Jun 28, 2024 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following guidances that were on the list: New Dietary Ingredient (NDI)...
Jun 17, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
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Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s...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FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and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 New Date Coming Soon 1:00 – 3:00PM (Eastern) It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors,...
