An Overview of FDA Regulated Products

From Drugs and Cosmetics to Food and Tobacco

Eunjoo Pacifici, Susan Bain, Eunjoo Pacifici, Susan Bain

• Publisher: Academic Press
• Year: 2018
• ISBN:
  9780128111567
• Topic: Medicine
• Subtopic: Pharmacology

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

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

Description of 21CFR Parts

21CFR Parts	Content
1–99	General
100s	Food for human consumption
200s	Drugs: General
300s	Drugs for human use
400s	Reserved
500s	Animal drugs and feeds
600s	Biologics
700s	Cosmetics
800s	Medical...