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.
The transition of products from NHPs to foods will be facilitated through the issuance of Temporary Marketing Authorization Letters (TMALs). TMALs are granted where additional information is needed to propose a suitable amendment to the Food and Drug Regulations to allow for the marketing of a food or beverage, but where that information can only be obtained by real world marketing of the food. The information gathered during the TMA period is then used to propose a regulatory amendment to allow approval of the product under the Food and Drug Regulations.
This process will allow eligible products to be marketed (subject to specific conditions), while industry collects and provides to Health Canada the data required to finalize regulatory amendments for these products to be fully regulated by the Food and Drug Regulations.
To date, Health Canada has transitioned a number of foods from the NHP regime, and TMALs are being issued on a continuing basis. A continuously updated list of transitioned products can be found here. It includes a number of energy drinks, vitamin waters and juices. Caffeinated energy drinks are the first class of products in respect of which Health Canada has issued a Category Specific Guidance for issuance of TMALs.
Caffeinated energy drinks in a nutshell
Health Canada considers “caffeinated energy drinks” to be beverages containing caffeine in combination with other ingredients such as taurine, glucoronolactone and B vitamins, and that may also contain minerals, various herbal ingredients and other bioactive ingredients.
Caffeinated energy drinks are generally marketed with health claims relating to restoring energy and alertness. As I mentioned in this article, these health claims can be used by energy drink manufacturers to distinguish their beverages from sports drinks (and on some level, Health Canada uses these branding tools to discourage the use of caffeinated energy drinks in the place of sports drinks).
Caffeinated energy drinks cannot be approved as foods under the current Food and Drug Regulations because the Regulations restrict the addition of caffeine, vitamins and other ingredients found in caffeinated energy drinks. So, industry turned to the NHP regime to access the Canadian market; to date, caffeinated energy drinks have been regulated under the NHP Regulations and not the Food and Drug Regulations. Despite this, in its recent overhaul of the system, Health Canada determined that caffeinated energy drinks are actually “foods” based on the public perception and history of use of the beverages, the way they are branded, and the format they come in.
The Category Specific Guidance outlines the requirements for issuance of TMALs for caffeinated energy drinks. The process for individual products is dependent on the regulatory approval status of the product and its ingredients. Issued TMALs will allow for sale of the product for up to five years while data is gathered to support the required amendments to the Food and Drug Regulations.
The data that industry must commit to providing in the course of the TMA period includes data on:
- Canadians’ consumption patterns, in order to better estimate exposure to caffeine and other ingredients contained in these beverages;
- Consumer’s understanding and use of label information; and
- Data on the effectiveness of product labels as a risk management tool.
As much of this data is not product specific, Health Canada is encouraging industry to collect the research together – which is great from a company cost-saving perspective. Of course, additional product-specific information may be required for some products, to be determined by the manufacturer and Health Canada.
In order to be eligible for a TMAL, manufacturers will have to agree to a number of things, including:
- Limiting the amount of caffeine contained in the beverage;
- Not including alcohol in the beverage;
- Minimum and maximum levels of certain vitamins, minerals and amino acids;
- Statements on labelling regarding the maximum number of containers or servings that should be consumed daily;
- Additional labelling regarding the specifics of the caffeine in the product;
- Compliance with food labelling requirements, including the nutrition facts panel, ingredient and allergen labelling; and
- Not promoting the beverage to children.
The future for food-like NHPs
There are a number of other foods and beverages that are slated to make the transition from NHP to food. It is expected that once Health Canada paves the way with caffeinated energy drinks, other Category Specific Guidance will be soon to follow.
As I noted above, people in the know are suggesting that the caffeinated energy drinks model will be used as a template for the transition of other products. If this is true, it would be wise for food and beverage manufacturers who may face transition of their products to keep track of the movement of caffeinated energy drinks so they can prepare themselves for things to come.
Sara Zborovski is a partner at Gilbert’s LLP in Toronto, practicing food, beverage and drug law. She also hosts her own blog at www.thefoodlawyer.ca