Formulations Regulations And Challenges Of Nutraceuticals

Formulations, Regulations, and Challenges of Nutraceuticals focuses on various novel micro- and nanocarriers being employed in the formulation and delivery of nutraceutical ingredients to increase their efficacy, bioavailability, safety, and stability. It also highlights the current challenges and future strategies for the development of novel nutraceuticals and functional foods with enhanced health benefits. The focus is on the formulations and regulations. As compared to traditional drugs, there are no minimal regulations on nutraceutical products, which make them more market friendly. Since nutraceutical ingredients have no defined regulations at global level, they are not considered as medicine or therapeutic agents. Some countries have devised their own guidelines for regulating the usage of nutraceuticals, either as pharmaceutical ingredients or as food supplements. This volume addresses the need for common regulatory guidelines with important research on the production of stable and efficient nutraceutical formulations. The numerous regulatory frameworks being employed in Asia and European regulatory agencies in commercialization of nutraceutical products produced by manufacturing companies are discussed. Chapters examine the factors affecting the stability of nutraceuticals in food and gut environments by stressing the results generated from in vitro and in vivo studies and suggests good manufacturing practices to be followed for the development of nutraceuticals. Formulations, Regulations, and Challenges of Nutraceuticals will be valuable for upper-level students, faculty, nutraceutical researchers and practitioners, regulatory agencies, and those involved in the production and development of nutraceutical products.

For several years, the food industry has been interested in identifying components in foods which have health benefits to be used in the development of functional food and nutraceutical products. Examples of these ingredients include fibre, phytosterols, peptides, proteins, isoflavones, saponins, phytic acid, probiotics, prebiotics and functional enzymes. Although much progress has been made in the identification, extraction and characterisation of these ingredients, there remains a need for ready and near-market platform technologies for processing these ingredients into marketable value-added functional food and nutraceutical products. This book looks at how these ingredients can be effectively incorporated into food systems for market, and provides practical guidelines on how challenges in specific food sectors (such as health claims and marketing) can be addressed during processing. Nutraceutical and Functional Food Processing Technology is a comprehensive overview of current and emerging trends in the formulation and manufacture of nutraceutical and functional food products. It highlights the distinctions between foods falling into the nutraceutical and functional food categories. Topics include sustainable and environmentally–friendly approaches to the production of health foods, guidelines and regulations, and methods for assessing safety and quality of nutraceutical and functional food products. Specific applications of nutraceuticals in emulsion and salad dressing food products, beverages and soft drinks, baked goods, cereals and extruded products, fermented food products are covered, as are novel food proteins and peptides, and methods for encapsulated nutraceutical ingredients and packaging. The impact of processing on the bioactivity of nutraceutical ingredients, allergen management and the processing of allergen-free foods, health claims and nutraceutical food product commercialization are also discussed. Nutraceutical and Functional Food Processing Technology is a comprehensive source of practical approaches that can be used to innovate in the nutraceutical and health food sectors. Fully up-to-date and relevant across various food sectors, the book will benefit both academia and industry personnel working in the health food and food processing sectors.

In the last three decades, revolutionary achievements have taken place in nutraceutical and functional food research including the introduction of a number of cutting-edge dietary supplements supported by human clinical trials and strong patents. Novel manufacturing technologies including unique extraction processes, bioavailability improvements through delivery technologies such as nanotechnology, and innovative packaging have been critical steps for their successful positioning in the marketplace and consumer acceptance worldwide. Nonetheless, mixed messages have emerged from both the scientific community and the media concerning the potential benefits of foods and nutrients in the treatment and prevention of disease. This confusion, in addition to existing marketed products making questionable health claims, have led health practitioners and consumers to become skeptical about nutritional claims of new and emerging food products. Clinical Aspects of Functional Foods and Nutraceuticals provides an extensive overview of the clinical aspects of functional foods and nutraceuticals. It contains information on both nutritional challenges and potential health benefits of functional foods and nutraceuticals. In addition to exploring the underpinning science, the book also focuses on food innovation, functional foods in human health, food–drug interactions, functional foods in medicine, the seed-to-clinic approach, global regulatory frameworks, challenges, and future directions. The book provides an essential overview of the clinical aspects surrounding functional foods and nutraceuticals for key stakeholders, drawing links between areas of knowledge that are often isolated from each other. This form of knowledge integration will be essential for practice, especially for policy makers and administrators.

