Recent Changes to the Regulation of ‘Food-Like’ Natural Health Products in Canada

The Canadian regulatory landscape for foods and natural health products (NHPs), which are roughly equivalent to US dietary supplements, has experienced significant recent change.

The change is a result of an updated Health Canada regulatory policy under which many “food-like” NHPs––products at the food-NHP interface that meet the definition of both a food and an NHP––will be classified and regulated exclusively as foods.

As a consequence, thousands of products have transitioned from regulation under the NHP framework to regulation under the food framework, where many such products are now noncompliant with the stricter formulation or claim requirements of the food category. Although many manufacturers of transitioned products have been forced to reformulate or repackage to achieve compliance, some products not deemed to pose an unacceptable health and safety risk by Health Canada have been granted temporary authorizations to continue marketing their noncompliant products. In exchange, the manufacturer collects and shares with Health Canada certain data (such as market share, consumption information and incident reporting) to inform potential future amendments to food regulations applicable to these products.

Evolution of NHPs

In Canada, NHPs are considered a subclass of drugs. According to former interpretations of Canadian regulatory law, a product that met the regulatory definition of both a food and an NHP could be sold as either. A manufacturer could proceed through the licensing process for its “food-like” product as an NHP (NHPs require licensing in Canada), essentially choosing the NHP regulatory framework over the food regulatory framework as applicable to its product. The manufacturer would then enjoy the greater freedom in formulation, advertising and labeling that comes with selling a licensed NHP in Canada as compared to a food.

As the market evolved, more food-like NHPs emerged. These NHPs became so commonplace on store shelves that they are now familiar to most Canadians, including:

• products in pre-packaged, ready-to-consume drink format, such as caffeinated energy drinks (CEDs) and vitamin- or mineral-added waters and juices
• certain granulated powder products, such as drink mixes and meal replacements
• products in even more traditional food formats such as cereals and chewing gums

NHPs that looked like foods and were consumed like foods blurred the legal distinction between a food and a drug (as it was formerly understood). With the growing market overlap between traditional foods and these food-like NHPs, inconsistent regulatory treatment became problematic from a policy perspective.

For an example of this blurred regulatory landscape, one could have looked through the refrigerated drinks available in any Canadian convenience store. One might have found one drink categorized as a food and subject to one set of regulatory requirements for ingredients, quantities, claims and labeling. Next to it, one could have found another drink categorized as an NHP and subject to significantly different standards. CEDs, formerly regulated as NHPs in Canada (and typically not compliant with food regulations surrounding caffeine content) are a prime example and have been a focal point of discussions surrounding the regulation of food-like NHPs. Although both CEDs and traditional food competitors (e.g., cola) look like foods and are consumed like foods, former interpretations of law led to the application of different regulatory frameworks to these products.

Concerns of Regulators

Canadian regulators became concerned with the ability of consumers to make informed choices given the lack of consistent nutrition labeling and claims standards applicable to such products, which both generally are packaged in “food format” and often sold side-by-side. A corollary concern was the unlevel playing field faced by the food industry, whose products were competing against food-like NHPs for consumer dollars on the same store shelves, but were subject to generally more rigorous legal requirements. The Canadian government was forced to rethink both its short-term strategy and long-term goals for food regulatory policy.

To its credit, the Canadian government has adopted an approach focused on consumer risk, informed by best evidence and aimed at minimizing market disturbance. As of April 2012, the new policy is that products that look like foods and are consumed like foods are classified and regulated as foods, although they also may meet the definition of an NHP. Food-like NHPs already on the market as of April 2012 (those with issued NHP licenses or pending applications, a total of more than 1,000 products), faced transition to the food category.

Transition Challenges

This transition has caused many instances of interim noncompliance with the regulatory requirements for foods, particularly those relating to labeling, formulation and claims. Health Canada has facilitated this process by issuing temporary market authorization letters (TMALs) on a product-by-product basis. The terms vary, but in the case of low-risk products, TMALs generally provide sufficient time for the manufacturer to exhaust existing inventory while resolving issues of noncompliant labeling or formulation. All transitioned products were expected to achieve compliant nutritional labeling by January 2014.

Nuances of Formulation

The issue of compliant formulationis more nuanced. Products deemed not to pose an unacceptable health and safety risk by Health Canada following a risk-based review of current information may receive a TMAL authorizing a period of continued sale of a noncompliant formulation, provided the product contains an ingredient currently prohibited under the Food and Drug Regulations (either in identity or quantity) and requires research to address important information gaps. Through this mechanism, the Canadian government intends to explore the effects of food sales outside current legal bounds to inform future legislative amendments to the food regulatory framework. Ultimately, such amendments may codify into law certain exceptions that now are only temporarily authorized.

For example, under current Canadian food regulations, caffeine is considered a food additive permitted only in cola-type products up to a maximum of 200 ppm (~200 mg/L). Most CEDs meet neither of these requirements and therefore are not compliant foods under current regulations. However, Health Canada has issued TMALs to CEDs authorizing caffeine in the range of 200-400 ppm, so long as extensive additional criteria are met (the product must be a water-based, ready-to-consume beverage; cannot be in small “energy shot” format; cannot be represented as sweetened or flavored water; must meet additional metrics for added amino acids, vitamins and minerals; and must bear certain label statements, among other requirements). These TMALs additionally may authorize certain otherwise noncompliant claims tied to the formulation.

