The U.S. Food Safety Modernization Act (FSMA) final rule on Foreign Supplier Verification (FSVP) Programs for Importers of Food for Humans and Animals is a welcomed ally in the continued effort to increase supply chain transparency for food and beverage manufacturers in the United States.

FDA oversight for international sourcing

The FSVP rule provides the U.S. Food and Drug Administration (FDA) with greater oversight of food and beverage products entering the United States. The program is meant to ensure “food imported into the U.S. was produced in a manner that provides the same level of public health protection as that required of domestic food producers.” Therefore, manufacturers must have unwavering confidence in their suppliers, verify that they’re qualified, and adhere to applicable safety requirements. Because manufacturers shoulder the brunt of that burden, it’s essential that they adopt a proactive approach.

Importer Responsibilities

The FDA has declared that importers are responsible for actions that include:

• Determining known or reasonably foreseeable hazards with each food product.
• Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance.
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities.
• Conducting supplier verification activities.
• Conducting corrective actions.

Additionally, importers must establish and follow written procedures to ensure they import foods only from approved foreign suppliers, or when necessary, temporarily from unapproved suppliers whose foods submit to adequate verification activities before importation.

Importers must also develop, maintain, and follow an FSVP for each food brought into the United States and the foreign supplier.

Our Experts

Our Experts are frequent national speakers on FDA compliance issues affecting the food and dietary supplements industries. They are widely considered a leading voice in understanding FSMA. With a focus on international trade, They advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA-regulated products.