The dietary supplements and nutraceuticals industry in the U.S. is highly regulated under 21 CFR Part 111 to ensure product safety, quality, and accurate labeling. Compliance with FDA regulations is mandatory for manufacturers, distributors, and importers, covering facility registration, labeling, Good Manufacturing Practices (GMP), and reporting new dietary ingredients (NDIs).

At XPRO AMERICA, we provide comprehensive support to help companies navigate FDA requirements efficiently and confidently, minimizing regulatory risk while ensuring market access.

Key Services:

• Facility Registration & Product Listing (21 CFR Part 111): All domestic and foreign facilities producing, processing, or packaging dietary supplements must register with the FDA and list each product. Our team manages the registration process and ensures accurate listing to maintain compliance.
• Labeling Compliance: FDA requires accurate Supplement Facts Panels, ingredient statements, allergen disclosures, and permissible health claims. XPRO AMERICA reviews and approves labeling to ensure it meets regulatory requirements and avoids misbranding.
• GMP Audits & Quality Systems: We conduct Good Manufacturing Practices audits to ensure adherence to 21 CFR Part 111 standards. This includes evaluating production processes, documentation practices, sanitation, and personnel training to maintain product quality and compliance.
• New Dietary Ingredient (NDI) Notifications: For supplements containing new dietary ingredients, FDA requires premarket notification demonstrating safety. XPRO AMERICA assists with NDI preparation, submission, and communication with the FDA, ensuring timely approval and market readiness.
• Regulatory Guidance & Training: We provide ongoing support on changes in FDA regulations, labeling updates, and compliance strategies to help companies stay ahead of regulatory challenges.

Why Choose XPRO AMERICA?

• Expertise in dietary supplement regulations and FDA Part 111 compliance.
• End-to-end support from facility registration to labeling and GMP audits.
• Proven track record in NDI notifications and FDA communications.
• Minimizes compliance risk and supports efficient market entry.

Partnering with XPRO AMERICA enables dietary supplement and nutraceutical companies to maintain regulatory compliance, product safety, and market credibility. From premarket preparation to post-market oversight, our services streamline processes, reduce regulatory burdens, and support long-term business growth.

XPRO AMERICA ensures dietary supplement compliance with FDA 21 CFR Part 111, labeling, GMP audits, and New Dietary Ingredient notifications.