Human Milk Fortifier Regulations

Summary#

The final rule titled Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) creates a specific regulatory framework for human milk fortifiers (HMFs) in Canada. It requires pre‑market review and written authorization by Health Canada, sets new labelling and nutrient rules, and limits how HMFs can be sold; the regulations came into force when published on April 14, 2021.

What it does#

• Defines what a human milk fortifier is and adds it to the Food and Drug Regulations.
• Requires manufacturers to get written authorization from Health Canada before selling or advertising an HMF in Canada (a pre‑market assessment).
• Allows HMFs to contain added vitamins, mineral nutrients and amino acids. The government will review levels case‑by‑case (no fixed maximums set in the rule).
• Sets labelling rules that differ from ordinary foods:
  • Prohibits the standard Nutrition Facts table for HMFs.
  • Requires nutrition information (energy and amounts of protein, fat, carbohydrate, fibre, vitamins, minerals and amino acids) expressed for the quantity specified in the directions for use.
  • Requires directions for preparation, storage and use, an expiration date, lot number, and a statement that the product is to be used only under medical supervision.
  • Labels must be in both official languages.
• Restricts sales:
  • HMFs are primarily for hospitals and can be sold to individuals only with a written order from an authorized health professional (physician, nurse practitioner or dietitian, where permitted by provincial law).
  • A manufacturer may sell to an individual only if the hospital also requests the product.
• Allows Health Canada to require manufacturers to stop sales while they provide evidence (minimum time to respond is 24 hours unless there is a serious, imminent health risk).
• Prohibits a range of nutrition and marketing claims on HMF labels and adverts to avoid misleading information.
• Provides transitional arrangements:
  • A List of Human Milk Fortifiers Sold in Canada as of March 25, 2021 will be published.
  • Manufacturers of products on that list can continue to sell if they submit an attestation and label text and are authorized by Health Canada — the attestation/label info must be submitted in time for assessment before April 30, 2022.
  • A two‑year transition period is allowed for label changes.

Who's affected#

• Hospitals and their neonatal units, especially neonatal intensive care units (NICUs), which are the main users of HMFs.
• Manufacturers and importers of HMFs (currently 10 products were on the Canadian market at the time of the rule).
• Health Canada (responsible for pre‑market review) and the Canadian Food Inspection Agency (CFIA) (responsible for inspection and enforcement).
• Health professionals who may order or oversee HMF use: physicians, nurse practitioners and dietitians.
• Caregivers of preterm or medically vulnerable infants who might receive HMFs in hospital or, in some cases, at home under medical direction.
• It is unclear whether other groups (for example, pharmacies) will be involved; the rule keeps hospital distribution as the main route.

Why it matters#

• Safety and clarity: the rule creates a clear, official path for HMFs to be assessed and sold in Canada. That helps ensure products used with vulnerable infants have been reviewed for safety and nutritional adequacy.
• Access and continuity of care: hospitals keep access to HMFs, and the rules allow limited post‑discharge use under medical supervision. That can help some infants continue necessary nutrition after leaving hospital.
• Predictability for industry: a formal regulatory framework makes it clearer how new or changed HMF products can enter the Canadian market. That can speed access to newer products used elsewhere, like the U.S.
• Costs and paperwork: manufacturers must submit label text and other information and may need to change labels. The rule includes a transition window to reduce immediate disruption.
• Public health relevance: HMFs are used for preterm and medically fragile infants. The rule therefore matters most to families, clinicians and hospitals caring for those infants, including communities with higher preterm birth rates.