPR, including GMPs and labelling requirements.
The Food and Drugs Act (FDA) is the primary piece of legislation governing food, drugs, and cosmetics in Canada. The FDA prohibits the sale of any food, drug, or cosmetic that is unsafe for human use. The term “drug” includes any substance or mixture of substances manufactured, sold, or represented for use in: diagnosing, treating, or preventing disease in humans; restoring, correcting or modifying organic functions in humans.
Requirements for Selling Natural Health Products
In order to sell natural health products (NHPs) in Canada, you must comply with the Natural Health Products Regulations. These regulations are designed to demonstrate the safety, efficacy, and quality of NHPs.
All NHPs must have a product licence before they can be sold in Canada. To obtain a licence, manufacturers and importers must submit a product licence application to Health Canada. The application must include evidence that the NHP meets specific requirements for safety, efficacy and quality.
Health Canada assesses all applications for NHPs on a case-by-case basis. In general, the department looks at three main factors when considering whether or not to issue a licence:
- Does the NHP pose any safety risks?
- Is there scientific evidence to support the claims made about the NHP’s efficacy?
- Does the NHP meet good manufacturing practices?
If you are planning on selling NHPs in Canada, it is important that you are familiar with these requirements. Failure to comply with the Natural Health Products Regulations could result in fines and/or jail time.
The top natural health product regulations in Canada are designed to protect consumers and ensure that they are getting safe and effective products. The natural health product regulations Canada regulations are constantly evolving, so it is important to stay up-to-date on the latest changes.
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By familiarizing yourself with the regulatory landscape, you can be confident that you are using natural health products that meet the highest standards of safety and quality.
For 6 important things to know about your NPN and the NHPID click here:
How Quality Smart Solutions can help
At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.