Amendments to the Natural Health Products Regulations will implement new labeling requirements for natural health products (“NHPs”), including a product information table and revised allergen labelling.
Health Canada’s stated goal with the new requirements is to make it easier for consumers and healthcare professionals to find, read and compare important safety information about NHPs. According to Health Canada, inadequate communication of key information on NHP labels can lead to incorrect purchases or uses and preventable harms, including delayed treatment.
The new labeling requirements will come into effect three years after the registration of the Regulations Amending the Natural Health Products Regulations, but NHPs that are licensed before that date will have an additional three-year transition period to meet the new labeling requirements (for a total of six years before the new labeling requirements are met for currently registered products).
Summary of new requirements
The Amendments will implement the following four main labeling requirements:
- Product Information Table Certain important product information will need to be contained in a table in a standardized format, including:
- medicinal and non-medicinal ingredients,
- uses,
- warnings,
- manual,
- storage conditions, and
- contact information for questions.
An example of a product fact table is shown below1:
If the NHP label is too small to contain the table in a standard format, some deviations from the table content will be permitted (e.g., displaying nonmedicinal ingredients elsewhere on the label or on a leaflet, leaflet packaging or a website) .
An NHP will be exempt from the requirement to display a product information table if it meets certain risk-based criteria, including:
- having an available surface of 90 cm2 or less for the label,
- be intended for use within one day or less,
- containing three doses or less per package,
- or having only a localized effect and applied to the skin or in the mouth (eg throat lozenges, fluoridated toothpastes and topical aromatherapy products).
The requirement for a product information table for NHPs aligns with existing similar requirements for over-the-counter drugs.
- Allergen Labeling NHPs that list food allergens, gluten, added sulphites and/or aspartame on their labels as ingredients will need to include a bold source statement (eg.Allergens: Milk“) in the “Warnings” section of the product information table (or elsewhere on the label if the NHP is exempt from the product information table requirement). harmonizes with similar existing requirements for the labeling of food allergen sources.
- Legibility To improve the legibility of prescribed text, most statements, information or declarations that must appear on NHP labels under the regulations must be at least 6 point (or 5.5 point, if condensed). This text should be a single color, visually equivalent to 100% solid black (i.e. dark blue, green, brown or purple) and contrast against a uniform white or neutral background with maximum color tint by 5%. There are exceptions to these requirements for NHPs with small labels (area of 90 cm2 or less) and those intended for use within one day or less or containing three doses or less per package. Additionally, 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 manufacturer or importer of NHPs by allowing the display of an email address, telephone number or web address in the information table on the product (or elsewhere on the label if the NHP is exempt from the product facts table requirement), instead of a mailing address.
In addition to the new labeling requirements described above, amendments to the Natural Health Products Regulations remove safety packaging requirements for certain NHPs, such as sunscreens and other topical products, effective immediately.
Fasken’s Life Sciences team has considerable expertise in advising the pharmaceutical and natural health product industries on labeling and other compliance issues and is available to advise them on amendments to the natural health products.
See: Health Canada guidance document: Labeling of natural health products; Regulations Amending the Natural Health Products Regulations: SOR/2022-146
Footnote
1 Health Canada guidance document: Labeling of natural health products
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.
