Background

On July 6^th, 2022, Health Canada published new labelling requirements under the Natural Health Products Regulations (NHPR). These changes are driven by a need to help consumers make informed choices and manage preventable harms through consistent, clear, and easy to understand product labels. The amendments also ensure alignment with rules that have already been established for comparable non-prescription drugs. Below is a summary of the key requirements.

Product Facts Table

A Product Facts Table (PFT) is now required on Natural Health Product (NHP) labels, in both English and French. The PFT must comply with formatting specifications and requires the following information:

• "Medicinal ingredient(s)"
• "Uses"
• "Warnings"
• "Directions"
• "Other Information"
• "Non-Medicinal Ingredient(s)"
• "Questions?"

Exemptions and flexibilities for the PFT are available under certain conditions.

Allergens, Gluten, Added Sulphites, and Aspartame

It is now mandatory for NHP labels to disclose any sources of food allergens, gluten, and added sulphites, under "Warnings”.

Additionally, for products using aspartame, a “Contains aspartame” statement is required.

Other considerations include grouping sugar-based ingredients together in brackets after the name “sugar(s)” in descending order by weight. This is a similar approach to food labels and will help consumers identify all sources of sugar added to an NHP.

Single-Entity Mineral Supplements

Confusion between the elemental and salt content of a mineral displayed on labels has previously led to dosing errors. With the new rules, labels for single-entity mineral supplements like iron or calcium products need the quantities of both the element and the salt on the principal display panel.

Formatting

To address issues with readability, the amendments include formatting specifications for all mandatory information on NHP labels. This includes set requirements for font type, font size, the position and style of the headings, spacing of the words, and contrast between font and background. Again, flexibilities are offered for certain labels such as for small packages.

Implementation Timelines

While Health Canada encourages the implementation of the improved labelling requirements as early as possible, the following transition periods are in place:

• NHPs licenced before June 21, 2025 have until June 22, 2028 to comply.
• NHPs licenced on or after June 21, 2025 have to comply immediately.

SGS Nutrasource offers technical label review services to ensure regulatory compliance for your product label and ease your transition from the old labeling requirements to the new. Learn how we can help you achieve label compliance according to the latest regulations.

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