New rules for supplemented foods

Summary#

The Canada Gazette, Part I published a proposal on June 26, 2021 called the Regulations Amending the Food and Drug Regulations (Supplemented Foods). It would create a new, rule-based system for prepackaged products with added vitamins, minerals, amino acids, caffeine or herbal ingredients (called “supplemented foods”), with new labelling, limits and a way to add new ingredients; this is a proposal, not law yet and was open for comment for 60 days.

What it does#

• Sets up a new regulatory framework in the Food and Drug Regulations for “supplemented foods” and creates lists that say which food categories and which supplemental ingredients are allowed, and under what conditions (for example, which foods may contain added caffeine and at what levels).
• Requires a new label element, a Supplemented Food Facts table (SFFt), to replace the Nutrition Facts table on supplemented foods. The SFFt must list the amount of each supplemental ingredient under a “Supplemented with” heading.
• Requires warning text (grouped under a “Caution” heading) on products that reach certain ingredient thresholds, and a front-of-package visual cue (a supplemented food caution identifier) when those cautions are needed.
• Limits or bans certain health or performance claims for products that must carry cautionary statements (for example, claims about hydration, physical performance or vitamin benefits in some high‑caffeine products).
• Creates a submission process so companies or others can ask to add new ingredients or new food categories to the permitted lists if they provide safety evidence.
• Lets existing products sold under Temporary Marketing Authorizations (TMAs) stay on shelf during a transition period of three years while they move to the new rules; Health Canada would continue to accept TMA applications until the new rules come into force.

Who's affected#

• Health Canada — the department that wrote the proposal and would maintain the permitted-lists and review requests for new ingredients or categories.
• Canadian Food Inspection Agency (CFIA) — would enforce the new rules once in force.
• Manufacturers and distributors of supplemented foods (domestic and foreign) — Health Canada estimated 611 existing supplemented products on the market, made by about 90 firms.
• Small businesses — the department estimated about 67 small businesses make supplemented foods in Canada (about 126 products), and they were expected to face label and reformulation costs during transition.
• Consumers, especially people who are sensitive to added ingredients — the rules specifically aim to protect children, teenagers, pregnant and breastfeeding women, and people monitoring caffeine or nutrient intake.
• It’s unclear how many future new products or firms would be affected; the proposal relies on Health Canada’s lists and administrative review process.

Why it matters#

• Consumer information and safety: the SFFt, caution statements and front‑of‑package identifier are designed to make it easier to spot products with added stimulants or high supplemental nutrient levels and to understand risks (for example, caffeine limits, not recommended for children or pregnant women).
• Limits on claims: some marketing claims would be restricted for products that require cautions. That can change how manufacturers advertise benefits of added ingredients.
• Predictability for industry: replacing case‑by‑case TMAs with a rules-based list should make the system more predictable and reduce the paperwork of repeatedly applying for temporary permissions.
• Costs and savings: Health Canada’s analysis estimated direct annualized savings from removing TMA review and post‑market reporting of about $7.8 million, and one‑time industry transition costs averaging $2.7 million annualized (net annualized benefit estimated at about $5.1 million). These are Health Canada’s estimates and depend on assumptions in the department’s cost‑benefit analysis.
• Transition and next steps: the measure is a proposal (Canada Gazette, Part I) and would need to be finalized (Canada Gazette, Part II) to become law. The proposed transition gives current TMA products up to three years to comply once the final rules start.