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An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco

An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco

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An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco

Lunghezza:
594 pagine
13 ore
Pubblicato:
Jun 13, 2018
ISBN:
9780128111567
Formato:
Libro

Descrizione

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.

  • Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations
  • Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference
  • Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Pubblicato:
Jun 13, 2018
ISBN:
9780128111567
Formato:
Libro

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An Overview of FDA Regulated Products - Academic Press

An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

Edited by

Eunjoo Pacifici

International Center for Regulatory Science, University of Southern California, Los Angeles, CA, United States

Susan Bain

International Center for Regulatory Science, University of Southern California, Los Angeles, CA, United States

Table of Contents

Cover

Title page

Copyright

Dedication

Contributors

Foreword

Preface

Acknowledgments

Chapter 1: Introduction to FDA-regulated products

Abstract

1.1. What is a Regulated Product?

1.2. How are Different Products Regulated?

1.3. Product Classification

1.4. History of the Modern Regulatory System

1.5. Focus on Postmarketing Oversight

1.6. The Modern Regulatory System

Chapter 2: Regulatory agencies of the ICH: Authorities, structures, and functions

Abstract

2.1. Introduction

2.2. United States of America: Food and Drug Administration

2.3. Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

2.4. European Union: European Medicines Agency

2.5. Role of CIOMS and ICH

2.6. Overall Summary

Chapter 3: Drugs

Abstract

3.1. Is the Product a Drug?

3.2. How are Drugs Categorized?

3.3. What is a Regulatory Strategy and What Does It Entail?

3.4. What are the Key Steps of a New Drug Development Process?

3.5. What are the Key Steps of a New Drug Approval Process in the United States?

3.6. What Happens after a Drug Product Receives Regulatory Approval?

3.7. How is a New Drug Developed and Approved in International Markets?

3.8. What are the Key Steps of a Generic Drug Development and Approval Process?

3.9. What are the Key Steps of an Over-The-Counter (OTC) Drug Development and Approval Process?

Chapter 4: Biologics

Abstract

4.1. What is a Biologic?

4.2. Which Center at the FDA Regulates Biologics? CBER OR CDER?

4.3. What is FDA’S Role Regarding Biological Products?

4.4. How do Biologics Differ from Conventional Drugs?

4.5. The Regulatory Pathways (How do I Bring a New Biologic to Approval?)

4.6. Submission and Review Process

4.7. Postmarketing Activities

4.8. Special Topics

4.9. Conclusions

Chapter 5: Medical device and diagnostic products

Abstract

5.1. Regulating Devices in the United States

5.2. Recent Initiatives to Encourage Innovation

5.3. Regulatory Strategy

5.4. Assuring Compliant Manufacturing

5.5. Conducting Clinical Trials

5.6. Gaining Regulatory Approval

5.7. Medical Device Regulation in Other Countries

5.8. In Vitro Diagnostics—a Special Type of Medical Device

5.9. International Regulation of IVDs

Chapter 6: Combination products, borderline products, and companion diagnostics

Abstract

6.1. What is a Combination Product or a Companion Diagnostic and Why are These Types of Products So Important?

6.2. Challenges for the Regulation and Classification of Combination Products and Companion Diagnostics

6.3. US Perspective

6.4. European Perspective

6.5. The Proposed Medical Device Regulation

6.6. Regulation of Companion Diagnostics

6.7. Conclusions

Chapter 7: Food

Abstract

7.1. Food Regulatory History

7.2. Which Agency is Responsible for Regulating Food?

7.3. Key Food Regulatory Standards

7.4. Adulteration

7.5. Misbranded

7.6. What is Healthy?

7.7. Natural

7.8. Organic

7.9. Nutrition Labeling (USA)

7.10. Functional Foods (USA)

7.11. Health Claims

7.12. BE Labeling

7.13. Safety Assessment (GRAS)

7.14. New Dietary Ingredient

7.15. Investigational New Drug

7.16. Clean Labels (USA)

7.17. What is Free?

7.18. Conclusion

Chapter 8: Veterinary products

Abstract

8.1. How are Veterinary Products Regulated?

8.2. Animal Drugs

8.3. Animal Feeds

8.4. How are Dietary Supplements for Animals Regulated?

