The Natural and Non-prescription Health Products Directorate (NNHPD) has announced that they will be delaying Phase I and II of the changes to the Self-Care Products Framework. These changes were to implement Plain Language Labelling of natural health products (NHPs), non-prescription drugs, and cosmetics as well as simplify the application process of low-risk products. The NNHPD feels that these changes will streamline the application and labelling of the aforementioned products, ultimately updating old regulations in an attempt to minimize confusion as all three categories are governed separately.
The changes were planned to be implemented in the spring of 2019. However, the NNHPD has announced that the changes will not be implemented until spring of 2020. This decision came from feedback and task force meetings stemming from members in the industry who expressed concerns over these changes, that implementing them at this time would prove to be a challenge.
When the changes are implemented, they will come in the following three phases:
The goal of phase 1 is to simplify labels on natural health products to make them more consumer friendly and to ensure that consumers understand the products that they are using. This will introduce the “Product Facts” table along with a flexible version for products with smaller labels.
Phase 2 aims to make amendments to the Food and Drug Regulations so that products that are deemed “low-risk” can go through an expedited licensing process.
Phase 3 will introduce regulatory amendments to standards of evidence required for product applications, extending risk-based oversight (similar to Phase 2, but more all-encompassing of the application process), and lastly giving Health Canada the power to regulate label changes and recalls of on-shelf products.
The NNHPD feels that delaying the release of the new guidelines will allow the industry more time to prepare for the changes, as well as facilitate more time for members to provide feedback on the regulations.