Understanding FDA Prior Notice

Every country has its own indigenous food, ingredients, packaging processes, and regulatory mandates for maintaining safety standards. When importing food or drug items from another country, the native country must consider the potential health and safety risks that these differences could likely cause the citizens.

Every importer of such items in the USA must, thus, notify the FDA, or the US Food and Drug Association, about the foodstuff or drugs being imported. Through inspections, regulatory mandates, established standards, and protocol, the FDA determines the suitability of such items for import such that consuming these products does not compromise public health and safety.

The importers thus need to file an FDA PN (FDA Prior Notice) to the authority to notify them of all the details of the items being imported. Upon receiving the FDA prior notice web entry, the FDA, with support from the US Customs and Border Protection (CBP), proceed with inspections of the shipment to ascertain their compliance with import criteria and mandates.

The importance and role of the US FDA Prior Notice are more significant than one would imagine. It is an instrument that aids the government in establishing food security even in cross-border trade while helping to maintain excellent health standards. It is pivotal to reducing socioeconomic risks to the nation arising from the food and drug trade. Let’s explore how.

1. Safeguarding Against "Dumping"

The concept of “Dumping” in international trade isn’t new. It is malpractice where traders mark or target the demand for specific products in a country and ship sub-standard quality items at lower prices into their market.

In a nation where food and drug import is not regulated, such a trade mechanism poses significant risks to the citizens. This harms the importing nation’s economic balance – especially when the items are consumable; it also risks public health and safety.

The FDA thus sets stringent standards for all consumables in case they are imported. The quality, manufacturing, or production process, ingredient-specific tolerances or allowances, etc., are regulated by established quality benchmarks. The items that meet these quality benchmarks can be imported, whereas those that fail the inspections are destroyed or seized.

Given that over 78% of the US food supply is regulated by the FDA, furnishing your FDA prior notices diligently helps the government ascertain that the international market remains fair to the country and that there is no risk to the health of the citizens.

2. Regulating Food Trade Diversification

Each country has microbiology and chemistry of the native ingredients, food, and processes. It is essential to take a stand to preserve this biome while allowing room for experimentation, innovation, and trial of new types of food and ingredients. Keeping that in mind, prior notice FDA furnishes to the CBP and FDA the information about the following aspects of items being imported:

  • Item details like quantity, market name, FDA code, lot number, etc.
  • Details about its production include natural state, location of production or growth, and owner name.
  • Whether the food is manufactured or processed, and the name and details of the facility where it has been done.

This information helps FDA and CBP determine whether or not the food manufacturing, processing, or production techniques are up to the mark. This is one of the most important criteria determining a food item’s permissibility into the borders.

Furthermore, the constant experimentation and innovation with food technology keep providing a broader range of foods with varied and inventive preservation methods, packaging, and shipping methods. The information in FDA prior notice is the first step in assessing their suitability for admission into the US.

3. Preventing Trade Abuse and Malpractice

International trade is fraught with trade malpractices that arise from profiteering outfits that seek to exploit international customers using unfair trade practices. Especially where food and drug items are concerned, this could pose a serious risk to public health and safety if substandard products are allowed within the borders.

The FDA’s prior notice requires traders to furnish the details of the seller, manufacturer, shipper, and importer. The FDA maintains a list of defaulters on a public system highlighting the traders engaged in trading malpractices. The information in prior notices is tallied with FDA blacklists to prevent unfair trade from risking public health and safety in the nation.

This is especially true in the case of importing drugs and medical devices, which directly impact public safety. Over 20,000 approved drugs can be imported – malpractices with misleading or wrong labeling can be caught through details furnished in the FDA prior notice web entries.

4. Harmonization and Benchmarking of Food Standards

Across the globe, there is a stark difference between the established food control systems that may or may not have scientific or tariff-oriented barriers to trade. As such, the food items acceptable to other countries may not be accepted for trade with another.

The FDA establishes food and drug control mechanisms based on monitoring, sampling, inspections, detection, and data analytics to arrive at benchmarks and standards for food and drug quality control.

By identifying importable items through codes, categories, risk levels, tolerances, price caps or ranges, etc., the FDA looks into each imported item through a realistic, factual, and scientific approach to determining its safety.

The FDA’s prior notice summarizes all of this information for the CBP and FDA through established codes, IDs, and other information about the product and its manufacturer. It helps the FDA allow the import of good quality food items and drugs while ascertaining that any item that does not meet the food standards as prescribed is rejected at the borders.

5. Preventing Health Hazards from Crossing Borders

One of the major roles the FDA fulfils is to prevent health hazards from crossing borders by piggybacking on food and drug items.

For example, certain strains of grain or seed may display aggressive growth when planted in a new geography. This may pose a risk to the native flora or fauna by overtaking the ecosystem and disturbing the natural balance. It may permanently modify the biome and create risks of extinction of the native species.

The same applies to allowing food items imported from a country hit with health concerns – the shipment could possibly allow the entry of the same pathogen into the US borders if not regulated in time by temporarily shutting down trade with that country. The trade incidents during the Coronavirus pandemic are an excellent example of countries demonstrating self-preservation by closing off their borders.

FDA regulates the import of food and drug products that are likely to have contaminant content and thus pose a risk to public health and safety. By way of item labels and flags, FDA prior notice alerts the CBP systems if such items have arrived at the borders for clearance.

How Can Traders Simplify FDA Prior Notice Web Entry?

Traditionally there are two ways to submit your FDA import notice to the FDA and CBP:

Automated Broker Interface (ABI)

An interface already exists between the FDA and CBP, called the Automated Broker Interface of Automated Commercial Environment (ABI-ACE). Traders can get set up to submit these data via a Software Vendor to generate their FDA prior notices for each imported item and submit them directly via EDI protocols.

Prior Notice Systems Interface (PNSI)

The PNSI is available to those traders who do not have access to the ABI-ACE. The PNSI is available on FDA Industry Systems Access page. You need a login ID to complete your FDA prior notice web entry through this method – and it can get very complicated.

Alternatively, the CustomsCity FDA Prior Notice solution allows traders to establish direct communication between their import solutions and the CBP. The interface enables traders to successfully execute high volumes of FDA prior notices in record times.

Furthermore, since CustomsCity directly sends the FDA prior notice entry to CBP, there is no requirement to create a formal or informal entry or manually enter the information on the FDA portal. This saves a significant amount of time.

Traders can conveniently upload their FDA imports data in CSV/Excel format using JSON APIs and an intuitive user interface.

Since the entire process is electronic and automated, the traders may receive acceptance for their entries within seconds of sending.

To Summarize

It is essential to monitor the movement of food and drugs across borders to curb serious dangers like bioterrorism, contamination, infections, native-species extinction risks, trade malpractices, dumping, etc.

Here, diligence and sincerity on the part of traders take the front seat in driving healthy trade practices. By ensuring timely submission of FDA prior notice for every piece of FDA import, such nature of risks to American citizens’ public health and safety can be mitigated.

To aid businesses in supporting safe cross-border trade, CustomsCity’s FDA Prior Notice solution makes it extremely easy and cost-effective to submit FDA prior notices without errors. Visit the website to know more.

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