Importing goods into the United States involves navigating through a multitude of regulatory processes. As food safety and security have become paramount concerns, the Food and Drug Administration (FDA) plays a pivotal role in safeguarding the public from potential threats and emergencies. One critical aspect of this process is complying with the Food and Drug Administration’s (FDA) Prior Notice requirements.

This comprehensive guide explores the intricacies of FDA Prior Notice and its significance. It offers businesses a step-by-step explanation of ensuring compliance with regulations and successfully navigating the customs clearance process.

What is Prior Notice?

FDA Prior Notice is integral to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, a comprehensive legislation designed to fortify the nation’s defenses against terrorism and public health emergencies. The act empowers the FDA, the regulatory agency responsible for food safety, to enforce measures that mitigate risks associated with importing food and animal feed into the United States.

At its core, Prior Notice entails the submission of electronic notifications to the FDA before food and beverage products are shipped to the US.

It is a crucial step that allows the FDA to assess and take necessary measures to protect public health, prevent illegal importation, and facilitate the efficient clearance of goods through customs.

What is the importance of the FDA Prior Notice?

The significance of the FDA Prior Notice becomes apparent when we consider the paradigm shift brought about by the FDA Food Safety Modernization Act (FSMA) in 2011, which renewed focus on prevention rather than a mere response to contamination. That said, here is how the FDA’s Prior Notice plays a crucial role in imports into the US. 

  1. Public health protection: The primary objective of the FDA Prior Notice is to safeguard public health. With advanced information about imported goods, the FDA can evaluate potential health risks associated with the products and take necessary actions to prevent the entry of unsafe or contaminated items into the US market.
  2. Preventing illegal importation: FDA Prior Notice plays a vital role in combating illegal importation of unapproved, counterfeit, or adulterated products. The Notice mandates importers to provide detailed information about their shipments in advance, which the FDA can use to identify and intercept potentially problematic goods, protecting consumers and legitimate businesses.
  3. Efficient customs clearance: Fulfilling FDA Prior Notice requirements enables importers to facilitate smooth customs clearances. When done right, importers can help expedite the processing of their goods at the border, reducing delays and potential additional costs associated with additional inspections or non-compliance issues.

When do you need Prior Notice?

An FDA Prior Notice is required to import food, dietary supplements, animal feed, and specific cosmetic products regulated by the FDA. It is important to note that not all goods require prior Notice. However, checking whether your product falls under the FDA’s jurisdiction is advisable to ensure compliance.

How to submit an FDA Prior Notice?

Submitting an FDA Prior Notice may seem intimidating, but in reality, it is a straightforward process – 

  1. Determine if the FDA regulates your goods: First, determine whether your imported goods fall under the FDA’s regulatory purview. This includes food products (including beverages and dietary supplements), animal feed, certain cosmetics, and products that emit radiation.
  2. Entry submission process and information required: To file an entry with the FDA, an importer must provide specific information about the imported goods. This includes:
  •  
    • Product descriptions: An accurate description of the imported goods, including their composition, contents, and intended purpose.
    • Manufacturer/shipper information: An importer must submit information on the manufacturer and shipper and their personal contact information.
    • The country of origin: The importer must submit information about the country where the product was manufactured or produced.
    • Importer information: According to records, the importer must include their name, address, and contact information.
    • Carrier information: The importer must submit information on the carrier in charge of transporting the goods, such as the vessel name, flight number, or vehicle registration.
    • Arrival information: The expected date and time of arrival, port of entry, and mode of conveyance.
    • Product codes from the FDA: The importer must provide all FDA requirements.

Avoiding common entry errors

To ensure a smooth Prior Notice submission, it is essential to avoid common entry errors. These may include incorrect or incomplete information, inconsistent product descriptions, or missing FDA product codes. Pay careful attention to every detail and verify all provided information for a smooth customs clearance process. 

The two systems for submitting FDA Prior Notice

To facilitate the smooth submission of FDA Prior Notice, the US Customs and Border Protection (CBP) and the FDA have established two distinct systems that importers can utilize. Each system is designed to provide importers with options based on their specific needs and preferences.

