The U.S. dietary supplements and nutraceuticals market is one of the largest in the world, but gaining entry requires strict compliance with U.S. Food and Drug Administration (FDA) regulations. Companies manufacturing or distributing dietary supplements, vitamins, minerals, herbal products, protein powders, or fortified beverages must meet specific FDA requirements before marketing their products in the United States.

A key regulation governing supplements is 21 CFR Part 111 – Current Good Manufacturing Practices (GMPs). This rule ensures that supplements are manufactured consistently, with quality standards that protect consumer health. GMP compliance requires companies to follow strict procedures for raw material sourcing, production, packaging, labeling, storage, and distribution. Facilities must also maintain detailed records, conduct quality control testing, and ensure proper staff training.

Another critical requirement is FDA labeling compliance. Supplement labels must include a Supplement Facts Panel, ingredient list, allergen statements, and manufacturer details. Claims such as “supports immunity,” “improves energy,” or “boosts metabolism” must be truthful, not misleading, and substantiated with scientific evidence. Certain claims, such as disease treatment or prevention, are prohibited unless approved by the FDA.

For nutraceuticals and fortified beverages, companies must also ensure compliance with both supplement and food regulations. This includes correct categorization, claims review, and adherence to FDA definitions for terms like “natural,” “sugar-free,” or “gluten-free.”

Non-compliance with GMP or labeling regulations can lead to FDA warning letters, product recalls, import refusals, or significant brand damage. Since U.S. distributors and retailers demand proof of compliance, regulatory readiness is essential for market success.

At XPRO America, we provide end-to-end FDA compliance services for dietary supplements and nutraceuticals. Our team assists with GMP compliance audits, label and claims review, and regulatory submissions. With our expertise, companies can confidently launch safe, compliant, and competitive supplement products in the U.S.

For global supplement manufacturers, compliance is more than a regulatory obligation—it is the foundation for building trust, credibility, and long-term success in the U.S. market.

XPRO America helps supplement companies achieve FDA 21 CFR 111 GMP compliance with label and claims review for dietary supplements and nutraceuticals.