Many companies entering the Canadian market ask the same question: does my product require an NPN?
The answer depends on scope. In Canada, a product may require a Natural Product Number (NPN) if it is classified as a Natural Health Product (NHP) under Health Canada’s framework. That classification depends on the product’s ingredients, dosage form, intended use, and claims.
An NPN is an 8-digit number issued by Health Canada for an authorized Natural Health Product. In general, NHPs are naturally occurring substances used to restore or maintain good health, and they may come in forms such as tablets, capsules, tinctures, solutions, creams, ointments, and drops. Health Canada’s NHP category includes vitamins and minerals, herbal remedies, probiotics, homeopathic medicines, traditional medicines, and other products like amino acids and essential fatty acids.
So the real question is not just “what products require an NPN?” It is: Is my product being regulated as a Natural Health Product in Canada?
Products commonly requiring an NPN include:
That means many products marketed as supplements will likely require pre-market authorization in Canada before sale.
It can also extend beyond classic capsules and powders. Some personal care products may fall into NHP territory where they contain qualifying ingredients and make health-related claims. Health Canada specifically notes that products such as skin creams, shampoos, and toothpastes are regulated as NHPs only if they meet both the function and substance parts of the NHP definition.
In practice, that is why products such as the following often need closer review:
A plain cosmetic shampoo may not need an NPN. A shampoo marketed with therapeutic or health claims may. A basic moisturizer may not need an NPN. A topical product promoted for a health purpose may need further classification analysis. The same is true for oral care products that move beyond cosmetic positioning.
One of the most common points of confusion is whether a product should be regulated as a Natural Health Product or a Supplemented Food.
In Canada, if a product looks like a food, is packaged like a food, and is consumed like a food (e.g., a beverage, a nutrition bar, or a caffeinated snack), it is often regulated under the Food and Drug Regulations rather than the NHP framework.
Key factors that move a product into the Supplemented Food category include:
If your product is classified as a Supplemented Food, it will not receive an NPN. Instead, it must comply with specific labelling requirements, such as the Supplemented Food Facts table (SFFt) and potentially cautionary identifiers, depending on the ingredients used.
Usually, yes if your product is being sold in Canada as a natural health product and is intended to maintain or restore health.
Usually, not necessarily if it is strictly a cosmetic, food (including supplemented foods), or another regulated product category without NHP-type ingredients or claims.
The challenge is that classification is not based on product format alone. It depends on:
If the product falls within NHP scope, the company must submit a Product Licence Application (PLA) to Health Canada. A product licence is required to sell an NHP in Canada, and the application must include information supporting the product’s safety, efficacy, and quality.
At a high level, that typically means:
Health Canada generally uses three PLA pathways:
The evidence burden increases as products move away from established monograph support.
Health Canada’s review is not just about ingredients. The application must support the product’s safety, efficacy, and quality under its recommended conditions of use. For many products, monographs can help support this. For others, additional scientific, traditional, or other acceptable evidence may be needed, especially where claims are more modern or the formulation is less straightforward.
If your product is a vitamin, mineral, probiotic, enzyme, amino acid, herbal remedy, traditional medicine, homeopathic medicine, or certain health-positioned personal care product, there is a strong chance it may require an NPN or related Health Canada authorization before sale in Canada.
The key issue is scope: not every wellness product needs an NPN, but many do once ingredients and claims are assessed under the Natural Health Products framework.
If you are unsure whether your product requires an NPN in Canada, contact dicentra to help assess classification, review claims and ingredients, and identify the right regulatory pathway before you go to market.