Main certifications and policy requirements for exporting health products to the United States in 2025 (organized in conjunction with the latest regulations and trade environment)一、Core Certification Requirements
1. FDA Registration and Factory Certification
1.1 FDA Factory Registration: All factories that produce, package, or store dietary supplements must be registered with the FDA, and registration must be renewed every two years (October to December of even-numbered years). Unregistered factories may result in products being detained or returned.
1.2 CGMP (Current Good Manufacturing Practice) Certification: The production process must comply with FDA's cGMP standards, covering raw material procurement, production environment, quality testing, and record traceability, etc.
2. New Dietary Ingredient (NDI) Notification
If the product contains ingredients first used in the United States after October 15, 1994 (such as new plant extracts), an NDI notification must be submitted to the FDA 75 days prior to marketing, providing safety evidence. Failure to submit may result in
创建于04.29