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.

Canada

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:

• Heading “Nutrition Facts” and heading “Valeurs Nutritives” in French
• Serving size in both English and French
• Calorie
• % Daily Value
  • Fat/Lipides
  • Saturated / saturés
• Trans / trans
• Carbohydrate / Glucides
• Protein / Protéines
• Cholesterol / Cholestérol
• Other nutrients such as fibre, sugars, cholesterol, sodium, potassium, calcium, iron
• Nutrient that is the subject of a statement, claim or representation
• Sugar alcohol, vitamin or mineral nutrient added to the product (other than iodine added to table salt, or fluoride added to water or ice)
• Footnote to link the absolute values (g, mg) to the product as sold

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).

United States

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:

1. Dietary ingredients without RDIs (Recommended Daily Intake) or DRVs (Daily Reference Value) must be listed in the “Supplement Facts” panel for dietary supplements, but these ingredients are not allowed in the “Nutrition Facts” panel for foods.
2. The source of a dietary ingredient may be listed in the “Supplement Facts” panel for dietary supplements (if applicable), but is not permitted in the “Nutrition Facts” panel for foods.
3. The source of a dietary ingredient does not need to be listed in the ingredient statement if it is already listed in the “Supplement Facts” panel for dietary supplements.
4. The part of the plant used for a dietary ingredient must be indicated in the “Supplement Facts” panel for dietary supplements, but is not allowed in the “Nutrition Facts” panel for foods.
5. When the amount of a nutrient is zero, this nutrient is not permitted to be listed in the “Supplement Facts” panel for dietary supplements, but must be listed in the “Nutrition Facts” panel for foods.

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.

• Health claims refer to a description of a relationship between a substance (a food, food component, or dietary supplement ingredient) and the reduced risk of a disease or condition.
• Nutrient content claims are those that characterize the level of a nutrient in descriptive terms, such as “low sodium food”, “10 mg of calcium”, “40% fatty acid”
• Structure/function claims are the proposed effects of a nutrient or dietary ingredient that affect the normal structure or function of the human body, such as “calcium builds healthy bones”, “fiber helps to maintain bowel regularity”
• Dietary supplements containing such claims focus on both the nutritive and non-nutritive effects. When making such claims, a notification must be submitted to FDA within 30 days after marketing the product. The product itself must include two disclaimers: one states that this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease and the other one indicates that FDA has not evaluated the claim(s).
• Conventional foods containing such claims tend to focus more on the effects derived from nutritive value. When making such claims, it is not required to notify FDA about the claims nor to include the two disclaimers as mentioned previously for dietary supplements.

If you would like to learn more about the differences between food and supplement labelling or need help becoming compliant, contact us today.