Importing Through FDA? Learn all about FDA Compliance

Table of Contents:

1. FDA Prior Notice and FDA Compliance 
2. FDA Prior Notice Timeframes
3. FDA Registration and Filing Process
4. Section 321 Shipments
5. Type 86 Benefits
6. CrimsonLogic FDA Managed Services: Integrating FDA Compliance with Customs & Logistics

If you import food into the United States, one of the key steps you must take is submitting Prior Notice of imported food shipments to the U.S. Food and Drug Administration (FDA.) FDA compliance is done through the FDA Prior Notice. Aside from FDA compliance, the overall food shipment process involves customs compliance and logistics. Moving your cargo across these processes as smoothly and efficiently as possible can be make a huge difference for your business. Read on to learn more about how integrating FDA compliance with customs and logistics services helps you save money and time.

FDA Prior Notice and FDA Compliance  

The FDA and the Customs and Border Protection (CBP) are two key agencies that determine whether food coming from foreign locations can be admitted into the country. Under the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002, CBP is responsible for enforcing food regulations set by the FDA and other agencies to protect the country against actual or potential threats to its food supply.

FDA Prior Notice is an electronic notification that importers or their authorized agents must submit to the U.S. Food and Drug Administration (FDA) before any shipment containing food or feed products arrives in the U.S. Prior notification of food imports improves risk assessment and inspection processes and helps CBP intercept contaminated products.

FDA Prior Notice Timeframes

In general, all food and feed commodities require a Prior Notice, except for the following:

• Meat, poultry and egg products that are under exclusive jurisdiction of the U.S. Department of Agriculture (USDA) and comply with the USDA regulations
• Homemade food and all personal food shipments sent person to person for non-commercial use
• Food samples for non-consumption valued below $200, including food samples destined for testing labs or manufacturers, but not for retailers or individuals
• Food for personal use accompanying a traveler
• Imported food for immediate export (without leaving the port of arrival)

FDA compliance can have a major impact on your resources, particularly money and time. The FDA must receive and validate the pre-arrival Prior Notice within mode-specific timeframes. Noncompliant food shipments may be refused entry, turned back, abandoned or destroyed, and the importer may receive financial and criminal penalties.

FDA Registration and Filing Process

All facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the FDA. These include facilities that handle bread, beverages (alcoholic and nonalcoholic), agri-food or agricultural food (grains, organic, beans), animal feed products, poultry (meat, red meat, white meat), fruits and vegetables, processed food (snacks, chocolates), and dietary supplements and ingredients.

Registration must be renewed every two years to comply with regulations. Foreign manufacturers and distributors of food products must also be registered with FDA before the shipment can enter the U.S. The foreign facility is required to have a U.S.-based agent to serve as a liaison. After registration, the filer must include on all documentation for food shipments the FDA food facility registration number, name and address of the manufacturer, and the last place the product was stored, packed or processed. Any individual with the required information, including importers/exporters, brokers and U.S. agents, may submit the Prior Notice.

Some companies assign an in-house employee to handle registration and filing. But in most cases, it might be a really good idea to consider hiring a service provider. A service provider with expert staff who have the experience, knowledge and the latest technology can help save a lot of time and money by ensuring that all the compliance processes are in place and running smoothly. Integrating FDA compliance with your customs and logistics through a service provider is a step higher and can provide the most benefits.

Section 321 Shipments

Food shipments (excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in airtight containers stored at room temperature) that are valued at $800 or less can be entered into the U.S. as Section 321 shipments. Prior Notice filing is still required for FDA-regulated products eligible for Section 321 clearance. CBP and the FDA may conduct periodic audits to determine the type and volume of FDA-regulated goods entered as Section 321.

Section 321 shipments can enter the U.S. free of tax and duty and without complex paperwork required to be submitted to customs. This helps ecommerce retailers and importers move large volume of parcel shipments into the country faster and at a lower cost, while easing the burden on CBP and other agencies.

Type 86 Benefits

The new Section 321 entry called Type 86 expands the eligibility of low-value shipments to include PGA-regulated goods for the first time. This means sellers and importers can now expedite the release of parcel shipments containing food and cosmetics, among others. However, additional data elements in the form of the Harmonized Tariff System of the U.S. (HSTUS) code and Importer of Record (IOR) number must be submitted to CBP on top of the usual requirements.
 

If you are an importer of high-volume ecommerce parcels and have a thorough understanding of HS code classification, Type 86 is a fast and affordable way to clear your shipments. You don’t have to pay the $1 per HBL fee unlike express clearance through an ECCF. For new importers or those who want to take advantage of type 86 benefits but need help with HS code classification, a third-party provider of compliance, customs and logistics services can help with customs processing as well as compliance optimization, trade advisory, providing options for logistics arrangements and fulfillment.

CrimsonLogic FDA Managed Services: Integrating FDA Compliance with Customs & Logistics

Entry filing, customs compliance and logistics for FDA-regulated shipments can be time-consuming and expensive for food, beverage and animal feed manufacturers and distributors wishing to import these products into the U.S. First-time importers may also find it challenging to navigate the complex and constantly changing U.S. regulatory environment.

FDA Prior Notice filing can be done via the Automated Broker Interface (ABI) in ACE or via the Prior Notice System Interface (PNSI) on the FDA website. PNSI filing is free of charge, but it is not designed for high-volume traders. Information for each notice must be entered manually in the system, which takes up a lot of time. On the other hand, hiring a customs broker, carrier or agent to file the PN on your behalf is not cost-effective or practical, particularly if you are a larger size business that imports into the US frequently.

Global eTrade Services (CrimsonLogic) is a leading provider of trade facilitation solutions like the FDA Managed Services, a flexible, cost-effective way to meet FDA Prior Notice compliance, customs and logistics requirements. CrimsonLogic FDA Managed Services can help you save on transaction costs and boost productivity with time-saving functionalities.

To learn more about integrating FDA compliance with customs and logistics services, visit our FDA Managed Services page or contact us today!