Automated Broker Interface or the Automated Commercial Environment (ABI/ACE)

This system operates through the existing interface between CBP and FDA, taking advantage of the seamless integration between the two agencies. The ACE system serves as a comprehensive platform that not only caters to submitting Prior Notices but also encompasses various other essential aspects of the import and export procedures.

This robust system efficiently handles crucial tasks such as managing manifests, facilitating cargo release, overseeing post-release activities, managing exports, and coordinating with partner government agencies. 

Prior Notice System Interface (PNSI)

The PNSI caters to diverse scenarios where filing through CBP may not be feasible or preferable. For instance, importers shipping goods through international mail, making In-Bond entries or admissions into Foreign Trade Zones (FTZ) without requiring a full CBP entry, or those facing limitations with the availability of the ACE/OASIS interface can all leverage the PNSI to fulfill their Prior Notice obligations. 

What are the consequences of not filing a Prior Notice?

Non-compliance with FDA Prior Notice regulations can have serious ramifications. The FDA has the authority to refuse entry of goods that do not have a valid Prior Notice on file which can result in delayed shipments, additional costs, and potential spoilage or degradation of perishable goods.

That said, the penalties for non-compliance may include the following:

  • Refusal of admission: If an FDA Prior Notice is not submitted or the information provided is erroneous or insufficient, the FDA may refuse the entrance of goods into the United States.
  • Detention or seizure: The FDA has the authority to detain or confiscate products that it believes pose a risk to public health.
  • Civil and criminal sanctions: Importers who intentionally breach FDA restrictions may face civil penalties such as fines and, in extreme circumstances, criminal charges.
How to ensure compliance with Prior Notice regulations?
  1. Stay informed: Keep abreast of FDA regulations and updates that may impact your imported goods. Regularly check the FDA’s website, and subscribe to relevant newsletters. You can also consult with industry experts or legal professionals specializing in FDA compliance.
  2. Maintain immaculate records: Maintain meticulous records of all transactions. This includes invoices, bills of ladings, certificates of analysis, and any changes in the product information. Doing so will demonstrate your ability to comply with FDA regulations and can help expedite customs clearance in the future.
  3. Keep your information updated: As importers, you must keep all product information up to date, especially if there are any changes in ingredients, manufacturing processes, or intended use. Failure to provide accurate and current information in the Prior Notice can result in your FDA Notice getting rejected, thus leading to complications during customs clearance.
Can an FDA prior notice be rejected? What are the next steps?
  1. If a Prior Notice submission is rejected, importers should take immediate action to rectify the situation. This may involve resubmitting the Prior Notice with the corrected information or providing additional documentation requested by the FDA. 

    That said, there are a few tips to ensure your imports pass the FDA inspection. 

    1. Understand FDA inspection processes: Knowledge is your ally. Familiarize yourself with the FDA’s inspection processes and requirements for your specific product category. 
    2. Implement Good Manufacturing Practices (GMP): Adhering to GMP guidelines is essential for ensuring the safety and quality of imported goods. Establish and maintain robust quality control systems, implement proper documentation practices, and regularly audit your manufacturing facilities to ensure compliance.
    3. Maintain proper storage and handling conditions: Proper storage and handling practices are something the FDA takes seriously. This specifically applies to perishable goods. Ensure you adhere to appropriate temperature controls, labeling requirements, and storage conditions to prevent spoilage or contamination. 
    4. Collaborate with FDA inspectors: Cooperate and provide the necessary support to FDA inspectors during inspections. Address any concerns or observations promptly and transparently, demonstrating your commitment to compliance and consumer safety.

Summing it up

The FDA’s Prior Notice is an unavoidable step in the customs clearance process that must be taken seriously. Compliance with FDA Prior Notice regulations not only facilitates the entry of your goods into the country but will also contribute to the overall safety and well-being of your fellow citizens. 

Contact the Customs City Solutions team if you need assistance navigating the customs clearance process.

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