Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social media has added increasing complexity to the issue for the agency as well as for FDA-regulated industries. As a result, the… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout the U.S., EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).
Our July Issue of the Month article titled “Why Submit a GRAS Notification for a Dietary Ingredient?” drew a lot of attention from readers. In this follow-up note, Jim Hoadley responds to one significant question. Is an NDI exempt from the NDI notification requirement when the same substance is the subject of a food ingredient… Read More
A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the United States as a dietary supplement ingredient before October 15, 1994. Manufacturers of NDI-containing dietary supplements must notify FDA of their intent to market a NDI-containing supplement at least 75 days before the supplement is marketed in the U.S. The… Read More
In March, FDA published proposals for changes to Nutrition Facts and Supplement Facts. The proposed changes include reformatting of all conventional food labels in the servings per container and calorie declarations. The specifics of the new format may change a little based on information in comments, but it is likely that the basic approach of… Read More
FDA expects industry to begin submitting higher-quality applications to facilitate expedited reviews and approvals of generic drugs, agency officials explained at the Generic Drug User Fee Amendment (GDUFA) and You Conference in Lake Buena Vista, FL, March 27-28. The goal of the meeting — which was hosted by the Office of Small Business and Industry Assistance (SBIA)… Read More