Labelling your natural health product for Canada.
One of the most common questions from clients looking to enter the Canadian natural health market is, “What do I need to include on my label?” Most prospective sellers are familiar with the requirement for French text on Canadian labels, but a common misconception is that label content (claims, ingredient listings, graphics) may remain the same as is used for the product in other markets. To the contrary, Health Canada strictly regulates label content for natural health products, and, in addition to French text, specific labelling regulations need to be met before selling a natural health product (NHP) in Canada.
Labels are one of the first things consumers use to compare products and guide purchasing decisions, and Health Canada regulates the important information to help consumers make informed choices. One regulation very different between Canada and the USA is Health Canada’s requirement for full disclosure of active medicinal ingredients, which must be listed in full with quantities and source materials on Canadian product labels: Proprietary blends are not permitted in Canada without full disclosure of their constituents.
It can be challenging to interpret Health Canada’s labelling guidance to understand the exact requirements for a natural health product label, but here is a quick checklist of the required elements, where applicable, each of which needs to be in line with the information assessed and approved by Health Canada during product licensing:
- Product brand name
- Natural Product Number (NPN) (an eight-digit number assigned by Health Canada after the product has been reviewed and approved for safety and efficacy)
- Dosage form (e.g. cream, spray, capsules)
- The word “sterile,” if applicable
- Quantity of product in container (e.g. 5 mg, 5 %, or 5 capsules)
- Name and address of product license holder
- Name and address of importer
- List of medicinal ingredients and associated quantities and source materials [e.g. Echinacea angustifolia (Echinacea) (root)…..1 mg]
- List of non-medicinal ingredients
- Purpose or claims approved by Health Canada (e.g. “For use in treatment of X condition”)
- Route of administration (e.g. oral, sublingual, topical)
- Dose (e.g. “Take 1 capsule once daily”)
- Duration of use (e.g. “Do not use product for more than one month”)
- Cautions and warnings (e.g. “Do not use product if taking medication”)
- Contraindications (conditions or situations where a product should not be used e.g. “Do not use if pregnant”)
- Adverse reactions (side effects that can occur after using a product e.g. “May cause upset stomach”)
- Special storage conditions (e.g. “Store product in freezing temperatures below 0°C”)
- Lot number
- Expiry date
- Security features (e.g. “Do not consume if seal is broken”)
In addition to the requirements outlined above, there are also special regulations for small packages, extremely small packages, and for certain products, such as those in pressurized containers. If the information on the above checklist can’t be included in full on your product label in both English and French due to space constraints (a common concern when transitioning to a Canadian natural health product label from a US Dietary Supplement label), it is possible that a separate set of regulations may be applied to reduce the amount of required text. Our team can advise on compliant use of labelling regulations for small packages and extremely small packages, as well as provide strategies for fitting all required text on a product label being prepared in accordance with the regulations for normal packages.
Label compliance can be overwhelming, but it doesn’t need to be. Our consultants have created and reviewed thousands of natural health product labels. We can assess existing labels for compliance with Health Canada’s regulation and help you create label content in line with your license, then translate to French and ensure your product is ready to sell in Canada. Contact us for more information.