Are You Ready to Comply with the New NHP Labelling Requirements?

1.   Product Facts Table (PFT)

As mentioned, the most significant update was the introduction of a new table to display important information. Previously, Health Canada did not require NHPs to have a specified table format as is required for foods (i.e., the Nutrition Facts Table).

Now, important product information is required on the NHP label in the format of a standardized facts table called a Product Facts Table (PFT).

There are some exemptions, such as products in very small packages, those that are low-risk, and those that are to be used within a day or less, and those that contain 3 dosage units maximum.

The Product Facts Table must display the title (“Product Facts Table/Info-produit” with the following headings, and information under each – either in a bilingual table, or as one English, one French separately:

• Medicinal Ingredients
  • Quantitative list of each medicinal ingredient, by its proper name or by common name if the proper name is the chemical name, per dosage unit and, if any, the authorized potency
  • Description of the source material of each medicinal ingredient
• Uses
  • At least one of the recommended uses or purposes of the NHP – this is sometimes known as “health claim” or “product claim”
• Warnings
  • Risk information of the NHP, including any cautions, warnings, contra-indications or known adverse reactions associated with its use, approved as part of the product’s licence
  • If the product contains a food allergen, gluten, or added sulphites, “Allergen(s):” in bold, followed by the food allergen source, gluten source and added sulphites statement;
  • If the product contains aspartame, a bolded “Contains aspartame” statement.
• Directions
  • Recommended dose and duration of use
• Other Information
  • Recommended storage conditions
• Non-Medicinal Ingredients
  • Qualitative list by common name of all non-medicinal ingredients
  • If applicable, a statement on the quantity of mercury, or any of its salts or derivatives, contained in the NHP
• Questions?
  • Phone number, email, or website address/URL of a contact person representing the NHP product licence holder that lets customers report problems or ask questions

2.   Labelling of food allergens, gluten, added sulphites, and aspartame

 To help Canadians have clearer information in allergens, NHP labels now must display a statement on the label if the product contains:

• A priority food allergen (e.g. mustard, sesame)
• Gluten or added sulphites
• A food allergen source
• A gluten source or added sulphites.
• Aspartame

3.   Clearly and prominently displayed label text

The amendments aim to make all regulatory label text more legible (including Product Facts Table). This includes minimum font size, required font type, and contrast.

There are some exemptions which are based on risk, such as marketing information, and those with very small packages, or that must be used within one day, or those that contain 3 dosage units maximum.

4.   Modernized contact information

To update the ways companies can be contacted, manufacturers and importers must list an email address, phone number, or website URL instead of the previously required postal/mailing address.

This will enable consumers to contact brands for questions or to report concerns.