The Challenge

Bringing an infant formula to the U.S. market isn’t just about innovation. It’s about navigating one of the most rigorous regulatory landscapes in the world. A global manufacturer had developed a novel formula with a unique ingredient but needed to make sure their product claims would hold up under U.S. FDA scrutiny. That’s where RegASK stepped in.

The Mission

Ensure that the structure/function (S/F) claims for the product met U.S. FDA standards without losing the scientific integrity or competitive edge of the formula.

The RegASK Approach

RegASK combined its AI-driven platform with deep domain expertise to lead a targeted review, ensuring speed, accuracy, and regulatory alignment:

• We conducted a robust literature review, focusing exclusively on data relevant to the U.S. infant population.
• Our experts translated complex clinical findings into FDA-compliant, scientifically substantiated claims.
• All insights were compiled into a claim substantiation dossier, built for scrutiny, approval and success.

Points clés

Learn more about the RegASK approach with our Team

The Result

With RegASK’s proactive regulatory intelligence and claim validation, the client successfully launched in the U.S. market on time and with confidence. Backed by compliant, substantiated claims, their innovative formula met FDA scrutiny and entered the U.S. market successfully.

This wasn’t just about meeting compliance. It was about unlocking market potential, faster and smarter with RegASK by their side.

Frequently Asked Questions

Q1: How can RegASK help companies enter the U.S. infant formula market?

RegASK supports companies entering the U.S. infant formula market by providing expert guidance on FDA regulations, labeling, safety requirements, and registration pathways.

We conduct formula and label compliance reviews, ingredient assessments, formulation checks, and both quantitative and qualitative evaluations. It helps ensure compliance, streamlining approval and market entry.

 

Q2: What makes RegASK different from traditional regulatory consultants?

RegASK combines advanced technology with deep regulatory expertise. Its global community of subject matter experts and practical, business-oriented approach deliver faster, actionable insights for product compliance and market entry. You can leverage RegASK’s global network of local SMEs while having a single point of contact with RegASK experts to ensure the quality of deliverables.

 

 

Q3: Can RegASK support product launches in highly regulated categories like infant nutrition?

Absolutely. RegASK has a strong track record in the life sciences and nutrition sectors, including infant formula, Foods for Special Medical Purposes (FSMP), fortified foods, and dietary supplements. Our expertise goes beyond regulatory knowledge, we understand the scientific principles behind product formulation, safety, and nutritional efficacy.

This allows us to provide precise, evidence-based guidance tailored to complex, highly regulated categories. Combined with our practical experience in regulatory applications, we help ensure a smooth path to market entry and compliance.

 

 

Q4: What happens if regulatory standards change mid-launch planning?

That’s where RegAlerts comes in. RegASK continuously monitors relevant regulatory changes and updates your team with curated insights, so your strategy stays aligned with the latest standards.