FDA Detained My Shipment: Import Holds, Refusals and Import Alerts Explained

FDA COMPLIANCE · IMPORT HOLDS

Updated November 2026. For brands that import food, supplements, cosmetics, OTC drugs or devices to sell on Amazon, Walmart, TikTok Shop or Shopify, an FDA hold is one of the most expensive surprises in the supply chain. Inventory sits at the port, storage fees build, and listings go out of stock. This guide explains the FDA import process step by step, what to do at each stage, and how to keep future shipments moving. It is general information, not legal advice.

How does FDA review imported products?

When an FDA-regulated product is offered for import, the customs entry is shared with FDA, which screens it electronically. Most shipments are released. Others are flagged for a closer look. FDA’s import process pages describe several outcomes:

• May proceed: FDA releases the shipment.
• Examination or sample collection: FDA wants to inspect or test the product. A Notice of FDA Action goes to the importer of record, consignee and filer. You must tell the FDA office where the goods are available and hold them. Products pending exam must not be distributed. If they are, FDA can ask CBP to demand redelivery.
• Detention: the product appears to violate FDA requirements and is subject to refusal.
• Refusal: FDA refuses admission and the product cannot enter U.S. commerce.

The legal standard is worth knowing. Section 801 of the Federal Food, Drug, and Cosmetic Act lets FDA refuse products that appear to violate the law. FDA calls this the appearance standard. FDA does not have to prove a violation at the port. The importer has to show the product complies.

What should you do when FDA detains a shipment?

A detention starts a clock. FDA’s detention and hearing page says the Notice of FDA Action shows a “respond by” date. FDA’s Regulatory Procedures Manual allows 10 business days from the date of detention, and the notice generally gives up to 20 calendar days to allow for weekends, holidays and mail. If FDA receives no response, the compliance officer can refuse admission. You can ask for more time if you need it to gather evidence.

Work through these steps quickly:

1. Read the charge. The notice cites the section of the law and the specific way the product appears to violate it. That is the only description of the problem you will get, so match your response to it.
2. Keep the goods held. Do not move detained goods into your 3PL or fulfillment center inventory.
3. Gather evidence. Depending on the charge, that might be a corrected label, laboratory analysis from a qualified lab, facility registration records, a product listing, or documents showing the product is a different category than FDA assumed.
4. Submit testimony. FDA accepts testimony in several forms, including email, phone, mail and in person. Keep a written record of everything you submit.
5. Consider reconditioning. If the problem can be fixed, such as a missing label element, you can apply on Form FDA 766 for authorization to relabel or perform other action to bring the product into compliance. FDA sets conditions and a deadline. Any part that cannot be brought into compliance still has to be exported or destroyed.

What happens after FDA refuses a shipment?

A refusal of admission means the product cannot enter U.S. commerce. FDA’s import refusal page says refused products must be exported or destroyed under FDA and CBP supervision, generally within 90 days of the refusal notice. Refusals are also recorded publicly, and repeated refusals for the same firm or product can contribute to an import alert.

What is an FDA import alert?

FDA uses import alerts to protect consumers from products with a history of known violations. Once a product or firm is on an import alert, FDA can detain future shipments without testing or physically examining them. FDA calls this Detention Without Physical Examination, or DWPE. Violations can relate to the product, the manufacturer, the shipper, the importer or the country of origin.

How to read an import alert:

• Red or yellow list: firms and products on the list are subject to DWPE under that alert.
• Green list: firms and products on the list are exempt from DWPE under that alert. Firms not on the green list remain subject to it.
• Guidance section: each alert explains what evidence may be accepted to release a shipment and how to be removed from the alert.

FDA says importers should check, before shipping, whether a product is subject to DWPE. Search FDA’s import alert database by firm name and product before you place a purchase order with a new supplier.

How do you get removed from an FDA import alert?

Removal requires a petition to FDA that shows the cause was found and fixed. FDA’s removal page describes the kinds of evidence it looks for: the investigation and root cause, corrective and preventive actions, and supporting evidence. Depending on the alert, FDA may look for a series of non-violative commercial shipments, and some cases require an inspection. FDA considers the full body of evidence, so there is no single shortcut. Expect removal to take time, and plan inventory from another source in the meantime.

Why ecommerce shipments get held

The same causes come up again and again:

• Labeling problems: missing required statements, no English labeling, ingredient lists that do not match the formula, or Supplement Facts and Drug Facts panels in the wrong format.
• Claims that change the category: a cosmetic or supplement marketed to treat a disease can be charged as an unapproved new drug.
• Missing or stale filings: an expired food facility registration, no drug listing, or no Prior Notice. See our Prior Notice answer.
• A supplier already on an import alert.
• Undeclared ingredients or contaminants found in sampling.

Most of these are cheaper to prevent than to argue at the port. Our FDA registration and U.S. Agent guide covers the filings by category.

How to protect your marketplace inventory

1. Check new suppliers against FDA’s import alert database before ordering.
2. Review labels against FDA rules before production, not after the goods ship.
3. Confirm facility registration, listing and Prior Notice responsibilities in writing.
4. Keep a document pack per SKU so you can respond to a detention within days.
5. Split first orders from a new supplier, so one hold does not take out all your stock.
6. Keep marketplace listing claims identical to the compliant label.

How Eva Commerce helps

Eva Commerce serves as U.S. Agent for foreign facilities ($250 per year), handles facility registration and product listing filings, files Prior Notice ($30 per shipment), and reviews labels before production (basic formatting review $340 per label, full compliance review $590 per label). Prices are on our FDA compliance services page. Because we also run Amazon management and other marketplace channels, we can plan inbound timing and listing copy around your compliance status. We do not replace customs brokers or legal counsel on contested detentions, and no filing guarantees admission.

Book a call or call 858-315-2020 to review a supplier or a held shipment.

Frequently asked questions

How long does FDA hold a detained shipment?

The Notice of FDA Action sets a respond-by date, usually 10 business days and often written as up to 20 calendar days. The hold continues until FDA releases or refuses the goods.

What is a Notice of FDA Action?

It is FDA’s notice to the importer of record, consignee and filer about an import decision, such as a request to examine, a detention or a refusal. It lists the charge and response deadline.

Can I relabel a detained product?

Often, yes. You can apply on Form FDA 766 for authorization to relabel or recondition. FDA sets the conditions and a completion deadline.

What happens to refused goods?

They must be exported or destroyed under FDA and CBP supervision, generally within 90 days of the refusal notice.

What does DWPE mean?

Detention Without Physical Examination. Products under an import alert can be detained without testing until the importer shows they comply.

How do I get off an FDA import alert?

Petition FDA with the root cause, corrective and preventive actions and supporting evidence. FDA reviews the full body of evidence and may expect clean shipments or an inspection.

Sources: FDA, Detention and Hearing; FDA, Import Refusals; FDA, Import Actions and Enforcement; FDA, Import Alerts; FDA, Removal from DWPE Under Import Alert; FDA Regulatory Procedures Manual, Chapter 9. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA registration and U.S. Agent guide, Prior Notice for Amazon FBA.