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....
What to Expect in 2025: Key FDA Regulatory Trends Impacting Importers and Food Businesses
As the regulatory landscape continues to evolve in 2025, importers and food businesses must remain agile and informed. From updates to FSMA rules to advancements in tech-enabled compliance tools, here’s what you need to know to stay ahead. 1. Increased Enforcement of...
Understanding FDA Labeling Regulations: Common Mistakes and Compliance Challenges
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...
Beyond The Border: What’s Happening in FDA & Customs
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...
Understanding FDA and USDA Regulations for Food Imports
Introduction Importing food into the United States involves navigating a complex regulatory landscape governed primarily by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Each agency has distinct areas of responsibility, and...
Tariff Talk: Navigating Reciprocal Trade Laws
Understanding Reciprocal Tariffs Reciprocal tariffs are structured in a way that corresponds directly with the tariffs imposed by other countries on U.S. goods. Unlike standard tariffs, which typically arise from established agreements among countries—such as those...
Importing FDA-Regulated Products: Understanding FDA and Customs Enforcement Actions
Understanding the Role of the FDA and U.S. Customs in Regulating Imports When it comes to regulating imports, two key agencies play crucial roles: U.S. Customs and Border Protection (CBP) and the Food and Drug Administration (FDA). Here's a breakdown of how these...