FDAImports.com recently assisted a cosmetics company correct a labeling issue and subsequently attain release on their detained product.  FDA had detained an entry of their cosmetics because the ingredient list named a color additive based on the Color Index name and not the established FDA name. The exporter and the importer were small businesses who were not in a position to re-label and the goods arrived via an international carrier who would not release the goods for relabeling while FDA detained the entry. The FDAImports.com team worked … READ MORE

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FDAImports.com recently declared victory for two clients with many shipments of products under FDA automatic detention due to FDA Import Alerts.  An Import Alert will always cause shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why they should not be on Import Alert.  FDAImports.com is pleased to report on two recent success stories of obtaining removal from FDA Import Alert on relatively short time frames.
Case #1: Sunglasses (Import Alert #86-07)
FDA began automatically … READ MORE

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The Food and Drug Administration is no small government agency.  In 2009 it boasted a 2.6 billion dollar budget and employed over 11,500 people spread from its suburban Maryland Headquarters to various national and international offices.  The charts and data below illustrate how the ever-expanding global network of importing and exporting has increased the roles (and burden) of FDA in regard to regulatory oversight.  As globalization continues to impact specific industries and the speed of communication and transport increases, we can only expect to see increased spending, staffing and legislation from FDA in the years ahead.  The FDAImports.com team brings decades of … READ MORE

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FDAImports.com has obtained a copy of some very recent email correspondence sent by U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg to her employees announcing her decision to restructure the agency’s top management tier.  Although she cites increased growth in agency responsibilities, technological and scientific trends, globalization, and agency administration demands, it appears more like she is creating an additional layer of management between herself and career FDA managers. For instance, Center Directors who used to report to the Commissioner now will report to Deputy Commissioners (who we affectionately dubbed “Overlords”). Dr. Hamburg cited four … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, will be presenting at a RAPS webinar on July 20th, 2011 titled, “Imports and the FDA:  Insight Into Evolving Regulations.”  This webinar will cover the changing landscape of FDA import regulation and requirements and the various implications new regulations will have on regulatory affairs professionals, sourcing and supply managers, consultants, executive management, manufacturing directors, risk management specialists and others.  Mr. … READ MORE

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Months ago the expert consultants at FDAImports.com petitioned the U.S. Food and Drug Administration (FDA) to remove a Chinese processor of soybeans from Import Alert # 99-08, “Detention Without Physical Examination of Processed Foods for Pesticides.”  FDA’s basis to put this processor on Import Alert was initially unlawful and based on an assumption that a certain illegal pesticide was present on the goods. While convincing the FDA that it acted unlawfully in its decision was challenging, the team at FDAImports.com nonetheless battled on behalf of its client … READ MORE

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