Guide to FDA certification for Sri Lankan food businesses

2025-08-15

Sri Lanka exports a wide range of products, with food and agricultural items playing a crucial role in its international trade. The United States of America (USA) is a key destination for Sri Lankan goods, accounting for a significant portion of the country’s export revenue. According to Trading Economics, Sri Lanka's exports to the USA were valued at approximately US$2.79 billion¹ during 2023, with spices, Ceylon tea, seafood, and processed food items being among the most in-demand products.

As of March 1, 2025, 321 Sri Lankan food facilities had registered with the United States Food and Drug Administration (FDA)², reflecting the increasing demand and compliance efforts by Sri Lankan exporters. Securing FDA certification is essential for Sri Lankan businesses aiming to export food to the USA. This certification ensures that products meet stringent safety and quality standards, facilitating smooth entry into the market and building consumer trust.

Understanding what is FDA certification

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. Its key responsibilities include:

• Regulating the importation of food products to prevent contamination and health risks
• Enforcing strict quality and hygiene standards for manufacturers and exporters
• Ensuring proper labeling and ingredient disclosure to protect consumer interests
• Identifying and managing foodborne illness outbreaks and potential bioterrorism threats

Under the Food Safety Modernization Act (FSMA), all foreign food facilities must be registered with the FDA before exporting to the United States. FDA registration is a legal requirement, and failure to comply may result in shipment detentions, product recalls, or permanent bans from the USA.

Why is FDA certification important

Getting a FDA certification is critical for Sri Lankan food exporters looking to ship products into the USA market. The key benefits include:

Ensuring product safety and quality

Strict FDA regulations guarantee that food products are free from harmful contaminants, properly handled, and stored under optimal conditions. This ensures that consumers receive only high-quality and safe food items.

Legal compliance

Meeting FDA requirements is a legal necessity. Non-compliance can lead to shipment detentions, financial losses, legal penalties, and reputational damage. Ensuring compliance minimizes risks and facilitates smooth customs clearance.

Enhancing market access and credibility

FDA certification boosts consumer trust by assuring that Sri Lankan food products meet the highest safety standards. This credibility attracts more buyers, strengthens relationships with importers, and increases market penetration in the USA.

Without FDA approval, shipments may be held at the port of entry until compliance is verified, resulting in costly delays and potential product spoilage.

Who needs FDA certification in Sri Lanka

The following Sri Lankan businesses must obtain FDA certification to export food products to the USA:

• Food manufacturers: Companies involved in the production of food items intended for human or animal consumption
• Food processors: Businesses that refine raw ingredients into finished food products
• Food packers: Companies responsible for packaging, labeling, and preparing food items for distribution
• Storage and warehouse operators: Facilities that store food products before they are shipped to the USA

Food products that require FDA registration

The following food categories require facility registration with the FDA:

• Spices and condiments, including cinnamon, black pepper, and cloves
• Tea and herbal infusions
• Fresh, frozen, and processed fruits and vegetables
• Bottled beverages, including alcoholic drinks and mineral water
• Dairy products and eggs
• Fish and seafood
• Canned and frozen foods
• Baked goods, confectionery, and snack foods
• Live food animals
• Pet food, pet treats, and animal feed

Exporters must verify whether their specific food products require FDA registration to avoid regulatory setbacks and shipping issues.

How to get FDA certification

FDA registration for food facilities

This process is free of charge, and there is no need to engage third-party services for registration.

• When to register: Your facility must register before you begin manufacturing, processing, packing, or holding food for consumption in the United States.

• Who may register: The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

• Designation of a foreign agent: Foreign facilities must designate a USA agent, who lives or maintains a place of business in the United States and is physically present in the United States, for purposes of communication between the facility and FDA.

Step-by-step guide to FDA registration:

• Access the FDA registration website: The first step in obtaining FDA registration is to register your food facility through the FDA’s official website.

• Provide required information: Submit details such as facility name, address, contact number, unique facility identifier (UFI), and trade names.

• Enter optional information: FDA also requests optional registration information, such as facility fax number, email addresses, emergency contact information, and approximate dates of operation. While not mandatory, providing this information enables the FDA to communicate more effectively during emergencies.

FDA approval process

Once the application is submitted, you will be issued a registration number. However, the registration does not imply automatic approval. The FDA may conduct verification procedures, including:

• Sending an email to the person identified as the USA agent
• Conducting facility inspections

Upon approval, you will receive a unique FDA certification number. To maintain your FDA-approved status for exporting food to the USA, businesses must complete bi-annual renewals and adhere to evolving regulatory requirements.

FDA prior notice submission

In addition to registration, all food imports to the USA require FDA prior notice. This notice must be submitted by the importer through U.S. Customs and Border Protection (CBP) or the Prior Notice System Interface (PNSI). This advance notice enables the FDA to effectively target import inspections, safeguarding the food supply chain against potential bio threats and public health emergencies.

(Source: DHL Logistics Advise, 24.03.2025)