Natural Health Product Labelling Rules

Summary#

Health Canada finalized the Regulations Amending the Natural Health Products Regulations (SOR/2022-146), registered June 21, 2022 and published July 6, 2022. The rules require clearer, standardized labelling for most natural health products (NHPs) and narrow which products must have tamper‑ or security‑packaging; most new labelling rules come into force in 3 years, with an extra 3‑year transition for already‑marketed products (a total of 6 years for existing products).

What it does#

• Requires a standardized “Product Facts / Info‑produit” table on most NHP labels. The table must list key items such as:
  • “Medicinal ingredients” (name and amount per dose) and source material.
  • “Uses”, “Warnings”, “Directions”, “Other information”, “Non‑medicinal ingredients” and a “Questions?” contact.
• Requires bolded allergen/gluten/added sulphites and aspartame statements when present. “Added sulphites” are treated as present when total is 10 p.p.m. or more.
• Sets minimum legibility rules:
  • Required text generally at least 6 points (or 5.5 points if condensed);
  • Non‑medicinal ingredients at least 5.5 points (or 5 points if condensed);
  • Single‑colour high‑contrast type (visual equivalent of solid black on light background).
• Lets some information be moved off the main table if space is tight:
  • Non‑medicinal ingredient lists, source descriptions or ingredient‑source details may be placed on a leaflet, package insert or website with a clear reference on the label.
  • Flexibilities apply only after minimum condensed type sizes are used.
• Exempts certain low‑risk or small products from the Product Facts table and some legibility rules, including products where the available label area is 90 cm² or less, products to be used within 1 day per label directions, products with 3 or fewer dosage units, and specific low‑risk categories (e.g., throat lozenges, aromatherapy, organotherapy, flower essences, some topical/localized products).
• Narrows the security‑packaging requirement so that only certain types must have security packaging: mouthwashes; products to be inhaled, ingested (other than lozenges) or inserted into the body; and ophthalmic products. This removes the universal requirement that previously covered most topicals (e.g., sunscreens).
• Clarifies and modernizes regulatory text in several places, for example:
  • Replaces required postal address on labels with a required telephone number, e‑mail or website contact for the product licence holder or importer.
  • Clarifies deadlines such as the ability for applicants to seek reconsideration within 30 days of a notice, and some notice periods of 90 days for suspension‑related responses.
  • Updates requirements for recall information, record keeping, returned product approval, and clinical trial authorizations.
• Timing:
  • Clarifying and security‑packaging changes come into force on registration (June 21, 2022).
  • Labelling changes come into force 3 years after registration, with marketed products given an additional 3‑year transition (total 6 years) to comply.

Who's affected#

• Manufacturers, packagers, labellers and importers of natural health products (vitamins, supplements, herbal remedies, some topical products, hand sanitizers, etc.).
• Distributors and retailers who handle packaged NHPs.
• Consumers who buy and use NHPs, including people with food allergies, gluten sensitivity, or who need easy‑to‑read labels (e.g., older adults).
• Health professionals who advise patients about NHPs (pharmacists, naturopaths, clinicians).
• Small businesses in the NHP sector (Health Canada estimates many small firms will bear a share of relabelling costs).
• It is unclear exactly how many individual product SKUs will change at once, but Health Canada used an analysis based on 50,000 SKUs to estimate impacts.

Why it matters#

• Easier to read, consistent labels should help consumers choose the right product and avoid accidental use of the wrong product. That can reduce allergic reactions, bad interactions with prescription medicines, and other preventable harms.
• Clearer allergen and gluten statements (and a threshold for added sulphites) make it simpler for people with allergies or intolerances to spot risks.
• Having an email, phone number or website on the label makes it faster for consumers and health professionals to ask questions or report problems.
• Narrowing security‑packaging rules for many topicals may reduce plastic use and packaging costs for some products.
• There will be costs for industry to redesign labels and, in some cases, change packaging. Health Canada’s analysis estimates overall monetized benefits and costs over 15 years (for example, benefits estimated at $292 million (present value) and costs $159 million (present value), for a net benefit of about $134 million PV), but those are the Department’s estimates and actual effects will vary by company and product.
• The long implementation timeline (labelling rules in 3 years with a total 6‑year window for current products) aims to give businesses time to adjust and avoid sudden supply or waste problems.