Canada

• In Canada, food supplements fall under the scope of Natural Health Products and are governed by the Natural Health Product Regulations(January 2004), under the authority of the Foods and Drugs Act.
• The term natural health product (NHP) is used in Canada to describe substances such as ‘vitamins and minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, medicines and other products like amino acids and essential fatty acids.
• These products do not require a prescription to be sold. Products requiring a prescription are regulated under the Food and Drug Regulations

In Canada,food supplements (as Natural Health Products) require pre-market approval from Health Canada before they can be legally sold. This requires a Site Licence and Product Licence.

I. Site Licence requirements

1. Pursuant to section 28 of the regulations, an application for a site licence must contain the following information:

• the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant
• a statement specifying which one or more of the activities of manufacturing, packaging, labelling or importing the applicant is proposing to conduct
• if the applicant is proposing to manufacture, package or label a natural health product, the address of each building in which each activity is proposed to be conducted;
• if the applicant is proposing to import a natural health product, the address of each building in which that natural health product is proposed to be stored
• for each activity specified under paragraph (b), a statement indicating whether or not the applicant is proposing to conduct the activity in respect of a natural health product in sterile dosage form;

Pursuant to section 35 of the Regulations, the site licence expires on the first anniversary of the day on which it was issued, unless renewed in accordance with section 36 of the Natural Health Products Regulations.

2. The following forms and documents to apply for site licence must be transmitted to theNatural and Non-prescription Health Products Directorate (NNHPD):

• Site Licence Application (SLA) Form
• Designated Party Authorization (DPA) Form: applicable when applicants who have designated a third-party person to file a submission on their behalf. This form must be resubmitted with each application and/or when the designated party changes.
• Pursuant to Part 3 of the Regulations, evidence of Good Manufacturing Practices compliance(1).

II. Product Licence requirements

Pursuant to section 5 of the Natural Health Products Regulations, an application for a product licence must contain the following elements:

• the name, address and telephone number, and if applicable, the facsimile number and electronic mail address of the applicant;
• If the address is not a Canadian address,the same elements are required for the applicant’s representative in Canada;
• for each medicinal ingredient of the natural health product:
  • a. proper name and its common name,
  • b. quantity per dosage unit,
  • c. potency, (if applicable)
  • d. description of its source material, and
  • e. statement indicating whether it is synthetically manufactured;
• a qualitative list of the non-medicinal ingredients that are proposed for the product and for each ingredient listed, a statement that indicates the purpose of the ingredient;
• each brand name under which the product is proposed to be sold;
• the recommended conditions of use for the product;
• information that demonstrates the safety and efficacy of the product when it is used in accordance with the recommended conditions of use;
• the text of each label that is proposed to be used in conjunction with the product;
• a copy of the specifications to which the natural health product will comply; and
• one of the following attestations filled in by the applicant:
  a. If the product is imported, an attestation that the product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the requirements of Good manufacturing Practices.
  b. If the product is not imported, an attestation that the product will be manufactured, packaged, labelled, distributed and stored in accordance with requirements of Good Manufacturing Practices.

After it has been decided that the product is safe and of high quality, Health Canada issues a product licence along with an eight-digit Natural Product Number (NPN), which must appear on the label.

References:

1. Good Manufactering Practices, Part 3, Section 43 of the Natural HealthRegulations, see https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/page-5.html#docCont

I. Vitamin and minerals

• - Vitamins and minerals areregulated as a sub-set of drugs, under the Natural Health product Regulations.
• A vitamin means the following (D.01.002 (1) Food and Drugs Regulations):
  • vitamin A;vitamin D;vitamin E;vitamin K;vitamin C;thiamin, thiamine or vitamin B1;riboflavin or vitamin B2;niacin;vitamin B6; folacin or folate;vitamin B12;pantothenic acid or pantothenate;biotin; andcholine.
• Minerals mean the following (D.02.001 (1) Food and Drugs Regulations):
  sodium;potassium;calcium;phosphorus;magnesium; iron;zinc;iodide;chloride;copper;fluoride; manganese;chromium;selenium;cobalt;molybdenum; tin;vanadium;silicon;nickel.
• They come in the form of pills, chewable tablets, powders, and liquids.
• Specific RDI, Estimated Average Requirements (EARs), and Adequate Intakes (AIs) levels are stablished for men, women, pregnant and breastfeeding women and 4 different age groups of children on Health Canada Website.(2)

