Should Infant Formula Approval Rules Change Based on Risk Level?
Official title: Consultation: Proposed risk-based approach for the authorization of infant food for a special dietary purpose
Why This Matters
Have a baby or planning to? This affects what formula and specialized infant foods reach store shelves. Parents of infants with special dietary needs—like premature babies needing human milk fortifiers—could see more products available faster. But the trade-off is less government review before some products hit the market.
What Could Change
New regulations would create a three-tier approval system. Low-risk infant foods could reach shelves with just a post-market notification. Moderate-risk products would get expedited review. Only higher-risk products would need the full pre-market authorization that all products require today. Draft regulations are expected in the Canada Gazette, Part I.
Key Issues
- Should low-risk infant foods be allowed on the market with only post-market notification?
- Is a three-tier risk-based authorization system appropriate for infant formula and medical foods?
- How should products be classified into risk tiers?
How to Participate
- Review the proposed risk-based approach document, paying attention to Section 6.0 which lists the specific questions for stakeholders.
- Send your responses to the consultation questions by email to bns-bsn@hc-sc.gc.ca.
Submit Your Input
Questions Being Asked (4)
- What are your views on the proposed three-tier risk-based framework for authorization of infant food for a special dietary purpose?
- Is post-market notification appropriate for lower-risk products (Tier 1)?
- Is expedited pre-market review appropriate for moderate-risk products (Tier 2)?
- Is full pre-market authorization appropriate for higher-risk products (Tier 3)?