DIETARY SUPPLEMENTS – Revised Draft Premarket Guidance
Release: The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers. Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new... Read More
CBP announces FDA biennial registration
CSMS# 14-000518 – FDA Food Facility Registration Renewal09/29/2014 01:50 PM EDT The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, enables FDA to better protect public health by strengthening the food safety system. Among many other changes, FSMA amended Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D], which requires domestic and foreign facilities that manufacture, process, pack or... Read More
FDA Biennial Registration
IMPORTANT NOTICE! The 2014 Biennial Registration FDA renewal period starts Oct 1st, 2014 and ends December 31, 2014. As we discussed two (2) years ago it is imperative that all FDA importers re-register their existence with the U.S. Food & Drug Administration during the Biennial Registration period. This entire process and requirement for FDA re-registration deals with the importers of edible food products that are subject to the requirement of an FDA “prior-notice” under the FDA’s... Read More
