Importing FDA-Regulated Products: Understanding FDA and Customs Enforcement Actions

Understanding the Role of the FDA and U.S. Customs in Regulating Imports

When it comes to regulating imports, two key agencies play crucial roles: U.S. Customs and Border Protection (CBP) and the Food and Drug Administration (FDA). Here’s a breakdown of how these agencies work together to ensure the safety and compliance of products entering the United States.

The Role of U.S. Customs and Border Protection (CBP)

Customs is responsible for overseeing all goods crossing U.S. borders, whether they are imports or exports. Operating under the Department of Homeland Security, CBP focuses primarily on risks to national security but also handles the collection of duties and taxes on imported goods. Customs ensures compliance with trade agreements and applies additional duties when necessary, such as when another country subsidizes an industry competing with U.S. businesses. The U.S. Department of Commerce, along with the U.S. Trade Representative, can impose extra duties on products from specific industries or countries. Customs enforces these duties by collecting taxes and monitoring imports to ensure compliance.

The Role of the FDA

The FDA, on the other hand, is responsible for regulating the safety, quality, and efficacy of foods, drugs, medical devices, and cosmetics. Other agencies, such as the U.S. Department of Agriculture (USDA), regulate certain products like meat, poultry, eggs, and dairy. The FDA ensures that products entering the U.S. are safe for consumers, properly labeled, and meet necessary regulatory requirements, including certifications, licenses, and permits.

One of the FDA’s key roles is to examine imported products. The FDA uses both electronic data and physical inspections to determine whether products meet U.S. standards. When goods are imported, detailed transactional data is submitted to the government, including information about the manufacturer, product name, harmonized tariff codes, and FDA product codes. The FDA may already have a history of issues with certain products, and if so, they may stop the cargo without even inspecting it, leaving the burden on the importer to prove that the product is safe.

How FDA Inspects Products at the Border

The FDA may examine electronic data alone, such as product details, shipment information, and previous records of the manufacturer. In cases where the FDA identifies a risk or previous problem, they may stop the cargo from entering the U.S. without physically examining the product. This process is known as detention without physical examination. The FDA also uses an “import alert system” to flag potentially problematic products, and if a product is flagged, it will be detained without inspection.

In cases where a physical examination is necessary, the FDA may inspect the product at the port or customs warehouse. They check for issues like labeling errors, contamination, or improper storage conditions. If the product is suspected of contamination (e.g., pesticides, heavy metals, or pathogens like salmonella or E. coli), the FDA may take samples for laboratory testing.

Consequences of Non-Compliance

If the FDA determines a product does not meet safety or regulatory standards, they may refuse the cargo, leading to a seizure or exportation of the goods. If refused goods are not properly exported or destroyed, Customs supervises the process, ensuring that the goods are either safely disposed of or returned to the country of origin.

Common Mistakes Leading to FDA Enforcement Actions

There are several common mistakes businesses make that can lead to FDA enforcement actions. Some of these include:

1. Mislabeling: Failing to properly label allergens, ingredients, or product claims can result in serious enforcement actions. For example, failing to declare milk or dairy ingredients in a food product can be classified as adulteration, and the FDA may mandate a recall.
2. Improper Registration or Documentation: Businesses may fail to verify that their foreign suppliers and manufacturers meet U.S. regulations. FDA registration is necessary, but it’s essential to ensure that your foreign suppliers comply with the FDA’s regulatory standards. Note that FDA registration does not imply approval of the product—it simply provides the FDA with necessary information about the manufacturer.
3. Lack of Documentation: Failure to maintain proper documentation to show compliance with FDA regulations can lead to problems. This includes failure to provide proof of ingredient sourcing, manufacturing processes, or certifications.
4. Failure to Monitor Supplier Practices: Businesses should verify that their suppliers are following best practices and meeting regulatory standards. Even if a supplier claims to comply with FDA requirements, it’s important to confirm that they are following all necessary safety and labeling procedures.

