How Should Canada Approve Infant Formula and Baby Medical Foods?

Official title: Consultation: Proposed risk-based approach for the authorization of infant food for a special dietary purpose

Open Regulations & Permits Agriculture & Food Health & Safety
Health Canada wants to change how it approves infant formula and specialized baby foods like human milk fortifiers. Right now, all these products go through the same review process. The proposal would create three tiers based on risk—lower-risk products could notify the government after going to market, while higher-risk ones would still need full pre-approval.

Why This Matters

Have a baby or planning to? This affects what formula and specialized infant foods make it to store shelves. Parents of premature babies or infants with medical conditions rely on products like human milk fortifiers. The new system could speed up access to some products—but critics might worry about less oversight for "lower-risk" items.

What Could Change

Lower-risk infant foods could reach the market faster through post-market notification instead of pre-approval. Moderate-risk products would get expedited reviews. Higher-risk products would still need full pre-market authorization. These changes would eventually become formal regulations published in the Canada Gazette.

Key Issues

  • Should lower-risk infant foods be allowed to market with only post-market notification?
  • Is the proposed three-tier risk classification appropriate for these products?
  • How should regulatory oversight be balanced with faster market access?

How to Participate

  1. Review the proposed risk-based approach document, paying attention to Section 6.0 which lists the specific questions for stakeholders.
  2. Email your responses to the consultation questions to bns-bsn@hc-sc.gc.ca by the deadline.

Submit Your Input

Draft Email
Questions Being Asked (4)
  1. What are your views on the proposed three-tier risk-based framework for infant food authorization?
  2. Is post-market notification appropriate for lower-risk products?
  3. Should moderate-risk products receive expedited pre-market review?
  4. Are there concerns about the proposed approach for higher-risk products?

Key Documents