One of Health Canada’s largest initiatives in the past few years has been the Self-Care Framework, which implements a different approach to regulating products, that are purchased and applied directly by consumers, based on their level of perceived risk. While seeming a straightforward concept, Health Canada is struggling to amalgamate the myriad of self-care products under the same framework. While the current frameworks for cosmetics, Natural Health Products (NHPs), and Non-Prescription drugs are functioning adequately with separate rules, Health Canada is finding challenges to unify them into one regulatory structure as they desire.
Health Canada’s initial proposal of Self-Care Framework involved a multitude of changes being implemented all at the same time. There was pushback from the industry and now Health Canada has split the Self-Care Framework into three distinct phases to be rolled out on their own timelines to make the changes more manageable and make their progress more tangible:
Phase I: “Plain Language Labelling” (PLL) – Health Canada wants labels for self-care products (particularly NHPs) to be easily understandable to consumers. Proposals for PLL include making the language on the labels simpler and more understandable to Canadians and having a “Facts” Table on the label containing required information like ingredients (similar to Nutrition Facts Table seen on Canadian Food Labels). Other proposed changes include a minimum font size (to ensure greater legibility of labels) and having a specific strong contrast between the lettering and background (black-and-white contrast).
Phase II: “Non-Prescription Drug Incorporation into Framework” – Health Canada wants “over-the-counter” (OTC) drug to adopt the risk-based approach so that comparisons can be made possible between them and other self-care products that are deemed to have the same level of risk. This would actually necessitate amending certain portions of the Food & Drug Regulations. Health Canada also wants to determine how lower-risk products that are not OTC could have expedited pathways to licensing at this phase too.
Phase III: “Evidence Standards” – Health Canada wants to determine the evidence standards for health claims at this stage and try to have similar health claims have similar standards. These Evidence standards will be fundamental in the licensing system for the Self-Care Framework. Health Canada also wants to implement changes to the GMP requirements for self-care products. As well, Health Canada wants greater regulatory oversight powers over all self-care products such as the ability to force label changes or demand recalls. As with Phase II, there will have to be regulatory amendments to the Food and Drug Regulations again to make these changes legal.
While this Phased Approach was intended to be more manageable and have each phase completed before proceeding, Health Canada is finding it challenging to reach a satisfactory consensus and a completion of a Phase. Originally, Phase I and Phase II was supposed to be sent to Canada Gazette (the official newspaper of the Canadian government where proposed regulation is posted) Part 1 for publication for September 2019. However, Health Canada (specifically the Natural and Non-Prescription Health Directorate (NNHPD)) has recently announced that they will be delaying publishing either Phase in the Canadian Gazette until Spring 2020.
Despite this new Phased Approach was hoped to be more acceptable to the industry than the everything-at-once approach, many in the industry are feeling that the different phases are too interlaced together. Rolling out one phase first without having a significant effect on the future phase that hasn’t been released. In any case, the implementation of the Self-Care Framework is delayed for the time being, resulting in an ongoing process with several issues still to be resolved. Time will tell if Health Canada can maintain this Phased Approach for the Self-Care Framework in the future. Keep your eyes on dicentra’s News & Articles section for the latest happenings on the Self-Care Framework.
While the Self-Care Framework is being sorted out, dicentra can help prepare your cosmetics, NHPs, and non-prescription drug products for registration as well as ensure the labels of your products are compliant for sale in the Canadian market. We can help prepare the labels to be consistent with what is expected to be applicable to Plain Language Labelling (Phase 1 of the Self-Care Framework). Give us a call or reach out by email today!
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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.