Food Law and Regulation for Non-Lawyers

1. Front Matter

   Pages i-xii

   PDF

2. Introduction to Statutory Framework and Case Law

   • Marc C. Sanchez

   Pages 1-29

3. Federal Inspections and Enforcement

   • Marc C. Sanchez

   Pages 31-67

4. Adulteration

   • Marc C. Sanchez

   Pages 69-99

5. Misbranding

   • Marc C. Sanchez

   Pages 101-129

6. Regulation of Dietary Supplements and Other Specialized Categories

   • Marc C. Sanchez

   Pages 131-164

7. Food Additives

   • Marc C. Sanchez

   Pages 165-195

8. Private Actions and Personal Liability

   • Marc C. Sanchez

   Pages 197-232

9. Back Matter

   Pages 233-241

   PDF

The book offers a succinct overview of key topics and core concepts for food scientists, quality managers, and others who need to understand the regulation of food and dietary supplements in the U.S. It was designed and modeled after a six-week introduction to food law course currently taught at Northeastern University, and serves as a practical tool for regulatory professionals. The book includes a chapter on each major topic, with summations of the legislative history and general legal landscape. Each chapter focuses the reader on major and emerging issues encountered by facilities. A comparative law section at the end of every chapter offers readers an ability to view alternative methods of regulation and enforcement.  This design is unique and allows students and working professionals alike to understand core concepts and the practical application of the law to their work.  Using a modified casebook method approach, the book also serves as a practical toolfor regulatory professionals.

• Color additive
• Dietary supplement regulation
• Food additive
• Food adulteration
• Food inspection
• Food laws
• Food misbranding
• Food regulations
• Food safety
• Form 483
• Labeling litigation
• Warning letter

“Food Law and Regulation for Non-Lawyers is a phenomenal textbook introducing students to the fundamentals of U.S. food law, its associated legislations and local enforcement agencies. Its contents is aptly and functionally structured to target ‘non-lawyers,’ both American food practitioners, and academics intrigued by the legal functions of the industry. … The textbook contains an abundance of highly valuable information. … The clear organization and presentation of information in various diagrams in the textbook is worth a mention.” (Impeccable Business, impeccablebusiness.wordpress.com, June, 2016)

• Founder and Senior Counsel, Contract In-House Counsel & Consultants, LLC, Washington, USA

  Marc C. Sanchez

Marc represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues and is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.

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