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)

1. 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 the 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 a product contains ingredients that were 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 the product being banned.

3. Label Compliance Certification 3.1 Supplement Facts Table: Must label ingredients, dosage, allergens (such as nuts, dairy) and disclaimers (such as "not intended to diagnose, treat, cure, or prevent any disease") according to FDA requirements.

3.2 Language and Format: Labels must be in English, the place of origin must be clearly marked (e.g., "Product of China"), and the font and layout must comply with the standards.

4. The quality inspection report must be conducted by a third-party laboratory (such as an ISO 17025 accredited institution) to test for heavy metals (lead, arsenic, etc.), microorganisms, pesticide residues, and other indicators, and provide a testing report.

5. Other optional certifications 5.1 NSF Certification: Certifies that the product meets international quality standards, enhancing market competitiveness.

5.2 USDA Organic Certification: If the product contains organic ingredients, it must pass this certification to meet U.S. organic standards.

5.3 Non-GMO Certification: Meet consumer demand for non-GMO products.

II. Policy Changes and Compliance Key Points in 2025

6. FDA Regulation Update 6.1 Mandatory Cosmetic Registration Extension: Starting in 2025, health products containing cosmetic ingredients (such as beauty oral liquids) will need to complete additional FDA cosmetic registration.

6.2 Cross-border e-commerce label requirements: Small packaged food (including health products) must provide English ingredient labels, and must indicate net content and calories.

7. Market Access Risks 7.1 Advertising Statement Restrictions: Claims of treating diseases (such as "lowering blood sugar") are prohibited, only structural/function claims (such as "supports bone health") are allowed.

7.2 Allergen Labeling: 9 major allergens (peanuts, milk, etc.) must be clearly labeled on the packaging.

The core challenges for health supplement exports to the United States in 2025 are the rising compliance costs and increasing trade barriers. Companies need to prioritize completing FDA registration, NDI notification, and label compliance, while flexibly adjusting their supply chains to respond to tariff fluctuations. It is recommended to combine services from professional institutions to ensure compliance throughout the entire process and reduce market entry risks.

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