Food Law and Regulation for Non-Lawyers

1. Front Matter

   Pages i-xiii

   PDF

2. Introduction to Statutory Framework and Case Law

   • Marc C. Sanchez

   Pages 1-28

3. Federal Inspections and Enforcement

   • Marc C. Sanchez

   Pages 29-67

4. Adulteration

   • Marc C. Sanchez

   Pages 69-100

5. Misbranding

   • Marc C. Sanchez

   Pages 101-131

6. Regulation of Dietary Supplements and Other Specialized Categories

   • Marc C. Sanchez

   Pages 133-165

7. The Food Safety Modernization Act

   • Marc C. Sanchez

   Pages 167-204

8. Food Additives

   • Marc C. Sanchez

   Pages 205-235

9. Private Actions and Personal Liability

   • Marc C. Sanchez

   Pages 237-269

10. Back Matter

    Pages 271-280

    PDF

Designed and modeled after a six-week introductory food law course taught at Northeastern University, Food Law and Regulation for Non-Lawyers 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 in the U.S.  This second edition includes critical updates on the Food Safety Modernization Act-- the first change to the food safety laws in over 70 years. The seven foundational rules, finalized in 2015, are discussed in detail. The new edition also includes other regulatory updates such as the new Nutrition Fact Panel, changes to the definition of fiber, and the FDA’s attempt to regulate the widely used “healthy” claim. These timely updates, along with the core concepts of the first edition, make the volume an essential and practical tool for 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

• Contract In-House Counsel & Consultants, LLC (the FDA Atty), Washington, DC, USA

  Marc C. Sanchez

Marc Sanchez 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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