Nutraceutical and functional food regulations in the United States and around the world [Third edition] 9780128164679, 0128164670, 9780128175200, 0128175206

Table of contents :
Content: Front Cover
Nutraceutical and Functional Food Regulations in the United States and around the World
Nutraceutical and Functional Food Regulations in the United States and around the World
Copyright
Dedication
Contents
List of contributors
Preface
1 --
Introduction
1 --
Nutraceuticals and functional foods: innovation, insulation, evangelism, and evidence
1.1 Introduction
1.2 The mirage that moves
1.3 Misinformation and missed opportunities
1.4 Value addition or illusion?
1.5 Transforming evangelism into evidence
1.6 Land mines and weapons of brand destruction 1.7 Mirage to mass demand1.8 Conclusion
References
Further reading
2 --
Nutritional supplements and functional foods: functional significance and global regulations
2.1 Introduction
2.2 History
2.3 Health behaviors and food markets
2.3.1 Possibilities to boost food health- promoting properties
2.3.1.1 Fiber
2.3.1.2 Xylitol
2.3.1.3 Polyphenols
2.3.1.4 Antioxidants
2.3.1.5 Unsaturated fatty acids
2.3.1.6 Micronutrients
2.3.1.7 Plant sterols
2.3.1.8 Probiotics
2.4 Research needs: safety and efficacy
2.4.1 Dietary Supplement Health and Education Act of 1994 2.4.2 Codex: harmonizing food and supplement rules among all nations of the world2.4.3 International Alliance of Dietary Food Supplement Associations
2.5 Conclusion
Acknowledgments
References
3 --
Global market entry regulations for nutraceuticals, functional foods, and dietary/food/health supplements
3.1 Introduction
3.2 Market entry requirements
3.2.1 Positive and negative ingredient lists
3.2.2 Botanicals
3.2.3 Notification versus registration
References
4 --
Industry self-regulatory activities complement FDA's dietary supplement regulations
4.1 Introduction 4.2 Brief overview of legislative and regulatory history4.3 Definitions
4.4 Dietary supplement safety
4.4.1 Current good manufacturing practices
4.4.2 Adverse events reporting
4.4.3 Ingredient safety
4.4.4 Food and Drug Administration Food Safety Modernization Act
4.5 Dietary supplement labeling
4.5.1 Dietary supplement claims
4.5.2 Dietary supplement claims enforcement
4.6 Food and Drug Administration and Federal Trade Commission guidance
4.7 Industry self-regulatory activities
4.8 Transparency initiatives
4.9 Online databases
4.10 Accountability initiatives 4.11 Best practices and voluntary guidelines4.12 Advertising
4.13 Conclusion
References
5 --
The Food Safety Modernization Act (FSMA)'s role in the safety of functional foods and their ingredients
5.1 Introduction
5.2 Existing food safety regulatory framework
5.3 Challenges associated with the US regulatory approach
5.4 The Food Safety Modernization Act
5.4.1 Background
5.4.2 Preventive Controls for Human Food rule
5.4.3 Foreign Supplier Verification Programs rule
5.4.4 Intentional Adulteration rule
5.4.5 Accredited Third-Party Certification rule
5.5 Summary and concluding remarks

Citation preview

Nutraceutical and Functional Food Regulations in the United States and around the World Third Edition Edited by Debasis Bagchi

Academic Press is an imprint of Elsevier 125 London Wall, London EC2Y 5AS, United Kingdom 525 B Street, Suite 1650, San Diego, CA 92101, United States 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom Copyright © 2019 Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Library of Congress Cataloging-­in-­Publication Data A catalog record for this book is available from the Library of Congress British Library Cataloguing-­in-­Publication Data A catalogue record for this book is available from the British Library ISBN: 978-­0-­12-­816467-­9 For information on all Academic Press publications visit our website at https://www.elsevier.com/books-­and-­journals

Publisher: Charlotte Cockle Acquisition Editor: Nancy Maragioglio Editorial Project Manager: Hilary Carr Production Project Manager: Divya Krishna Kumar Cover Designer: Mark Rogers Typeset by TNQ Technologies

Dedicated to Dr. Sankar Basak, Ph.D., who is my friend, philosopher, and guide. Sankar is blessed with an unique talent and skill in mathematics, and he taught me mathematics.

