What Is FDA Notice of Action (NOA)? A Complete Guide for U.S. Import Customs Clearance

What Is FDA Notice of Action (NOA)?

All goods imported into the United States must be declared to U.S. Customs and Border Protection (CBP) and processed through the Automated Commercial Environment (ACE) screening system.

During this process:

• CBP determines whether a shipment is subject to FDA jurisdiction

• If yes, the entry is referred to the FDA for review

• The FDA evaluates the submitted data and issues a Notice of Action (NOA), which defines the import outcome

The FDA has legal authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow or refuse products entering the U.S. market.

Products Regulated by the FDA

The FDA regulates a wide range of imported products, including but not limited to:

• Food and beverages

• Cosmetics

• Medical devices

• Radiation-emitting electronic products

• Tobacco products

• Pharmaceuticals and health-related items

Each category is governed by specific statutory and regulatory requirements. Non-compliance can result in detention or refusal.

FDA Entry & Screening Process

Step-by-Step Entry Process

1. Import entry data is submitted to CBP via ACE

2. FDA screens the entry data for compliance

3. FDA proceeds with Import Disposition

4. FDA issues an official Notice of Action (NOA)

5. NOA is sent to:

   • CBP

   • Importer of Record (IOR)

   • Customs broker (if applicable)

Types of FDA Notices of Action (NOA)

The FDA may issue one of the following NOAs:

• Release of the Product – Shipment is cleared for entry

• Request for Additional Information (AI) – More documents or data required

• Request for Sample – Physical product sample required for evaluation

• Detention of Entry – Shipment is held pending further action

Each NOA directly impacts clearance timelines and costs.

Additional Information Requests & ITACS

When the FDA issues an Additional Information (AI) Notice, the importer or broker must respond promptly.

How to Submit AI Documents

• Upload documents electronically via FDA ITACS (Import Trade Auxiliary Communications System)

• Use ITACS to track entry status

⚠️ Failure to respond within the specified timeframe may result in detention or refusal.

FDA Import Refusals: Common Reasons

If the FDA determines that a shipment does not comply with regulations, it may be refused entry into the U.S.

Common refusal reasons include:

• Adulterated products (contaminated, unsafe, or non-compliant)

• Misbranded products (false or misleading labels)

• Unapproved new drugs

• Prohibited or restricted products

This list is not exhaustive.

FDA Import Refusals Report (IRR)

For deeper insights, importers can consult the FDA Import Refusals Report (IRR):

• Updated monthly

• Categorized by country/region and industry code

• Public record of products suspected of violating FDA regulations

The IRR is a valuable compliance reference for exporters and importers.

What Happens After an FDA Import Refusal?

Once the FDA issues a Refusal Notice, it is considered the final decision.

Refused goods must be:

• Destroyed or exported

• Within 90 days of the Notice of FDA Action (or an extended period approved by CBP)

• Under CBP and FDA supervision

Legal reference: 21 U.S.C. § 381

How YIDA Helps Importers Navigate FDA NOA

At YIDA International Freight Forwarding, we support FDA-regulated shipments by:

• Pre-checking product compliance risks

• Assisting with FDA entry data accuracy

• Supporting ITACS submissions

• Coordinating with customs brokers

• Advising on detention and refusal mitigation

Early compliance planning significantly reduces delays and costs.