Health Canada defines Natural Health Products (NHPs) as “naturally occurring substance that are used for the number of reasons such as the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health.” These products are widely sold in as over-the-counter products. NHPs are identified by an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

According to Health Canada, “71% of Canadians use NHPs like vitamins and minerals, herbal products, probiotics, and homeopathic remedies.” Consumer products such as toothpaste, antiperspirant, shampoo, facial products, and mouthwash are everyday products which can also be classified as NHPs. The general perception of NHPs are that they are safe and have fewer side effects than traditional medications but just because they are “natural” does not guarantee that they are risk-free. About 12% of Canadians who use the NHPs have experienced unwanted side effects. In order to protect Canadians, Health Canada regulates these products under the stream of Non-Prescription and Natural Health Products. These products are licensed in Canada by ensuring that they are safe, effective, of high quality and carry detailed label information to let people make safe and informed choices.

Certain products in food like form with added vitamins, minerals or amino acids which include energy drinks, water, juices, and bars are commonly viewed as NHPs however, these products should be considered primarily as food products in Canada.

In terms of regulation, to be an NHP, the product must have a specific health claim such as help to relieve joint pain, have the medicinal ingredients on schedule 1 of Natural Health Product Regulations (NHPR) and not any medicinal ingredients on Schedule 2 of NHPR. Despite this, other components should be taken into consideration – the direction of use (i.e. take one capsule daily), presence of any risk information on the label associated with the use of the product (i.e. do not use if pregnant) and location of the product in retail shelves. (i.e. shelved in the vitamins or over the counter health products section in the grocery store). While this provides some guidance on defining what is an NHP is, there are still many factors should be taken into consideration to distinguish NHP’s from food products.

To ensure that the correct regulatory framework is applied, the products are required to be classified in the correct category as established in current regulations. There are four determining factors to determine product classification: product composition, product representation, product format and public perception and history of use.

1. Product Composition

• Does the product contain ingredient(s) for which the primary purpose is to provide nourishment, nutrition, hydration, energy (in form of source of Calories) or to satisfy hunger, thirst or desire for taste, texture or flavour?

If yes, the product would be most likely classified as food.

If no, the product would be most likely classified as an NHP.

• Does the product contain ingredient(s) that aren’t added for food purposes but have a medicinal role in the product such as (Cascara, Senna or horsetail)? Inclusion of these ingredients are more likely to classify the product as an NHP.

2. Product Representation

• Does the product label, package insert or advertisement refer to any use or claim such as part of regular diet with the objective to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst or desire for taste, texture or flavour presented as a sentence, a picture, a symbol or a paragraph and mostly importantly location of the product among consumer food products in retails establishment (grocery or convenience stores)?

If yes, the product would be most likely classified as food.

If no, the product would be most likely classified as an NHP.

3. Product Format

• Does the product come in the format of conventional food, prepackaged for consumption, or ready-to-consume drink products? Can it be consumed freely, does it provide nourishment, nutrition, hydration, the satisfaction of hunger/thirst, taste, texture or flavour?

If yes, the product would be most likely classified as food.

If no, the product would be most likely classified as an NHP.

• Does the product format allow the consumer to take in measured or controlled amounts such as liquid products having single dosage unit with less than 90 ml or packaged with a measuring tool or presented in a way to know consumer that the product is intended to be taken in controlled amounts?

If yes, the product would be most likely classified as an NHP.

If no, the product would be most likely classified as food.

It’s important to note that the product format on its own is insufficient to decide whether the product can be classified as an NHP or food product. The format of the product alone isn’t sufficient to determine the correct classification.

4. Public Perception and History of Use

• Does the product have a historical pattern of use as a food or is perceived as a food in the marketplace?

If yes, the product would be most likely classified as food.

If no, the product would be most likely classified as an NHP.

The most important factors when classifying a product whether it is a food or NHPs are the product composition, product representation, and product format. Product representation indicates how a product is to be used and the absence of any specific health claim on the label or package inserts except to provide nourishment, nutrition, hydration, the satisfaction of hunger/thirst or desire for taste, texture or flavour. Drink products that use terms such as “beverage”, “water”, “juice”, or “cocktail” and are found in retail food stores are typically represented to consumers as foods. Product composition means the presence of ingredients which are generally considered/known as product and only consumed as a supplement to provide the nutrition or to satisfy hunger/thirst or craving for the taste/flavour. Product format means how a product is packaged such as drink boxes, bottles, or cans.

If you’re still unsure whether your product should be classified as an NHPs or food product, please contact us and we will help you determine the correct regulatory class for your product(s). We’re your strategic partner to provide easy guidance for market authorization of the products.