Infant formula and baby foods are subject to strict FDA regulations to ensure safety, nutritional adequacy, and labeling accuracy for vulnerable populations. Manufacturers must comply with specialized review requirements, register facilities, and maintain adherence to nutrient content standards before marketing their products in the United States.

At XPRO AMERICA, we provide comprehensive guidance and regulatory support for companies producing infant formula and baby foods, helping them navigate FDA requirements efficiently while ensuring compliance and market access.

Key Services:

• FDA Registration of Infant Formula Manufacturers: All domestic and foreign manufacturers producing infant formula must register their facilities and products with the FDA. XPRO AMERICA manages accurate and timely registration submissions, ensuring compliance.
• Specialized FDA Nutritional Review: The FDA requires demonstration of nutritional completeness and safetyfor infant formula. Our experts assist with preparation of required documentation, data submission, and communications with the FDA to facilitate approval.
• Labeling & Nutrient Content Compliance: Accurate labeling is critical, including ingredient lists, nutrition facts, allergen statements, and nutrient content declarations. XPRO AMERICA reviews product labels and packaging to ensure full compliance with FDA requirements and prevent misbranding.
• Regulatory Strategy & Ongoing Support: We provide guidance on FDA inspections, post-market compliance, and changes in infant nutrition regulations, helping manufacturers maintain regulatory readiness and continuous compliance.

Why Choose XPRO AMERICA?

• Expertise in FDA regulations for infant formula and baby foods.
• End-to-end support from facility registration to labeling and nutritional compliance.
• Proven experience in FDA review processes and regulatory communications.
• Minimizes compliance risk and ensures safe, market-ready products.

Partnering with XPRO AMERICA allows infant formula and baby food manufacturers to confidently navigate FDA regulatory requirements, ensuring product safety, nutritional adequacy, and compliance. Our comprehensive services reduce risk, streamline regulatory approvals, and support ongoing market readiness.

XPRO AMERICA supports infant formula and baby food manufacturers with FDA registration, labeling, nutrient compliance, and regulatory review.