When it comes to food and supplement labeling, there are significant differences between the US and Canada – even spelling the word “labelling (labeling)” is different. Both markets have their own set of regulations which detail the mandatory content required on a product label. The regulations also give guidance on voluntary content such as claims. It’s important to know which governing bodies have oversight, which regulations apply and how to properly classify your product to make sure you use the right set of regulations from the beginning.

Regulatory Agencies

USA

The regulatory agencies in the US responsible for enforcing food/supplement product compliance include:

Food and Drug Administration (FDA), USDA, Federal Trade Commission, US Department of Homeland Security – US Customs and Border Protection. There are also relevant state laws that could be applicable (for example, California’s Prop 65).

CANADA

The regulatory agencies in Canada responsible for enforcing food/supplement product compliance include:

Health Canada, Canadian Food Inspection Agency (CFIA), Canadian Border Services Agency (CBSA). There are also some provincial laws that may apply, such as Bill 96 in Quebec.

Product Pathways By Country

You have a product; but what is it?

USA

Under the Federal Food, Drug and Cosmetic act, the term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.¹

If the product is edible but does not meet that definition, it could be a Dietary Supplement.

Prior to 1994 in the US, there was only food and drugs. Following the implementation of DSHEA (Dietary Supplement Health and Education Act), dietary supplements were defined and included as a new pathway to market in the US. This includes products such as vitamins, minerals, herbs, amino acids, dietary substances used to supplement the diet, concentrates, metabolites, constituents, extracts or combination of all these ingredients.

The FDA has published guidance on the product formats which may not qualify as dietary supplements (beverages, for example), and how to correctly determine the proper pathway. There is a lot of “grey area” and potential confusion around the pathway determination, which is where we can help to sort it all out.

CANADA

The Food and Drugs Act in Canada has a very similar definition for food: food includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.²

Foods can fall into a couple of categories (excluding those for special dietary purposes such as meal replacements and infant formula), including conventional foods and supplemented foods. Conventional foods would be those that are historically thought of as foods, sold for the purpose of satisfying hunger and thirst.

Supplemented foods would be products which fit into one of the (9) approved food categories and contain at least one permitted supplemental ingredient added for purposes other than nutrition, used within the acceptable limits.

Natural Health Products (NHPs) include naturally occurring substances such as vitamins, minerals, probiotics, amino acids, herbal ingredients and synthetic duplicates, that are used to maintain or restore health in humans. NHPs are often thought of as the equivalent to Dietary Supplements in the US, though that is not always the case.

REGULATORY CLASSIFICATION

Generally, there are four considerations for product classification determination – Format, Composition, Representation, and History of Use. Without considering all four, it’s not possible to confidently say what the product type should be.

1. PRODUCT FORMAT

Product format refers to the physical form of the product – is it a typical “food” format such as a beverage, bar, snack, or meal, where consumers can eat/drink as much as they want? Or is it a controlled dose format such as a tablet, capsule, powder, softgel, gelcap, liquid where consumers take a certain number of pills or scoops based on the product's Directions for Use.

• Conventional food format: In the US, this would be a food. In Canada, this would be a food or supplemented food.
• Dose format: In the US, this would be a dietary supplement. In Canada, this would be a Natural Health Product.

But how about a format which could be both, such as a powder? We’d need to assess the other criteria.

2. COMPOSITION

Composition refers to the ingredients that make up the product. Determining the product classification based on composition alone is no easy feat. Ingredients used may have restrictions, and just because an ingredient is allowed in a product in one country, does not mean it is allowed in another. Due diligence must be taken to ensure that the relevant regulations and other guidances/lists are reviewed prior to confirming the product type and any limits of use. In some cases, an ingredient could have lower and upper limits associated with their safety and efficacy within a product. In other cases, it is up to the brand owner to ensure the product is safe and efficacious.

Without history of safe use, an ingredient may be subject to review as a novel food in Canada, and a GRAS (generally recognized as safe) dossier in the US. Dietary ingredients may also require a New Dietary Ingredient Notification (NDIN) prior to its use in a dietary supplement intended for the US market.

3. REPRESENTATION

Representation generally refers to the claims being made about the product on the label, but all label aspects including images, implied claims, even a single word, could make an impact here. Foods have a limited amount of therapeutic or health claims that can be made about them, since their sole function should be for satisfying hunger and thirst.

Within Canada, NHPs must have an associated therapeutic purpose as the function of this product type is to supplement human health. In contrast, US Dietary supplements may make structure/function claims which describe the effects of the supplement's ingredients on the normal structure or function of the body, but may not make any therapeutic claims as these are reserved for drugs in this market. Foods may make structure/function claims as well, but these must derive from the product's character as a food, i.e. the nutritive value.

How a product is represented is a very important factor for product classification, so knowing the ins and outs of the regulatory requirements can sometimes “push” a product into its intended category for the market.

4. HISTORY OF USE

The last criteria to consider is history of use – how has this product type been sold previously in the market? There is often lots of overlap, and changing regulations make this area a bit more complicated.

An example would be energy drinks in the Canadian market. Energy drinks were initially represented as Natural Health Products, per Health Canada. In 2012 Health Canada removed beverages and other products in food-format from under the NHP regulatory umbrella with the intention of creating new regulations that would address this new category. A regulatory pathway referred to as Temporary Marketing Authorization letters (TMALs) was used for ten years, until 2022, when the Supplemented Food Regulations came into force, once again changing the pathway for energy drinks within the Canadian market.

WHAT WE CAN DO

Assessing classification criteria and relevant regulations governing the intended market is complicated, to say the least. Partnering with an experienced firm with dozens of experts in many markets can ensure that your product enters the market compliantly, avoiding costly mistakes along the way. SGS Nutrasource can be your market access partner from concept to claim. Reach out to us today to find out how we can help.

References:

1. CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
   SUBCHAPTER II – 321, 2f U.S.C. Title 21 - FOOD AND DRUGS
2. Food and Drugs Act https://laws-lois.justice.gc.ca/eng/acts/f-27/page-1.html#h-234002