Amendments to the Natural Health Products Regulations will implement new labelling requirements for natural health products (“NHPs”)
Health Canada’s stated goal with the new requirements is to make it easier for consumers and healthcare professionals to locate, read, and compare important safety information about NHPs..
The new labelling requirements will come into force three years after registration of the Regulations Amending the Natural Health Products Regulations (SOR/2022-146 June 21, 2022), but NHPs that are licensed prior to that date will have an additional three-year transition period within which to meet the new labelling requirements (for a total of six years before the new labelling requirements must be met for currently licensed products).
Summary of the new requirements
The amendments will implement the following four key labelling requirements:
- Product Facts Table
Certain important product information will need to be contained within a table in a standardized format, including:
- medicinal and non-medicinal ingredients,
- uses,
- warnings,
- directions for use,
- storage conditions, and
- contact information for questions.
If the NHP label is too small to accommodate the table in standard format, certain variances to the contents of the table will be permitted (e.g., display of non-medicinal ingredients elsewhere on the label or on a leaflet, package insert, or website).
An NHP will be exempt from the requirement to display a product facts table if it meets certain risk-based criteria, including:
- having an available surface area of 90 cm2 or less for the label,
- being intended for use within one day or less,
- containing three or fewer dosages per package,
- or having only a localized effect and applied on the skin or in the mouth (e.g., throat lozenges, fluoride toothpastes, and topical aromatherapy products).
The requirement for a product facts table on NHPs aligns with existing similar requirements applicable to non-prescription drugs.
- Allergen Labelling
NHPs that list food allergens, gluten, added sulphites and/or aspartame on their labels as ingredients will be required to include a source statement in bold (e.g., “Allergens: Milk”) in the “Warnings” section of the product facts table (or elsewhere on the label if the NHP is exempt from the product facts table requirement). This new requirement for NHPs aligns with similar existing requirements for allergen source labelling of foods.
- Legibility
To improve the legibility of prescribed text, most statements, information, or declarations that are required by the regulations to be shown on NHP labels must be in a type size of at least 6 points (or 5.5 points, if condensed). Such text must be a single colour, visually equivalent to 100% solid black (i.e., dark blue, green, brown, or purple) and be contrasted with a white or uniform neutral background with maximum 5% colour tint.
There are exceptions to these requirements for NHPs with small labels (surface area of 90 cm2 or less) and those intended for use within a day or less or containing three or fewer dosages per package. In addition, lot numbers, product numbers, brand names, and advertising claims are not subject to these new requirements.
- Contact Information
The amendments modernize the contact information that must be provided by the NHP manufacturer or importer by permitting display of an e-mail address, telephone number, or web address within the product facts table (or elsewhere on the label if the NHP is exempt from the product facts table requirement), instead of a postal address.
In addition to the new labelling requirements described above, the amendments to the Natural Health Products Regulations remove security packaging requirements for certain NHPs, such as sunscreens and other topical products, with immediate effect.
For more information or to discuss a particular matter please contact us.