Canada’s thriving food industry grows more sophisticated by the day as AgTech advancements pave the way for an ever-expanding array of new and innovative products to hit the market.
After the years of research and development that goes into perfecting a product, manufacturers can feel like the finish line is in sight as they transition to marketing their new creations.
But the final stretch from the lab to consumer plates comes with its own unique set of regulatory hurdles. To help you navigate them, here are the top three questions new food manufacturers need to ask themselves before going to market.
1. Is my product a “novel” food?
Considering how tightly the food industry as a whole is regulated, it comes as a surprise to many that individual food products – unlike drugs and natural health supplements – generally do not need licensing or approval ahead of a public launch.
However, an exception to that rule can be found in novel foods, which must be reviewed for their safety by Health Canada before sale in this country. Novel foods are defined as one of the following:
A substance that does not have a history of safe use as a food
A food manufactured, prepared, preserved or packaged by a process that has not previously been used for that food or that causes the food to undergo a major change
A food derived from a genetically modified plant, animal or microorganism
Critically, the onus is on manufacturers themselves to determine whether or not their product is a novel food, which puts them in a tricky position, since it is not always a straightforward determination to make.
The process for approval of novel foods can be a complex and lengthy one, partly because of the substantial documentary and scientific evidence requirements, and partly because of how rarely it is engaged in comparison with drug approvals.
But the consequences of a misjudgment on classification could be even worse: if the regulator steps in later and finds that the product should have been declared a novel food, then manufacturers could find themselves subject to a recall or even charged with offences under the Food and Drugs Act.
To cut down on the chances of a dispute, Health Canada encourages producers to seek a pre-determination from them on the novelty of their food, and also maintains a list of food and ingredients it has previously found to be non-novel.
Separate from novel foods, on July 20, 2022, Health Canada published amendments to the Food and Drug Regulations¸ known as the “Supplemented Food Regulations”. The Supplemented Food Regulations allow the sale of certain foods that have added vitamins, mineral nutrients, amino acids or other substances that were otherwise not previously permitted. Foods subject to this new regulatory regime do not require pre-market approval, but must meet a host of other composition and labelling requirements.
2. What will go on my label?
One of the hidden costs of food innovation is the unique labelling issues it can bring up, going beyond the core requirements expected of all products available for sale.
For example, plant-based alternative protein companies may be the darlings of the AgTech venture capital space, but they have had a much rougher ride when it comes to the regulation of the product names and descriptions appearing on their labels.
Companies that make dairy substitutes and simulated meat and poultry have met resistance – not only from industry groups, but also from the Canadian Food Inspection Agency – over possible confusion or regulatory non-compliance involving the use of words like cheese, milk, butter, burger and other terms traditionally linked to animal-based products.
But there is better news for the makers of foods with genetically modified ingredients: their products are not required to carry labelling that identifies them as such. That puts Canada at odds with our European Union counterparts, but so far, regulators in this country have taken the position that genetically modified foods which progress through the approval process for novel foods do not need to be distinguished from any other product deemed safe to eat.
Food manufacturers should also be aware that labelling requirements are constantly changing. In July 2022, new regulations have come into effect setting out new labelling requirements for supplemented foods and requiring most packaged food labels to include standardized front-of-package disclosure when foods are considered high in saturated fat, sugars or sodium. There is a multi-year transition period for these new requirements.
3. Which health claims can get me into trouble?
Most people are aware that the Competition Act and Food and Drugs Act bar brand owners from making false or misleading representations in their marketing material, but when it comes to health claims on labels or in food advertisements, even the truth is not always a defence.
Canada’s food laws and regulations set out some specific health-related claims that are allowed, depending on the characteristics of an individual product. However, departing from the approved list can be risky for food manufacturers, as certain claims – even if true – may inadvertently trigger regulation as a drug, transforming a previously unregulated product into one that requires approval.
In addition, Canadian law requires food manufacturers to have adequate evidence to substantiate health claims prior to their use by food manufacturers, so a study verifying the health benefits of your product will not be looked on kindly be regulators if it was run after the fact.
For more information, please contact:
Laura Weinrib +1-416-863-2765
or any other member of our Food, Beverage & Agribusiness group.
Blakes and Blakes Business Class communications are intended for informational purposes only and do not constitute legal advice or an opinion on any issue. We would be pleased to provide additional details or advice about specific situations if desired.
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