Much of the issue surrounding the marketing of food-like NHPs turns on the legal definitions of a “food” and a “drug” in the Canadian Food and Drugs Act. Similar to the US definition, the main legal distinction between a food and a drug is based on how the product is represented. A drug includes anything manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease, or for restoring, correcting or modifying organic functions (i.e., anything for “therapeutic use”). A food includes anything manufactured, sold or represented as a food or drink for humans, chewing gum and any ingredient that may be mixed with food for any purpose (e.g., a food additive). No overlap between these traditional food and drug classifications is contemplated, meaning if a product meets the definition of a food and is regulated as a food, it cannot make a therapeutic use claim reserved for drugs. In this respect, the Canadian and American landscapes are aligned.

Canada and US Differences

Where the two systems diverge is on the regulation of the NHP subcategory. In contrast to the US, where dietary supplements are classified as a subset of foods, in Canada, NHPs are defined as a subset of drugs. This is a significant difference in framework and the basis for the regulatory sea change currently afoot in Canada surrounding food-like NHPs.

Specifically, the definition of an NHP includes any product for therapeutic use (i.e., a drug) that is, alone or in combination, a plant material or non-human animal material (including extracts), most vitamins, amino acids, minerals, fatty acids and probiotics, so long as the substance is not specifically excluded.

Notionally, this definition permits the argument that a product otherwise considered a food should instead be classified as a drug. The product need only contain a substance selected from an especially “food-friendly” list (e.g., vitamins, amino acids or plant material) and make a therapeutic use claim. The benefits of taking such a position are clear: unlike a food, an NHP can make therapeutic use claims and is not subject to the often stringent formulation standards applicable to foods, such as those about caffeine content. Most significantly of all, the Natural Health Product Regulations divert the regulation of NHPs away from the drug provisions of the Food and Drug Regulations (which otherwise would be applicable) and toward its own more manufacturer-friendly regulations within the drug framework. The NHP framework doesrequire premarket licensing of the product, including a review of its safety and efficacy in light of the intended claims, but the process is not the regulatory behemoth demanded of drugs under the Food and Drug Regulations.

The former policy of Health Canada was to recognize products meeting the definition of an NHP as NHPs, even if they also met the definition of a food. Consequently, relying on the argument outlined above, many manufacturers gained access to the market with NHPs in food format.

New Policy: Four Main Criteria for Distinguishing a Food From an NHP

Under Health Canada’s new policy,¹ a product that meets the definition of a food (“anything manufactured, represented or sold as a food or drink”) cannot also be an NHP. For this inquiry, four main criteria will be considered: product format, public perception and history of use, product representation to consumers and product composition. Some considerations may overlap.

In general, food formats include pre- and bulk whole foods, edible oils, spreads, bars, cereals, dairy products, confections, condiments, dressings and seasonings. However, traditional food format still can be used for an NHP as it is the balance of all factors that determines the classification. Where the product is in food format, public perception and product representation become especially important. Notably, a food will be more closely associated with ad libitum consumption, while an NHP will direct more-precise consumption (i.e., dosing). For this reason, while products in granulated powder format can be either a food or an NHP, those in the sports nutrition market are being classified as NHPs due to their perception by consumers in that particular market as dosed supplements. By comparison, a whey protein product targeted to the general public may not enjoy the same perception as a dosed supplement. Many such products now are considered foods, were issued TMALs and, in many cases, were forced to amend label claims and formulation. This seems consistent with the desire to classify products based on how they are understood in the market by a consumer. However, one cannot help but notice the result is the same non-uniform regulatory treatment of compositionally similar products.

Another important factor to consider: Health Canada recently indicated the inclusion of food-related terms in a brand name may be sufficient representation as a food to make that product ineligible as an NHP. It seems that manufacturers of food-like NHPs in Canada should avoid brand and product names incorporating terms such as drink, beverage, shake, juice or cocktail if they do not want to risk their NHP status.

Conclusion

The regulation of food-like products in Canada is in the middle of an important transition. The short-term plan for this transition, including improving the quality of information made available to consumers at the point of sale and leveling the regulatory playing field among competing products, is just coming into effect. Generally, this transition has been positive, although the process of distinguishing a food from a food-like NHP requires a complicated balancing of factors. In the long term, the collection of data tied to the sale of temporarily authorized products is reason for optimism; useful regulatory reform based on informed decisions is a welcome means of progress.

References

1. Canada, Natural Health Products Directorate & Food Directorate, Classification of Products at the Food-Natural Health Product Interface: Products in Food Format (June 2010).

About the Author

John Lucas is an associate at Deeth Williams Wall LLP in Toronto, Canada, where he practices intellectual property and regulatory law. He can be reached at [email protected].

Cite as: Lucas J. “Recent Changes to the Regulation of ‘Food-Like’ Natural Health Products in Canada.” Regulatory Focus. June2014. Regulatory Affairs Professionals Society.