EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Front-of-Package Nutrition Information; Extension of Comment Period
In response to requests for an extension, the FDA is extending the comment period for the proposed rule entitled ‘‘Food Labeling: Front-of-Package Nutrition Information’’ that appeared in the Federal Register of January 16, 2025, by 60 days. Either electronic or written comments must be submitted...
Animal Feed Regulatory Pathways
by Adam Orr, EAS Consulting Group Independent ConsultantAs you know, food is regulated by the FDA under the Federal Food Drug and Cosmetic Act (FDCA). In brief, it defines food as articles used for food or drink for man or other animals and defines food additives as any substance which may result,...
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
May 06, 2025Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change builds upon...
Drug and Device Corner April 2025
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May The following types of generic industry facilities, sites, and organizations are required to...
Special Alert: FSIS Withdraws Proposed Salmonella Framework for Raw Poultry Products
Special Alert: Constituent Update April 24, 2025 FSIS is withdrawing its proposed rule and determination titled “Salmonella Framework for Raw Poultry Products”, published on August 7, 2024, to further assess its approach for addressing Salmonella illnesses associated with poultry products. The...
HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
For Immediate ReleaseApril 22, 2025The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s...
Transforming Your Food Safety and Regulatory Compliance Programs with Artificial Intelligence
Simply put, Artificial Intelligence (AI) is the ability of a computer to perform tasks commonly associated with humans. In the area of food safety and food regulatory compliance, there are many tasks in which AI applications can be used, some more advanced than others.
In Memoriam: Bruce Elsner
We have sad news to share on the passing of Bruce Elsner who was a long-time member of the EAS family and consulting team. Bruce had over 28 years of experience working in FDA regulated Fortune 500 companies, who manufactured and packaged drug, medical device, and cosmetic products. His...
FDA hiring contractors to replace fired staff who supported safety inspections
The FDA is planing to hire contractors to replace fired staff who supported safety inspections, including those who arranged foreign travel and tested food samples. The cuts, which include positions in communications and policy, are expected to strain the agency’s already overburdened...
EAS Consulting Group Expands Expertise with the Addition of Two Former FDA Staffers
EAS Consulting Group is pleased to announce the addition of two highly accomplished former FDA staff members, Gabriel Muñiz and Adam Orr, to its team of independent consultants. Their expertise in regulatory compliance and experience in the FDA’s tobacco and animal feed sectors will further strengthen EAS’s ability to provide superior guidance to clients navigating complex regulatory landscapes.
Drug and Device Constituent Update 2025 April
We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes. The following 3 points have come to our attention in the last few days. For any questions regarding the status of a product in the NDC Directory, you may access downloadable NDC...
Health Claims and Dietary Fiber
by Mark Kantor, EAS Consulting Group Independent ConsultantHealth claims are allowed voluntarily in food labeling if sufficient scientific evidence exists that a specific food or food component – referred to as a “substance” by FDA – may reduce the risk of a disease or a health-related condition....
Major Shakeup at FDA Continues as Tobacco Chief Removed
We wanted to share this important AP News article about the latest developments at the FDA, where tobacco director Brian King has been placed on administrative leave amid sweeping cuts to the federal health workforce. Key developments: King, who joined the FDA in 2022, had ordered thousands of...
HHS Restructuring and Organizational Streamlining
March 28, 2025View on the HHS WebsiteThe U.S. Department of Health and Human Services (HHS) announced significant organizational changes. Key Highlights of the HHS Restructuring: Organizational Transformation Workforce reduced from 82,000 to 62,000 employees Divisions consolidated from 28 to 15...
Webinar on the Updated “Healthy” Claim
March 27, 2025View on the FDA WebsiteThe FDA Webinar on the Updated “Healthy” Claim has been rescheduled for April 10, 2025, from 1-2 pm EDT. Please note, the webinar is open to new registrants, but you do not need to re-register if you previously signed-up for this event. A separate communication...