8.5. Veterinary Devices

8.6. Veterinary Biologics

8.7. Pesticides

8.8. Animal Grooming Aids

Chapter 9: Dietary supplements

Abstract

9.1. How are Dietary Supplements Regulated Within FDA?

9.2. What are Dietary Supplements?

9.3. What are New Dietary Ingredients?

9.4. How are Dietary Supplements Labeled?

9.5. Claims that may be Made for Dietary Supplements

9.6. Manufacturing and Distributing Dietary Supplements

9.7. Adverse Event Reporting for Dietary Supplements

9.8. The Federal Trade Commission and the States, and the Advertising and Marketing of Dietary Supplements

Chapter 10: Cosmetics

Abstract

10.1. Is It a Cosmetic, a Drug, or a Cosmetic-Drug?

10.2. How are Cosmetics Defined?

10.3. How are Cosmetics Regulated?

10.4. International Approaches to Cosmetics Regulation

10.5. Future Regulatory Outlook for Cosmetics in the United States

Chapter 11: Tobacco products

Abstract

11.1. History of Tobacco and Tobacco Control

11.2. History of Tobacco Product Regulation

11.3. Tobacco Control Act

11.4. Center for Tobacco Products

11.5. Tobacco Products Scientific Advisory Committee (TPSAC)

11.6. What is a Public Health Standard?

11.7. How can Tobacco Products be Marketed?

11.8. Sale and Distribution

11.9. Other Regulatory Requirements

11.10. Conclusions

Addendum/Postscript

Chapter 12: Quality

Abstract

12.1. Background

12.2. Good Laboratory Practices for Nonclinical Laboratory Studies

12.3. Good Clinical Practices

12.4. Good Manufacturing Practices

12.5. Conclusion

12.6. Useful Web Sites

Index

Copyright

Academic Press is an imprint of Elsevier

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Copyright © 2018 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: 978-0-12-811155-0

For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals

Publisher: Mica Haley

Acquisition Editor: Erin Hill-Parks

Editorial Project Manager: Megan Ashdown

Production Project Manager: Mohanapriyan Rajendran

Designer: Greg Harris

Typeset by Thomson Digital

Dedication

For Dr. Alex Sevanian Kyo Hyun and Hee Jae Kim Choungil Kim

Contributors

Lilit Aladadyan,     Tobacco Center of Regulatory Science (TCORS), University of Southern

California, Los Angeles, CA, United States

Susan Bain,     International Center for Regulatory Science, University of Southern California,

Los Angeles, CA, United States

Paul Beninger,     Tufts University School of Medicine, Boston, MA, United States

Roger Clemens,     University of Southern California School of Pharmacy, International Center for

Regulatory Science, Los Angeles, CA, United States

Mary Ellen Cosenza,     MEC Regulatory & Toxicology Consulting, LLC, Moorpark, CA, United States

Daniela Drago,     George Washington University, Washington, DC, United States

David A. Dzanis,     Regulatory Discretion, Inc., Santa Clarita, CA, United States

Shayesteh Fürst-Ladani,     SFL Regulatory Affairs & Scientific Communication, Basel, Switzerland

Nanae Hangai,     Sanofi, Paris, France

Michael Jamieson,     International Center for Regulatory Science, University of Southern California,

Los Angeles, CA, United States

Christy Kadharmestan,     College of Law, Michigan State University, East Lansing, MI, United States

Michael M. McGuffin,     American Herbal Products Association, Silver Spring, MD, United States

Eunjoo Pacifici,     International Center for Regulatory Science, University of Southern California,

Los Angeles, CA, United States

Nancy Pire-Smerkanich,     International Center for Regulatory Science, University of Southern California,

Los Angeles, CA, United States

Frances J. Richmond,     International Center for Regulatory Science, University of Southern California,

Los Angeles, CA, United States

Jonathan M. Samet,     Colorado School of Public Health, Aurora, CO, United States

Sai S. Tatavarty,     Abbott Diabetes Care, Alameda, CA, United States

Simone E. Turnbull,     Sanofi, Chattanooga, TN, United States

James William Woodlee,     Kleinfeld, Kaplan and Becker LLP, Washington, DC, United States

Anthony L. Young,     Kleinfeld, Kaplan and Becker LLP, Washington, DC, United States

Foreword

The products regulated by FDA constitute over 20% of all consumer-spending in the United States, amounting to several trillion dollars per year, with a notable impact on the global economy. Fundamental regulatory principles provide the basis for the Agency’s role and its work to enhance public and individual health.

