How to Comply with FSVP Food Safety Regulations
Every importer of food, beverages and supplements into the United States should be aware of the U.S. FDA’s Foreign Supplier Verification Program, or FSVP. FSVP rules require importers to have a FSVP plan verifying that imported products are manufactured in accordance with U.S. food safety standards. The FSVP also requires importers to designate a qualified FSVP Agent to serve as the point of contact with the FDA.
What is the Foreign Supplier Verification Program?
The Foreign Supplier Verification Program (FSVP) was created by FDA after passage of the Food Safety Modernization Act in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food, beverages and dietary supplements brought into the United States have been produced in a manner that meets U.S. food safety standards. The FSVP rule is complex and can be confusing to importers.
What is the role of an FSVP Agent?
Foreign businesses who don’t have headquarters or employees physically located in the US are required to designate a US-based FSVP Agent. The FSVP Agent can assist importers in several FSVP actions. For one, they often help develop FSVP plans for foreign importers and exporters. That is because FSVP Agents can help identify any hazards associated with the imported food, beverages, or dietary supplements, review an importer’s compliance records and history, update an existing FSVP plan, and/or advise on appropriate verification activities. FDA Agents can also assist importers and exporters with updates and modifications to business FSVP plans as their processes and practices change.
Who qualifies as an FSVP Agent?
An importer’s FSVP Agent must be physically located in the United States and must be a qualified individual, as determined by the FDA rules. The FDA defines a qualified individual as “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under [FSVP], and can read and understand the language of any records that the person must review in performing this activity.”
This means that your FSVP Agent must understand FSVP laws and be able to review company records for compliance with an FSVP Plan. Companies should seek an FSVP Agent with a proven track record, experience, and appropriate education. Without a reliable FSVP Agent, importers risk compliance errors and disciplinary action from the FDA, including product detentions, warning letters, and refusals of entry into the U.S. Setbacks like these could cost your business valuable time and money. It’s best to avoid these consequences by hiring an FSVP Agent.
How US Imports can help
US Imports can help develop or review FSVP Plans to ensure compliance with FDA regulations. US Imports can also serve as your qualified U.S.-based FSVP Agent.
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