Who Helps With FSVP For International Supplement Brands Importing to the US?

Expanding a supplement brand from the UK, EU, Australia, Canada etc into the U.S. is exciting, but it comes with regulatory hurdles. Chief among them is FDA’s Foreign Supplier Verification Program (FSVP). This rule requires importers to verify that foreign manufacturers meet U.S. safety and GMP standards. Without FSVP, shipments can be detained at customs or outright refused.

FSVP compliance demands a U.S.-based company/agent to take responsibility for recordkeeping and verification. That means reviewing supplier audits, certificates of analysis, and testing records. The agent must maintain ongoing files that are accessible for FDA inspection at any time. For many international brands, this requirement isn’t discovered until a shipment gets delayed, which can cripple a U.S. launch.

Blue Ocean Regulatory serves as the U.S. FSVP partner for international supplement brands. We will establish your required standard operating procedures, assess your supplier’s documentation, review your label and website copy, establish your testing specifications, and manage FDA communication. Our process ensures that your supply chain aligns with U.S. standards before your first shipment arrives, avoiding unnecessary customs problems.

We recently supported an EU pre-workout powder brand that has a US company and office located in the US, preparing to launch on Amazon U.S. We reviewed their manufacturer’s compliance, created their FSVP file, and established the testing needed at the manufacturer and third party lab. The shipment cleared without issue, and the brand quickly got to work on their online channels across the country.

For international brands, the right FSVP partner is the difference between stalled products at the border and a seamless U.S. entry. That expertise is what makes expansion successful.