I just stumbled on your page and LOVE your content. Such valuable information summarized so well, detailing all the pertinent information. I do have one question and hoping you could provide some guidance (or where to start looking). Since these monographs exclude foods and food-like mediums, could one still use these monographs for their PLA in the example below? There is guidance for products that fall in the food-nhp interface, and it boils down to how the product is perceived, packaged and labeled to the public. Does this imply that, if I produce a NHP confectionery (chocolate bite, nutritive, possible satisfaction of hunger depending on recommended dose (food-like)), packaged in a Child-Resistant Bottle and labeled as a Supplement), that this product is considered an NHP and therefore the monographs can be used even though it is a food or food-like medium? Would other types of Substantiation have to be used to support the NPN registration?
Great question. I prepare these videos for my undergraduates, but found that many want to refer back to them when they graduate. I'm glad you are finding them helpful for you. I will be making a whole new series this January. As for food-NHP interface products, inevitably it is up to your Health Canada regulators to make a final disposition on the product. The guidance document for deciding is here: www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/classification-products-at-food-natural-health-product-interface.html
The statement that stands out from the Health Canada document is as follows - In deciding whether a product in food format is an NHP or a food, the following criteria will be taken into account: Product composition; Product representation; Product format; and Public perception and history of use. So thinking of this product, how is it being represented in advertising and marketing? What are the other SKUs within your company portfolio and how are they being represented? What is the branding differentiation between food products in your company portfolio versus NHP products in the company portfolio? What is the meaningfulness of the dosing within the product? In general, confectionery inspired products that try to fit as NHPs tend to end up as foods when assessed by HC. A lot of this food-NHP interface conflict comes from abuse of the food industry of NHP loopholes prior to tightening of the legislation in 2016. The reference I just shared has a section in 2.1 describing the interface challenges of confectionery type products. Feel free to connect with me on Linkedin to discuss further.
@@amyproulx78 I love that you’re creating content for your undergraduates to refer back to and looking forward to your new series in January! And appreciate you responding to my question - thanks for confirming my assumption :)
I just stumbled on your page and LOVE your content. Such valuable information summarized so well, detailing all the pertinent information.
I do have one question and hoping you could provide some guidance (or where to start looking).
Since these monographs exclude foods and food-like mediums, could one still use these monographs for their PLA in the example below?
There is guidance for products that fall in the food-nhp interface, and it boils down to how the product is perceived, packaged and labeled to the public.
Does this imply that, if I produce a NHP confectionery (chocolate bite, nutritive, possible satisfaction of hunger depending on recommended dose (food-like)), packaged in a Child-Resistant Bottle and labeled as a Supplement), that this product is considered an NHP and therefore the monographs can be used even though it is a food or food-like medium?
Would other types of Substantiation have to be used to support the NPN registration?
Great question. I prepare these videos for my undergraduates, but found that many want to refer back to them when they graduate. I'm glad you are finding them helpful for you. I will be making a whole new series this January. As for food-NHP interface products, inevitably it is up to your Health Canada regulators to make a final disposition on the product. The guidance document for deciding is here: www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/classification-products-at-food-natural-health-product-interface.html
The statement that stands out from the Health Canada document is as follows -
In deciding whether a product in food format is an NHP or a food, the following criteria will be taken into account:
Product composition;
Product representation;
Product format; and
Public perception and history of use.
So thinking of this product, how is it being represented in advertising and marketing? What are the other SKUs within your company portfolio and how are they being represented? What is the branding differentiation between food products in your company portfolio versus NHP products in the company portfolio? What is the meaningfulness of the dosing within the product? In general, confectionery inspired products that try to fit as NHPs tend to end up as foods when assessed by HC. A lot of this food-NHP interface conflict comes from abuse of the food industry of NHP loopholes prior to tightening of the legislation in 2016. The reference I just shared has a section in 2.1 describing the interface challenges of confectionery type products. Feel free to connect with me on Linkedin to discuss further.
@@amyproulx78
I love that you’re creating content for your undergraduates to refer back to and looking forward to your new series in January!
And appreciate you responding to my question - thanks for confirming my assumption :)