Health claims are integral to the success of Natural Health Products (NHPs) here in Canada. They provide products with a competitive edge in the marketplace and consumers with the information needed to choose the product that’s right for them.
What you may not know is that Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is currently looking to update the manner in which self-care products, including NHPs, cosmetics, and non-prescription drugs, are regulated.
To help ensure consumers have access to safe and effective self-care products across the board, a new risk-based approach is expected to be implemented within the next few years. This means that the evidence required to support certain health claims for NHPs may differ from the current standards.
The Current Process: Making Health Claims Outside of NNHPD Monographs
Under the current regulatory framework for NHPs, health claims can either be taken from the NNHPD’s pre-cleared information – called “monographs” – or, unique health claims can be proposed. The timelines for receiving your product licence vary, based partially on where your desired health claims are coming from:
60 days: Class I products (using claims from a single monograph)
90 days: Class II products (using claims from a combination of monographs)
210 days: Class III products (proposing unique claims outside of the monographs)
Many companies wish to have unique health claims for their products, giving them a competitive edge in the market. Using the NNHPD’s Pathway for Licencing Natural Health Products Making Modern Health Claims guidance document along with our 17 years of experience in successfully achieving unique product health claims, dicentra can help create a unique health claim for your NHP while compiling the appropriate evidence to put forth to the NNHPD to get that claim approved.
Upcoming Changes: A New Approach to Evaluating Proposed Health Claims
Once the new self-care regulatory framework is live, products will likely be reviewed with a new risk-based approach. This means that the evidence required to support certain health claims on NHPs will very likely differ from what we are used to now.
Since this newly proposed framework is still in the consultation phase, details remain limited and nothing has been set in stone. However, this also means that it remains unclear as to whether existing products and their health claims will be grandfathered – or excused – when the new self-care regulatory framework comes into play.
With a potentially more stringent review process and standards for scientific evidence for NHP health claims upon us, it is advisable to apply for your desired unique health claims as soon as possible to ensure the best chance of being grandfathered into the new regulations.
An Alternate Route for Making Claims Outside of NNHPD Monographs
If time is of the essence to bring your product to market, there may be the option to get your product licence as fast as possible with the intention of adding your desired unique health claims at a later date.
dicentra can perform a formula review to determine whether your product will be eligible for this route, and prepare and file a Class I or Class II product licence application for your product. While the application is under review, dicentra can simultaneously prepare an amendment to add new, unique health claims that fall outside of the monographs.
Once the product licence is received, the amendment to add unique health claims can be submitted. This way, you will be able to bring your product to market right away, while implementing a simple label update to add your new health claims once the amendment has been approved and added to your product licence.
Whether you’re looking to add a new health claim to your existing NHP or file a brand new application before the new self-care framework kicks in, dicentra can assist you with strategizing, substantiating your health claims, and preparing all required documentation for submission.
Get in touch with dicentra today to ensure your product’s unique health claims have the best chance of being grandfathered into the new regulations. You can find out more about the current status of the proposed self-care regulatory framework here.
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.