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,...
Private Label Pitfalls: Customs and FDA Risks You Didn’t See Coming
What does private labeling look like in the FDA-regulated import world? Attorney Benjamin L. England explains that private labeling has become increasingly common, particularly with the rise of e-commerce and global trade. Many U.S. companies today operate as virtual...
Government Shutdown Impact: How FDA and Customs Operations Are Affected
How the FDA continues to function during a government shutdown Benjamin England explains that while the phrase “government shutdown” often causes alarm, these events are not uncommon. Drawing from his experience at the FDA, he shares that the agency continues to...
Import Alerts and Red Flags: How Businesses Can Stay Off FDA’s Watch List with Benjamin L. England
What are FDA import alerts and which industries do they impact? Benjamin L. England explained that FDA import alerts are guidance documents issued by FDA headquarters to field personnel. These alerts identify companies and products that have previously presented...
Country of Origin Declarations: Compliance Risks and Strategies with Benjamin L. England
What is a country of origin declaration and why does it matter for businesses? Benjamin L. England explained that country of origin declarations are critical because tariffs and duty evaluations are based on the origin of goods, not where they were shipped from....
Trump, Tarrifs and the New FDA Import Inspectors
How are recent political shifts affecting U.S. importers, particularly those regulated by the FDA?Attorney Benjamin L. England explained that the return of Trump-era tariffs has created a new baseline for trade. Instead of assuming zero tariffs under trade agreements,...