Oct 7, 2024 | FDA and USDA Regulatory Update, Foods
The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food. Since...
Oct 7, 2024 | FDA and USDA Regulatory Update
In addition to a reminder of the Drug Establishment Registration Renewal period (1 October – 31 December) EAS would like to remind you of significant changes being implemented for OTC monograph drug product listings. The changes were announced by FDA last year and...
Oct 7, 2024 | Foods, Issue of the Month
Investigating Pesticide Tolerance By Dr. Bill Reeves, EAS Regulatory Consultant Consistent, scientifically justified regulations enable over $1.5 trillion in global agricultural exports every year. The world economy depends on these regulations to ensure whatever goes...
Sep 30, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31...
Sep 30, 2024 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal...
Sep 26, 2024 | FDA and USDA Regulatory Update
The U.S. Food and Drug Administration (FDA) has released the third video in the “Importing FDA-Regulated Products” series. This new video provides an overview of the process for importing seafood, focusing on key regulatory requirements. It is designed to help...
