JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to impart the fundamental knowledge on Regulatory

Requirements, Registration and Labeling Regulations of Nutraceuticals in India, USA and Europe. It prepares the students to learn in detail on Regulatory Aspects for nutraceuticals and food supplements.

Course Outcome

Upon completion of the course, the student shall be able to

• a. Know the regulatory Requirements for nutraceuticals
• b. Understand the regulation for registration and labeling of nutraceuticals and food supplementsin India, USA and Europe.

UNIT - I

Nutraceuticals: Introduction, History of Food and Nutraceutical Regulations, Meaning of Nutraceuticals, Dietary Supplements, Functional Foods, Medical Foods, Scope and Opportunities in Nutraceutical Market.

UNIT - II

Global Aspects: WHO guidelines on nutrition. NSF International: Its Role in the Dietary Supplements and Nutraceuticals Industries, NSF Certification, NSF Standards for Food And Dietary Supplements. Good Manufacturing Practices for Nutraceuticals.

UNIT - III

India: Food Safety and Standards Act, Food Safety and Standards Authority of India: Organization and Functions, Regulations for import, manufacture and sale of nutraceutical products in India, Recommended Dietary Allowances (RDA) in India.

UNIT - IV

USA: US FDA Food Safety Modernization Act, Dietary Supplement Health and Education Act. U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements, Labelling Requirements and Label Claims for Dietary Supplements, Recommended Dietary Allowances (RDA) in the U.S

UNIT - V

European Union: European Food Safety Authority (EFSA): Organization and Functions. EU Directives and regulations for manufacture and sale of nutraceuticals and dietary supplements. Nutrition labelling. European Regulation on Novel Foods and Novel Food Ingredients. Recommended Dietary Allowances (RDA) in Europe.

TEXT AND REFERENCE BOOKS:

• 1. Regulation of Functional Foods and Nutraceuticals: A Global Perspective by Clare M. Hasler(Wiley Online Library)
• 2. Nutraceutical and Functional Food Regulations in the United States and Around the World byDebasis Bagchi (Academic Press, Elsevier)
• 3. http://www.who.int/publications/guidelines/nutrition/en/
• 4. http://www.europarl.europa.eu/RegData/etudes/STUD/2015/536324/IPOL_STU(2015)5363 _EN.pdf
• 5. Handbook of Nutraceuticals by Yashwant Pathak (CRC Press)
• 6. Food Regulation: Law, Science, Policy and Practice by Neal D. Fortin (Wiley)
• 7. Country Specific Guidelines from official websites. M.Pharm I Year II Sem (Pharmaceutical Regulatory Affairs)