Author Profile

Dr. Neelam Pawar Assistant Professor, Department of Pharmaceutical Sciences, Chaudhary Bansilal University, Bhiwani, Haryana. Chirag Rathi M Pharm, Department of Pharmaceutical Sciences, Chaudhary Bansilal University, Bhiwani, Haryana. Ravi Sharma M Pharm, Department of Pharmaceutical Sciences, Chaudhary Bansilal University, Bhiwani, Haryana. Geeta Parmar M Pharm, Department of Pharmaceutical Sciences, Chaudhary Bansilal University, Bhiwani, Haryana.

About The Book

The global food and nutraceutical industries are rapidly evolving, driven by increasing consumer focus on health, wellness, and preventive care. Regulatory Aspects of Food and Nutraceuticals is a comprehensive guide designed to navigate the complex regulatory frameworks governing these sectors. This book serves as an essential resource for professionals, researchers, regulatory authorities, and students, offering detailed insights into the safety, efficacy, and quality standards required for functional foods, dietary supplements, and nutraceuticals. The book begins with an introduction to nutraceuticals, covering their history, benefits, and categories, including dietary supplements, functional foods, and medical foods. It explores global regulatory guidelines, such as those from the World Health Organization (WHO), and highlights the role of NSF International in certification and standards. Regional frameworks are examined in detail, including India’s Food Safety and Standards Act (FSSAI), the U.S. Food Safety Modernization Act (FSMA) and Dietary Supplement Health and Education Act (DSHEA), and the European Union’s regulations under the European Food Safety Authority (EFSA). Each section provides a clear understanding of compliance requirements, certification processes, and labeling standards. Additionally, the book addresses ethical considerations in medical research, Good Clinical Practice (GCP) guidelines, and the application of biostatistics in clinical trials. Practical case studies and comparative analyses of regional regulations offer real-world insights. Whether you are a professional, researcher, or student, this book equips you with the knowledge to navigate the dynamic regulatory landscape of food and nutraceuticals, fostering innovation while

Table of Contents

Preface
Unit- I Nurtaceutical
Unit- II Global Aspects
UNIT- III India (Regulatory Aspects of Food & Nutraceuticals)
Unit- IV Regulatory Aspects of Food & Nutraceuticals (USA)
Unit- V European Union (Regulatory Aspects of Food & Nutraceuticals)
Unit- VI Medical Research
Unit- VII Clinical Research Related Guidelines