What’s happening with Health Canada’s proposed NHP changes?
As reported last year by NutraIngredients-USA, a new structure for classifying products based on a product's risk was proposed. Products like many vitamin, mineral, probiotics, herbal preparations, and homeopathic products and cosmetics would be classed as “low risk”, meaning that Health Canada would not review or license these products.
Companies would still be required to meet requirements on quality standards set by Health Canada, but the agency would not review claims, and the claims could not be made about the diagnosis, treatment, prevention, mitigation of a disease or condition.
The consultation document, which can be read HERE, stated that there are inconsistencies and gaps in the current post-market powers.
Speaking with NutraIngredients-USA at this week’s 17th Annual Oxford International Conference on the Science of Botanicals, Krista Coventry, director of regulatory services, Eastern Canada for Source Nutraceuticals, explained that industry is concerned that NHPs (natural health products) and non-prescription drugs would be lumped together under one set of legislation.
“Other industry concerns include the potential de-regulation of some products, meaning they wouldn’t be able to bear an NPN, but more importantly the potential for a disclaimer similar to the DSHEA disclaimer in the US, which says that these health claims haven’t been reviewed or approved by Health Canada. We currently have a robust pre-market approval system in Canada,” she said.
“I’m wondering why if we have an established regulatory system in place why we would want to change that. Our regulations in Canada have been in effect for 13 years and during that time Health Canada has reviewed and approved almost 60,000 NHPs for market access. Clearly we have a system where suppliers know how to gain access to the market and consumers know to look for the NPN [natural product number] as a symbol of Health Canada approval.
“Aside from that, globally the NPN is recognized as a symbol of high quality health products that have been approved by Health Canada. So I guess a lot of us in industry are wondering why, if we have this great working system in place would we look to change that,” said Coventry.