However, new and emerging life science discoveries, innovation in product development, advances in manufacturing and commerce, as well as socioeconomic changes represent rapidly evolving challenges and opportunities to regulatory science. Providing knowledge and offering dialogue, guidance, and instruction for the safe and effective development and use of FDA-regulated products reduces uncertainties for all stakeholders, including innovators and investors. This book addresses both the challenges and opportunities, by connecting information and reference material to the principles in FDA regulation with selected practical examples of regulatory case work, derived from key technology and fast-paced product development categories. Experienced educators and regulatory professionals have provided a remarkably comprehensive, user-friendly book for a broad audience. But more importantly, it also prepares for the future by guiding consumers, patients, and professionals in the food and health industries on how to interpret and apply information so that it leads to tangible results.

Readers will therefore be equipped with the practical knowledge to more effectively participate in critically important dialogues with the FDA, that will support the Agency’s goal to make regulatory decisions based on the best available data, information, and knowledge. This investment in education and training in regulatory science will advance FDA from an Agency historically focused on policing and enforcing, to a science-driven, expert-guided authority that uses proactive innovation to keep up with technological change and communicates responsively and transparently with all interest groups.

Frank F. Weichold, MD, PhD

Director, Critical Path and Regulatory Science Initiatives

Office of Regulatory Science and Innovation (ORSI)

Office of the Chief Scientist (OCS)

Office of the Commissioner (OC)

Preface

Is toothpaste considered a cosmetic or a drug? What about sunscreens? Does the FDA approve food products before they can be sold? Are drugs that are approved for human use also considered safe and effective for use in animals? The answers to these questions are not apparent to most people. And for those interested in working in the food, health, and medical product industry, it is reassuring to know that there is a high demand for professionals trained in regulatory science who can connect the legal and regulatory requirements to scientific evidence.

Regulatory science as an academic discipline is relatively new. And it is by nature, interdisciplinary, where science, business, and law intersect. For many not familiar with the field, it can be quite daunting when trying to navigate the subject in a maze of laws, regulations, products, and companies. As educators, we have seen first-hand how simple explanations can help the students grasp fundamental concepts. It is in this spirit that we conceived of developing a book that would provide the novice reader with a practical guide to a wide array of FDA regulated products.

To tackle this project, we assembled authors who are experts in their fields. Most, in fact, lecture in our introductory level courses and understand the needs of our target audience as well as concepts that are most difficult for students to grasp. We, therefore, instructed our authors to consider approaching their writing as if they were lecturing to their students. Please note that the writings in this book represent the personal views of authors and not those of their employers.

There are other books that explore particular aspects of regulated products, including drug discovery and development, and clinical trial management. There are also books that cover legal and regulatory requirements for medical products and some that discuss business issues of the biopharmaceutical industry. However, currently there is no single book that provides a comprehensive overview of regulatory frameworks for a broad range of product categories. Our goal was to create a book that is both concise and easily accessible for a wide and diverse audience.

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any professional in this field. Our book aims to convey a summary of the key information that individuals with an interest in the regulated industry should know, and—more importantly—to unveil the meaning of critical regulatory concepts.

Although similarly structured, each chapter can also stand on its own to tackle a single product category. Hence the reader can enjoy reading the entire book from beginning to end or select an individual chapter to focus on a particular topic. Hopefully, you will find this field as fascinating and interesting as we do and will be inspired to further your studies.

Eunjoo Pacifici

Susan Bain

Acknowledgments

We are guided by our students, past, present, and future, from all corners of the world, who teach and inspire us every day with their curiosity, courage, and optimism; and their desire to contribute to the health and well-being of humans and animals.

This book would not have been conceived without a nudge from Frances Richmond, who thought it would be fun to develop an approachable book for this not-so-approachable subject. Frances has the most admirable talent for delicately nudging people to places that they never envisioned for themselves and yet upon their arrival realize that it was their destination all along. For that and so much more, we will forever hold her in our hearts with the utmost affection and gratitude.

We are indebted to our chapter authors who, with their passion for teaching and generosity of their hearts, agreed to embark on this journey with us. From the moment you gave your tentative nod to the submission of your final manuscript, you were gracious, responsive, and diligent despite all your competing obligations. Thank you, thank you, thank you!

A big thank you goes out to Daniela Drago, our coauthor, who helped with the original book proposal and the initial organization of the book. Our final product has benefited from your valuable input.

