TABLE OF CONTENTS
CHAPTERS NAME OF THE CONTENTS
II India’s regulation of nutraceuticals
III Regulatory components for nutraceuticals
IV Licensing and registration of nutraceuticals
V Good Manufacturing Practices
VI Method of preparation of nutraceuticals
VII Laboratory and sample analysis
IX Claims and advertisements
X Recommended Dietary Allowances (RDA) in India
XI Food safety auditing
XII Recall guidelines
XIII India’s nutraceutical marketing growth
XIV Challenges in nutraceutical market
XV Future developments
XVI Comparison of nutraceuticals in US, India, Europe
I would like to express my special thanks of heartfelt gratitude to my guide Dr. P. SHAILAJA, Department of Pharmaceutical technology, Andhra University College of Pharmaceutical Sciences, Andhra University, for her vital support, relentless motivation, encouragement, and valuable guidance throughout my course.
I am very much thankful to Prof. J. VIJAYA RATNA, Guest faculty for her valuable suggestions and encouragement during my course of study and project work.
I take this opportunity to extend my gratitude to Prof. Y. RAJENDRA PRASAD, Principal, Andhra University College of Pharmaceutical Sciences, Andhra University, for encouraging me to carry out my project work.
I express my sincere thanks to K. SATYA ASHOK, & G. SNEHALATHA, our scholars for their guidance during my project work.
I wish to express my special thanks to each of my Regulatory, & Technology classmates, for their encouragement and help during my project work.
I owe my thanks to my SENIORS and JUNIORS for providing me with everything that is needed for my work.
I would like to express my deep gratitude to my beloved parents P. GANGI REDDY and P. SUBBALAKSHMI and my brother P. SANJEEVA REDDY for their affection and support, which helped me a lot in the successful completion of my project work.
I take this opportunity to sincerely thank all the people involved either directly or indirectly in my project work. I would like to thank all the teaching and non-teaching staff who supported me during my course completion.
Thankfully, I ever remain…
DEDICATEDTO MY PARENTS, FAMILY, FRIENDS AND ALL MY GURU
LIST OF ABBREVIATIONS
ABBREVIATIONS FULL FORM
FSSAI Food Safety Standards Authority of India
DSHEA Dietary Supplements and Health Education Act
RDA Recommended Dietary Allowances
FDA Food and Drug Administration
EFSA European Food Safety Authority
FBO Food Business Operator
ICMR International Council of Medical research
IP Indian Pharmacopoeia
BP British Pharmacopoeia
USP United States Pharmacopoeia
GMP Good Manufacturing Practices
GCP Good Clinical Practices
NOC No Objection Certificate
NNFA National Nutritional Foods Association
ISO International Organization for Standardization
CLA Central Licensing Authority
SLA State Licensing Authority
HACCP Hazard Analysis Critical Control Point
NSF National Sanitation Foundation
LIST OF TABLES
NAME OF TABLE
1 Difference between nutraceuticals and pharmaceuticals
2 Regulatory Authorities of nutraceuticals
3 List of schedules
4 Examples of schedule I
5 Examples of schedule II
6 Examples of schedule IV
7 Examples of schedule VA
8 Examples of schedule VE
9 Examples of schedule VF
10 Examples of schedule VI
11 Examples of schedule VII
12 Examples of schedule VIII
13 Offences and Penalties
14 Summary of RDA for Indians
15 RDA intakes for other elements and trace elements
16 RDA intake for other vitamins
17 RDA Values for amino acids for age group > 2 years
18 Comparison table
LIST OF FIGURES
S. No NAME OF FIGURE PAGE No
1 Classification of nutraceutical
2 Label of nutritional information
AIM AND OBJECTIVE OF WORK
AIM OF WORK:
The aim of the present work is to study the nutraceutical regulations in the Indian market and comparison with the Unites states & Europe.
OBJECTIVE OF WORK:
The main objective of present work is the nutraceuticals are useful to provide a physiological benefit and help to maintain good health and not intended to treat or cure any medical condition, disease or disorder.
