Importing Medical Device Industry: Stay Alert in This Changing Environment
Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and...
100% Re-inspection ≠ 100% Testing: USDA/FSIS’s Inspection of Imported Catfish
Starting on August 2, USDA required all shipments of siluriformes (colloquially catfish)[1] fish and fish products’ to be presented to USDA’s FSIS for re-inspection. While FSIS will perform 100% “re-inspection” for all imported shipments, the agency does not intend to...
Food and Drug Administration Reorganization
Using the argument that the acceleration of scientific innovation and expansion of global markets require it, the Food and Drug Administration (FDA) is seeking new program models to meet the demands of a changing world. According to FDA, these needs led to the recent...
What is Healthy Food? FDA Hasn’t decided yet
Healthy is a word that we use every day, but when we use it in terms of food labeling, the word takes on a more important and controversial meaning. In 2015, the FDA issued a warning letter to the KIND company stating that the use of the motto “healthy and tasty” on...
What do Vending Machines and Menus have in Common? FDA Rules of Course!
Editor’s Note: On September 29, 2017, FDA proposed to extend the compliance dates for the Nutrition Facts panel final rule to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food...
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 hundreds of facilities. Here are some things you need to know to ensure your renewal is completed...
Got Milk: Is Your Dairy Organic?
From famous ad campaigns to research touting chocolate milk as an exercise recovery drink, it seems milk is ubiquitous in the US food landscape. As a processed animal product, milk is highly regulated; the staple product is regulated by both the United States Food and...
U.S. Lifts Antidumping Duties on Brazilian Shrimp, Keeps Duties on Asian Shrimp
On June 1, 2017, the U.S. Department of Commerce (DOC) published a notice to lift the antidumping duties imposed on Brazilian frozen warm water shrimp, while extending the antidumping duties currently imposed on shrimp from four Asian countries (China, Vietnam,...
FDA Registration and Listing: Fact or Fiction?
Over the years we’ve worked with hundreds of companies to get their facilities registered and their products listed so they can meet their obligations, during which, we’ve come across a lot of misconceptions about registration. Here are some of the primary issues we...
FDA Implementing FSMA: Program Realignment Building a Firm Foundation
FDA is full-speed ahead with rolling out the Food Safety Modernization Act (commonly referred to as “FSMA”). With FSMA, FDA seeks to overhaul the U.S. regime for food safety – from a regime that reacted to safety outbreaks to one that seeks to preventive them. A key...