Determine the Right Regulatory Framework for your Food or Natural Health Product
Learn to determine whether your product is regulated as a food or as a natural health product.
Food or natural health product?
An important first step when planning the development of a new food product is to determine whether it is a food or a natural health product, as each category has its own regulations.
The industry is encouraged to determine the suitable regulatory framework for a specific product well in advance of a product launch. A number of factors, such as the format and composition, determine whether products are regulated as a food or as a natural health product.
- Natural Health Products (NHPs):
- Over-the-counter substances taken in a specified dose for the prevention or treatment of an illness or condition, or the maintenance of good health. NHPs come in a wide variety of formats like tablets, capsules, tinctures, solutions, creams, ointments and drops. NHPs are regulated under the Natural Health Product Regulations, which set out specific requirements such as site and product licenses.
- Items manufactured, sold or represented for use as a food or drink, and any ingredients that may be mixed with food. This includes herbs, spices, chewing gum, candy, energy drinks, vitamin waters, energy bars and most powdered drinks. Foods are regulated under the Food and Drug Regulations.
- Supplemented foods:
- A new regulatory category. Supplemented foods are broadly defined as pre-packaged products that are manufactured, sold or represented as a food, which contain added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements.
- Find help for navigating through food regulatory requirements
Access resources that help industry navigate the relevant regulatory approval processes, including scientific substantiation, for innovative food products.
- Foods Marketed as Natural Health Products, Health Canada
Includes guidance that explains the four basic principles used in determining whether products are regulated as a food or as a natural health product.
- About Natural Health Product Regulation in Canada, Health Canada
The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.
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