Regulatory Comparison: Natural Health Products vs. Supplemented Foods in Canada

In Canada, both Natural Health Products (NHPs) and Supplemented Foods (SFs) involve substances or ingredients that are intended to provide health benefits or contribute to the overall well-being. Their overlap in purpose and function and similar associations with health and wellness are confusing for both industry stakeholders and consumers. Therefore, understanding the similarities and differences is crucial for stakeholders aiming to ensure compliance and successfully navigate the Canadian market. This article provides a comprehensive analysis of the regulatory framework, compliance requirements, and market access considerations for NHPs and SFs in Canada.

1. Regulatory Framework

Natural Health Products (NHPs):

Under the oversight of Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD), NHPs are defined as products used and marketed for various health purposes, including disease prevention, treatment, risk reduction, and maintenance of good health. NNHPD regulates NHPs through a comprehensive framework that includes the issuance of Natural Product Numbers (NPNs), Good Manufacturing Practices (GMPs), labeling and packaging requirements, and post-market surveillance and reporting.

Despite of the food-like nature of some NHPs, they are not considered foods. Instead, they are regulated as a subset of drugs under Natural Health Products Regulations, which sets out requirements for the manufacture, packaging, labelling, storage, importation, distribution, sale and clinical trials involving human subjects in Canada. NHPs include a wide range of health products such as vitamin and mineral supplements, herbal and plant-based remedies, traditional medicines, homeopathic medicines, omega and essential fatty acids as well as probiotics. Moreover, other consumer products such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs due to their medicinal ingredients and intended uses.

Supplemented Foods (SFs):

SFs, on the other hand, fall under the jurisdiction of the Canadian Food Inspection Agency (CFIA). CFIA ensures that SFs are compliant in product composition and claims, labeling, as well as import and export. These products are conventional foods with added nutrients and/or bioactive substances, such as vitamins, minerals, amino acids and caffeine. Typical examples include: beverages with added mineral nutrients, caffeinated energy drinks, and snack bars with amino acids. However, several foods are not eligible as SFs, including:

a) foods required or permitted the addition of nutrients for fortification purposes;

b) foods for special dietary use;

c) infant foods and foods targeted to children under 4 years of age, pregnant or breastfeeding women;

d) prepackaged unprocessed foods or minimally processed foods;

e) alcoholic beverages;

f) specialty foods; and

g) novel foods.

On July 21, 2022, Health Canada published Supplemented Foods Regulations to provide a new regulatory environment for SFs. A transition period ending on December 31, 2025 was provided for some existing SFs. However, new SFs introduced to the market after the regulations came into force are required to immediately comply with the new requirements.

Notes: In deciding whether a product in food format is an NHP or a food, several aspects will be taken into account: product composition, product representation, product format, as well as public perception and the history of use. To assist manufacturers and distributors with the classification of their products, Health Canada has published the Guidance Document: Classification of products at the food-natural health product interface: products in food formats.

2. Product Compliance Requirements

NHPs are required to meet Natural Health Products Regulations, while SFs should ensure the compliance with Supplemented Foods Regulations. The two types of products vary a lot with each other in terms of in terms of product compliance, such as the product forms, ingredients, and labeling.