List of contributors Jennifer Adams Amin Talati Upadhye LLP, Chicago, IL, United States Sanjiv Agarwal NutriScience LLC, East Norriton, PA, United States Imtiaz Ahmad Cepham Life Sciences, Inc., Baltimore, MD, United States Sameer K. Akolkar Laila Nutraceuticals, Vijayawada, India Anthony L. Almada IMAGINutrition, Inc., Dana Point, CA, United States Rend Al-­Mondhiry Amin Talati Upadhye LLP, Chicago, IL, United States Okezie I. Aruoma Department of Chemistry and Biochemistry, California State University Los Angeles, Los Angeles, CA, United States; School of Professional Studies, Southern California University of Health Sciences, Whittier, CA, United States Debasis Bagchi Department of Pharmacological and Pharmaceutical Sciences, University of Houston College of Pharmacy, Houston, TX, VNI, Inc. Lederach, PA, United States Theeshan Bahorun ANDI Centre of Excellence for Biomedical and Biomaterials Research, University of Mauritius, Réduit, Republic of Mauritius Jordan R. Bailey Venable LLP, Washington, DC, United States Kiran Bhupathiraju Laila Nutraceuticals, Vijayawada, India Katie Bond Amin Talati Upadhye LLP, Chicago, IL, United States George A. Burdock Burdock Group, Orlando, FL, United States Ioana G. Carabin Island ENT, Key West, FL, United States Alessia Cavaliere Department of Environmental Science and Policy, Università degli Studi di Milano, Milan, Italy

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List of contributors

Digambar Chahar Consulting Quality & Regulatory Affairs Scientist, Mississauga, ON, Canada Pradip Chakraborty Food Safety and Standards Authority of India, New Delhi, India Jayson Chen Product Safety Labs, Dayton, NJ, United States Gregory J. Chinlund Marshall, Gerstein & Borun LLP, Chicago, IL, United States Leighton K. Chong Udell Associates, Castro Valley, CA, United States Patrick Coppens EAS Strategies, Brussels, Belgium Willette M. Crawford Katalyst Consulting, LLC, Tiburon, CA, United States Amitava Das Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine, Indianapolis, IN, United States Praneel Datla Laila Nutraceuticals, Vijayawada, India Cristian Del Bo’ Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, Milan, Italy Bernard W. Downs VNI, Inc. Lederach, PA, United States Meggan F. Duffy Marshall, Gerstein & Borun LLP, Chicago, IL, United States Asim K. Duttaroy Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway Matthew Farrell Gowling WLG (Canada) LLP, Ottawa, ON, Canada Thomas Frey NSF International, Ann Arbor, MI, United States Dilip Ghosh Nutriconnect, Sydney, Australia Nandini Ghosh Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine, Indianapolis, IN, United States; Department of Human Nutrition, The Ohio State University, Columbus, OH, United States

List of contributors

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Trimurtulu Golakoti Laila Nutraceuticals, Vijayawada, India Raghavendra Gowda Product Safety Labs, Dayton, NJ, United States James C. Griffiths Council for Responsible Nutrition, Washington, DC, United States Neelam Gulati Quest Picong Sàrl, Étoy, Switzerland Om P. Gulati Quest Picong Sàrl, Étoy, Switzerland John R. Harrison JRH Toxicology, Ottawa, ON, Canada Michael Harvey NSF International, Ann Arbor, MI, United States James E. Hoadley EAS Consulting Group, Alexandria, VA, United States Stein Hordvik Hordvik’s Consulting, Elkhorn, NE, United States Chun Hu Nutrilite Health Institute, Buena Park, CA, United States Hideko Ikeda Biohealth Research Ltd., Tokyo, Japan Michelle C. Jackson Venable LLP, Washington, DC, United States Urmila Jarouliya School of Studies in Biotechnology, Jiwaji University, Gwalior, India Sam Jennings Berry Ottaway and Associates Limited, Hereford, United Kingdom Sewon Jeong BiofoodCRO Co., Ltd., Seoul, South Korea Danielle K. Johnson Marshall, Gerstein & Borun LLP, Chicago, IL, United States Raj K. Keservani School of Pharmaceutical Sciences, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal, India Ji Yeon Kim Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul, South Korea Seong Ju Kim Ministry of Food and Drug Safety, Chungcheongbuk-­do, South Korea

