This month Health Canada released the consultation document on their proposed model in Canada for regulation of “self-care” products. The aim of the new approach is to regulate this group of products in a consistent manner and approach, and remove some of the challenges of the current system.
Health Canada defines self-care products as those that are available directly without a prescription from a physician; the category is made up of:
Cosmetics, which are used for cleaning, improving or altering the complexion, skin, hair or teeth, such as moisturizing creams, deodorants, and shampoos;
Natural health products, which include vitamin and mineral supplements, probiotics, herbal preparations, homeopathic remedies, and traditional medicines; and
Non-prescription drugs, also commonly referred to as “over-the-counter drugs” which include products for pain relief, cold and flu symptoms, and allergy relief.
While Health Canada’s Food & Drugs Act govern the sale of these three categories of products, each subcategory is regulated under a separate set of regulations. This separate approach has been shown to create some inconsistencies with respect to requirements for pre-market review, allowable package claims, time to market and even costs for application review.
Health Canada’s proposed regulatory framework for self-care products will look to:
- revise the term “health claim” so that only those claims related to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition are subject to a pre-market review.
- introduce a risk-based approach where products with the same risk profile would be treated in a similar manner, thereby providing a level of oversight which directly corresponds to the risks posed by certain health products.
Health Canada’s Proposed Risk Classification System Would have 3-Risk Levels:
(1) Lower Risk Self-Care Products
Health Canada will set requirements that companies would need to meet to sell these products, including quality expectations. Exclusions would be set regarding which ingredients/products would not be eligible for inclusion into this lower risk group. Health Canada would not review claims or license these products. Products in this group such as cosmetics, toothpaste and vitamin and mineral products would not be permitted to make claims about the diagnosis, treatment, prevention, or mitigation of a disease or condition.
(2) Moderate Risk Self-Care Products
For products in this category such as laxatives, cough and cold products or pain relievers Health Canada may do some review and licensing based on evidence of safety and effectiveness published in a Health Canada monograph (labelling standard).
(3) Higher Risk Self-Care Products
This category would be limited to those self-care products that contain new or higher risk ingredients or make claims to treat serious medical conditions (such as cardiovascular disease). These products require more attention by Health Canada because the safety or failed efficacy of these products are a concern for some consumers. For higher-risk products, Health Canada would review and approve all products before they could legally be sold in Canada.
Q. How will the changes impact the industry?
A. Many additional products for self-care will no longer require review or approval before their sale in Canada. Companies would only be required to notify Health Canada that their product is now available for sale.
Link for consultation document: