CHFA East 2019 Regulatory Round-Up

CHFA East 2019 Regulatory Round-Up

The CHFA East Conference and Trade Show (held in Toronto September 12-15, 2019) boasted over 1,100 trade show exhibitors and a 2-day education session. Krista Coventry (Director of Regulatory Services for Eastern Canada) attended the education sessions to keep Source’s finger on the regulatory pulse for self-care products and functional foods!  Read more to learn about Krista’s key takeaways from the 2019 education sessions.

At the Regulatory Forum (September 12), senior officials from Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) and Regulatory Operations and Enforcement Branch (ROEB) provided an overview of recent Compliance Monitoring Project (CMP) activities. In Phase 1 of the CMP project, Health Canada visited the facilities of 23 NHP site license holders, to assess their compliance with Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs).  Several key deficiencies were identified, primarily with respect to various aspects of NHP quality assurance, including premises, operations, sanitation programs, and stability programs. Phase 2 of the CMP project was reportedly recently completed, with another 23 facilities being assessed, and similar deficiencies noted upon inspection.

Health Canada plans to release the results of CMP Phase 2 in the coming months.  If you are interested in NHP site licensing and have questions about aspects of the process, or have had compliance issues and need regulatory support, connect with Source’s Regulatory team today!

On Friday, September 13, CHFA hosted two regulatory-themed sessions on cannabis, one of the hottest topics on the North American regulatory scene.  These education sessions discussed some of the key issues associated with the recent legalization of cannabis in Canada.

There has been much interest amongst industry and consumers about exploring the potential health benefits of cannabis.  Recent research from McMaster University indicates a 4323% increase in prescription cannabis use in Canada over the past 5 years.  Cannabidiol (CBD), a non-psychoactive constituent of the cannabis plant, has many purported health benefits, including relief of pain and initial symptoms of certain neurological disorders (i.e.seizure disorders, anxiety and depression).  Researchers remain keen to explore the potential health benefits of CBD in various body systems.

However, challenges remain with respect to including CBD in cannabis products in the Canadian retail market.  Under the recently published Cannabis Regulations, although you can legally purchase cannabis at licensed government stores, it is not legal to sell CBD at the retail level (i.e.in any self-care products, including Natural Health Products).  However, regulations allowing the inclusion of cannabis itself in foods (“cannabis edibles”) are anticipated for the fall of 2019.

Have questions about cannabis?   Is your company interested in CBD research or potential product commercialization options in the future?  Ask Source’s regulatory team your questions today.

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