By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
Health Canada’s Natural Health Products regulations are changing to include new plain language labeling requirements. Let Dell Tech assist you with navigating Natural Health Product labeling and compliance.
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Natural Health Products Regulations: Changes to Plain Language Labeling
Here’s a quick summary of the changes Health Canada is making to NHP regulations:
- Implementation of the Product Fact Tables (PFT)
- NHPs are currently required to list important information on the product label, but the PFT brings a new standardized format of presenting information
- Revisions to existing formatting requirements
- This is intended to improve current legibility requirements by providing font size and type, and contrast restrictions to optimize the label surface area
- New allergen labeling requirements
- Labelling of food allergens, gluten, sulphites, and aspartame
- Tamper evidence alignment under CUSMA
- The mandatory requirement for security seals will go away for Hand Sanitizers and other topical use NHPs. It remains for products that are ingestible, inhalable or insertable, mouthwashes and eye care products
- Modernized contact information for manufacturers or importers
- The change will replace the current requirement of a postal address with an e-mail address, telephone number, or website
The labelling guidance document, which can be found on the Government of Canada website, also states a requirement for cautions, warnings, contraindications or known adverse reactions associated with the product.
The Regulatory Impact Analysis Statement (RIAS) suggests that Health Canada will be coordinating monograph updates with these new labelling requirements and simplifying warnings and precautions as part of the monograph review. The expected completion of all monographs is within the next three (3) years.
How does this NHP labeling change affect new products?
NEW PRODUCTS: The specific parts of the regulation update that relates to PLL are coming into force with a three (3) year transition period after which all new products must comply (July 6, 2025).
How does this NHP labeling change affect existing products?
EXISTING PRODUCTS: Implementation of PLL regulation changes for existing products need to take place on a schedule that will ensure full compliance to the level of retail within the next six (6) years. All those with an existing NHP product licence must comply (to the level of retail) by July 6, 2028.
How can Dell Tech help with NLP labeling requirements?
Let Dell tech help you navigate the new labelling requirements and ensure you remain in compliance with the new regulations. Our regulatory specialists can be your direct contact with Health Canada to questions during your product’s review period.
Contact:
Dell Tech Laboratories
Jacqui Jenskey
Director of Regulatory Affairs
519-858-5021 x 2028
jjenskey@delltech.com
Joanna Chudyk, M. Sc.
Regulatory Affairs Specialist
joanna@delltech.com
