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).
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.
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!
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.
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.
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.
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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).
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