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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...

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...

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...

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....

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,...

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...

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...

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....

Introduction Food labeling is a complex process with numerous technical requirements and legal considerations. Many companies struggle to comply with FDA regulations, often making mistakes that lead to misbranding, consumer confusion, or even legal action. This...

Impact of New Tariffs on FDA and USDA-Regulated Goods There have been significant developments regarding tariffs, particularly those affecting FDA and USDA-regulated goods. While Mexico and Canada successfully negotiated to avoid new tariffs, China remains a major...