Globalization of the nutraceutical and functional food industries presents significant challenges, not the least of which is the regulatory variance between countries active in the marketplace. Nutraceutical and Functional Food Regulations in the United States and Around the World has been written by eminent experts in the field with the specific intention of addressing these important considerations. Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures. Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, Nutraceutical and Functional Food Regulations in the United States and Around the World provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area. Overview of nutraceutical and functional food regulations around the world Discusses the important of GRAS status and DSHEA regulations Provides insight on quality manufacturing techniques, cGMP and standardized analytical techniques Includes salient features on overcoming regulatory hurdles Addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance Highlights anti-terrorism safety assurance through traceability Explores the significance of intellectual property, trademark and branding on marketing

As soon as Dr. Stephen DeFelice coined the phrase nutraceutical, product and supplement developers swung into action. Yet among the numerous books available on nutraceuticals, there is none that systematically lists, categorizes, and analyzes nutraceutical extracts and formulations in a pharmacopoeia-like manner. Handbook of Nutraceuticals, Volume 1: Ingredients, Formulations, and Applications lists information on many ingredients used in nutraceuticals, developing their formulations and applications. The book includes contributions from experts with pharmaceutical backgrounds, providing an examination of nutraceuticals from a pharmaceutical perspective. Building a foundation with coverage of historical background, definitions, and challenges, the book offers insight into nutraceutical ingredients from plant, animal, and mineral origin. It then covers the characterization of nutraceuticals’ physicochemical, analytical, pharmacological, and pharmacokinetic classification, followed by information on regulatory requirements. The book highlights applications in cardiovascular disease, bone and joint treatments, diabetes management, weight management, skin health, probiotics and prebiotics, tranquilizing medicinal plants, dietary foods, and more. Interest in new diet regimens and new products for increased health and longevity will continue to grow, giving dietary supplements an increasing amount of cupboard space in most households. With quality of content unsurpassed by many resources, the book discusses the characterization processes for nutraceuticals based on the contributors’ experience in pharmaceuticals. It then explores how those proven techniques may be applied to the development and manufacture of nutraceutical products.

Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets. International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within the framework of existing regulations will be addressed in individual chapters. Overview chapters will discuss global principles, inter-country trading issues, and present a comparison of the laws and regulations within different countries graphically. A "must-have" handbook for research professionals, management, and marketing strategists in the worldwide functional foods/nutritional supplements business. Food technicians and engineers responsible for manufacturing quality in this industry should add it to their library to ensure that they have a thorough knowledge of the applicable legal requirements. The book will also serve as an indispensable shelf reference for lawyers in the food industry and government health professionals with regulatory responsibilities.

This book highlights recent innovative work in nutraceutical delivery systems, focusing on strategies and approaches for delivering maximum health benefits from foods. It presents recent research-oriented work from diverse global perspectives on isolation techniques for nutraceutical components, phytosomes, liposomes, solid dispersions, micelles, self-emulsifying drug delivery systems, microemulsions, solid lipid nanoparticles, polyelectrolyte complexes, oral delivery, polymeric nanoparticles, and more. The book begins with an overview of recent facts and diverse perspectives on the use of nutraceuticals in medicine and proceeds to discuss recent techniques in isolation of nutraceuticals from plants and in solubility enhancement. It looks at innovations and advances in nanoparticles-based nutraceutical delivery, such as in solid lipid nanoparticles (SLNs), fabrication methods of therapeutic nanoparticles, and polymeric nanoparticles-based nutraceutical delivery system. It also discusses vesicular delivery systems and biphasic systems for nutraceutical applications. The book also looks at the challenges in oral delivery and the latest taste-masking techniques.

As soon as Dr. Stephen DeFelice coined the phrase nutraceutical, product and supplement developers swung into action. Yet among the numerous books available on nutraceuticals, there is none that systematically lists, categorizes, and analyzes nutraceutical extracts and formulations in a pharmacopoeia-like manner. Handbook of Nutraceuticals, Volume 1: Ingredients, Formulations, and Applications lists information on many ingredients used in nutraceuticals, developing their formulations and applications. The book includes contributions from experts with pharmaceutical backgrounds, providing an examination of nutraceuticals from a pharmaceutical perspective. Building a foundation with coverage of historical background, definitions, and challenges, the book offers insight into nutraceutical ingredients from plant, animal, and mineral origin. It then covers the characterization of nutraceuticals’ physicochemical, analytical, pharmacological, and pharmacokinetic classification, followed by information on regulatory requirements. The book highlights applications in cardiovascular disease, bone and joint treatments, diabetes management, weight management, skin health, probiotics and prebiotics, tranquilizing medicinal plants, dietary foods, and more. Interest in new diet regimens and new products for increased health and longevity will continue to grow, giving dietary supplements an increasing amount of cupboard space in most households. With quality of content unsurpassed by many resources, the book discusses the characterization processes for nutraceuticals based on the contributors’ experience in pharmaceuticals. It then explores how those proven techniques may be applied to the development and manufacture of nutraceutical products.