Food Dish — Where food, science and regulation meet

As has been widely reported in a number of forums, Health Canada is in the process of pushing food-like natural health products (NHPs) out of the NHP approval scheme and into the food regulatory regime. Health Canada wants to ensure that products that look like foods and are consumed as foods are regulated as foods – if it looks like a duck and quacks like a duck, it’s a duck, right?

In some cases, the transition will be straightforward and won’t require amendments to the regulations, reformulation or re-labelling of products. Other cases won’t be so simple. One such case, that Health Canada has decided to tackle first, is the question of caffeinated energy drinks.

Health Canada recently released a Category Specific Guidance that sets out the way caffeinated energy drinks will be transferred from the NHP regime to the food regime. People in the know are suggesting that this model will then be used as a template for the transition of other products.

Background – foods marketed as NHPs

A number of products that are quite food-like in nature have been approved and marketed in Canada pursuant to the Natural Health Product Regulations. These foods and beverages have added vitamins, minerals or amino acids, and make certain health claims that would not be permitted under the Food and Drug Regulations. And so manufacturers sought market access through the NHP regime.

However, Health Canada has said “no more,” and has set out general criteria pursuant to which it will classify products as either NHPs or foods, including product format, public perception and history of use, product representation to consumers, and product composition.

Health Canada has identified certain products currently marketed as NHPs that cause confusion among consumers, and has announced it would be transitioning them out of the NHP regime and into the food regime. These products include beverages such as energy drinks, vitamin waters and juices, and foods such as yogurts and bars with specific health claims.

What will the transition mean to industry?

There are two primary implications of the transition: differences in labelling, and differences in allowable health and other label claims. Among other things, products that are transitioned will need to comply with all of the food labelling provisions, including the nutrition facts table, ingredient labelling and allergen labelling.

In addition, there are differences in the health and other claims that are allowed for foods and NHPs. Health claims on foods are generally not subject to pre-market review, unless they pertain to diseases, disorders, or abnormal physical states as specified in the Food and Drugs Act, or are nutrient content claims that are not yet provided for in the Food and Drug Regulations. Note, however, that health claims on foods must be truthful and not misleading, and that manufacturers must be able to substantiated them with appropriate scientific evidence. Another difference between the claim regimes is that health claims on foods must be linked to a specific substance or substances in the product, and not to the consumption of the product itself.

The transition process

Since May 2010, Health Canada has been working with manufacturers to transition food-like NHPs to the food regulatory regime. Three categories of products have been identified:

• Those ready to transition immediately that require no changes to either the regulations or product before they can be marketed as foods;
• Products that would require regulatory changes (i.e., the addition of claims, fortification, or additives to the Food and Drug Regulations); and
• Products that are likely unsuitable to be sold as food without major reformulation or changes to the way they are represented to consumers.

As a first step, Health Canada announced in October 2011 that caffeinated energy drinks (considered to be within the second category) would be making the transition. In part, this was in response to concerns about adverse health effects associated with excessive consumption of caffeine, especially among children and adolescents.