Regardless of whether you are developing a new food or dietary supplement/natural health product (NHP) that you intend to sell in either the United States, or Canada, you must follow the label requirements in the jurisdiction you wish to sell your product in. However, the type of product, and whether it is a food product, or dietary supplement/NHP, and where you intend to sell the product will determine exactly what type of label requirements you need to follow. For the purposes of this blog, we will be focusing on the labelling requirements for foods and dietary supplements/NHP’s sold in Canada, and the United States.
In Canada, the food and NHP labelling requirements share a lot in common, such as bilingual requirements for important information, inclusion of the net quantity, common names, a list of ingredients, etc. However, there are many labelling requirements that are specific to food and NHPs. A major difference between food and NHP labelling are the types of claims that can be made on the product.
Food cannot make drug claims to suggest that the product has the properties of a drug or has an effect that is beyond what can be achieved by eating food. For example, claims that are intended to treat, mitigate, or prevent a disease, or contribute to restoring, correcting, or modifying a function in the body, are not permitted on a food label. However, general health claims, nutrient content claims, as well as function claims that promote beneficial effects on the normal functions or biological activities of the body due to the consumption of a food or food constituent are permitted on a food label.
NHPs on the other hand, can make drug and health claims if supported with sufficient evidence and approved by Health Canada. Given the fact that NHPs can make therapeutic claims, NHPs must contain information pertaining to the route of administration, recommended dosage, duration of use must be presented to guide and inform the consumers on the proper intake of the product. Any potential risks, cautions, warnings, contraindications, and known adverse reactions must also be present on the label.
Nonetheless, the Food and Drug Regulations (Section B.01.401) mandates a Nutrition Facts Table to be presented on the label of a pre-packaged food product, which contains the following information:
Natural health products do not need to include a Nutrition Facts Table. Instead, they require a detailed list of the medicinal ingredients including the proper name, common name, source, quantity, potency, extract ratio, and quantity dried equivalent (as applicable).
In the United States, both food and dietary supplement labelling require a nutrition table to be present on the labels. However, the content and requirements differ slightly for food and dietary supplement. First, the name of the nutrition table is called “Nutrition Facts” for foods and “Supplement Facts” for dietary supplements. The major differences between them are as follows:
Unlike the mandatory requirements to include at least one claim for natural health products in Canada, foods and dietary supplements in the United States do not need to bear a claim. If a claim is made on the label, it cannot explicitly or implicitly indicate that the product is intended to diagnose, treat, cure, or prevent any disease, because such claims are only permitted for drugs.
Nonetheless, there are three types of claims that can be made on food and dietary supplement labels in accordance with FDA’s regulations: health claims, nutrient content claims, and structure/function claims.
If you would like to learn more about the differences between food and supplement labelling or need help becoming compliant, contact us today.