Specializing in FDA Regulatory Matters

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., Europe and Asia, EAS Consulting Group is a sought after expert in regulatory matters, assisting firms with highly technical submissions from GRAS, DMF, NDI, ANDA, 510(k) and others, to label reviews, structure function claims, GMP audits, US Agent assistance and to serve as expert witnesses. EAS consultants are routinely asked to speak at worldwide events on regulatory issues and is EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters.

Recent Issue of the Month Article

GRAS Final Rule: May Result in More Rejects and/or Longer FDA Reviews

On August 17, 2016, FDA published a final rule which formally codifies the requirements for GRAS Notices that originated with the GRAS proposal published in 1997. FDA states that the expressed intent of this final rule is to “... clarify the criteria used to determine whether the use of a substance in human or animal food is generally recognized… Read More

New NDI Guidance – Still a Work in Progress

On August 11, 2016, FDA issued an updated revised draft guidance on new dietary ingredients used in dietary supplements which replaces draft guidance the agency issued in 2011. FDA developed the draft guidance to address confusing issues involving new dietary ingredients, synthetic dietary ingredients, botanicals, and requirements for New Dietary Ingredient Notifications. In FDA’s own words: “The… Read More

Recent White Papers

Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling

Prepared By Bruce Silverglade, Expert Consultant, EAS Consulting Group, LLC August 25, 2016 Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed ("RACCs") that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the amount of nutrients for customary servings of… Read More

Recent Blog posts

EAS Consulting Group Launched New Strategic Consulting Service for Food Product Development & Labeling

July 8, 2016  Media Contact: Cathryn Sacra (571) 447-5505 csacra@easconsultinggroup.com Alexandria, VA, USA – EAS Consulting Group, LLC (EAS), a leading consulting, training and auditing firm that specializes in Food and Drug Administration (FDA) regulatory matters, is now offering a new strategic consulting service to the food industry, as they struggle to develop new foods and dietary… Read More

Quality Agreements in the Complex World of Dietary Supplements

One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU).  The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition… Read More

How to Successfully Respond to FDA 483s and Warning Letters

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how… Read More