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List of contributors

Alla A. Kochetkova Federal Research Centre of Nutrition, Biotechnology and Food Safety (former Institute of Nutrition of the Russian Academy of Medical Sciences), Moscow, Russia Alluri V. Krishnaraju Laila Nutraceuticals, Vijayawada, India Lisa Glymph Lattimore NSF International, Ann Arbor, MI, United States Teck-­Chai Lau Department of International Business, Universiti Tunku Abdul Rahman (UTAR), Cheras, Kajang, Malaysia Claudia A. Lewis Venable LLP, Washington, DC, United States Daniela Martini Human Nutrition Unit, Department of Food and Drugs, University of Parma, Parma, Italy Nikita McGee Coldwell Banker Gundaker, O’Fallon, MO, United States Colleen McMullin Gowling WLG (Canada) LLP, Ottawa, ON, Canada Odete Mendes Product Safety Labs, Dayton, NJ, United States Sandra Morar McGrath North Mullin & Kratz PC LLO, Omaha, NE, United States Hiroyoshi Moriyama The Japanese Institute for Health Food Standards, Bunkyo-ku, Tokyo, Japan Chelsea M. Murray Marshall, Gerstein & Borun LLP, Chicago, IL, United States Vidushi S. Neergheen-­Bhujun ANDI Centre of Excellence for Biomedical and Biomaterials Research, University of Mauritius, Réduit, Republic of Mauritius; Department of Health Sciences, Faculty of Science University of Mauritius, Réduit, Republic of Mauritius Haiuyen Nguyen Council for Responsible Nutrition, Washington, DC, United States Hirobumi Ohama Biohealth Research Ltd., Tokyo, Japan Peter Berry Ottaway Berry Ottaway and Associates Limited, Hereford, United Kingdom Tobey-­Ann Pinder SFI Australasia, Sydney, Australia Jon-­Paul Powers Gowling WLG (Canada) LLP, Ottawa, ON, Canada

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Rabbi Gavriel Price Ingredients Approval Registry, Orthodox Union, New York, NY, United States Jennifer Radosevich Hill’s Pet Nutrition, Topeka, KS, United States Nancy E. Rawson Monell Chemical Senses Center, Philadelphia, PA, United States Joe M. Regenstein Cornell Kosher and Halal Food Initiative, Department of Food Science, Cornell University, Ithaca, NY, United States Lewis Retik Gowling WLG (Canada) LLP, Ottawa, ON, Canada Chandan K. Sen Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine, Indianapolis, IN, United States; Department of Human Nutrition, The Ohio State University, Columbus, OH, United States Krishanu Sengupta Laila Nutraceuticals, Vijayawada, India Andrew Shao Global Nutrition Solutions, LLC, Los Angeles, CA, United States Anil K. Sharma School of Medical and Allied Sciences, GD Goenka University, Gurugram, India Jeffrey S. Sharp Marshall, Gerstein & Borun LLP, Chicago, IL, United States Julia Shenkar Council for Responsible Nutrition, Washington, DC, United States Svetlana A. Sheveleva Federal Research Centre of Nutrition, Biotechnology and Food Safety (former Institute of Nutrition of the Russian Academy of Medical Sciences), Moscow, Russia Makoto Shimizu The University of Tokyo, Tokyo, Japan; Tokyo University of Agriculture, Tokyo, Japan Elena A. Smirnova Federal Research Centre of Nutrition, Biotechnology and Food Safety (former Institute of Nutrition of the Russian Academy of Medical Sciences), Moscow, Russia Boris P. Sukhanov Federal Research Centre of Nutrition, Biotechnology and Food Safety (former Institute of Nutrition of the Russian Academy of Medical Sciences), Moscow, Russia Anand Swaroop Cepham Inc., Somerset, NJ, United States Izabela Tańska IGI Food Consulting, Warsaw, Poland

