Top Five Compliance Items Importers Need to Know about FSVP for FDA

The Food Safety Modernization Act (FSMA), signed into law in 2011, ushered in a new era of food safety regulations in the United States. The FSMA aims to establish clear safety guidelines. The FSMA mandates the Foreign Supplier Verification Programs (FSVP), which follows the central tenet that the same preventive food safety standards apply to food consumed in the U.S., regardless of where the food is produced. This has a major impact on companies that import food products into the U.S. Read on to learn more about the top five compliance items importers need to know about FSVP for FDA

Proper Documentation is Crucial for FVSP Compliance

The FSMA directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services. The goal is to better protect public health by adopting a modern and preventive approach to food safety regulation. The FDA in turn publishes and enforces the compliance rules of the Foreign Supplier Verification Programs. The FSVP requires importers to verify that their foreign suppliers of food for animal and human consumption meet applicable FDA safety standards.  Importers are also required to follow written procedures to verify suppliers and correct any FDA violations. Proper documentation is crucial since this is how the FDA will establish compliance with FSVP.

What Is Required of Importers Under the FSVP Regulation for FDA?

In general, the FSVP regulation requires:

• • Conducting a hazard analysis
  • Evaluating the foreign supplier’s performance and, based on the hazard analysis, assessing the risk posed by a food
  • Maintaining a list of approved suppliers and determining the appropriate supplier verification activities using the foreign supplier’s evaluation
  • Conducting foreign supplier verification and related activities
  • Taking corrective actions, if necessary
  • Maintaining records of these FSVP activities

These steps are intended to show that the suppliers are producing food using processes that offer the same level of public health protection as the preventive controls (PC) requirements for human and animal food. The food should also be properly labeled to indicate allergens.

Are you considered an importer under FSMA’s Foreign Supplier Verification rule?

Under the FSMA, you are considered the importer if you are the U.S. consignee or owner of food items that are delivered to the U.S. from any other country. If there is no U.S. consignee or owner at the time of entry into the U.S., the importer is the U.S. representative or agent of the foreign owner of consignee. You are also considered the importer if you:

• • Control the finances of the imported food
  • Control the agent
  • Control the goods, for example, your company controls where the products are stored or the truck that picks up the goods
  • Separate FVSP for Each Food Product

There must be a separate verification in place for each food product and each foreign supplier. If you are not the importer, it’s best to have copies of what your importer says they have on file regarding each food product and supplier.

FVSP for FDA Timeframes

All FSVP records must be available promptly to the FDA for inspection and copying. Records requested must be available within 24 hours. The FDA may also request that importers send records to FDA electronically. You may be asked to send records from two years back so it’s a good idea to keep FSVP records for at least 2 years after you create or obtain them. If importing food from small foreign suppliers, you must retain documentation on procedures and processes for at least two years after use is discontinued. Consider an automated system or working with a service provider that can enable automation. It’s the best way to manage a wide range of documents for compliance across a vast supplier base and several verification processes such as sampling/testing, on-site audits, records, continuing guarantees, and certificates of conformance.

CrimsonLogic FDA Managed Services

Entry filing for FDA-regulated shipments can be time-consuming, expensive, and challenging to navigate, given the complex and constantly changing regulatory environment. FDA Managed Services is a packaged import service for FDA regulated goods that combines our expertise in compliance and logistics for US bound products. The program is tailored to your needs so that you are able to comply faster with US customs requirements and improve delivery promises. We aim to provide an easier and secure way for international importers to get their goods through US Customs and delivered on time. FDA Managed Services includes compliance documentation assistance, FDA and FSVP Agent services, label consultations and more. Visit our FDA service page or contact us today to learn more.