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Editors: Debasis Bagchi Sreejayan Nair. Hardcover ISBN: Imprint: Academic Press. Published Date: 29th September Page Count: For regional delivery times, please check When will I receive my book? Sorry, this product is currently out of stock. Flexible - Read on multiple operating systems and devices.

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Institutional Subscription. Free Shipping Free global shipping No minimum order. Examines key considerations in product development Provides a streamlined approach for product development Addresses manufacturing and quality control challenges Includes key lessons for a successful product launch and effective marketing.

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Powered by. Wellness: Wellness benefits are about feeling good and finding balance. This is a holistic approach to health care that includes the body, mind, and spirit. Nurturing: Foods that can supply a sense of caring for the health and quality of life for others and the associated sense of satisfaction for the caregiver. Marketing a product from this platform would include a focus on growth and development, aging, and healing.

Cosmetics: Cosmetic benefits are about looking good and enhancing self-esteem through improved physical condition and personal appearance. Fast moving consumer goods companies and pharmaceutical companies are major players in the Indian nutraceutical market Figure Food research, product and process innovation and change in consumer behavior facilitate adaptation of food regulations.

Increasingly, the awareness is manifested through consumption of particular foods and dietary supplements believed to con- tribute to good health and in some cases, to hold therapeutic value in the treatment or prevention of specific diseases. Many of these food products are becoming commonly known as nutraceuticals or functional foods. Nutraceuticals are products that have the characteristics of both a nutrient and a pharmaceutical.

Taken as dietary supplements, they can modulate the symptoms of various disease conditions by providing the additional nutrients our bodies may need to maintain well-being. The issue of adulteration became a national issue in when Congress passed the Drug Importation Act, requiring inspection by the U.

The genesis of U. This legislation created food standards, mandated inspections of factories and provided for the issuance of court injunctions in addition to the already existing seizure and prosecution remedies. Since , the FDCA has been amended a number of times and addi- tional supporting laws have been enacted relating to food safety, security threats, and nutrition.

Additionally, this federal framework is supplemented by state laws. These two federal agencies encompass all phases of the food regulatory system: they evaluate, investigate, regulate, inspect and sanction. Under the DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to the FDA all serious adverse event reports.

Barriers to growth in this food sector include poor infrastructure and logistic and tight food regu- lation. The multiplicity of food regulation policy makers and enforcement agencies prevailing in different sectors of the food industry contributed to considerable confusion among the consumers, producers and retailers and busi- ness and is detrimental to the growth of the functional food and nutraceutical industry [12 13].

Further, integrating all acts and orders relating to food and eliminating multilevel and multidepartmental controls over food, special emphasis was given to nutraceutical and functional food, a poorly defined segment with growing potential and implications on consumer heath. In , a national nonprofit association had been constituted with main objectives that every food manufacturing company should provide scientific- based support to their products in order to protect the consumers and to promote and defend a regulatory environment conducive to the industry in general as well as consumer protection.

Functional Food 2020

In , a Ministry of Health expert group report indicated the need to create new categories for regulating functional food and dietary supplements in the pres- ent food laws. It is recommended that there should be mandatory safety testing for these products. In India voluntary standards are developed by the Bureau of Indian Standards and National Standards body, which comprise representatives from various food sector stakeholder groups. These standards basically deal with product certification, quality, system certification and testing and consumers affairs.

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Efforts are made to match Indian standards with international ones [14]. In , a number of committees, including the Standing Committee of Parliament on Agriculture, have emphasized the need for a single regulatory body and integrated law. Finally, the Indian Food Safety Standard Bill , signed into law, promised a major impact on the Indian food processing industry. The Indian Food Safety and Standard Act came into enforcement in with two main objectives: to introduce a single statute relating to food and to provide for scientific develop- ment of the food processing industry.

It incorporates the salient provisions of the Prevention of Food Adulteration Act and is based on inter- national legislations, Instrumentalities and the Codex Alimentarius Commission [12]. FSSA will be aided by several scientific panels and a central advisory committee to lay down standards for food safety. These standards will include specifications for ingredients, contaminants, pesticide residue, biological hazards, labels and others.

