The FDA regulates color additives and food contact substances (FCS) to ensure safety for consumers. Companies introducing new color additives or materials intended for contact with food must comply with rigorous FDA requirements, including premarket approval, notifications, and safety testing.

At XPRO AMERICA, we provide end-to-end guidance for manufacturers, distributors, and packaging companies to ensure full compliance with FDA regulations for color additives and food contact substances.

Key Services:

• FDA Approval for New Color Additives: Any new color additive intended for food, drugs, cosmetics, or medical devices requires FDA premarket approval. XPRO AMERICA prepares and submits comprehensive safety, toxicology, and usage data to support approval.
• Food Contact Substance (FCS) Notifications: Materials intended to contact food, such as packaging or coatings, require an FCS notification to FDA. Our experts manage the preparation, submission, and tracking of FCS notifications to ensure timely compliance.
• Migration Testing & Safety Assessments: Testing evaluates the potential for substances to migrate from packaging or additives into food. We coordinate laboratory testing and prepare safety assessments in accordance with FDA guidance to validate compliance.
• Labeling & Regulatory Consultation: Proper labeling and documentation are essential to demonstrate safe use and regulatory adherence. XPRO AMERICA reviews formulations, labeling, and usage instructions to avoid misbranding or noncompliance.
• Regulatory Strategy & Ongoing Support: Our team monitors changes in FDA regulations, provides guidance on compliance strategy, and assists in responding to FDA inquiries or inspections.

Why Choose XPRO AMERICA?

• Expertise in FDA color additive and food contact substance regulations.
• End-to-end support from submission preparation to FDA approvals.
• Coordination of testing, safety assessments, and documentation.
• Minimizes regulatory risk and ensures smooth market entry.

Partnering with XPRO AMERICA allows companies to confidently navigate FDA requirements for color additives and food contact substances, ensuring safety, regulatory compliance, and consumer confidence. Our services streamline approvals, reduce risk, and maintain market readiness.

XPRO AMERICA supports FDA submissions for color additives, food contact substances, migration testing, and safety assessments for compliance.