Logistics & Import 2 min read · February 08, 2026

Importing Supplements to the U.S.: Customs, FDA Holds, and How to Avoid Delays

The Import Process: More Than Just Shipping

Many international supplement brands underestimate the complexity of importing products into the United States. Beyond standard shipping logistics, your products must clear FDA inspection at the port of entry — and failures here can result in detention, refusal, or even destruction of your goods.

Key Steps in the Import Process

Prior Notice: The FDA requires prior notice of imported food and supplement shipments. This must be submitted electronically before the product arrives at the U.S. port of entry.
Customs Entry: Your customs broker files entry documents with U.S. Customs and Border Protection (CBP), including commercial invoices, packing lists, and bills of lading.
FDA Review: The FDA reviews import entries and may conduct physical examination, label review, or laboratory analysis of your products.
Release or Detention: Products that pass review are released. Products with issues receive an Import Alert or Detention Notice.

Common Reasons for FDA Import Holds

Labeling violations: Missing required elements, non-English text, or non-compliant claims
Unregistered facility: Manufacturing facilities not registered with the FDA
Unapproved ingredients: Ingredients not recognized as GRAS or approved dietary ingredients
Missing prior notice: Failure to submit electronic prior notice before arrival
Import Alert history: Previous violations can trigger automatic detention of future shipments
Country-wide alerts: Some countries have blanket import alerts for certain product categories

Working with a U.S. Agent

The FDA requires that foreign food and supplement facilities designate a U.S. Agent — a person or company located in the U.S. who serves as the point of contact between the foreign facility and the FDA. Your U.S. Agent must:

Be available 24/7 for FDA communications
Assist the FDA in scheduling inspections
Respond to questions about your facility or products

Tips to Avoid Import Delays

Ensure all labels are fully FDA-compliant before shipping
Register your manufacturing facility and renew annually
Work with an experienced customs broker who specializes in FDA-regulated products
Maintain detailed records of all ingredients, sourcing, and testing
Submit prior notice accurately and on time
Consider NPI's full-service import management to handle the entire process

importing supplements customs FDA holds import alerts supply chain U.S. agent

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