Apr 3, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s...
Mar 5, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements...
Feb 6, 2024 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct...
May 5, 2023 | Dietary Supplements, Seminar
Claims Substantiation Seminar Presented by Paula Brock, PhD., EAS Senior Regulatory Consultant March 14, 2024 1:00 – 3:00PM (Eastern) It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers,...
Apr 5, 2023 | Dietary Supplements, Issue of the Month
By Paula Brock, Ph.D., MSCI, EAS Independent Consultant It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about their...
Mar 29, 2023 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans make informed food choices. FDA has long actively supported consumer awareness of...
