Boring day today, so I asked "what problem does Health Canada have with antimicrobial coated HVAC filters?"
Health Canada, through its Pest Management Regulatory Agency (PMRA), had concerns about ZenGUARD™ HVAC filter coating's potential health and environmental impacts, requiring a rigorous review under the Pest Control Products Act, which led to Zentek withdrawing its submission in October 2024, due to the lengthy PMRA review timeline not aligning with Innovative Solutions Canada funding requirements. Additionally, the coating contains per- and polyfluoroalkyl substances (PFAS) — known as "forever chemicals" with potential health effects on the liver, kidneys, and immune system — raising environmental concerns for the Government of Canada. Zentek has since shifted its strategy to market the filter as a Class I medical device, allowing them to bypass the PMRA's pest control regulations and proceed with sales under medical device licensing.
Regulatory Challenges
Pest Control Products Act:
The PMRA regulates products that control pests, which included the ZenGUARD™ coating for its claimed antiviral properties.
Lengthy Review Process:
The PMRA's review of the product could take up to 22 months, which was far longer than the timeline required for Zentek to meet its Innovative Solutions Canada (ISC) funding commitments, forcing the company to withdraw its submission.
PFAS Presence:
The ZenGUARD™ coating includes PFAS, which are environmental pollutants with potential health risks.
Zentek's Strategy Shift
Withdrawing PMRA Submission:
On October 31, 2024, Zentek withdrew its PMRA submission for ZenGUARD™ Enhanced Air Filters, effectively ending the pest control product review process.
Marketing as a Medical Device:
Zentek then announced plans to market the ZenGUARD™ Enhanced Air Filters as a Class I medical device, which falls under different regulations.
Bypassing PMRA:
By reclassifying the product as a medical device, Zentek can avoid the PMRA's lengthy pest control review and proceed with sales under its existing Medical Device Establishment Licence (MDEL).
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