Part INoticePublished: June 26, 2021

Improved Labelling for Natural Health Products

Canada Gazette, Part I, Volume 155, Number 26: Regulations Amending the Natural Health Products Regulations

Health Canada proposed amendments to the Natural Health Products Regulations to require standardized, more legible labels — including a bilingual Product Facts table, bolded allergen/gluten and aspartame statements, minimum font and contrast rules, and modern contact options (email/phone/website). The proposal includes exemptions for very small, short‑use or low‑risk products and sets a multi‑year coming‑into‑force/transition approach for industry compliance.

Published
June 26, 2021
Department
Unavailable
Section
REGULATORY IMPACT ANALYSIS STATEMENT
Comment deadline
September 4, 2021
Effective date
Unavailable
Publication part
Part I

Summary

Summary#

This is a proposed set of changes from Health Canada to the Natural Health Products Regulations. The changes would require clearer, standardized labels for natural health products — like a bilingual "Product Facts" table, bigger type, allergy warnings, and modern contact options — with most label rules coming into force after a transition period.

What it does#

  • Introduces a bilingual standardized table on product labels called a Product Facts table.
  • Requires a bolded allergy statement if the product contains a priority food allergen or gluten, and a bolded “Contains aspartame” statement if applicable.
  • Sets minimum legibility rules for label text (font style, contrast and minimum type sizes: 6 points for most text or 5.5 points if condensed; 5.5 points for non‑medicinal ingredients or 5 points if condensed).
  • Allows a manufacturer or importer to show an e-mail address, telephone number, or website address on the label instead of a postal address.
  • Creates exemptions and flexible options so very small packages, low‑risk items, short‑use products, and products with few dosage units do not have to show the full Product Facts table. Key thresholds are: outer label area 77.5 cm², duration of use 1 day or less, and 3 or fewer dosage units.
  • Gives details about where each required item (medicinal ingredients, uses, warnings, directions, storage, non‑medicinal ingredients, contact) should appear within the table and what can be moved to a leaflet or website if space is tight.
  • Makes a few clarifying edits to other parts of the Natural Health Products Regulations (these are described as not creating new obligations).
  • Timing: clarifying edits would start when registered; the main labelling rules would come into force 3 years after registration. Products already on the market would have an extra 3‑year transition (so up to 6 years total before all existing labels must comply). The Canada Gazette notice set a public comment window of 70 days after publication (June 26, 2021).

Who's affected#

  • Consumers who buy natural health products (NHPs), especially people who rely on labels to compare products — for example, seniors and people with allergies.
  • Manufacturers, importers, packagers, labellers, distributors and retailers of NHPs. Health Canada used 50,000 stock keeping units (SKUs) as an example in its cost estimate.
  • Small businesses: Health Canada estimated about 2,847 small businesses could be affected and included flexibilities aimed at reducing their costs.
  • Health professionals and poison control centres may see changes in the ease of identifying product contents and reporting problems.

Why it matters#

  • Clearer, consistent labels make it easier for shoppers to compare products and pick the right one. That can reduce accidental misuse, unwanted drug interactions, and allergic reactions.
  • Health Canada’s cost‑benefit analysis estimated total monetized benefits of about $320 million (present value over 15 years), and total incremental costs of about $159 million, for a net benefit of $162 million ($18 million annualized). These are Health Canada’s estimates and include assumptions about future behaviour.
  • Allowing email, phone or web contact on labels should make it easier for consumers to get answers or report adverse reactions quickly. That could improve safety monitoring.
  • The rules include several exemptions and a long transition period (3 + 3 years) to reduce the risk of supply disruptions, extra waste from relabelling, and pressure on small businesses.
  • This is a proposal published in the Canada Gazette, Part I; it was open for comment (see the notice for the exact deadline). The changes are not law until finalized.

Key topics

Natural Health Products RegulationsNHPRFood and Drugs ActProduct Facts tableDrug Facts tableaspartameglutenmercuryNatural health productsplain language labellinglabel legibilityadverse reaction reportingCompendium of MonographsHealth Canada

Source: Canada Gazette

Official source