Effective January 20, 2025, President Trump issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries.
The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or similar regulatory activity until the new administration has had an opportunity to review what the previous administration proposed or promulgated. In this case, the order:
Precludes federal agencies from proposing or issuing a rule until a department or agency head appointed or designated by the Trump administration reviews and approves the rule.
Requires agencies to withdraw rules that have been sent to the Federal Register but not published so they can be reviewed and approved.
Directs agencies to “consider postponing” for 60 days the effective date for rules that have been published or issued in the Federal Register but have not taken effect so they can be reviewed regarding questions of fact, law, and policy that the rules may raise.
Food, Dietary Supplements
FDA revoking the use of Red No. 3 in food and ingested drugs
FDA proposed rule regarding Front-of-Package Nutrition Labeling
FDA final rule on the nutrient content claim “Healthy” because it is not effective until February 25, 2025
FDA final rule on traceability (FSMA 204) because it is not effective until January 2026
USDA Food Safety and Inspection Service proposed rule regarding Salmonella as an adulterant at certain levels in raw poultry
Proposed Dietary Supplements Access Act which would allow consumers to use their FSAs and HSAs to purchase dietary supplements
Proposed Rule on Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
While these regulatory actions are subject to review it does not mean they will be discarded or rescinded. However, these rules will be reviewed by the new administration. After which, they will move forward unchanged, withdrawn, or subject to additional rulemaking activities.
EAS Consulting Group will closely monitor these and other FDA updates throughout 2025 and beyond, communicating expectations and analyses to our clients as available.
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”
Reviewed and Approved by Steven Rogers, Corporate Quality Manager, Certified Group; Lisa El-Shall, Sr. Director of Drug & Device Consulting, EAS Consulting Group; Tim Lombardo, Sr. Director, Food Consulting Services, EAS Consulting Group
On Jan. 15, 2025, the U.S. Food and Drug Administration (FDA) announced a ban on the use of FD&C Red No. 3 (commonly known as Red Dye 3) in food and ingestible drugs. This decision, influenced by studies indicating potential health risks, will significantly affect manufacturers and distributors of food products, over-the-counter (OTC) drugs, and dietary supplements.
To assist in navigating these changes, this FAQ addresses key questions about Red Dye 3, its ban, testing methods, and alternatives. Whether you’re reformulating products or preparing for compliance, this guide offers insights to meet both regulatory requirements and consumer expectations.
Our Claims Substantiation Seminar presented by Paula Brock, PhD., will take place Tuesday, February 11, 2025, from 1-3pm ET.
This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Along with real case examples, topics to be discussed include: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.
New for 2025: The Role of Your US Agent. An EAS complimentary webinar presented by EAS’ Victoria Pankovich and Lisa El-Shall on Tuesday, March 18, 2025, at 1pm ET.
Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment registrations and product listings; submissions such as Foreign Color Manufacturers Testing and Approval through FDA; drug submissions such as IND, DMF, ANDA and their required submissions (Annual Reports, Amendments, LoAs); and medical device applications such as 510(k), 513(g), deNovo, etc.
EAS Consulting Group’s Dietary Supplement GMP Seminar helps firms prepare for FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements. Instructed by two cGMP experts with 30+ years combined industry experience this intensive training program will help your firm stay on top of cGMP requirements.
As the food and supplement industries turn their focus to compliance with the latest FDA guidance for labeling regulations, the significance of those changes and how they influence nutrition and supplement facts panels, as well as claims are raising questions. Our experts will walk you through the requirements of a label, what information is required and in what order, how to determine amounts and how to list ingredients. You’ll learn the complex set of labeling rules and get answers to your most challenging questions.
This five-part virtual seminar, consisting of five one-hour sessions, will take place May 6, 13, 20, 27, and June 3, 2025, starting at 1pm ET each day.
Meet EAS’ Tim Lombardo and the Certified Laboratories, Inc. team at the Refrigerated Foods Association (RFA) 44th Annual Conference & Exhibition in Orlando, FL, February 16-19! Our team will be on-site at Booth #102 to discuss your regulatory consulting and outsourced lab testing needs. Learn how Certified Group can help you make safe, high-quality products. Learn more:https://www.refrigeratedfoods.org/rfa-conference
The International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and U.S. Food & Drug Administration (FDA) since 1976. It is a not-for-profit conference that was founded on the principle that FDA and the pharmaceutical industry needed a neutral forum in which to discuss and debate critical drug and biologic manufacturing issues. It has evolved over the past four decades into a forum where very complex and sophisticated policies and procedures are presented and discussed.
The speakers are distinguished leaders in FDA, foreign governments and industry who will present the latest information on issues related to pharmaceutical quality and manufacturing. Attendees will leave the conference with valuable information and ideas that will facilitate the production of safe, high quality drugs for consumers. The conference is the oldest and best GMP conference and is consistently rated outstanding by its attendees.
The 2025 Seafood Expo and Seafood Processing North America is happening March 16-18 in Boston, MA. Meet EAS’ Mark Moen and the Certified Laboratories, Inc. team at Booth #681! This year’s event will feature more than 30 educational sessions led by top seafood industry experts. Attendees will take away engaging and practical information covering the most important and timely issues relevant to today’s seafood business environment. Learn more:https://www.seafoodexpo.com/north-america/
The Society of Toxicology’s 64th Annual Meeting & ToxExpo will take place March 16-20 in Orlando, FL! Join EAS’ Maged Sharaf and the Labstat team at Booth #1350, along with leading toxicologists and industry professionals as they dive into cutting-edge science and technology.
Join FDLI for their annual Food and Dietary Supplement Safety and Regulation Conference on March 25, 2025, in Washington, DC, and Virtually.
This event brings together leading regulators, attorneys, industry representatives, academics, consumer advocates, and consultants to discuss current issues and trends in food and dietary supplement regulation with a focus on product safety. Topics will include federal and state regulatory compliance, inspections and recalls, updated ingredient safety and regulation under the new administration, product innovation, and novel technologies. This is a must-attend event for all stakeholders involved in food and dietary supplement policy, regulation, compliance, manufacturing, and technology.
Do you have a regulatory question or concern? Are you interested in seeing a particular topic covered in a future issue of eNews? We want to hear from you! Use the EAS Contact Us form to send a note or question to our team any time.
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We’re Hiring Independent Contractors!
EAS is always interested in broadening our industry experience and expanding our independent consultant team. If you’re interested in joining EAS as a 1099 contract employee, please email your CV to Dean Cirotta at dcirotta@easconsultinggroup.com.
Consultant Corner
EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients.
Dionne Meehan is an accomplished Senior Regulatory Professional with over 15 years of leadership experience in food safety quality regulatory compliance for food processing and manufacturing industries. Meehan is a recognized expert in FSIS, USDA, and FDA regulatory systems, with a proven track record of securing FSIS regulatory exceptions, implementing innovative compliance strategies, and delivering measurable value to organizations. She is adept at fostering cross-functional collaboration among R&D, Sales, Marketing, and Operations to align regulatory solutions with business objectives, and demonstrates exceptional leadership in risk management, regulatory policy development, and international trade compliance, driving operational excellence and productivity savings.
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