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John Travis NSF International, Ann Arbor, MI, United States Victor A. Tutelyan Federal Research Centre of Nutrition, Biotechnology and Food Safety (former Institute of Nutrition of the Russian Academy of Medical Sciences), Moscow, Russia Lawrence J. Udell Udell Associates, Castro Valley, CA, United States Jessica White Gowling WLG (Canada) LLP, Ottawa, ON, Canada Jerzy Zawistowski University of British Columbia, Faculty of Land and Food Systems, Food, Nutrition, and Health, Vancouver, BC, Canada

Preface It is quite exciting and thrilling to restructure and redesign Nutraceuticals and Functional Food Regulations in the United States and around the World for its third edition, highlighting salient features of regulatory updates around the globe and their impact on manufacturers, consumers, traders, and social infrastructure. Innovation and marketing of nutraceuticals and food supplements are one of the fastest growing segments in the world economy [1]. Concurrently, rising costs and the alarming toxicity of drugs and pharmaceuticals are driving the world to move forward with less expensive but safety-­ affirmed nutraceuticals and functional foods. Backed by scientific research studies and clinical investigations. these well-­ known and recognized nutraceuticals and functional foods include vitamins, antioxidants, structurally diverse dietary supplements and botanical supplements; functional beverages such as sport and energy drinks; as well as products fortified with probiotics. Indeed, we are delighted to partner with Elsevier/Academic Press in publishing the third edition of the book. This edition is particularly expanded to broaden the reader’s scope and understanding of the intricate aspects of nutraceutical and functional food regulatory changes and how these changes will ultimately help consumers, researchers, and scientists working in the field, including regulatory and health professionals and public health advocates. The term “nutraceuticals” has no existence in the United States as a regulatory category. However, in 1980, the term “functional foods” was used by the Japanese government during the regulatory approval process for functional foods, which referred to them as Foods for Specified Health Use (FOSHU). Currently, the International Food Information Council defines functional foods as “foods or food components that may provide benefits beyond basic nutrition”; possibly, this will serve as a foundational definition. Despite this lack of a consistent definition, regulatory constraints are enforced in the United States and around the world, and this third edition has made it a point to include those constraints. For example, the European Food Safety Authority (EFSA) has enforced the need to provide scientific requirements for health claims and to find new regulatory issues for health food products. Accordingly, the EFSA asked its Dietetic Products, Nutrition, and Allergies panel to draft additional guidelines on scientific assessment of these claims. A new approach for a strict substantiation of health issues in selected fields, Regulation (EC) No. 1924/2006, established that health claims applications should be authorized only after a high level of scientific validation conducted by the EFSA using appropriate measures in the evaluation. The legislation should not only protect consumers but also define specific research areas with appropriate outcome measures to assess the quality, relevance, safety, and adequacy of studies conducted for the scientific validation of health claims. Similarly, in Japan, which is well-­known to be the world’s functional foods birthplace, FOSHU is classified as a food, of which a functional component was identified, of which the biological regulation function has been confirmed in clinical trials, and of which a health claim is permitted by the Ministry of Health, Labor, and Welfare. This new edition explores and addresses the impact of these classification definitions. The third edition has 11 updated chapters providing health food regulatory aspects from North America, Canada, the United Kingdom, Europe, Australia, Asia, Africa, and selected countries in the Pacific Rim. A chapter is now included from the Council of Responsible Nutrition (CRN), a well-­ recognized US-­based organization whose mission is to enhance a professional and regulatory climate to

