For many businesses, the COVID-19 pandemic saw the advent of new sources of demand for sanitizing products for personal use or in public environments, stimulating the growth of anti-microbial claims being made in relation to existing products or the development of new products making such claims. From UV disinfecting wands and air filters for the home to disinfecting sprays for high-touch surfaces in public spaces, the demand is there and the market looks to be here to stay.
From a business perspective, widely advertising any and all anti-microbial properties a product may have to capitalize on the market potential of these types of products makes perfect sense. However, improper anti-microbial claims may trigger compliance issues for your business. Among other issues, consumer products generally and health products in particular are classified based upon how the product is “manufactured, sold or represented for use.” An anti-microbial claim, e.g., “useful against COVID-19” or “kills 99% of bacteria” may affect the regulatory classification of a product. In turn, the re-classification of a product may trigger a host of regulatory requirements, such as product approval, registration, labelling, site licencing etc. Where non-compliance is found, enforcement can include stop-sale or recall requirements until the claim is removed from the marketplace or the product is otherwise brought into compliance.
Health Canada is on high alert for products claiming to be effective against COVID-19 or more generally against any virus, bacteria, irritants, disease and the like and the regulatory landscape for these products is in rapid flux. The lines between different regulatory regimes have blurred, bringing to the fore novel questions of interpretation and application. Some examples of recent developments include:
- At the start of the pandemic, Health Canada issued an advisory regarding false or misleading claims to prevent, treat or cure COVID-19. Health Canada clearly signalled its intent to monitor all such claims, stating, “selling or advertising health products that make false or misleading claims is illegal. The Department takes this issue seriously and will not hesitate to use all mechanisms and tools at its disposal to stop these activities.” This increased monitoring of products making inappropriate anti-microbial claims is expected to extend to general anti-microbial claims.
- In March of this year, the Pest Management Regulatory Agency (PMRA) of Health Canada issued an information note that “treated articles”, i.e. consumer goods or goods sold business to business that claim to have anti-microbial properties based on the incorporation of a pest control agent in the good, may be themselves considered pest control products requiring registration under the Pest Control Products Act (PCPA).
- In June, the Interim order regulating certain UV radiation-emitting and ozone-generating devices under the Pest Control Products Act (June IO) came into effect. The June IO clarifies that certain ultraviolet radiation-emitting devices and ozone-generating devices claiming to kill bacteria and viruses are pest control products subject to the regulatory requirements of the PCPA, including the requirement to register and additional labelling requirements.
- By contrast, devices including UV wands and air filters, which make claims beyond simply killing microbes but also claim to prevent infection with COVID-19 or other illnesses are exempt from application of the June IO, but may be regulated as a medical device.
Judging from the rapid pace at which Health Canada is issuing iterative guidance and passing new legislation that introduces new regulatory requirements for products making these claims, Health Canada is clearly on the alert for products making anti-microbial claims.
One thing is certain in this evolving regulatory landscape: there is a high risk Health Canada will detect products making anti-microbial claims that may be non-compliant with one or more regulatory regimes triggered by the anti-microbial claim – be it for pest control products, medical devices, drugs or natural health products.
Please contact Monica Song or Yulia Konarski if you have any questions about how your product may be regulated in Canada.
