If you have ever had a meal, used a cosmetic product, or taken medication in America, there is a high likelihood that all of the above have been regulated by the Food and Drug Administration (FDA). The FDA has only one goal: promoting and protecting public health.

America is the largest importer of food in the world. According to the U.S. Department of Agriculture, the U.S. imported $194 billion worth of agricultural products in 2022, projected to rise to $198 billion this year.

With such high figures, the most effective tool in the FDA’s arsenal to ensure food safety for all citizens is the FDA’s prior notice. This blog will examine its critical role in the customs process to ensure consumer safety across America. 

The US FDA Prior Notice - A Brief History

The origins of the FDA can be traced back to 1858 with the creation of the Agricultural Division. Its role as a federal consumer protection agency came to be as a result of the Pure Food and Drug Act of 1906, signed into law by President Theodore Roosevelt. It was originally intended to curb foreign imports and interstate movement of adulterated or mislabelled food and drug products. 

Over the years, its purview has expanded significantly to regulate food, biologics, drugs, cosmetics, medical devices, and tobacco products. Today, it functions under the umbrella of the U.S. Department of Health and Human Services.

The Anthrax attacks that followed the September 11, 2021, attacks led to five deaths and 17 infections. These attacks brought to the surface the U.S.’s lack of preparedness and response capabilities to bioterrorism. 

In response, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 was introduced, which, among other things, also prioritized enhancing the safety and security of food, water supply, and drugs in the country. Special emphasis was laid on the control and regulation of biological agents or toxins that could pose a threat to human lives. 

The FDA’s Prior Notice was introduced as a part of this Act. As the name alludes, it requires prior notification of any food imported to the United States for animal or human consumption. The FDA’s prior notice came into effect on December 13, 2013. 

When Do You Need an FDA Prior Notice?

An FDA Prior Notice comes into play when an item that falls under the regulatory purview of the FDA is imported into the country. This includes any of the following items:

  • Food for Human Consumption
  • Active pharmaceutical ingredients used in the manufacture of medications
  • Biologic Products such as human blood, tissue or plasma, embryos, and any equipment essential to blood bank operations
  • Medical devices ranging from bandages to surgical instruments
  • All cosmetic products
  • Any device that emits radiation, such as X-ray machines, laser pointers, or microwaves
  • Food and medication for animals
  • All tobacco products, including e-cigarettes and electronic nicotine delivery systems (ENDS)

The exporter or importer must create an FDA Prior Notice Web Entry via the Prior Notice System Interface (PNSI) when importing any of the above products. 

There are strict deadlines in place to create and submit a prior notice when importing anything into the country. These deadlines vary based on the mode of transportation used to ship the goods.

The deadlines are as follows: 

Mode of Transportation
Number of Hours Before Arriving at The Port of Arrival to Submit a Prior Notice
Land via Road
2 Hours
Land via Rail
4 Hours
4 Hours
8 Hours
International Mail
Before the Shipment Is Sent

How Does the FDA's Prior Notice Help with Customs, Compliance, and Consumer Safety?

It should also be noted that several additional laws, regulations, and agencies come into the picture when imports are involved. The U.S. Customs and Border Protection (CBP) is one such federal agency that works alongside the FDA. Together, they ensure that all imports comply with laws such as the FDA Food Safety Modernization Act (FSMA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

The advanced notice that the Prior Notice provides helps the FDA work towards its end goal more efficiently and effectively in many ways. 

1. Act Proactively

With advanced notification of inbound shipments, the FDA has crucial time to identify shipments that may pose a higher risk of violating any of the above laws or regulations. The FDA uses a risk-based approach to prioritize which food shipments to inspect based on factors such as the type of food, the country of origin, the history of compliance, and the potential for contamination or adulteration. 

If and when needed, the FDA also coordinates with the CBP to facilitate the clearance or refusal of food shipments at the U.S. ports of entry. The ability to act proactively, with the necessary information beforehand, also enables a seamless customs clearance process. Not only does this benefit consumers (American citizens), but it can also aid importers by minimizing delays in the customs clearance process, which proves costly. 

2. Lower Response Time

The second advantage the US FDA Prior Notice offers the FDA is the ability to respond more effectively in the case of any food-related emergencies or outbreaks. The FDA’s prior notice captures a lot of crucial information, such as the manufacturer/shipper Information, importer and carrier information, the country of origin of the goods, and an accurate description of all the imported products. 

In the event of an emergency, this information becomes vital in tracing the items in question. The FDA can then work backward to trace the items back to the source and communicate and coordinate with foreign agencies or manufacturers to take appropriate action. It also allows the FDA to track where the contaminated items are in the country by tracing them via distributors and retailers. 

3. Preventive Control and Modernizing Food Safety Systems

Finally, the US FDA Prior Notice aids the FDA in implementing preventive control and modernizing its food safety systems in accordance with the FDA Food Safety Modernization Act (FSMA), which was signed into law in 2011. In short, the FSMA aims to create a paradigm shift to focus on preventing an incident in the first place rather than scrambling to contain it. 

To achieve this, the FSMA gave the FDA a heightened authority to oversee imported food, such as requiring importers to verify that their foreign suppliers meet U.S. standards, establishing a voluntary program for accredited third-party certification of foreign facilities, and enhancing partnerships with foreign governments for information sharing and capacity building.

As you can see, the FDA’s Prior Notice is key to providing the necessary information to anticipate and get ahead of a potentially dangerous situation. 

So, How Do You Submit an FDA Prior Notice?

Currently, two systems are in place to submit a US FDA Prior Notice. Each system is specifically set up to ensure a seamless prior notice submission based on an importer’s specific needs. They are the.

All the specific information requested by the FDA while submitting the Prior Notice should be accurate to mitigate any changes of the notice being rejected. The FDA also provides the most common entry errors that can lead to a rejection, so take special care to avoid making them. 

It is crucial to note that if the FDA regulates the product being exported to the U.S. or imported into the U.S., it is mandatory to submit the Prior Notice beforehand as per the guidelines. Please do so to avoid the refusal of admission of the consignment into the port of entry or its seizure.

Intentional violation can lead to civil penalties and, in extreme cases, criminal charges. 

Summing It Up

The U.S. FDA’s Prior Notice is a valuable source of information for the FDA. It allows the FDA to smoothen the customs process, ensure compliance with all necessary laws and regulations and, most importantly, ensure the safety of its citizens. It also benefits exports by ensuring strict adherence to global standards, thereby improving their reputation and opening up opportunities to the global market, which makes it a win-win scenario. 

In short, the information the Prior Notice provides ahead of time gives the FDA the head start it needs to protect the U.S. food supply from potential threats and hazards and respond more effectively to food-related emergencies or outbreaks. If you want to export to the U.S., consider partnering with a professional service to ensure your business ticks the triple Cs of FDA Prior Notice. 

Contact us to know more.  

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