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,...
FDA Registration Renewal Season Opens October 1
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
Tariffs, FDA Delays, and What Importers Should Watch Next
What’s happening with pharmaceutical tariffs in 2024 and why should importers care?Benjamin explains that tariffs on certain pharmaceuticals have increased due to concerns about pricing disparities between the U.S. and other countries. Customs has warned companies not...
How to Reverse an FDA Import Refusal or CBP Seizure
What is the difference between an FDA import refusal and a CBP seizure?FDA cannot seize goods itself, it can only refuse admission to products that appear violative. A refusal means the product cannot enter the U.S. and must be exported or destroyed, but the importer...
Understanding Section 232, Reciprocal Tariffs, and Their Impact on Pharmaceutical Trade: Insights from Attorney Benjamin L. England
How accurate were the predictions about reciprocal tariffs after April 2nd? The predictions proved accurate, though not necessarily in a positive way. The government's approach to reciprocal tariffs went beyond just duties, encompassing taxes and other trade barriers....