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title: "EAS-e-News: What’s Hot in the Regulatory World"
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Friend, Get the latest FDA and USDA regulatory information in our monthly EASeNews.

| View in browser Foods  •  Dietary Supplements  •  Drugs  •  Medical Devices  •  Cosmetics  •  Tobacco  •  Cannabis 1700 Diagonal Road, Suite 750, Alexandria, VA 22314  •  571-447-5500  •  easconsultinggroup.com/contact April 2025 Issue of the Month Health Claims and Dietary Fiber by Mark Kantor, EAS Consulting Group Independent Consultant Health 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. FDA recognizes three general categories of health claims: authorized health claims, qualified health claims, and FDA Modernization Act claims. These categories are based on the level of scientific evidence for the claim, or the source of that evidence. All three categories include claims related to dietary fiber, but only authorized health claims include the term “fiber” in the claim’s description. The others refer to “whole grains,” which are sources of dietary fiber.   Authorized health claims require the strongest level of scientific support for the substance/disease relationship, i.e., there must be “significant scientific agreement” (SSA) and a high level of confidence among experts that the claim is valid. Three authorized health claims specific for dietary fiber are found in Title 21 of the Code of Federal Regulations: (1) Fiber-containing grain products, fruits, and vegetables and cancer risk (§ 101.76); (2) Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease (§101.77); and (3) Soluble fiber from certain foods and risk of coronary heart disease (CHD) (§ 101.81). Read Full Article Under the Microscope Label Claims: A Guide for Food & Beverage Manufacturers 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.” As product label claims play an increasingly important role in informing consumer purchasing decisions, manufacturers are pressed to develop products – and food label claims – that best position their food and beverage products in the market. For some companies, the manufacturing process drives the development of claims. For others, the desire for their product to bear a certain label claim drives the manufacturing process.   From processing claims such as non-GMO, organic, and allergen-free, to health claims on food labels that indicate products or their ingredients may play a role in affecting the structure or function of the body, choosing the appropriate food claim is advantageous.   But there are regulations to consider. In this blog, we review the U.S. regulations for label claims to help your products stand out on store shelves while meeting regulatory requirements. Read Full Article Upcoming Training Events Transforming Your Food Safety and Regulatory Compliance Programs with Artificial Intelligence Webinar April 23, 2025   Food and Dietary Supplement Labeling Compliance Seminar April 28, 30, May 2, 2025   Drug OTC GMPs and Labeling Seminar Series May 6, 13, 20, 27, and June 3, 2025   Pet Supplements Unleashed: Navigating the Regulatory Maze Seminar May 14, 2025   Dietary Component Specifications and Testing Webinar May 21, 2025 Raising Your Nutrition Label IQ Webinar June 4, 2025 Upcoming Tradeshows and Conferences American Tobacco & Nicotine Forum Arlington, VA April 15-17, 2025 Event Sponsor, Exhibitor   Petfood Forum Kansas City, MO April 28-30, 2025 Visit us at FSNS Booth 1819!   ASQ’s World Conference on Quality & Improvement Denver, CO May 4-7, 2025   Food Safety Summit Rosemont, IL May 12-15, 2025 Visit Certified Group at Booth 426!   FDLI Annual Conference Washington, DC May 15-16, 2025 Event Sponsor, Exhibitor   Next Generation Nicotine Delivery USA Miami, FL June 4-5, 2025   CRN 13th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements New York, NY June 25-26, 2025 Event Sponsor   IFT First Annual Event & Expo Chicago, IL July 13-16, 2025 Visit FSNS and EAS Booth #S-2949   IAFP Annual Meeting Cleveland, OH July 27-30, 2025 Visit FSNS Booth #518! Food Safety Net Services (FSNS) Education Interested in more food safety training? FSNS offers live and virtual education events. Our food safety courses are taught by leading food industry technical authorities, and are primarily designed for:   Quality Assurance/Quality Control Supervisors and Technicians   Corporate Food Safety Managers, Directors, and Vice Presidents   Production and Plant Management/Personnel   HACCP Coordinators and Plant HACCP Team Members   Regulatory Affairs Supervisors   In–House Lab Personnel Visit FSNS.com/education to learn more. FDA and USDA Regulatory Updates ▪️Major Shakeup at FDA Continues as Tobacco Chief Removed ▪️HHS Restructuring and Organizational Streamlining ▪️Webinar on the Updated “Healthy” Claim Rescheduled for April 10 ▪️New Searchable Web Page for the Food Allergen Labeling Guidance for Industry ▪️HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families ▪️FDA Intends to Extend Compliance Date for Food Traceability Rule ▪️HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods ▪️HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe ▪️2024 CARES Act Drug Volume Reporting Reminder EAS in Action EAS is on the go. Find out about our latest seminars, webinars, speaking engagements, articles published in industry journals, tradeshows and more! Food and Dietary Supplement Labeling Compliance Seminar This three-day virtual seminar will take place April 28, 30, and May 2, 2025, from 11am-5pm ET each day.   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.   Register today for our popular Food and Dietary Supplement Labeling Compliance Seminar! Register Now Drug OTC GMPs and Labeling Seminar Series 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.   