Prior Notice Violation Defense

Experienced Defense Counsel for Importers and Others Accused of FDA Prior Notice Violations

Under the US Food and Drug Administration (FDA) prior notice regulations, importers are required to proactively disclose all incoming shipments of food products. Failure to submit prior notice to the FDA can have serious consequences, and intentional efforts to evade import compliance requirements for food importers can lead to federal criminal charges.

John W. Sellers — **Attorney John Sellers**
International Trade Team Lead
Former DOJ Trial Attorney

**Glenn Karabeika**
International Trade Team
Former HSI Special Agent

All companies that import food into the United States are required to comply with the requirement to provide “prior notice” information to the US Food and Drug Administration (FDA). Submitting a timely prior notice submission is an essential aspect of import compliance for food arriving from other countries into ports of arrival throughout the country.

Failing to submit a valid prior notice to the FDA can have serious consequences, including criminal consequences in some cases. Submitting an inaccurate prior notice can have similar consequences as well. The FDA’s prior notice requirement is intended to ensure compliance with several federal statutes that are intended to protect public safety, including the federal Food, Drug, and Cosmetic Act; Federal Meat Inspection Act; Poultry Products Inspection Act; and Public Health Security and Bioterrorism Preparedness and Response Act. As a result, federal authorities take compliance seriously, and allegations of noncompliance require a prompt and effective response.

International Trade Lawyers for Compliance, Investigations, and Defense

Our international trade lawyers assist food importers with all aspects of federal compliance—including import compliance and FDA compliance more broadly. We also represent food importers and other parties during federal investigations and law enforcement proceedings. From public health security and safety concerns to concerns about customs declaration fraud and other federal import violations, we handle all types of cases, and we rely on extensive relevant experience to protect our clients by all means available.

Prior Notice is Required for “All Food for Humans and Animals”

As the FDA explains, “[p]rior notice must be provided for all food for humans and animals that is imported or offered for import into the United States.” For purposes of prior notice compliance, “food” is defined broadly, and importers are required to issue a valid prior for an extremely wide range of imported products. This includes (but is not limited to):

Alcoholic beverages
Animal feed
Dietary supplements
Infant formula
Live food animals
Pet food
Raw agricultural commodities
Snack foods

The FDA’s prior notice requirements also expressly apply to:

“Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples);”
“Food transshipped through the U.S. to another country;” and,
“Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the [FDA’s] list of exemptions . . . .”

Importers have two options for submitting an original prior notice to the FDA when expecting a shipment from a foreign supplier. They can either submit a prior notice through the FDA’s Prior Notice System Interface (PNSI), or they can submit a prior notice through the US Customs and Border Protection (CBP) Automated Commercial Environment (ACE). While both are sufficient for complying with the applicable FDA regulations, all prior notices must be timely, accurate, and complete in order to withstand FDA review and avoid triggering a federal investigation.

Matters We Handle

At Oberheiden PC, we handle all types of prior notice violation cases nationwide. Whether you have been refused admission and need to challenge the government’s determination of noncompliance or you are being accused of a prohibited act constituting federal import fraud, we can help. Representative examples of matters we handle include those involving allegations of:

Failure to Provide Prior Notice to the FDA

Failure to provide advance notice of a food import can result in entry authorization being refused. Food imports refused entry at the border are subject to being held at the port of entry, and prior notice violations can trigger other consequences as well. Foods imported without a valid prior notice submitted to the FDA are also subject to confiscation, and noncompliant importers can also face criminal investigations and prosecution in may cases.

Submitting Incorrect FDA Product Codes

Using incorrect FDA product codes in an effort to avoid CBP or FDA scrutiny can also have serious criminal implications. Here too, if a food shipment arrives at a port of entry and a valid prior notice has not been submitted, this can lead to seizure and other consequences.

Inadequate Prior Notice

Prior notice submissions must include numerous types of information. These include the FDA Country of Production, the common product name, the manufacturer’s registration number (or both the both the full address of the manufacturer and the reason the registration number is not provided), the anticipated date of arrival, the type of food carried and estimated quantity, and other planned shipment information (though an express consignment operator or carrier tracking number can be used in lieu of anticipated arrival information, a Bill of Lading, or an airway bill number or flight number in some cases).

Forging FDA Prior Notice Confirmation Numbers

Forging FDA prior notice confirmation numbers is strictly prohibited. While arguing lack of actual knowledge and promptly correcting notice defects can serve as defenses to civil or criminal liability in many cases, defending against allegations of forging FDA prior notice confirmation numbers generally requires a different approach.

Importing Food in Violation of Federal Law (Including in International Mail)

Circumventing the FDA’s prior notice requirements and importing food in violation of federal law can lead to serious criminal charges carrying substantial fines and long-term imprisonment. The FDA can also seek debarment for serious and repeated violations of federal import laws. In these cases, the US Department of Justice (DOJ) will often pursue smuggling charges that carry six-figure fines and up to 20 years of federal prison time.

FAQs: FDA Prior Notice Compliance for Importers in the US

When do importers need an FDA prior notice confirmation number?

Importers need an FDA prior notice confirmation number when receiving food shipments from manufacturers in foreign countries. Specific filing timeframes apply, and prior notice must be confirmed by the FDA before shipment arrival to avoid violations.

While the prior notice requirement applies to the vast majority of food imports, personal gifts of food are generally exempt from the FDA’s prior notice requirements if they are homemade and mailed from one individual to another.

Do food contact substances count as “food” for purposes of FDA prior notice compliance?

No, food contact substances are expressly excluded from the definition of “food” under the FDA’s prior notice regulations. As a result, while food contact substances imported from a foreign country may be subject to FDA inspection (and may be refused entry for other reasons), filing a prior notice is not part of the entry submission process for these imports.

What if an importer does not provide prior notice to the FDA for food imported into the US?

Failure to provide timely prior notice to the FDA for food imported into the US can result in seizure at the border. In many cases, it can result in other adverse consequences as well. If federal authorities suspect that a food importer has intentionally attempted to evade the federal prior notice requirements, this can lead to criminal charges.

Do I file a prior Notice through the FDA’s Prior Notice System Interface (PNSI) or CBP’s Automated Commercial Environment (ACE)?

Both the FDA’s Prior Notice System Interface (PNSI) and CBP’s Automated Commercial Environment (ACE) accept prior notice submissions, and food importers have the ability to choose either platform. FDA PNSI and CBP ACE are both generally available for prior notice submissions 24/7, and both should provide a confirmation number upon accepted submission.

What are the consequences of accepting a food shipment offered for import without providing prior notice to the FDA?

The consequences of accepting an imported food shipment without providing prior notice to the FDA depend on the specific circumstances involved. If federal authorities allege that an importer willfully violated the law, this can potentially lead to criminal charges.

When facing enforcement actions related to prior notice violations, food importers may have various defenses available. Some examples of potential defenses include:

Challenging the government’s evidence of intent to engage in federal import fraud;
Demonstrating that no actual harm occurred as a result of a claimed violation; and,
The “fair notice” defense (which argues that inadequate notice of prosecution, or lack of proper service, prevents the imposition of penalties).

These defenses, among others, are available in different sets of circumstances. If you need to know what defenses you have available under the circumstances of your case, we encourage you to contact us for a free and confidential consultation.

Schedule a Free and Confidential Consultation with a Prior Notice Violation Defense Lawyer at Oberheiden PC

If you need to speak with a lawyer about defending against allegations of violating the FDA’s prior notice requirements, we invite you to get in touch. To speak with a senior defense lawyer at Oberheiden PC in strict confidence as soon as possible, call 888-680-1745 or contact us online today.

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