There used to be a time, not so long ago, when sports nutrition products were black market commodities in Canada. Getting innovative products to market that consumers demanded was virtually impossible given the inflexibility of the Canadian regulatory environment. However, the tide is turning and Canada is currently reviewing its classification and regulation of products, particularly sports nutrition products, vitamin- and mineral-supplemented foods, and energy beverages.
Sports nutrition products include food (e.g., bars), beverages (e.g., electrolyte replacement, carbohydrate/protein sources, energy) and supplements/natural health products (e.g., tablets, capsules and “shots"). Energy beverages typically refer to beverages containing caffeine in combination with other ingredients such as taurine, glucuronolactone and B vitamins. These products may also contain minerals, various herbal ingredients and other bioactive ingredients, and they generally feature health claims related to their capacity to restore energy and alertness in the individual consuming the product.
The sports nutrition category (excluding beverages) represented an international market opportunity of more than USD $10 billion in retail value sales in 2014. However, its strongest competition came from sports and energy drinks with sales of more than USD $50 billion in 2014. It is predicted that sports and energy drink sales will grow by nearly 30 percent to USD $64.1 billion in 2019, according to an analysis by Euromonitor International.
The sale and growth of sports nutrition products is influenced by discretionary income, social demographics and lifestyle considerations. Once restricted to gyms and health food stores, sports nutrition products, including beverages, are increasingly finding their way into the mass market, both grocery- and pharma-focused stores, and convenience stores.
However, as more people enter the sports nutrition category, the need to target specific segments of the market increases. Recreational athletes and lifestyle shoppers are more interested in taste, nutrition and convenience, whereas serious athletes are looking for performance enhancing products with novel ingredients and sound science behind the claims.
Knowing what your consumers want and demand and being able to provide it to them within the constraints of the existing regulatory environment are sometimes quite difficult.
In Canada, products consumed orally are classified as foods, drugs or natural health products. Drugs are formulated to have specific metabolic/therapeutic effects and require extensive preclinical and clinical testing before they ever reach the market. By definition, the “drug" classification does not typically encompass sports nutrition products. Foods, on the other hand, are consumed for taste, nutrition, energy and satiety, and they encompass many sports nutrition products, including bars, beverages and some powders.
Natural Health Products (NHPs) fall somewhere in between. Formulated to contain physiologically active ingredients and required to make a scientifically substantiated health claim, NHPs are neither foods nor drugs. Although the NHPs regulations require premarket approval (review of safety, efficacy and quality) and licensing of products, as well as licensing of Canadian-based manufacturers, packagers, labelers and importers of natural health products based on compliance with GMPs (good manufacturing practices), the NHP route seems to offer the most opportunities to get innovative sports nutrition products legally into the Canadian market.
However, the boundaries between foods and natural health products and their classification are not always clear. For example, energy drinks are considered foods, but if they are energy drink “shots," they are considered natural health products; single-ingredient protein powders are foods, multi-ingredient powders are NHPs, and ready-to-drink protein-based beverages (with or without added nutrients) are foods.
If your product is classified as a natural health product, the route to market is fairly clear. With the provision of sufficient safety and efficacy data, you can receive your product license within 30 days of submitting a complete application. If your product and/or claim is novel, it could take up to 210 days from the submission of a complete application to receive a decision from Health Canada.
The food side is slightly more complicated. There are currently many products that are only legally on the market now because they have a temporary marketing authorization letter (TMAL) from Health Canada. For example, caffeine and caffeine citrate are only permitted as food additives in cola beverages at a maximum level of 200 ppm, and in non-alcoholic, carbonated, water-based, flavored and sweetened beverages at a maximum of 150 ppm singly or in combination in the finished product. Energy beverages typically exceed these levels of caffeine, and most also contain vitamins, minerals and or amino acids not currently allowed under the food regulations. Even the word “energy" is only legally permitted on food products in the context of caloric value, not in the context of mental and/or physical performance (as is allowed on natural health products where supported by evidence).
Thus, in order to enter the market, the legal agent must apply for a temporary marketing authorization. If the product does not comply with the food regulations, but is deemed to be safe for consumption, it will generally be issued a TMAL. Specific to energy beverages, compositional and labelling guidelines have been drafted and the product must comply with these guidelines in order to receive a TMAL. If the product is not deemed safe, the manufacturer will have the option of reformulating to remove or lower the level of the substance of concern and then reapply for a TMAL. The product, once issued a TMAL, still needs to be labeled in compliance with the food regulations (including a nutrition facts panel and comprehensive allergen labeling). The legal agent must also collect specific market data for Health Canada including reports of adverse events.
A temporary marketing authorization letter, however, is just that—a temporary measure (typically two to five years) to allow safe, non-compliant products on the market with the expectation that the regulations will eventually be amended to allow their legal sale.
Now is the time to look at Canadian market opportunities for sports nutrition products. There are opportunities for innovation on the natural health product side and flexibility to formulate on the food side. Whatever the need—a natural health product license, a temporary marketing authorization letter or simply a compliant, bilingual label—to bring a product to market, now is the time to look to Canada to expand your market.
Anne Wilkie is the senior government relations and regulatory strategy specialist for Source Nutraceutical Inc., in Winnipeg, Canada. She can be reached at firstname.lastname@example.org.