New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of June 21, 2022. The purpose of these amendments to the label requirements is to better align Natural Health Products (NHPs) with comparable Canadian non-prescription drug labelling requirements, as well as with labelling requirements in other countries and jurisdictions such as the United States, and the European Union.

The updated requirements are as follows:

Product Facts Table

A Product Facts Table (PFT) is now required with the following headings:

• Medicinal ingredient(s).
• Uses.
• Warnings.
• Directions.
• Other information.
• Non-Medicinal ingredient(s).
• Questions?

The information must be presented in either a bilingual table or two unilingual tables (one in French and one in English).
There are flexibilities in place if the NHP label is too small to accommodate a PFT, such as changing font size, or inclusion of a leaflet in the packaging instead of printing on the label.

Labelling of food allergens, gluten, sulphites

If a product contains a food allergy, gluten, or sulphite, it must be disclosed on the product’s label along with a statement of the source of the food allergen, gluten, or sulphite. In addition, aspartame must also be disclosed on the product’s label.

Clearly and prominently displayed label text

Product labels are also subject to improved legibility requirements, including:

• Minimum font size (e.g. non-medicinal ingredients at least 5.5 point font, medicinal ingredients at least 6 points)
• Allowed font types (e.g. sans serif)
• Contrast

Exemptions

• Very small packages.
• Products with a short duration of use (one day’s use or less).
• Products with multiple or single-dose packs that provide 3 or fewer doses.
• Low-risk products.

Modernized contact information

Products are required to display an email address, telephone number, or website address within the PFT or elsewhere on the label if a PFT is not required, instead of a postal address.

Transition Period:

The labelling requirements stated that all NHPs licenced after July 06, 2022, need to comply with the amended NHPR within three years by July 06, 2025. If an NHP has an NPN licenced before July 06, 2022, it will have an additional three-year transition period (until July 06, 2028) to comply. However, Health Canada recommends that all NPN holders comply with the amended regulations as soon as possible.

Next Steps:

Reach out to dicentra for NHP labelling support now.