Comparison of Product Compliance Requirements Between NHPs and SFs

Item	NHPs	SFs
Example of products	Multi-vitamin tablets	Beverages with added mineral nutrients
Description	Dosage formats that are not typical foods (e.g., capsules, tablets, powders, tinctures, etc.) May not be suitable for the general population Require a limit for consumption May carry directions for use	Nine kinds of food formats in List of Permitted Supplemented Food Categories, such as juices, bars, carbonated beverages, etc. May not be suitable for the general population May require a limit for consumption
Ingredients	Permitted medicinal and non-medicinal ingredients in Natural Health Products Ingredients Database	Subject to List of Permitted Supplemental Ingredients Subject to Ingredients Not Permitted in Foods, Including SFs
Labeling	Subject to Guidance Document: Labelling of NHPs Typical items include product name, dose, route of administration, product license number, recommended use (i.e. its health claim), complete list of ingredients, and any risks associated with the product's use, such as cautions, warnings, contra-indications and known adverse reactions	Subject to Labelling of Supplemented Foods Subject to general labelling requirements for prepackaged products such as bilingual labelling, common name, country of origin, date markings and storage instructions, name and principal place of business, list of ingredients and allergens, lot numbers, net quantity, and the legibility and location of this information. Comply with additional specific labeling requirements for SFs, such as Supplemented Food Facts table (SFFt), list of Cautionary statements, and Supplemented Food Caution Identifier (SFCI)
Product claims	Subject to Pathway for Licensing Natural Health Products Making Modern Health Claims Health claims for NHPs can be divided into claims by health condition, claims by health effect, and general health claims	Subject to Regulatory Requirements and Guidance for Use of Nutrition and Health-related Statements and Claims on Supplemented foods As conventional foods, nutrition and health-related statements and claims may be made for SFs on a voluntary basis.

3. Market Access Requirements

NHPs:

Product Licence Application (PLA)

In Canada, all NHPs must obtain a product licence before they can be sold in the market. To obtain this licence, manufacturers and distributors must submit a Product Licence Application (PLA) that includes comprehensive information about the product, such as its medicinal and non-medicinal ingredients, dosage, potency, and recommended uses. The application must also include supporting evidence to demonstrate the product's safety, efficacy, and quality under the recommended conditions of use. Once the product has undergone assessment and is deemed safe, effective, and of high quality, a product licence will be issued. The licence is accompanied by an 8-digit Natural Product Number (NPN) or Homeopathic Medicines Number (DIN-HM) which must appear on the label. To search for licensed NHPs, the Licensed Natural Health Products Database can be utilized.

Depending on the use of NNHPD monographs, there are three types of PLAs. Class I applications are supported by a single monograph, Class II applications are supported by two or more monographs, and Class III applications involve a full assessment, which is necessary for certain cases such as novel preparations, ingredient master files, ingredient combinations, and where go beyond NNHPD monograph parameters. For more details about the PLA, please refer to Natural Health Products Management of Applications Policy.

Site Licence Application (SLA)

Canadian manufacturers, importers, labellers and packagers of NHPs must have site licences. To obtain a site licence, these entities must submit a Site Licence Application (SLA) along with supporting documentation that demonstrates adherence to appropriate GMPs in the manufacturing, packaging, labeling, and importation processes of NHPs. NHP site license holders can be found at List of Natural Health Product Site Licence Holders.

Canadian importers are also obliged to provide evidence that products from foreign sites meet Canadian GMPs. Acceptable forms of evidence include Foreign Site Reference Number (FSRN) Authorization, GMP certificate, Quality Assurance Report (QAR), as well as other certificates from qualified authorities. For more details about SLA, please refer to Site Licensing Guidance Document.

SFs:

Before the introduction of Supplemented Foods Regulations, manufacturers and distributors of SFs in Canada could gain market access by obtaining a temporary marketing authorization letter (TMAL). With the implementation of the new regulations since July 21, 2023, the TMALs issued for SFs are no longer valid. However, for products with previously issued TMAL for market access, a transitional period till December 31, 2025 was given for stakeholders.

Moreover, new SFs that meet the new regulations are now eligible to enter the market without requiring premarket authorization from Health Canada.

4. Conclusion

In summary, NHPs and SFs in Canada have distinct regulatory frameworks. NHPs are regulated as a subset of drugs and are required to enter the market via a series of strict assessment and authorization process, while SFs are conventional foods with added nutrients and/or bioactive substances, facing lower market access threshold. Understanding these regulatory differences is crucial for stakeholders aiming to ensure compliance and successfully navigate the Canadian NHPs and SFs market.