I. INTRODUCTION ([]-[])
History of nutraceuticals:
Traditional foods and herbal extracts have been acknowledged as an essential component of the holistic effort to attain total well-being and health throughout history, particularly in the ancient Ayurveda system of medicine in India but also in traditional Chinese, Roman, and Greek medicine. “Let food be thy medicine and medicine be thy food," as Hippocrates (460-377 BC), the well-known father of modern medicine, declared, to emphasize the correlation between suitable foods for nutrition and their therapeutic effects.The guiding principle was “Focus on prevention”. Theophrastus (370–285 BC), Cato (234–149 BC), Pliny the Elder (23–79 AD), and Galan (131–201 AD) all issued statements warning against the adulteration of food products at that time.Since 2000 BC, Schwan has used microorganisms (fungi or yeast) 1837 to produce products through the alcoholic fermentation process.Funk (1884–1967), the father of vitamin therapy, started a new investigation on vitamins and identified them as nutritional required components for the survival of good health.Dr. Stephen L. De Felice, the chairman and founder of the innovation of medicine, coined the word "nutraceuticals." in 1989 by the combination of two words “nutrition” and “pharmaceutical”. Essentially, this is a marketing tool.
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Nutraceutical: According to DeFelice, Nutraceutical can be defined as, "a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease. A product that has been separated and purified from food and is typically sold in medical form is typically connected to food. It has been proven that a nutraceutical has physiological advantages or offers a defense against chronic conditions. The food products used as nutraceuticals were categorized asdietary fiber, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants, and other different types of herbal/ natural foods.
Dietary supplements: “Dietary Supplement Health and Education Act” (DSHEA) of 1994, states that dietary supplements are products that can be taken as the dietary ingredients by individuals to maintain and improve health and not to cure diseases. Supplements are ingested and come in the form of tablets, capsules, soft gels, powders, and liquids.
Examples: vitamins, minerals, botanical compounds, amino acids, and probiotics.
Functional foods: These are foods that can do it to supply nutrients; they also help health improvement and disease control. These foods include components that boost antioxidant and anti-inflammatory effects, both of which are useful in disease prevention.
Examples: rice, wheat, kidney beans, chocolate, citrus fruits, fermented milk, etc.
Health supplements: these supplements shall contain a concentrated sources of one or more nutrients and compounds from animal origin or other comparable substances with known and documented nutritional or therapeutic physiological effects, which are marketed as such and are offered alone or in combination but aren't drugs.
Novel foods: A novel food may contain ingredients or sources from which it was derived that have not previously been consumed by humans. It may also be a food or ingredient obtained using new technology and an inventive engineering process, where the process may result in significant changes to the structure, size, or consumption of the food or its ingredients, which may change their nutritional value, metabolism, or level of suitability.
Medical food: medical foods to be consumed or administered internally under the supervision of a qualified physician. Its intended use is specific dietary management of a disease or condition for which distinctive nutritional requirements are established by the medical evaluation and based on recognized scientific principles.
Nutraceuticals are bioactive substances that are organically sourced and have beneficial health effects. The dietary supplement or/and functional food may be used to deliver the nutraceutical consumer product. Nutraceutical is a broad term used to describe any product derived from food sources that offer additional health benefits over and above the essential nutritional content included in foods.
The term "nutraceutical" refers to dietary ingredients in India that are derived from herbal or botanical raw materials and are intended to prevent or treat various acute and chronic illnesses. Major components of nutraceuticals include nutrients, herbs, and dietary supplements, making them essential for preserving health, fighting against various chronic conditions, and promoting good. The best way to deal with issues relating to nutrition and health is through the use of nutraceuticals. These terms are used to describe foods that have therapeutic or nutritional properties.
The production of new nutraceutical molecules has greatly increased due to increased technological use, which is very beneficial in encouraging the public to live a healthy lifestyle. As a result, using nutraceuticals has become popular as a way to maintain quality of life because they eliminate the need for additional nutrition and vitamin therapy. These types of nutraceuticals not only improve the lifestyle by promoting good health but also have other beneficial effects.
Nutraceuticals offers physiological benefits and support health maintenance. In controlled environments, they can be isolated, extracted, and purified from sources that are either foodor non-food-related and made from amino acids and their derivatives. Granules, tablets, powders, capsules, jellies, liquids, semisolids, and other food-like forms can be created and solidified using them. They may be packaged in measured unit quantities in ampoules, sachets, bottles, or any other format, but not in those designed for parenteral delivery. Numerous types of researches that looked into and reported on nutraceuticals, functional foods, and naturally occurring substances concluded that their products are highly active, have a significant impact on cell metabolism, and frequently have few adverse effects. Nutraceuticals are now becoming recognized as helpful in treating chronic and degenerative disorders like Parkinson's and Alzheimer's disease, as well as coronary heart disease, obesity, diabetes, cancer, and osteoporosis.