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responsibly develop, manufacture and market dietary supplements [2], functional foods, and nutritional ingredients. A total of 91 well-­reputed authors and coauthors contributed to this third edition. Part I: Introduction. The opening section of this edition discusses the scope and significance of global regulations on nutraceuticals and functional foods, market opportunities, and future directions of nutraceuticals and functional foods. With the inclusion of an exploration of global market entry regulations and the mission of CRN in enhancing the standards and compliance of nutraceuticals and functional foods, the reader will find insight into the role of the Food Safety Modernization Act (FSMA) in the safety of functional food ingredients [3], and the pros and cons of gluten-­free foods. Part II: Manufacturing compliance and analytical validation emphasizes the impact of Good Manufacturing Practice and Current Good Manufacturing Practice compliance on consumer confidence in dietary supplements. Part III: Importance of safety assessment presents the importance of safety assessments, Generally Recognized As Safe Status, efficacy aspects, and allied claims of the functional foods and nutraceuticals. The international role of NSF in the dietary supplement and nutraceutical industries is included to provide perspective. Part IV: Regulations around the world includes expert insight into US regulations on food label claims, US regulatory constraints and considerations regarding new product formulations and advertisement aspects, and nutritional claims for functional foods and supplements in the United States. An understanding of medical foods under Food and Drug Administration regulations for US and Canadian regulations and the intricate aspects of the Natural Health Products Directorate are also presented in individual chapters. European regulations are individually demonstrated, presenting the health claims made for botanically sourced functional and fortified foods and food supplements in the European Union. Japanese regulations are included, as well as a chapter especially focused on health claims, which also explains the intricate aspects of FOSHU. Australian and Russian regulations are presented, as are nutraceutical and functional food regulations in India, China, Korea, and Africa. An extensive review is provided of the regulatory system for functional foods in the eight countries of the Pacific Rim (Taiwan, Hong Kong, South Korea, Malaysia, Indonesia, Singapore, the Philippines, and Thailand) as well as their diverse acts, regulations, and guidelines. Moreover, Malaysian regulations are summarized, as is the impact of World Trade Organization and food regulation on the food supply chain. Part V. Kosher and halal certification is a new part for this edition, highlighting the emerging importance of these foods and their preparation for targeted health as well as societal roles. Part VI. Regulations on pet foods provides a thorough overview of the stringent pet food regulations. Part VII. Adverse event reporting. Global adverse event reporting regulations are becoming important for the nutraceutical and functional food industries. Keeping in mind the timely need, a detailed chapter on global adverse event reporting regulations on functional foods as well as dietary, food, and health supplements has been included. Part VIII. Intellectual property, branding, trademark, and regulatory approvals in nutraceuticals and functional foods. This important aspect is covered with the latest information. As with the previous editions, this new edition is designed to ensure that health professionals, nutritionists, and regulatory toxicologists can work together strategically to derive appropriate regulations to provide optimal health, nutrition, and therapeutic benefits to mankind.

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Finally, I offer my sincere regards and gratitude to all of the eminent scientists, researchers, doctors, and authors who contributed to this book. My very special thanks go to Ms. Nancy Maragioglio, who always extended her utmost and prompt support, cooperation, and criticisms, and Ms. Hilary Carr, for continued support, help, and cooperation.

References [ 1] U.S. functional foods market -­statistics & facts. https://www.statista.com/topics/1321/functional-­foods-­market/. [2] CRN survey reaffirms trust and confidence in dietary supplement industry. https://www.nutraceuticalsworld. com/contents/view_breaking-­news/2018-­10-­19/new-­data-­from-­crn-­survey-­reaffirm-­trust-­and-­confidence-­in-­ industry/2013. [3] Understanding FSMA’s impact. https://www.nutraceuticalsworld.com/issues/2014-­11/view_columns/ understanding-fsmas-­impact.

