
Importing Dietary Supplements: The 2026 Compliance Roadmap
The US dietary supplement market is projected to reach $85 billion by 2027, and a growing share of products originate from Chinese manufacturers. However, importing supplements into the US involves a unique regulatory framework that differs significantly from cosmetics or general goods.
Key Regulatory Bodies
- FDA — Regulates dietary supplements under DSHEA (Dietary Supplement Health and Education Act)
- USDA — May get involved if products contain animal-derived ingredients
- CBP — Customs clearance and tariff classification under HTS Chapter 21
Essential Compliance Checklist
- FDA Facility Registration — Both the foreign manufacturer and US importer must register with FDA before shipping
- Ingredient Verification — Ensure all ingredients are either approved food additives, GRAS (Generally Recognized As Safe), or NDI (New Dietary Ingredient) with proper notification
- Labeling Requirements — Supplement Facts panel, ingredient list, net quantity, manufacturer/distributor address, and disclaimer statement
- GMP Certification — Manufacturers must comply with FDA Current Good Manufacturing Practices (21 CFR Part 111)
- Prior Notice — Submit FDA Prior Notice before arrival (required for all food/dietary supplement shipments)
- HTS Classification — Most supplements fall under HTS 2106.90.9998, with duty rates typically 6.4%
Common Pitfalls to Avoid
- Disease Claims — Never label supplements as treating, curing, or preventing diseases. The FDA classifies such products as unapproved drugs.
- Novel Ingredients — If your product contains an NDI not previously notified to FDA, expect delays or detention.
- Country of Origin — “Made in China” labeling must be clear; mislabeling can trigger CBP penalties.
“Dietary supplements sit at the intersection of food, drug, and customs regulations. A single labeling mistake can result in an FDA detention order that holds your entire container for weeks.”
— COHO Regulatory Desk
How COHO Streamlines Supplement Imports
With warehouses across New York, Los Angeles, Seattle, and New Jersey, COHO provides end-to-end DDP logistics for dietary supplement importers:
- Pre-shipment FDA documentation review
- GMP manufacturer verification assistance
- Customs bond and FDA Prior Notice filing
- Temperature-controlled warehousing for probiotic and enzyme products
- Last-mile delivery to Amazon FBA, wholesale distributors, and retail chains
Our compliance team stays current with FDA enforcement trends, which have intensified in 2026 — particularly around NDI notifications and GMP inspections of foreign facilities.
Importing dietary supplements into the US? Let COHO handle the complexity.
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