II. Probiotics

• Pursuant to the natural health product regulations, probiotics are defined by as “a monoculture or mixed culture of live microorganisms that benefit the microbiota to humans.”
• Health Canada has developed ‘The Probiotic monograph’ which includes detailed information on acceptable health claims, associated doses, source materials and required risk information related to probiotics. (3)

III. Nutritional Supplements

• Pursuant to B.01.001(1) of the Food and Drug Regulations,nutritional supplements are “a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients.”
• The compositional requirements for a nutritional supplement are set out in B.24.201 of the Food and Drug Regulations. These differ depending on the Calories per serving provided by the nutritional supplement.(4)

References:

• 2. Dietary Reference Intakes, see https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/dietary-reference-intakes/tables/reference-values-vitamins-dietary-reference-intakes-tables-2005.html
• 3. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=probio
• 4. https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-84.html#docCont

I. General Labelling Requirements

The outer and inner label must contain a principal display panel.

Pursuant to section 93 of the Natural Product Regulations, the inner and outer labels shall show the following information:

a. On the principal display panel,

• a brand name,
• product number,
• dosage form,
• if it is sterile, the words “sterile”
• the net amount in the immediate container in terms of weight, measure or number

b. On any panel,

• the name and address of the product licence holder;
• if the product is imported, the name and address of the importer;
• the common name of each medicinal ingredient that it contains;
• the proper name of each medicinal ingredient it contains, but only if the proper name is not the chemical name;
• recommended use or purpose;
• recommended route of administration;
• recommended dose;
• recommended duration of use, if any;
• its risk information including cautions, warnings, contra-indications or known adverse reactions associated with its use;
• recommended storage conditions, if any;
• lot number;
• expiry date;
• a description of the source material of each medicinal ingredient that it contains;

II. Small Package Labelling

Pursuant to section 94 of the Regulations, special labelling requirements apply tosmall packages such as multiple-dose packs and single-dose packs.

I. Health claims

• A health claim is optional for food. However, when it is made, it must be truthful and not misleading (Subsection 5(1) of the Food and Drugs Act (FDA)). This information must be based on Scientific evidence.
• - Claims about diseases and health conditions listed in Schedule A of the FDA cannot be directed to the general public unless authorized in regulations. (5)

II. Function claims:

• Function claims must be based on scientific evidence in order to validate the claim prior to its use on food labels or in advertisements. These elements must comply with Food and Drugs Act and Regulations.
• - In addition, manufacturers areencouraged to contact the Food Directorate of Health Canada for advice regarding the acceptability of function claims on food products prior to their use. Acceptable Claims will be added to the Table of Acceptable Food or Food Constituent Function Claims. (6)
• Nutrient function claims must be present in both English and French unless the product is subject to a bilingual labelling exemption. [B.01.311(5) and B.01.012(3) or (7), Food and Drugs Regulations]. They may include nutrients such as vitamins and minerals, carbohydrate, fat, protein, fatty acids, sugars and the vitamins and minerals listed in Division D, Food and Drug Regulations.

References:

• 5. Appendix A – Statutory Provisions, Food and DrugsAct (1985), see https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-schedule-section-3-food-drugs-act.html
• 6. Acceptable function claims table,see https://www.inspection.gc.ca/food-label-requirements/labelling/industry/health-claims-on-food-labels/eng/1392834838383/1392834887794?chap=8#s13c8/li>