The saga of how to regulate food like NHPs continues. The Natural Health Products Directorate and the Food Directorate, have come out with another policy, entitled "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats which attempts to provide more certainty to industry in understanding how Health Canada will classify products in food format1, i.e. food or an NHP.

The Food-NHP Classicisation Committee (F-NCC), will adjudicate and classify products in food format based on 4 criteria:

Product Composition;  

Product Representations;  

Product Format; and  

Public Perception and History of Use.

The policy does not indicate which if any of the criteria have priority over any other criteria and whether the decision will be based on a majority of the four criteria favouring one classification over the other. In addition, the criteria below appear to be best directed to black and white situations, which for the most part is not the case. As such it is suggested that the decision will continue to be resolved on a case by case basis, with little predictability in outcome.

Product Composition

When a product or ingredient is present solely to provide nourishment, nutrition or hydration or to satisfy hunger, thirst or a desire for taste, texture or flavour (food attributes) then such criteria are indicative that the product or ingredient is a food. Conversely a product that is or has an added ingredient that has no known food purpose, the ingredient has been added for its therapeutic use, then the ingredient or food is likely to be classified as an NHP.

Product Representation

A product that might for composition or other reasons be classified as a food may nonetheless be an NHP if it represented or sold as a product having therapeutic uses. Claims that provide for a therapeutic use not based on the use of the product as a food, suggests the product is an NHP.

Product Format

Products sold in a manner that lends itself to dosing, i.e. sold in single dose units for measured amounts, is an indication that product is an NHP.

Public Perception and History of Use.

If a product has a historical pattern of use as a food or if public perception is that the product is a food, then these are indications that the product is to be classed as a food. This latter criteria appears to be a general catch all, that if desired, would allow the F-NCC to classify a product in a food format as a food.

In summary, keep in mind the policy does not provide any guidance on which if any characteristics play a greater role in the classification process, if the ultimate classification is based on a majority of the forgoing criteria pointing one way or the other and how to apply the criteria in situations where the facts are not black and white. While the policy may shed additional light on the classification process in certain cases, unpredictability will remain.

For more information, please see: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/food_nhp_aliments_psn-2009-eng.php