The nutraceutical industry is a competitive, developing sector that gives fresh chances to combine scientific progress with rising consumer interest in foods that promote good health. Functional foods, dietary supplements, and herbal/natural products make up the three primary segments of the nutraceutical market. Although there are many tiny nutraceutical enterprises in India, they are quite important in the fight against health-related issues. Due to the potential quality of health benefits supplied to the human body, nutraceutical products have attracted a lot of customer interest. The global demand for nutraceuticals goods in the Indian market has been rising quickly due to the rising percentage of health problems, poor lifestyles, and unhealthy food choices we make. By overcoming the barriers to marketing nutraceuticals to consumers, the Indian nutraceuticals industry is predicted to increase at a rate of 21% annually in the future.
Differences between nutraceuticals and pharmaceuticals:
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Classification of nutraceuticals:
Nutraceuticals are categorized into broad classes based on food availability, chemical nature, and mechanism of action of active components.
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Nutraceuticals based on food availability:
1. Traditional nutraceuticals - These foods are entirely natural and have not been modified. Examples: lycopene in tomatoes, omega-3 fatty acids in salmon, or saponins in soy.
A) Chemical constituents
- Nutrients - vitamins, minerals, amino acids, fatty acids
- Herbals - willow bark (Salix nigra), Parsley (Petroselinum cripsum)
- Phytochemicals - carotenoids (fruits, vegetables, egg yolk), flavonoidpolyphenolics (berries, fruits, legumes)
- Polyunsaturated fatty acids (PUFAs) - omega 3 fatty acids, sunflower oil, corn oil, soyabean oil, fish oil
B) Prebiotics- Fructo-oligosaccharides, inulin
C) Probiotic microorganisms- Bacillus bulgaricus, lactobacillus
D) Nutraceutical enzymes- catalyze cellulose, invertase, hemicellulase enzyme, and hancreolipase.
2. Non-traditional nutraceuticals - These are biotechnology-aided artificial foods that have been produced. Bioactive ingredients found in food samples are used to develop products for human wellness.
A) Fortified nutraceuticals- These are foods that have additional micronutrients or vitamins added to them to strengthen their effectiveness, such as orange juice with calcium added or milk with cholecalciferol vitamin.
B) Recombinant nutraceuticals- These are food products that are both genetically altered and developed to create recombinant substances and proteins that would make them nutritious. Examples: iron rice, golden rice, maize, golden mustard, multivitamin corn, and gold kiwifruit.
3. Commercial nutraceuticals - It is now more expensive, dangerous, and challenging than ever to find a novel molecule. Example: vita kids bread.
A) Dietary supplements- vitamins A, B, C, D, E, iron, folic acid, minerals, calcium, magnesium, and protein powder, etc.
B) Functional food- functional fats, oils, bakery, cereals, baby foods, protein bars etc.
C) Functional beverages- energy drinks, sports drinks, fortified juices, tea, coffee, and dairy beverages.
D) Medical foods- asparatus, carrots, broccoli, corn, spinach, nuts, etc.
E) Pharmaceuticals- vaccines, steroid hormones, eye drops, inhalers, etc.
Nutraceuticals based on chemical nature:
1. Isoprenoid derivatives - carotenoids, prenylated proteins, heme A, etc.
2. Phenolic derivatives - simple phenols, flavonoids, and lignans in plants and foodsof plant origin, fruits, vegetables, whole grains, tea, chocolates, cereals, seeds, legumes, oils, etc.
3. Fatty acids - vegetable oils, meat products, eggs, dairy products, fatty fish or fish oils, seaweeds, grains.
4. Carbohydrate derivatives - cereals, legumes, pulses, fruits, vegetables, fungi, algae, etc.
5. Amino acid derivatives - several natural plant proteins and animal products.
6. Microbes - milk and dairy products
7. Minerals - iron, zinc, iodine, selenium, copper, chromium, fluoride, molybdenum.
Nutraceuticals based on mechanism of action:
1. Ant- bacterial activity - products such as aloe, garlic, zinc oxide, St. John’s Wort, and zinc gluconate.
2. Anti-oxidant activity - beta-carotene, linoleic & linolenic acids, copper, vitamin C, and vitamin E, etc.
3. Anti-hypertensive activity - vitamin D3, vitamin C, vitamin B6, amino acids (taurine, arginine, carnitine), chlorogenic acids, probiotics, coenzyme Q10, resveratrol.
4. Anti-inflammatory activity - terpenoids, linalool, arachidonic acid, fatty acids, omega 3 & omega 6 PUFAs.
5. Anti hyper cholesterolemic activity - red yeast rice, bererine, dietary fibres, flavonoids, apple polyphenolic extract.