This authority will be in charge of categories like functional foods, nutraceuticals, dietetic products and other similar products [12 14]. Chapter IV, Article 22 of the act addresses nutraceutical, functional food, dietary supplements and the need to regulate these products such that anyone can manufacture, sell, or distribute or import these products. These products include novel foods, genetically modified articles of food, irradiated food, organic food and food for special dietary uses, functional food, nutraceuticals and health supplements, whereas Articles 23 and 24 address the packaging and labeling of food and restriction of advertisement regarding foods [12].

According to this act, foods for special dietary uses, functional food, or nutraceutical or dietary supplements are the following: 1. Foods that are specially processed or formulated in order to satisfy particular dietary requirements that exist because of a particular physiological or physical condition and that are processed as such wherein the composition of these foodstuffs must differ significantly from the ordinary food of comparable nature, if in such ordinary food exists one or more of the following ingredients, namely: a. Plants or botanicals in the form of powder, concentrates, or extracts in water, ethyl alcohol, single or in combinations.

Minerals, vitamins, or proteins amounts not exceeding recommended daily allowance RDA for Indians or enzymes. Substances from animal origin. A dietary substance used by human beings to supplement the diet by increasing the total dietary intake. Such product does not include a drug as defined in clause b and ayurvedic, siddha, and unani drugs as defined in clauses a and h of Section 3 of the Drugs and Cosmetics Act and rules made thereunder. Does not claim to cure or mitigate any specific disease, disorder, or condition except for certain health benefits or such promotion claims as may be permitted by the regulations made under this act.

Does not include a narcotic drug or a psychotropic substance as defined in the schedule of the Narcotic Drugs and Psychotropic Substances Act and rules made thereunder and substances listed in Schedules E and E1 of the Drugs and Cosmetics Rules Regulation primarily controls the product quality in case of food.

Developing New Functional Food and Nutraceutical Products [DOWNLOAD…

Every system of regulation has its own pros and cons. But the benefits from the implementation of the Food Safety and Standards Act overwhelmed the problems that rise due to implementa- tion of this act. Unlike in the United States, where the DSHEA is in place to regu- late these products, in India the government is in the process of drafting a law to regulate manufacturing, importing and marketing of health foods, dietary supple- ments and other nutraceuticals [13 14]. The United States and Europe are going to be emerging markets for nutraceutical exports from India, because an existing large market base is already in place and consumers are looking for better and healthier options to prevent lifestyle-related diseases [16,17].

Companies like Amway India and Herbalife are utilizing direct multilevel market- ing to reach new consumers about their products delivered by someone known and trusted. However, most of the large companies have not ventured into nutra- ceuticals or dietary supplements due to regulatory confusion, lack of adequate awareness and understanding and poor vision of the market [16]. Academics and food companies generally understand functional foods to contain or to be fortified with nutrients or other bioactive compounds that help to main- tain and promote health.

Functional foods in Asia tend to be regulated under the conventional food category. The following claims are permitted in Asian countries: Nutrient content claims: Which state the level of certain nutrients on the product label. Nutrient comparative claims: Which describe the nutrient content or energy value relative to other similar foods. Disease risk reduction claim established by international standard setting body the Codex Alimentarius references used by Asian food authorities for the national food legislation are generally not permitted in Asia.

However, these claims are used in northern Asian countries that have established regulations for functional food. However, a health claims regulatory environment is evolving and significant changes in the next 5 years are expected [18 20]. In order to enter the Indian nutraceutical market, some of the very important areas to focus include product evaluation, actual product analysis, procuring licenses and developing India-specific health and label claims. Hence, the due diligence in terms of carving a specific amount for each ingredient and the combination of ingredients becomes very crucial.

1st Edition

Also, manufacturers are unclear whether their products will be classified as food or food supplement or drug in the context of the Prevention of Food Adulteration Act and Rules , Food Safety and Standards Act and Drugs and Cosmetics Act and Rules The Food Safety and Standards Rules highlights the regulatory enforce- ment structure and procedures that central government proposes to make. The structure has a hierarchy from commissioner of food safety to the number of officers and designations such as food safety officer, food analyst, etc.

Developing extracts of documents and authenticating the same by concerned authority 2. Sample collection in the presence of witnesses 3. Sample dispatch to concerned authority different process for bulk package and single package 4. Food analysis 5.