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.
Drug and Device Corner July 2025
The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA regulated products will be reviewed...
Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food
July 17, 2025 View Full Press ReleaseThe Ensuring Safe and Toxic-Free Foods Act of 2025 aims to enhance food safety by tightening the FDA's regulations on food chemicals. Key provisions include: Manufacturers must submit GRAS notifications for all ingredients currently marketed under "self-GRAS"...
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
July 16, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products...
cGMP Responsibilities for Own Label Distributors and Brand Owners
cGMP Responsibilities for Own Label Distributors and Brand OwnersPresented by Shelly BlackwellDecember 18, 2025, 1pm (eastern)Own Label Distributors (OLD) in the dietary supplement industry often question their responsibilities for complying with current Good Manufacturing Practices (cGMP’s)...
FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline
July 14, 2025 View on FDA Website On January 15, 2025, the U.S. Food and Drug Administration issued an orderrevoking the authorization for the use of FD&C Red No. 3 in foods, including dietary supplements (permitted under 21 Code of Federal Regulations (CFR) 74.303), and in ingested drugs...
US Food and Drug Administration FDA Embraces Radical Transparency by Publishing Complete Response Letters
FDA News Release July 10, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological...
Comparative Perspective on Thermal Processing: Regulations and Practices in Mexico and the U.S.
By Fernanda Estefanía Jiménez Garzón, EAS Consulting Group Independent ConsultantWhat if the foodborne illness you experienced… could have been prevented? According to the World Health Organization (2024), approximately 600 million people worldwide suffer from foodborne illnesses each year, with...
Conducting Remote Regulatory Assessments Questions and Answers
Docket Number: FDA-2022-D-0810 Issued by: Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Tobacco Products Center for Veterinary Medicine Human Foods Program Office...
Foods Program FDA Guidance Under Development
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA is considering for Human and Animal Foods. The lists below include some of the guidance documents under consideration to be developed. That said,...
FDA Updates General Food Labeling Requirements Compliance Program
Constituent Updates June 24, 2025 Read on FDA Website The U.S. Food and Drug Administration has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import. This update replaces the previous 2010 version of the...
Drug and Device Corner June 2025
The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment. Proposed Administrative Order OTC000038 If finalized, this proposed order will specify requirements for industry to...
FDA Seeks Input on a New Method for Ranking Chemicals in Food for Post-market Assessments
Constituent Update June 18, 2025Today, the U.S. Food and Drug Administration (FDA) released for public comment its proposed method for ranking chemicals in the food supply. This method provides a transparent, systematic, and science-based approach to determine which chemicals the agency would...
FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests
For Immediate Release: June 17, 2025The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the...
Raising Your Nutrition Label IQ
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 about these and other labeling issues. This webinar will also discuss some of the science that went into developing the Nutrition Facts label and explain why FDA decided to update and modernize the label in 2016. By attending this webinar, you will become a more knowledgeable label reader.
Navigating Regulatory Shifts: The Importance of Quality Management in the Tobacco Industry
By Gabriel Muñiz, EAS Consulting Group Independent ConsultantThe tobacco industry is navigating a landscape of evolving regulations, prompting companies to reconsider their compliance strategies. Amid these changes, maintaining a strong Quality Management System (QMS) remains essential for...
Drug and Device Corner May 2025
Reminder that OMUFA FY2025 facility user fees are due Monday 2 June 2025. MDF fee is $37,556; CMO fee is $25,037. Please see the FDA website for full details. Do note below the agency will be providing an OMUFA user fee and registration webinar Tuesday 20 May 2025.FDA Announces Expanded Use of...
Dietary Component Specifications and Testing
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 complying with the specification and testing requirements for dietary supplement components.
HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers
May 13, 2025 View on the FDA WebsiteThe U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced the launch of a public Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The initiative is part of a...
FDA Approves Three Food Colors from Natural Sources
May 09, 2025The U.S. Food and Drug Administration announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food. The FDA is in line with U.S. Department of Health and Human Services Secretary...
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...