Navigating FDA requirements for OTC drugs can be complex and confusing. Join our expert presenters for a comprehensive 5-part virtual seminar series covering everything you need to know about OTC compliance.   This training is perfect for OTC drug manufacturers, quality assurance professionals, regulatory affairs specialists, and compliance teams.   This exclusive EAS series will cover: Registration and Listing Requirements Adverse Events Reporting OTC Labeling and Monographs Compliance Inspection Enforcement Private Label Distributor Requirements Register Now American Tobacco & Nicotine Forum EAS Consulting Group is a proud sponsor of the 2025 ATNF happening April 15-17 in Arlington, Virginia.   The American Tobacco and Nicotine Forum (ATNF) is the country's leading annual conference discussing the future of the tobacco and nicotine industries. ATNF is the global exchange for views and ideas between public health experts, government representatives, the industry and investors. Formerly the TMA Annual Meeting, the conference has been held every year for 110 years. View Details Visit Us at Petfood Forum The annual Petfood Forum is happening April 28-30 in Kansas City, Missouri. Visit Tim Lombardo and the FSNS team at Booth #1819! View Details New Training Announced: “Pet Supplements Unleashed: Navigating the Regulatory Maze” Presented by Kevin Ragland, EAS Consulting Group Independent Consultant May 14, 2025 at 1:00 PM ET   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 widespread adoption, these veterinary products face relatively limited oversight and regulation compared to human dietary supplements. This seminar explores the existing regulatory landscape for pet supplements and nutraceuticals designed for dogs, cats, and horses. Register Now! Upcoming Webinars Announcing our newest (free!) webinars April 23 Transforming Your Food Safety and Regulatory Compliance Programs with Artificial Intelligence May 21 Dietary Component Specifications and Testing June 4 Raising Your Nutrition Label IQ Submit Your Questions to the EAS Team Today! 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. Get Notified When Trainings Are Scheduled Are you looking for training in a particular industry or regulatory topic? Review our list of available topics and sign up to be notified when your course of interest is scheduled next. 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. Issue of the Month Author Mark Kantor EAS Consulting Group, EAS Independent Consultant Mark Kantor’s professional career has been at the intersection of food science and nutrition, including positions in government, academia, and industry. He was a nutrition scientist and regulation writer in FDA’s Office of Nutrition and Food Labeling for 14 years (2010-2024) where he contributed to the 2016 updates to the Nutrition Facts and Supplement Facts labels and Serving Size regulations. He also assisted in evaluating and responding to numerous citizen petitions pertaining to health claims and dietary fiber, and in writing the 2025 proposed rule on front-of-pack labeling. Prior to joining FDA, he was a faculty member at the University of Maryland for 25 years, where he taught and did research in the Dept. of Nutrition and Food Science, mentored graduate and undergraduate students, and conducted educational outreach programs through the Cooperative Extension Service. Mark has in-depth knowledge of FDA’s nutrition labeling and health claim regulations and vast experience in delivering presentations to both professional and consumer audiences. Meet New EAS Consultant Gabriel Muñiz EAS Consulting Group, EAS Independent Consultant Gabriel Muniz is a regulatory compliance expert with extensive experience in the tobacco industry, spanning both the U.S. Food and Drug Administration (FDA) and the private sector. For the majority and later part of his time at the FDA, he served as a Director within the Office of Regulatory Affairs (ORA), leading compliance and enforcement activities for the agency’s tobacco program. In this role, he built the tobacco operations program and played a critical part in shaping tobacco regulatory policy, conducting inspections, and overseeing enforcement actions, including first-of-their-kind regulatory interventions. He also collaborated with the Center for Tobacco Products (CTP) to develop compliance strategies and regulatory frameworks, such as the proposed Tobacco Product Manufacturing Practices (TPMP). After leaving the FDA, Gabriel joined Juul Labs, where he held multiple Director roles within the Quality and Regulatory departments. There, he contributed to the development of the company’s multiple Premarket Tobacco Applications (PMTA) and led efforts to align business operations with evolving federal regulations, ensuring adherence to complex quality and compliance requirements. Adam Orr EAS Consulting Group, EAS 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 of Animal Feeds) as a Subject Matter Expert working in pre-market review of animal feed ingredients and additives related to utility, target animal safety, protocols, and labeling. Expertise brought to EAS include label reviews, claims, regulatory study design, compilation and review of regulatory submissions including: animal Food Additive Petitions (FAP), Investigational Food Additives (IFA), Food Use (Slaughter) Authorizations (FUA), Generally Recognized as Safe (GRAS) Notifications, Animal Food Ingredient Consultations (AFIC), forthcoming Zootechnical Additives, and Feed Ingredient Definitions of the Association of American Feed Control Officials (AAFCO).   Learn more about working with EAS Consulting Group 👍 So the World Can Trust in What It Consumes EAS Consulting Group, 1700 Diagonal Road, Suite 750, Alexandria, VA 22314, USA, (571) 447-5500 Manage preferences |
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