Raising Your Nutrition Label IQ
Presented by Dr. Mark Kantor June 4, 2025, 1pm (eastern)Many people have difficulty understanding the Nutrition Facts label, especially with regards to properly interpreting and using the information about serving sizes and the percent Daily Values. This webinar will clear up some of the confusion...
New Searchable Web Page for the Food Allergen Labeling Guidance for Industry
March 26, 2025 View on the FDA WebsiteToday, the FDA published a web page, Frequently Asked Questions: Food Allergen Labeling Guidance for Industry, as a resource for the 5th edition of FDA’s Guidance for Industry titled: Questions and Answers Regarding Food Allergens, Including the Food Allergen...
HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families
For Immediate Release: March 18, 2025View on FDA WebsiteToday, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional...
EAS Consulting Group Welcomes Adam Orr as Independent Consultant
Adam Orr is a Certified Professional Animal Scientist and an Animal Nutritionist with a lifetime of experience in and around multi-species animal agriculture. The past 15 years have been spent at the FDA Center for Veterinary Medicine and the Division of Animal Food Ingredients (formerly Division...
Drug and Device Corner March 2025
The 2025 OMUFA facility user fees have been announced in the Federal Register (see link below). Facility User Fee Rates FY 2025 Monograph Drug Facility (MDF) Fee $37,556 Contract Manufacturing Organization (CMO) Fee $25,037 The background and legislation on this program can be reviewed on the...
Pet Supplements Unleashed: Navigating the Regulatory Maze
Presented by Kevin Ragland, EAS Consulting Group Independent ConsultantMay 14, 2025 1:00 PM (Eastern)Pet supplements and nutraceuticals are extensively used by dog, cat, and horse owners throughout the United States, contributing billions of dollars in revenue for manufacturers. Despite their...
FDA Intends to Extend Compliance Date for Food Traceability Rule
Constituent Update March 20, 2025 View on the FDA WebsiteToday, the U.S. Food and Drug Administration (FDA) is announcing its intention to extend the compliance date for the Food Traceability Rule (the “final rule”) by 30 months. The FDA intends to extend the compliance date using appropriate...
HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods
For Immediate Release: March 20, 2025View on FDA WebsiteToday, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database...
EAS Consulting Group Welcomes Gabriel Muniz as Independent Consultant
EAS is pleased to welcome Gabriel Muñiz to the EAS Consulting Group team of independent consultants. Gabriel is a distinguished expert in FDA regulatory compliance, quality systems, and risk management, with nearly two decades of experience in tobacco and other FDA regulated product industries....
Understanding the Role of Your U.S. Agent
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
Dietary Component Specifications and Testing
Presented by Shelly Blackwell May 21, 2025, 1pm (eastern)Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Specifically, industry continues to face challenges in...
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe
The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration are committed to promoting radical transparency to make sure all Americans know what is in their food. Today, as part of this commitment, HHS Secretary Robert F. Kennedy Jr. is directing the acting FDA...
Salmonella Framework for Raw Poultry Products
by Dionne S. Meehan, EAS Consulting Group Independent ConsultantOn August 7, 2024, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published its updated “Salmonella Framework for Raw Poultry Products” consisting of a proposed rule and proposed...
2024 CARES Act Drug Volume Reporting Reminder
Final reminder that CARES volume reports for 2024 are due no later than 31 March 2025 for all registered drug establishments. Do remember how vital it is to ensure all NDC listings reflect their correct status. The FDA will expect volume information for an NDC no longer manufactured that has not...
Drug and Device Corner February 2025
Reminder that CARES volume reports for 2024 are due no later than 31 March 2025. If you need assistance with the process, EAS is here to help.The FDA has updated the OTC MONOGRAPHS @ FDA website’s OTC Monograph Resources section. This includes a digital Catalogue of Pre-OMUFA Documents dataset in...