We thank Amelia Spinrad and Vaibhavi Chokshi for recommending quotes and graphics to include in the book, and for their assistance in reviewing drafts at various stages. We also thank Sahana Roopkumar for her hard work in creating the fictitious labels for veterinary products. Her creativity, hard work, and attention to detail is much appreciated.

It has been a pleasure to work with everyone at Elsevier. The project passed through many different hands but was managed seamlessly during the entire process. We give special thanks to Kristine Jones, who facilitated and guided the development of the original book proposal; and Megan Ashdown, our Editorial Project Manager, who has been resourceful, supportive, and helpful every step of the way.

We thank our children (Sarina, Noah, John, and Jennifer) for their great encouragement and the willingness to even review a few of the chapters. And finally, we each want to recognize the person whose love and support is weaved into the fabric of who we are and what we do. For Susan, that person is her father, Jim Waltrip, who continues to be her biggest fan and will be most delighted to receive his signed copy. For Eunjoo, it is of course her husband, Robert, from whom love was all that was asked but so much has been received.

Eunjoo Pacifici

Susan Bain

June 2018

Chapter 1

Introduction to FDA-regulated products

Eunjoo Pacifici

Susan Bain    International Center for Regulatory Science, University of Southern California, Los Angeles, CA, United States

Abstract

Products regulated by the United States Food and Drug Administration (FDA) represent close to one-fifth of all products sold in the country or more than $2.4 trillion. With the continuing growth of this sector, the globalization of the industry, and the challenges of meeting complex regulatory requirements, the need for trained professionals in this field is increasing. A product is considered regulated if a government authority determines when and how the product is allowed to be commercialized. In the United States, the FDA separates products into specific categories: food, dietary supplements, cosmetics, drugs, biologics, medical devices, veterinary products, and tobacco. The main law that governs these products is the Food Drug and Cosmetic Act, which provides definitions for the different product categories along with allowable claims. Although the major legislations during the FDA’s first 100 years followed on the heels of high-profile incidents, more recent legislations have been spurred by calls for the agency to actively promote innovation, expand earlier access to therapies, and engage patients as key stakeholders.

Keywords

food

drug

tobacco

cosmetic

veterinary products

dietary supplement

biologic

FDA

medical device

pharmaceutical

regulated products

regulatory authority

therapeutic claim

user fee

Chapter Objectives

After reading this chapter, the reader will be able to:

• identify the market size represented by the products regulated by the United States Food and Drug Administration (US FDA),

• describe different categories of regulated products,

• recognize and compare how different products within a product category are regulated differently,

• identify therapeutic claims and which products can make them,

• describe the history of the modern regulatory system, and

• identify the key concepts that underlie the current regulatory framework.

When a company creates a product that directly or indirectly adversely impacts the health of people, that product must be regulated. The process by which it's created must be regulated.

– Kenneth C. Griffin

Products regulated by the US FDA represent close to one-fifth of all products sold in the country or more than $2.4 trillion (United States Food and Drug Administration, 2017a). Globally, the pharmaceutical sector alone garners over a trillion dollars in sales. The public uses these products for nourishment, to maintain health and to derive therapeutic benefit. For the industry that develops and commercializes these products, it is important that their products address the needs of the public, are commercially viable, and meet the regulatory requirements of the FDA and, if they are sold abroad, of all the regulatory authorities of the relevant regions. With the continuing growth of this sector, the globalization of the industry, and the challenges of meeting regulatory requirements, the need for trained professionals in this field is increasing. As colleges and universities in the United States and elsewhere establish programs to prepare their students to enter the FDA-regulated industry, there is also an emerging need for a book that can be used in conjunction to aid in the instruction of the students. In addition, professionals working in other sectors like investment firms and media outlets may also be interested in the subject as they cover regulated industries and products. Therefore, this book was conceived to help interested novices gain a basic understanding of how products are regulated by the FDA.

We have focused primarily on the US system because, up to now, the United States represents the single largest market for many of the products and also because the US system is one of the oldest and most well-established regulatory systems. Other countries have their own regulatory authorities with their own requirements for gaining market authorization of regulated products. Although efforts to harmonize regulatory requirements have been ongoing for many decades, we are far from having universally harmonized standards. Levels of harmonization vary across countries and regions. For example, some countries require local clinical trials be conducted for a new product to understand its effects on local populations.

