Canadians use every day products like: cosmetic products for personal hygiene, pain relievers, vitamins, minerals, sunscreens, etc. All these products are called “self-care products”.
Self-Care products encompass cosmetic products, natural health products and non-prescription drug products. Canadians use self-care products to maintain their health, treat minor ailments or improve overall appearance. These products can be purchased without a doctor’s prescription from various pharmacies and/or supermarkets.
Even though these three categories of products are fitted under the same umbrella they fall under three different sets of regulations: Natural Health Products Regulations, Cosmetic Regulations and Food and Drug Regulations. Health Canada is proposing to prepare a new framework that treats equally substitutable products (from the three afore-mentioned areas) with similar risks. This new framework will remove current discrepancies between products and will not introduce new burdens to the industry. It will also permit Health Canada to recall any product that may pose a health risk to Canadians.
Health Canada proposes to prepare the self-care products framework in three phases which will include ample consultations with consumers, businesses, trade associations, etc.:
Phase One – Spring 2020 – will begin consultations regarding amending the Natural Health Product Regulations to improve the labeling of those products by aligning them with the labeling of drug products. The main areas of concern are: label standardized format, risk information, use of simple language.
Phase Two – Spring 2020 – will begin consultations regarding amending the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription/over-the-counter drugs. These include expedited pathways for lower-risk drug products.
Phase Three – Year 2021 – will begin consultations on regulatory amendments to address evidence standards for similar claims across all three self-care products categories, and extending risk-based regulatory oversight.
These proposals will align Canada with international regulatory actions and best practices in the United States, Europe and Australia.
The impact this self-care products framework will have on Canadians consists of helping consumers to make informed choices when selecting products, and will establish proportional risk-based rules applicable to all self-care products which will result in significant reductions in regulatory costs to the industry to bring new products on the market.
If this interests you, and you’d like to discuss how these updates could affect you and your products, please don’t hesitate to reach out to our team and see if maybe we can help develop a plan that is right for you! We’re here to help.