Customs Brokers vs. FDA Compliance: Where Importers Get Bad Information
What common assumption do importers often make about their customs brokers handling FDA compliance, and where does this assumption typically go wrong? Importers often assume that their customs brokers are responsible for FDA compliance as part of the entry process....
FDA Corrective Action Plans: Why Most CAPA Fail and What Actually Works
What is a corrective action plan in the FDA import context and when does FDA typically require one? A corrective action plan (CAP) in the FDA import context is initiated when the FDA finds a problem with a specific product, manufacturing operation, or foreign...
Tariffs Update: Navigating the Latest Legal Landscape
What triggered the lawsuits and key dates related to the IEEPA tariffs? The Supreme Court decision on February 20th invalidated the IEEPA tariffs imposed by Donald Trump in early April 2025. These tariffs, known as fentanyl tariffs, were challenged on constitutional...
Supreme Court Strikes Down Trump Part 2
What recommendations are you providing to your clients following the Supreme Court ruling on tariffs? We are advising our clients to file lawsuits in the Court of International Trade to recover tariffs paid. It's crucial to act swiftly to consolidate cases and...
Supreme Court Strikes Down Trump Part 1
What were the key events related to tariffs and Supreme Court rulings discussed in this episode? Trump initiated new tariffs on various countries' products, citing unfair trade practices and using the International Emergency Economic Powers Act (IEEPA) to impose these...
Navigating FDA Imports and Compliance Risks
What is the statutory basis for the FDA's authority over imports and exports? The FDA's authority over imports and exports stems from the Food and Drug Cosmetic Act, which mandates the agency to ensure the safety, effectiveness, and wholesomeness of FDA-regulated...
Post-Market Problems: When FDA Comes Knocking After Your Product Is Already on Shelves
What is the process like for imported cargo after it clears customs? After cargo clears customs, it can still be subject to questioning by customs. The cargo is initially held in a warehouse under a bond, giving customs the power to ask questions about duties,...
Supreme Court IEEPA Tariff Challenge: How Importers Can Preserve Refund Claims(180 Day Protest Rule)
What is the significance of the Supreme Court challenge involving tariffs under IEEPA for importers? The Supreme Court challenge involves tariffs imposed under the International Emergency Economic Powers Act (IEEPA) by the president. IEEPA allows the government to...
Supply-Chain Transparency 2.0: Tracing Every Ingredient from Source to Shelf
What does supply chain transparency mean for FDA-regulated importers today? Supply chain transparency for FDA-regulated importers entails knowing the origin of every ingredient they handle and being prepared to demonstrate this information to the government. Importers...
Data-Driven Enforcement: How FDA’s New Screening Systems Are Changing Border Compliance
How the FDA’s PREDICT System Revolutionized Import Screening Benjamin England begins by explaining how import screening has evolved from a manual process to a data-driven, automated system. In the past, customs brokers physically presented paperwork—such as invoices,...