One day your products are sailing smoothly; the next, you receive a notice that your container is “on hold.” 

But what does that really mean? 

And more importantly, who’s holding it? 

Two common key players are the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). 

While both can stop your shipment, the reasons and processes behind each hold are very different—and understanding those differences could save you time, money, and a lot of stress.

What is an FDA Hold?

Let’s talk about the FDA.

You might be thinking, “Wait a second—last week I imported auto parts from China without any issues.

But today, I brought in tomatoes from India and suddenly the FDA steps in. What gives?”

Here’s the key: the FDA only gets involved with products that can affect public health or perishable goods—foods, beverages, supplements, cosmetics, medical devices, and similar items. 

Auto parts? Not their concern. 

But fresh tomatoes? Absolutely. 

They want to make sure those tomatoes are safe to eat, free of contaminants, properly labeled, and compliant with U.S. food regulations.

So, if your shipment falls under FDA’s scope, expect the agency to take a closer look, especially with items like fresh produce, seafood, medicines, or anything that goes into or onto the human body.

When and Why the FDA Might Place a Shipment on Hold

The FDA doesn’t just stop shipments for fun—it steps in when there’s even a hint that something might not meet U.S. health and safety standards. 

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Think of it as the country’s quality control team for anything we eat, drink, or use on our bodies.

Here are the most common reasons the FDA hits the pause button:

  • Compliance checks: Making sure your products meet all U.S. regulations before they’re released.
  • Labeling issues: Are the ingredients listed correctly? Are there any misleading claims? Is the language clear and accurate?
  • Safety concerns: The FDA is watching out for contamination, unapproved additives, or products that could harm consumers.

And when they decide to hold a shipment, it usually falls into one of three main categories:

  • Detention – A temporary stop. The FDA suspects there might be a problem and wants to inspect or test the product before it’s cleared.
  • Import Alert – A bigger red flag. If a company or product has a history of violations, it can land on an alert list, which means future shipments may be automatically detained until proof of compliance is provided.
  • Refusal – The final “no.” If the FDA finds the product is unsafe or non-compliant, it won’t be allowed into the U.S. and will need to be exported or destroyed.

What is a Customs Hold?

Now, let’s talk about the other big player at the port: U.S. Customs and Border Protection (CBP). Unlike the FDA, which only steps in for products that affect public health, Customs is like the traffic cop for everything coming into the country. 

Whether it’s electronics, furniture, clothes, or yes, even those auto parts from China—Customs gets the first look.

A Customs hold happens when CBP decides your shipment needs a second glance before it’s cleared. Why? 

Here are some common reasons:

  • Documentation checks: Missing or incorrect paperwork is a major trigger.
  • Duties and taxes: They want to ensure you’ve paid the right fees.
  • Security concerns: Random inspections or red flags can lead to an exam.
  • Trade compliance: If there’s a question about origin, classification, or restrictions, your shipment might be held.

Customs holds can also come in a few flavors:

  • Manifest Hold: When CBP wants to verify information before the shipment is even unloaded.
  • Exam Hold: When your shipment is pulled for inspection—could be an X-ray, physical exam, or sampling.
  • Intensive Exam: A deep dive into your cargo, often the most time-consuming and expensive type.

A comparison chart between Customs hold and FDA Hold 

Aspect

FDA Hold

Customs Hold (CBP)

Who’s in charge?

U.S. Food and Drug Administration (FDA)

U.S. Customs and Border Protection (CBP)

Scope

Products that impact public health (food, cosmetics, medical devices, supplements, etc.)

All imported goods, regardless of type

Why shipments are held

Safety checks, labeling issues, contamination risks, regulatory compliance

Missing/incorrect documents, unpaid duties, security checks, trade restrictions

Types of holds

Detention, Import Alert, Refusal

Manifest Hold, Exam Hold, Intensive Exam

Goal

Protect consumer health and ensure products meet U.S. safety standards

Ensure legal trade, correct duties, and border security

Outcome if failed

Shipment may be refused entry or destroyed/exported

Shipment may be delayed, seized, or returned until resolved

What to Do if Your Shipment is on Hold

A shipment hold can feel like a full stop to your plans, but it doesn’t have to turn into a disaster. (Read)

The key is knowing who’s holding your goods and why—because the steps to fix it are different for the FDA and Customs.

If it’s an FDA hold:

  • Find out the reason. Your customs broker or the FDA notice will tell you if it’s a labeling issue, documentation gap, or safety concern.
  • Respond quickly. Provide any requested paperwork, lab results, or corrections. The faster you act, the sooner they can clear it.
  • Get expert help if needed. Regulatory consultants or FDA specialists can speed things up, especially for import alerts or complex cases.

If it’s a Customs hold:

  • Review your paperwork. Make sure all documents match—commercial invoice, packing list, bill of lading, and HS codes.
  • Pay any duties or fees promptly. Sometimes a hold is simply about unpaid taxes or incorrect values.
  • Be ready for inspections. If CBP needs to open or X-ray your shipment, expect delays and possible fees.

Pro tip: Work with an experienced international freight forwarder—they can often prevent holds before they happen or resolve them faster when they do.

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Wrap up

At the end of the day, an FDA hold and a Customs hold may feel the same—you’re stuck waiting for your shipment—but they’re driven by two very different missions. 

The FDA is the health keeper, making sure anything that touches consumers is safe and compliant. Customs is the gatekeeper of trade, focused on security, paperwork, and taxes.

Knowing who’s holding your shipment and why can save you time, money, and frustration.

It’s not about avoiding these agencies—it’s about being prepared: correct documents, clear labeling, compliant products, and the right partners to guide you through the process.

That’s where Air7Seas comes in. Our team specializes in helping businesses navigate complex import rules, resolve holds quickly, and keep goods moving smoothly across borders.

So, the next time you see the dreaded “hold” status, don’t panic. Ask the right questions, take quick action, and treat it as a checkpoint—not a roadblock.

Frequently Asked Questions 

1. Why did Customs hold my shipment?

Customs holds happen when U.S. Customs and Border Protection needs to check paperwork, verify duties, or inspect goods for compliance or security reasons.(contact to know why?)

2. How long does an FDA hold take to clear?

It depends on the issue. Minor labeling or paperwork checks may take a few days, while testing or import alerts can take weeks or longer.

3. How do I resolve a Customs hold quickly?

Ensure accurate documentation, pay all duties promptly, and work with a customs broker to respond quickly to CBP’s requests.(Read)

4. Can a shipment be held by both FDA and Customs?

Yes. If your product is subject to FDA oversight (like food or cosmetics), Customs and FDA may both review it before release.

5. How can I avoid FDA or Customs holds?

Prepare complete documentation, use correct HS codes, meet labeling rules, and partner with an experienced logistics provider like Air7Seas.