CHAPTER

Nutraceuticals and functional foods: innovation, insulation, evangelism, and evidence

1

Anthony L. Almada IMAGINutrition, Inc., Dana Point, CA, United States

You’ve got to start with the customer experience and work backwards to the technology. You can’t start with the technology and try to figure out where you’re going to try to sell it. —Steve Jobs

1.1 Introduction The nutrition industry thrives within a global footprint, enjoying substantial economic momentum and growth. Attending this trajectory are incremental regulatory enforcement actions and civil litigation. In this chapter I define “nutraceuticals,” an industrial term languishing without a regulatory definition, as supplements or complements to the diet composed of bioactives occurring in food or produced de novo in human metabolism, biologicals (e.g., a probiotic strain), and botanicals (or their constituents), each intended to impart a physiological or medicinal effect after ingestion; and vitamins and minerals, delivered in forms that differ from conventional foods or beverages (e.g., solid dosage forms such as capsules, tablets, powders, or liquid extracts). “Functional foods and beverages,” another nutrition industry/ scientific community descriptor lacking a regulatory parent, I define as before, yet delivered in conventional food and beverage formats (e.g., a single-­serving beverage, a fermented dairy product, or a food bar). This may also include fortified foods and beverages such as vitamin D–enriched milk, calcium-­ enriched almond “milk,” or a probiotic-­enriched bread. Collectively, I will refer to these two classes as NFx. Biologically, NFx are intended to impart a physiological, pharmacological, or medicinal effect, without or in addition to a nutritional effect.

1.2 The mirage that moves The consumer promise of an NFx holds the allure of improved or preserved physiologic and/or metabolic function, or it may be in the context of physical or anatomical features. The spectrum of consumer expectation ranges from disease or condition prophylaxis to disease or condition treatment, and even to cure. The quest for natural and “–free,” the drive to engage in self-­care, and the nearly boundless access to the virtual, ostensibly omniscient reference libraries called the Internet, social media, and customer reviews have forged a new breed of companies and consumers. Armed and dangerous, with a modicum of evidence or a scroll of testimonials, bioactives are birthed, brands are born, products are launched, Nutraceutical and Functional Food Regulations in the United States and around the World. https://doi.org/10.1016/B978-­0-­12-­816467-­9.00001-­0 Copyright © 2019 Elsevier Inc. All rights reserved.

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Chapter 1  Nutraceuticals and functional foods

tribes are formed, and evangelists disseminate the faith-­based message. Indeed, the global NFx industrial complex may vie with organized religion for the title of largest faith-­based industry. Few consumers activate critical thinking skills and employ scrutinizing due diligence in their path to buy a new NFx, to the degree seen when buying a durable good (e.g., a new computer, car, or home appliance). Given the absence of a central depository, an authoritative and ultracurrent clearinghouse for brand-­ specific evidence, the mirage of improved health and function moves through new ingredient and theme deserts, unaccompanied by thoroughly informed navigators and caravans of confidence.

1.3 Misinformation and missed opportunities In the world of NFx, from a seedling of science often emerges a fad or a trend. In 1981, a Canadian research team developed the glycemic index (GI), a tool conceived to provide a physiological metric related to a carbohydrate-­containing food, supplement, or beverage and its influence on blood glucose dynamics [1]. An NFx exhibiting a high GI value is widely believed to deliver its glucose to the circulation at a faster rate, whereas an NFx displaying a low GI value is believed to deliver its glucose at a slower rate. However, the GI does not reflect the rate of digestion and absorption of glucose entering the blood [2–7]. Rather, it is simply the net result of glucose influx into the blood (from the gut and hepatic gluconeogenesis) less glucose efflux (primarily disposal into tissues, especially skeletal muscle and liver among insulin-­sensitive individuals) over a certain time interval (usually 2 h). Despite this, numerous influencers and NFx marketers assert that GI is correlated to the rate of glucose influx and the insulinemic response, that fiber has a slowing effect, or that a low GI NFx is equivalent to a slow-­ burning carbohydrate [8–11], despite zero or contravening, direct evidence in place [2–7]. A more recent entrant into the faith-­fueled NFx category is the gluten-­free moniker. Despite the identifier, a gluten-­free NFx is not free or devoid of gluten but exhibits