See how we've helped clients navigate complex FDA and customs challenges — and come out ahead.
This case involved a consignment of herbal extract products that triggered FDA Import Alert 54-12 due to an undeclared ginseng component. Our team immediately mobilized our FDA compliance specialists to review the full ingredient list, coordinate with the manufacturer for corrected documentation, and prepare a comprehensive response package including revised labels and third-party heavy metal testing results. The cargo was released from automatic detention after our documentation was accepted.
A Vitamin K2 supplement shipment was rejected because the manufacturing facility's testing reports were not recognized by FDA. Facing potential cargo destruction, our team acted swiftly — filing 7512 in-bond documentation to facilitate emergency re-export, buying critical time. We then worked with the client and their manufacturer to obtain proper FDA-recognized facility certification and testing documentation. A new batch was successfully imported and cleared three months later, saving the client significant losses.
A shipment of green tea extract supplements was detained due to label violations under 21 CFR Part 101, specifically unauthorized medical claims that implied disease treatment. Our team arranged immediate transfer to our bonded warehouse facility, engaged our label compliance specialists, and coordinated a complete label redesign with the client. All medical claims were removed and replaced with compliant structure/function claims. The revised labels were approved and the cargo was released within 5 business days with no penalties imposed.