We have, in selected chapters, for example, Drugs and Medical Devices, included other agencies for the purpose of comparisons. In addition, Chapter 2 provides an insight into the organizations and approaches used by three prominent agencies: US FDA, Japan’s Pharmaceuticals and Medical Device Agency (PMDA), and the European Medicines Agency (EMA).

1.1. What is a Regulated Product?

A product is considered regulated if a governmental authority determines when and how the product is allowed to be commercialized. For example, a regulatory authority may specify requirements for quality, safety, and effectiveness to be demonstrated for a product before granting marketing authorization and may have additional requirements to keep the product on the market.

1.2. How are Different Products Regulated?

In the United States, the FDA separates products into specific categories: food, dietary supplements, cosmetics, drugs, biologics, medical devices, veterinary products, and tobacco. Food, dietary supplements, and cosmetics fall under the jurisdiction of Center for Food Safety and Nutrition (CFSAN), drugs under Center for Drug Evaluation and Research (CDER), biologics under Center for Biologics Evaluation and Research (CBER), medical devices under Center for Devices and Radiological Health, veterinary products under Center for Veterinary Medicine (CVM), and tobacco under Center for Tobacco Products (CTP).

The main law that governs these products in the United States is the Federal Food, Drug, and Cosmetic Act (FDCA), which was established in 1938 and amended as needed over the years to strengthen the regulatory framework (see Chapter 2). The laws are passed in the United States as Acts of Congress and organized, or codified, into United States Code (USC). Of the 53 titles in the USC, title 21 corresponds to the FDCA (Legal Information Institute, 2017). To operationalize the law for enforcement, governmental agencies like the FDA are authorized to create regulations. The Code of Federal Regulations (CFR) details how the law will be enforced. The CFR is divided into 50 titles according to the subject matter. Of those, title 21 corresponds to food and drugs. Therefore, professionals working in the FDA-regulated sector have three types of references for regulatory compliance: FDCA, 21USC, and 21CFR. As can be seen in Tables 1.1 and 1.2, there are different numbering schemes corresponding to each of the three references.

Table 1.1

Table 1.2

Generally, products within each category are regulated according to the risks they pose. For example, heart valves are more rigorously regulated than stethoscopes although both are categorized as medical devices. Hence, the two devices follow different regulatory paths for commercialization (see Chapter 5). Similarly, not all drugs are regulated the same way. A brand-new drug is an unknown entity and poses greater potential risks than a generic drug that is a copy of the original that has been on the market for many years. Thus, there are different regulatory requirements for different categories of drugs. Dietary supplements often look like drugs in that they come in the form of tablets, capsules, and liquids in packaging with labels that make them look like drugs. But in the United States, dietary supplements are intended to supplement the diet and hence classified under the umbrella of foods (United States Food and Drug Administration, 2015a). Dietary supplements do not require premarket approvals and are regulated by CFSAN. Tobacco products are the most recent addition to fall under the jurisdiction of FDA and are subject to a unique regulatory framework in that these products pose only risks and no benefits. Chapter 11 examines in detail how tobacco products are regulated by the FDA. Table 1.3 shows the different regulatory routes for medical products. As you read the corresponding chapters, keep the comparisons below in mind regarding the types of products and the risk-based oversight of products within each category.

Table 1.3

1.3. Product Classification

In the United States, the FDCA provides definitions for the different product categories along with allowable claims. For example, drugs, biologics, and medical devices can make therapeutic claims like treatment of cancer or reduces symptoms associated with arthritis. Therapeutic claims also include implied statements like relieves bronchospasm or relieves congestion. It is illegal for nonmedical products, like dietary supplements and cosmetics, to make therapeutic claims. If the FDA discovers that a company has made those statements, the FDA may respond by sending the company a warning letter with a notice to act within 15 working days to correct the violation. Structure/function claims are shared across food, dietary supplements, and drugs. Examples include calcium builds strong bones and fiber maintains bowel regularity. If a product looks like a cosmetic but claims to treat eczema, it is a drug not a cosmetic and needs to meet all the regulatory requirements for a drug.

A product may be determined to be a drug if it contains a known drug ingredient. Hence, if an herbal remedy (a dietary supplement) contains sildenafil (the active ingredient in the prescription drug Viagra), it falls in the category of drugs and is not allowed to be marketed as a dietary supplement.