The Importance of FDA and Customs Registration for Importers

While having an FDA registration is a necessary step, it doesn’t hold much weight on its own. Simply being registered with the FDA does not guarantee that a product is safe or compliant. The real question is whether your supplier is manufacturing the product in a way that ensures its safety or effectiveness—whether it’s food, a drug, or a medical device. Failing to verify this can lead to serious issues.

One common mistake is not checking FDA Import Alerts. For example, one of our clients—a major retailer—ordered cosmetic products for the holiday season, only to discover that their supplier was listed on an FDA Import Alert right as the shipment was already on its way. The product was now stuck in customs, causing delays and complications. This could happen even when the product itself is perfectly fine; it’s simply the supplier’s history that triggers the issue. That’s why understanding your supplier’s history and checking FDA Import Alerts is crucial.

Being proactive and responsive to the government is also vital. We had a case where a shipment was refused by the FDA simply because the importer switched laboratories, and the new lab failed to request an extension for the testing deadline. The FDA refused the shipment, and the lab results were ignored. This illustrates the importance of attention to detail, clear communication with your broker, and ensuring that deadlines are met.

Common Mistakes and Enforcement Actions

Some violations are accidental, like failing to declare an allergen on a food label or not properly verifying the safety practices of your suppliers. These mistakes can lead to serious enforcement actions, such as recalls or detentions. But there are also more intentional violations, such as attempting to smuggle goods that shouldn’t be entering the country. The enforcement mechanisms for these types of violations differ significantly, and they can result in criminal investigations and penalties.

The FDA has broad authority when it comes to detaining and refusing shipments at the border. The standard for refusing a shipment is very low—essentially, if there is any appearance of a violation, the shipment can be detained or refused. However, FDA’s remedies are relatively mild compared to other enforcement actions. For example, they don’t seize the product, but they can require that the goods be exported or destroyed within 90 days.

Detention and Refusal: What Happens When FDA Refuses Entry?

When the FDA detains a shipment, it means they believe there might be a violation. The evidence needed to detain a shipment is much less stringent than for refusal. In this phase, the FDA will notify the importer about the potential issue, and the importer can try to resolve it by proving that the product isn’t in violation or that any issues can be corrected. However, if the FDA refuses the shipment, the importer must either export or destroy the goods within 90 days.

Failing to do so could lead to Customs taking action against the importer’s bond. If goods are worth more than the bond limit, Customs can impose higher penalties. For example, if a shipment of frozen lobster valued at $165,000 is refused by the FDA due to contamination and not properly dealt with, Customs could come after the bond for up to three times the value of the goods.

This mechanism is separate from penalties imposed for negligence or intentional violations, which could involve civil monetary penalties or even criminal action. Importers must be vigilant in ensuring compliance to avoid these serious consequences.

Strategies to Resolve FDA Detention and Refusal Issues

If FDA detains a shipment, the importer has several options:

1. Convince the FDA that the product isn’t in violation: This could involve correcting an issue or clarifying a misunderstanding.
2. Fix the problem: If the product is indeed in violation, the importer can make the necessary corrections.
3. Remove the product from FDA jurisdiction: If the product is subject to FDA regulation due to its intended use, changing that use could remove the product from FDA oversight.

If these efforts fail, the shipment will be refused, and the importer must export or destroy the goods. Failure to comply could result in Customs pursuing enforcement action against the bond.

In summary, navigating the complexities of FDA and Customs regulations requires careful attention to detail, proactive compliance measures, and a clear understanding of the potential consequences of violations. By being diligent and staying informed, importers can avoid costly mistakes and ensure their products meet the necessary standards for entry into the U.S.

Reach Out for Guidance

Navigating FDA and CBP regulations can be complex, but you don’t have to do it alone. If you need help with US regulatory compliance for imported goods, you can reach out to us at FDAImports. Our team is experienced in helping businesses manage the regulatory complexities of importing FDA-regulated products.

Visit us at FDAImports or contact us directly at contact@fdaimports.com for expert assistance.