On Thursday, September 21, 2023, representatives from dicentra attended the CHFA Now’s Regulatory Forum in Toronto in order to stay informed and be able to provide our clients, prospects, and audience with a summary of what is coming for our industry. Below is a comprehensive summary, and a dynamic Q&A video, outlining the topics discussed, along with the next steps and timelines for all interested parties.
According to the current regulations, the manufacture, and importation of single-use plastics (SUPs) such as checkout bags, cutlery, foodservice ware, ring carriers, stir sticks, and straws is now prohibited. Additionally, starting December 20, 2023, Health Canada will also ban the sale SUP checkout bags, cutlery, foodservice ware, stir sticks, and straws. On June 20, 2024, ring carriers and flexible straws packaged with beverage containers will also be included in the ban on sale.
During this session, Environment Canada announced its intent to release a stakeholder consultation on a new regulatory framework for recycled content, which is set to take place in the fall of 2023. This consultation will also define new requirements for a pollution prevention plan (P2) for food plastic packaging, which is expected to be in place for all manufacturers using recycled content (with some exceptions).
This consultation encompasses primary and secondary packaging, e-commerce packaging, and labelling for single-use plastics. However, certain categories of SUP items (notably food contact packaging and NHP packaging, among others) will be exempt from recycled content requirements.
We recommend all stakeholders review the 70-day consultation on recycled content and labelling regulations upon its release in the fall of 2023, as this will be your chance to influence the final recycled content regulations, which are expected to come into force during the fall of 2024.
The food regulatory modernization initiative by the CFIA aims to transition approximately 300 compositional standards into an incorporation by reference (IBR) document. By incorporating these compositional standards, this initiative promises less “regulatory burden”, and will “provide clarity and flexibility” and “support innovation” within the food industry. Because non-health and safety aspects of the food compositional standards currently reside in the Food and Drug Regulations (FDR), changes to them currently require amendments that are subject to the Canada Gazette process, which is assumed as the source of the “regulatory burden’ as described above.
Consultation for the food regulatory modernization is now closed, however, we encourage interested parties to read the discussion paper “A strategy for modernizing the food compositional standards”. An analysis of the consultation is due in fall 2023, with a report scheduled for winter 2024, and regulatory publication by 2025.
Proposed guidance for labelling and representation of plant-based, dairy, and egg alternative products is currently under development. The Canadian Food Inspection Agency (CFIA) is preparing to launch a public consultation on the draft proposal. This is a significant step in providing clear labelling guidelines for plant-based products in the Canadian market.
Health Canada is actively working to modernize the regulations for Foods for Special Dietary Use (FSDU) under Division 24. The current regulations are outdated and do not align with the evolving market. To address this, Health Canada is developing interim policies to allow products that fall outside of the current regulations to go to market.
In Fall 2023, Health Canada plans to launch a 70-day public consultation seeking input on the proposed modernization framework for Divisions 24 and 25 of the Food and Drug Regulations (FDR). This consultation is an opportunity for stakeholders to contribute to shaping the future of these regulations.
The labelling of Natural Health Products (NHPs) is a critical aspect of regulatory compliance. To provide businesses with sufficient time to adapt to new requirements, Health Canada has established a timeline for NHP labelling compliance.
Products that were licensed before June 21, 2025, will have a grace period until June 22, 2028, to ensure full compliance with NHP labelling regulations. In contrast, products licensed after June 21, 2025, are expected to adhere to these regulations immediately.
It’s important to note that these labelling regulations are considered final, and there are no further consultations planned. Businesses should take this timeline into account and prioritize compliance with NHP labelling requirements.
The Natural and Non-prescription Health Products Directorate (NNHPD) is currently revising its monographs, which can affect up to 800 monographs. They plan to send the revised drafts to industry stakeholders in batches of 20-25 for feedback. Public consultations for these revisions are set to commence at the end of October 2023.
In December 2022, Health Canada launched the NPD action plan to streamline NPD market authorizations. The plan proposes policy and operational solutions to address barriers to marketing NPDs ahead of regulatory changes. Medium short-term solutions, including providing clarity on post-authorization submissions, supporting the use of the NHPID, and finalizing and publishing an oral cold, cough, and flu monograph, are expected to be published by the end of 2023.
Bill C-47 amended Vanessa’s Law to include NHPs under its provisions, granting Health Canada increased enforcement authority on NHPs with significant penalties, including fines of up to $5,000,000 CAD for non-compliance. Some provisions requiring regulations are not yet in force, and Health Canada plans to consult with stakeholders on upcoming regulatory changes.
There are significant backlogs in various areas, including:
The NNHPD is addressing these backlogs by implementing improvements to increase transparency, share best practices, and conduct temporary risk-based measures, such as administrative renewals for lower-risk applicants.
The NNHPD will resume reviewing Finished Product Specifications (FPSs) submitted with product license applications. Starting November 1, 2023, risk-based screening will be applied to new product licenses and quality amendment applications. The screening will be looking for products where the following is true:
New guidelines, including the Quality of NHPs Guide and NHP GMP Guidance Document, are in development.
Health Canada received approximately 4700 comments during the consultation period for the proposed cost recovery program for NHPs. They are actively reviewing the feedback and anticipate engaging stakeholders soon to determine a way forward that adequately supports small businesses. Another consultation period, possibly in the fall, is being considered.
NHP GMP Inspections continue to be performed as part of the ongoing interim period.
During this period:
Common non-conformances were related to quality assurance, operations, specifications, and stability. Future steps include a deep dive into common issues, the development of a pre-inspection checklist, an NHP GMP Inspection Policy, and infrastructure building for a permanent NHP GMP inspection program.
The Regulatory Forum showed us 2 things – 1) that our industry is incredibly passionate, as evidenced by the spirited question and answer periods during each of the sessions, and 2) that a lot of regulatory changes are coming to the NHP industry, for better or worse. While we can’t transport you back to the forum to witness it firsthand, what we can do is provide you with our own perspectives of the forum, in the form of a Q&A, featuring dicentra’s Peter Wojewnik, Partner and VP of Growth, and William Morkel, Director of Quality and Compliance. Please enjoy this in-depth debrief of the regulatory forum, courtesy of dicentra.
The information presented herein is intended as a summary of the Regulatory Forum hosted by the CHFA on September 21, 2023. It is not intended to, nor does it possess any regulatory powers or authority over existing regulatory requirements, laws, or standards to which Natural Health Products are currently subject.
This information is provided on an “as-is” basis, for educational purposes only, and should not be considered a substitute for professional advice, guidance, or consultation. Users of this information are encouraged to seek the advice of qualified experts such as dicentra when dealing with specific regulatory or compliance matters.
If you require assistance interpreting these updates and how they pertain to your business, please contact us immediately.