Even if a product does not contain any drug ingredients, its intended use may cause it to be categorized as a drug. A product’s intended use may be determined through the company’s printed materials like advertisements and promotional materials or statements made by company representatives as well as information posted on the product website. Hence, even if the dietary supplement mentioned above does not contain sildenafil, it would be categorized as a drug if it claims to improve male sexual dysfunction.

Drugs that have high potential for abuse with no accepted medical use are illegal and cannot be imported, manufactured, distributed, possessed, or used. In the United States, the Controlled Substances Act is the law that oversees these dangerous products and the Drug Enforcement Agency (DEA) is the federal agency that enforces the law (United States Drug Enforcement Administration, 2016).

Sometimes, it is not clear as to which class a product belongs. For example, what if a dental bone grafting material is combined with a bone growth factor? Is it a device or a biologic? In this case, the product would be classified as a combination product with CDRH as the lead center for regulating the product. Chapter 6 addresses these combination products and the concept of the primary mode of action. One way to think about this question is to consider whether you would use one component without the other. The dental bone grafting material could be used without the bone growth factor in dental procedures to fill, augment, or reconstruct. But the growth factor alone would not be used for that intended use. What if a lipstick contains sunscreen? Is it a cosmetic or a drug? Today, many cosmetics like lotions and creams contain sunscreen components. In these cases, the products must be labeled as over-the-counter (OTC) drugs and meet OTC drug requirements. Chapter 3 examines the different classes of drugs and their regulatory pathways and Chapter 10 discusses cosmetics in more detail. Biologics include living cells and tissues as well as complex molecules that are, or similar to, natural substances such as enzymes, antibodies, or hormones. These products are different than traditional drugs, which are pure chemical substances with well-known structures manufactured through chemical synthesis. Although biologics are subject to federal regulation under the Public Health Service Act (PHS), they also meet the definition of drugs and are considered a subset of drugs. Hence, biologics are regulated under provisions of both PHS and FDCA (United States Food and Drug Administration, 2015b). Chapter 4 examines different types of biologics and how they are regulated.

1.4. History of the Modern Regulatory System

Prior to the early 1900s, food and drugs were not regulated in the United States, and the marketplace saw widespread adulteration and misbranding of food and drugs. Today, the US regulatory system enforced by the US FDA is considered to be the most advanced around the world, with a staff of approximately 15,000 employees and an annual budget of $5.1 billion projected for 2018. The US FDA has broad jurisdiction that includes most food products (other than meat and poultry), human and animal drugs, biologics, medical devices, radiation-emitting products, cosmetics, animal feed, and tobacco products. Examining the evolution of the US regulatory system will provide the reader with a greater understanding of the key concepts that underlie the current framework (United States Food and Drug Administration, 2017b).

1.4.1. Adulteration and Misbranding

Passage of major legislation in the area of food and medical products has occurred often following tragic incidents that revealed a need for, or further expansion of, government oversight. Prior to 1900, food products and drugs were routinely found to be substandard due to deceptive and fraudulent practices. For example, food products and drugs often contained low-cost substitutes or harmful additives (adulteration) without disclosing accurate information on the product labels (misbranding). Chemical preservatives and color additives were used without any control, milk was diluted with water, and quinine (drug to treat malaria) was mixed with ineffective ingredients. In Europe, Great Britain had already passed its national food and drugs act in 1860. The United States was slow to act but eventually passed its first landmark legislation, the Food and Drugs Act of 1906. This law prohibited the manufacture and interstate transportation of adulterated or misbranded food and drugs. Although the law was repealed and replaced by the Federal Food Drug and Cosmetic Act of 1938, the two terms, adulteration and misbranding, remain as key concepts in FDA regulation to this day. These terms, however, have broader implications in the modern era in that adulteration can include failure to follow good manufacturing practice (GMP) and misbranding can include misleading internet promotion and advertising. The original 1906 law also introduced the concept of conforming to the official drug standards as established by the United States Pharmacopeia (USP) and the National Formulary (NF). Advances in analytical chemistry during this era (1900s) were used to develop standards and assay methodologies.

But the 1906 law primarily focused on truth in labeling without requiring a product to demonstrate its safety or efficacy. There were no requirements for premarket submission of information, review, or approval. Hence, inferior and dangerous products remained on the market.

1.4.2. Safety

The next landmark food and drug legislation in the United States occurred after an elixir of sulfanilamide formulated in the toxic solvent diethylene glycol killed 107

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