The Food Processing (FP) sector has become a key component of the Indian economy, significantly contributing to GDP, employment, and exports. According to a Ministry of Food Processing Industries report, the FP sector has grown at an Average Annual Growth Rate (AAGR) of approximately 7.26% in the last few years. The sector’s Gross Value Added (GVA) has risen from ₹1.30 lakh crore in 2013-14 to ₹2.08 lakh crore in 2021-22.
The US and India are among the top food-producing nations globally, offering significant opportunities for collaboration and strengthening the sector’s foundation. The US is India’s largest market for F&B exports. India ranks 7th among the US’s F&B import sources, with imports valued at US$ 6.4 billion in 2022, reflecting a 4-year CAGR of 7% and a 2.95% market share. Experts expect these numbers to grow exponentially in the coming years.
The U.S. Food and Drug Administration (FDA) is a federal regulatory body within the Department of Health and Human Services (DHHS). The FDA, as a scientific authority, safeguards the safety of food (including additives), food contact materials, medical devices, radiological products, and pharmaceuticals manufactured or imported into the United States. Manufacturers must register or certify these products with the FDA before selling them in the U.S. market.
The US FDA registration is mandatory for all food facilities that manufacture, process, pack, or store food for consumption in the United States. This regulation applies equally to domestic and foreign food facilities, including those in India. Currently, 5414 food business operators in India are registered with the US FDA. The facility’s registration with the FDA must be renewed every two years between October 1 and December 31 of each even-numbered year. It’s also important to allow FDA facility inspections as mandated by the FD&C Act.
The Registration Process
The USFDA registration process for food facilities is relatively straightforward but requires attention to detail. Here are the key steps involved:
- Submission of Information/ FIS Account: Food facilities must submit detailed information about their operations, including the types of food products they handle, the processes they use, and the locations of their facilities. Facilities must update this information every two years.
- Unique facility identifier: The Data Universal Numbering System, also known as DUNS number is a nine-digit unique identifier for businesses across the world. the DUNS number is the preferred UFI recognized as acceptable to the FDA for food facility registration.
- Appointment of a U.S. Foreign facilities, including those in India, must appoint a U.S. agent. The agent acts as a communication link between the facility and the USFDA. They must be physically located in the United States and handle all FDA communications on behalf of the facility.
- FBOs must log in to the FDA Industry Systems (FIS) website to create an FDA account. They must then add a Food Facility Registration (FFR) to their FIS account.
- Verification and Inspection: The USFDA reserves the right to inspect registered facilities to verify compliance with U.S. regulations. Non-compliance can lead to enforcement actions, including the suspension of registration and the detention of products.
USFDA
The impact of USFDA registration on the Indian food processing industry has been significant. According to APEDA, the U.S. ranks among the top destinations for Indian food exports. It accounted for over 10% of India’s total food exports in 2022-23. USFDA registration has supported this growth by helping Indian manufacturers meet U.S. safety and quality standards.
USFDA registration has encouraged Indian food facilities to upgrade operations and adopt international best practices in food safety and hygiene. This has improved the quality of products exported to the U.S. It has also positively impacted the domestic market, where consumers increasingly demand high-quality and safe food products.
Indian food manufacturers can enhance credibility by complying with strict U.S. food safety regulations. They can avoid regulatory issues and meet the growing demand for high-quality food in the United States. As the Indian food processing industry grows, USFDA registration remains a key tool for accessing global markets and sustaining export success.
The article was published initially in F&B News, read full article here.