New U.S. Dietary Supplement Regulations in 2025: Challenges and Opportunities for Global OEM Manufacturers

The U.S. remains the world’s largest and most competitive dietary supplement market, projected to exceed $60 billion in 2025. For Chinese and global OEM/ODM manufacturers, compliance with the U.S. Food and Drug Administration (FDA)’s newly updated regulations is critical to gaining and maintaining market access. This article provides a detailed breakdown of the 2025 U.S. dietary supplement export regulations, the challenges for international manufacturers, and how GD B&H supports global brands in navigating compliance and growth.

Key Regulatory Updates in 2025

1. Labeling Requirements: All dietary supplements must comply with DSHEA guidelines, with updated FDA requirements mandating clear nutrition facts, dosage instructions, and standardized health claims. Misleading or exaggerated claims are strictly prohibited.
2. Ingredient Compliance: Supplements containing new dietary ingredients (NDIs) must undergo FDA notification, while all raw materials must either be GRAS-approved or undergo equivalent safety assessments.
3. cGMP Certification: Manufacturers must comply with current Good Manufacturing Practices (cGMP). Third-party certifications such as NSF, BRC, or USP are becoming essential for U.S. market entry.
4. Import Screening: U.S. Customs has strengthened import inspections, particularly for softgels, powders, and complex multivitamins. Companies must prepare complete testing reports, certificates of analysis, and compliance documentation.

Challenges for OEM/ODM Manufacturers

Label Translation Gaps: Many manufacturers misinterpret or mistranslate FDA labeling standards.
Certification Shortfalls: Lack of international certifications delays entry into the U.S. market.
Supply Chain Documentation: Missing or incomplete safety and testing documentation often results in customs delays.
Regulatory Sensitivity: Manufacturers without dedicated regulatory teams risk non-compliance with frequent FDA updates.

GD B&H: Your Compliance Partner for the U.S. Market

At GD B&H, we understand the complexity of entering and thriving in the U.S. dietary supplement market. With BRC, NSF, and GMP certifications, we provide end-to-end solutions for global clients:

Regulatory Expertise: Our compliance specialists monitor FDA, EU, and Asia-Pacific regulations, ensuring your products meet global standards.
Certified Manufacturing: Our GMP-certified facilities and international certifications ensure smooth U.S. entry.
Supply Chain Traceability: From raw material sourcing to finished product, we maintain a fully transparent and test-backed system.
Proven Track Record: We have successfully assisted multiple global supplement brands in achieving rapid market entry.

The new 2025 FDA regulations represent both a challenge and an opportunity. For brands and OEM partners, compliance will be the defining factor in building trust and long-term success in the U.S. market. GD B&H, with its internationally certified manufacturing capabilities, stands ready to help global clients achieve compliance, accelerate market entry, and expand their presence in the world’s largest supplement market.