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Selling vitamins and supplements in Canada

In Canada, vitamins, minerals, probiotics and similar supplements are generally natural health products under the Natural Health Products Regulations, overseen by Health Canada's Natural and Non-prescription Health Products Directorate. Each product needs a product licence and an eight-digit NPN on the label, and sites that manufacture, package, label or import need a site licence.

Updated · Each section links to the official source it comes from

Main rules
Natural Health Products Regulations (SOR/2003-196)
Regulator
Health Canada, Natural and Non-prescription Health Products Directorate
Product
A product licence and an eight-digit NPN
Sites
A site licence for manufacturing, packaging, labelling or importing
Label language
Conditions of use, ingredients and storage in English and French
Serious adverse reactions
Reported within 15 days

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a natural health product, a supplemented food or a drug? Read more
  2. 2Does it have a product licence and an NPN? Read more
  3. 3Do the sites that make, package, label or import it hold a site licence? Read more
  4. 4Does the label carry the required information in English and French? Read more
  5. 5Is there a system for adverse reaction reports and recalls? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

What counts as a natural health product

Where supplements sit in Canadian law.

  • Schedule 1 of the Natural Health Products Regulations includes vitamins such as biotin, folate, niacin and vitamins A, B6, B12, C, D, E and K, as well as amino acids, essential fatty acids, minerals and probiotics.
  • Except where the NHP Regulations say otherwise, the Food and Drug Regulations do not apply to natural health products (section 3).
  • Foods with added vitamins, minerals, amino acids or other supplemental ingredients may instead be supplemented foods under Division 29 of the Food and Drug Regulations, with their own labelling rules.
  • Substances on Schedule 2, such as antibiotics and substances administered by puncturing the dermis, are excluded from being natural health products.

How we help: Compliant Always records which regime a product falls under and why, so the licence, label and records that follow are the right ones. Ask about this

Product licence and NPN

Market authorisation for each product.

  • No person shall sell a natural health product unless a product licence is issued for it (section 4).
  • An application gives Health Canada detailed information on the product, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use.
  • Once licensed, the label bears an eight-digit product licence number preceded by NPN, or DIN-HM for a homeopathic medicine.
  • Certain changes to a licensed product need an amended licence before the affected lot is sold; others are notified within 60 days (sections 11 and 12).

How we help: Compliant Always keeps the licence, the formula it covers and each amendment with the product, and shows when a formula change does not match the licence on file. Ask about this

Site licences and good manufacturing practices

Who may manufacture, package, label or import, and how.

  • No person shall manufacture, package, label or import a natural health product for sale without a site licence for that activity (section 27).
  • A site licence expires one year after it is issued unless renewed (section 35).
  • Good manufacturing practices cover specifications, premises, equipment, personnel, sanitation, operations, quality assurance, stability, records, lot samples and recall reporting.
  • Manufacturers, packagers, labellers, importers and distributors keep a system that permits the rapid and complete recall of each lot or batch sold (section 50); lot records are kept for one year after the product's expiry date (section 58).

How we help: Compliant Always keeps each site licence, its renewal date and the GMP evidence for each lot together, and shows what is expiring. Ask about this

Labelling

What the inner and outer labels show.

  • The principal display panel shows the brand name, product number, dosage form, "sterile" and "stérile" if sterile, and the net amount (section 93).
  • The outer label, or the inner label if there is none, shows the product licence holder or importer, route of administration, lot number, expiry date, and a table titled "Product Facts / Info-produit" or an accepted alternative (section 93.1).
  • The recommended conditions of use, the names of medicinal and non-medicinal ingredients, the source material of a medicinal ingredient and storage conditions are shown in English and French (section 87).
  • Food allergen sources, gluten sources and added sulphites are shown in the prescribed manner (sections 91.1 to 91.4).

How we help: Compliant Always reads your label against the information the licence and the regulations call for, in both languages, and flags what is missing. Ask about this

Adverse reactions and recalls

What a licensee reports after the product is on sale.

  • A licensee reports each serious adverse reaction occurring inside Canada, and each serious unexpected adverse reaction inside or outside Canada, within 15 days of becoming aware of it (section 24).
  • A licensee prepares an annual summary report analysing adverse reactions.
  • A licensee who starts a recall gives the Minister the required information within three days (section 25).
  • Licensees keep records of the products they sell (section 23).

How we help: Compliant Always keeps adverse reaction records, annual summaries and recall documents with the product and lot, dated. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Product licence holderThe licence, the label, adverse reaction reports, annual summaries and recall reporting.Licence, formula, label and reports kept together and dated.
Manufacturer, packager or labellerA site licence and good manufacturing practices for its activity.Site licence and GMP records kept current, with renewals in view.
ImporterA site licence to import, GMP records and the recall system.Suppliers' certificates and lot records read and dated before goods arrive.
DistributorRecords at the storage site and the ability to recall each lot.Lot records ready when a recall or a customer asks.

Provinces and territories

The federal Acts and regulations in these guides apply across Canada. Provincial regulations may add labelling requirements for products sold within a province, and Quebec has additional requirements on the use of French on products marketed there.

Alcohol is largely provincial: provincial and territorial liquor boards set their own requirements, and liquor imported into a province is consigned to the provincial body authorised to sell it.

Questions businesses ask

Are vitamins and supplements regulated as food in Canada?
Generally not. Vitamins, minerals, amino acids, essential fatty acids and probiotics are generally natural health products under the Natural Health Products Regulations. Foods with added supplemental ingredients may be supplemented foods under the Food and Drug Regulations instead.
Do I need a licence to sell a supplement in Canada?
Yes. No person shall sell a natural health product unless a product licence has been issued for it. Health Canada assesses information on its medicinal ingredients, source, potency, non-medicinal ingredients and recommended use.
What is an NPN?
The Natural Product Number: an eight-digit product licence number preceded by the letters NPN, shown on the label of a licensed natural health product. Homeopathic medicines carry DIN-HM instead.
Who needs a natural health product site licence?
Anyone who manufactures, packages, labels or imports a natural health product for sale. Sites must have procedures for distribution records and recalls and meet good manufacturing practice requirements.
How long is a site licence valid?
A site licence expires on the first anniversary of the day it was issued unless it is renewed under section 36 of the Natural Health Products Regulations.
Do supplement labels have to be bilingual in Canada?
Largely. The recommended conditions of use, ingredient names, the source of medicinal ingredients and storage conditions are shown in English and French, and the Product Facts table is bilingual, titled "Product Facts / Info-produit", or given as two tables, one in each language.
What goes on the front of a natural health product label?
The brand name, the product number, the dosage form, "sterile" and "stérile" if the product is sterile, and the net amount in the immediate container.
When must adverse reactions be reported?
Within 15 days of the licensee becoming aware of a serious adverse reaction in Canada, or a serious unexpected adverse reaction inside or outside Canada. The licensee also prepares an annual summary report.
How quickly must a supplement recall be reported?
A licensee, manufacturer, importer or distributor who starts a recall gives the Minister the required information within three days after the day the recall starts.
Are good manufacturing practices required for supplements?
Yes. GMP under the Natural Health Products Regulations covers specifications, premises, equipment, personnel, sanitation, operations, quality assurance, stability, records, lot samples and recall reporting.
How does Compliant Always help with selling in Canada?
Our team reads the rules for the markets you sell in, including Canada's federal rules and the bilingual labelling they share. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Canada and what your paperwork needs to show.

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