FDA Import Alerts: what you need to know

The U.S. Food and Drug Administration (FDA) has a primary mission: protecting public health. One of its key tools to achieve this is the Import Alert, designed to ensure that products entering the United States meet established safety, quality, and labeling standards.

Have you ever heard that certain foods, cosmetics, or drugs are “prohibited” from being sold in the U.S.? This is precisely due to FDA import alerts.

What are import alerts?

Import alerts are issued when the FDA detects irregularities in imported products or identifies items that may pose a risk to consumers.

• Green List Alerts: These specify countries or producers not subject to the alert.

• Red List Alerts: These target specific producers whose products are under scrutiny.

Common reasons for alerts include:

• Contamination

• Incorrect or incomplete labeling

• Violations of Good Manufacturing Practices (GMP)

• Presence of prohibited ingredients

• Microbiological risks

• Counterfeit or adulterated products

When an import alert is issued, affected products are detained at the border without physical examination (DWPE). To avoid rejection, the importer must demonstrate to the FDA that the products no longer present the deviations that triggered the alert.

How do import alerts originate?

An import alert is generated when the FDA identifies, through routine inspections, document reviews, or sample analysis, that a product or its manufacturing process fails to meet safety, quality, or labelling regulations.

It’s important to note that an import alert does not automatically prevent export to the U.S., but it does require additional procedures that can be complex and require technical expertise.

Consequences of import alerts

Import alerts can pose serious regulatory and financial challenges, including:

• Delays in customs clearance

• Fines and penalties

• Additional logistical costs

• Product destruction

Understanding how to manage an import alert is critical to mitigating financial impact and protecting your brand’s reputation.

How to check if your product is under an Import Alert

Sometimes, products not intended for international trade enter the market through unofficial distribution channels, increasing regulatory risk. The FDA maintains an official, regularly updated list of products under import alerts.

How to resolve an Import Alert

Resolving an import alert requires a strategic approach. Key steps include:

1. Identify the cause of the alert: Analyze why the product was detained, ranging from simple labeling errors to issues requiring product reformulation.

2. Submit complete documentation: Provide sufficient evidence that the product complies with regulations.

3. Implement necessary improvements: Correct deficiencies in manufacturing, labeling, or other areas to prevent future alerts.

4. Request formal removal of the alert: Submit an official request to the FDA with all required information.

How CORE can help

Resolving an import alert, especially if it’s on the Red List, requires specialized expertise to ensure regulatory compliance and secure entry into the U.S. market.

At CORE, we understand the complexities of FDA import alerts. Our experts can help you:

• Prepare all necessary documentation

• Communicate effectively with the FDA

• Manage the removal of the alert

• Implement corrective actions to prevent future alerts

We guide you step by step, minimizing the impact on your business and ensuring your products meet U.S. standards.

Don’t let an import alert disrupt your operations or erode customer trust. Contact us today for specialized support to ensure full regulatory compliance for your products in the United States.