6. Anti-carcinogenic activity - kaempferol, ethonic extracts of Curcuma rhizome & Zingiber rhizome, curcumin, natural phenolic compounds.
7. Bone protective activity - vitamin D, magnesium, copper, resveratrol, green tea, melatonin, polyunsaturated fatty acids.
8. Anti-diabetic activity - isoflavones, phytoestrogens, dietary fibres from psyllium, magnesium, chromium picolinate, calcium, vitamin D, extracts of bitter melon and cinnamon, etc.
Regulatory authorities of nutraceuticals:
The regulatory authorities are proactive in protecting consumers by amending current legislation to take account of changing consumer requirements.
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II. INDIA’S REGULATION OF NUTRACEUTICALS ([], []-[])
Nutraceuticals are products that combine the properties of a nutrient and a pharmaceutical. By giving our bodies the extra nutrients they require to remain healthy when taken as dietary supplements, they can regulate the symptoms of many disease conditions. Every country has food laws that serve as the foundation for regulating all food types, including health food, dietary supplements, functional food, and nutraceuticals. Health food is specifically governed by its own set of rules and regulations.
History of FSSAI:
India is the second-largest producer of fruits and vegetables in the world, but only a small portion of its consumable agricultural products are processed—roughly 2% against 80% in the US. By the middle of the 1990s, there was a complete grid of rules governing the food processing industry, including numerous state rules and the following federal laws:
- Prevention of Food Adulteration Act (PFA) 1954
- Quality Control and Inspection Act 1963
- PFA (Ministry of Health and Family Welfare) with its last amendments in 1986
- Bureau of Indian Standards Act 1986
- Milk and Milk products order 1992
- Food Product Order 1995
- Every food manufacturing company should supply products to protect the customers, to promote and defend a regulatory environment, as well as to promote and defend consumer protection, according to a national non-profit association that was established in 2002.
- According to a recommendation by the Ministry of Health expert group in 2003, new categories should be added to the current food regulations to regulate functional foods and dietary supplements.
- Indian Food Safety Standard Bill became enacted in 2005.
- Indian Food Safety and Standard Act, which comes into force in 2006, had two basic objectives:
- To introduce a single food-related law
- To ensure the scientific development of the processed food industry.
Food Safety and Standards Authority of India (FSSAI):
The Food Safety and Standards act of 2006 unites the eight laws that control the food industry and creates the Food Safety and Standard Authority (FSSA) to regulate the market and other related committees. Everyone working in the food industry must obtain a license or registration from the local authorities. According to the Food Safety act of 2006, the Food Safety and Standards Authority of India (FSSAI) are in charge of creating and enforcing regulations for nutraceuticals. Functional foods, nutraceuticals, dietetic products, and other related categories will fall under the jurisdiction of this Authority. Article 22 of the Food Safety and Standard Act of 2006 emphasizes the necessity to regulate nutraceuticals, functional foods, and dietary supplements so that anyone can manufacture, sell, distribute, or import these products. Before manufacturing nutraceutical products, companies that have no history of safe use need to acquire some sort of approval from the Food Safety Authority. The nutritional supplements should follow all Food Safety Regulations, 2011 standards for residues, toxins, and contaminations. To operate a nutraceutical organization, the company owners must obtain a license from the producers specified by the Food Safety and Standards Regulations of 2011.The following main types of foods would be covered by the regulations, which include specific specifications about composition, claims, labeling, and other aspects. The following foods: Health supplements, Nutraceuticals, Foods for special dietary use and medical purpose, Specialty food containing plants or botanicals, Foods containing probiotics and prebiotics, and Novel foods.
Registration and licensing requirements:
A manufacturer cannot launch their company until they are turned down or have valid licensing. The safety officer has inspected the premises under the FSSAI Law's directives following the issuance of the ID number. The license granted by these regulations must be valid and in force for a minimum of fifteen years, unless so specified. Manufacturers must register with the state office commissioner, and those whose annual revenue exceeds 12 lakhs must legitimately obtain a license from the FSSAI office. The same holds for a petty food manufacturers. A license application must be submitted using form B of schedule 2. The license must be applied for to be granted, and it must be issued within 60 days after the day the application ID number was issued. The licensing authority may instruct the food safety officer to inspect the premises under these regulations after issuing the application ID number. In accordance with Schedule 2 of these regulations, the licensing authority must issue a license in format C. A registration or license issued under these regulations must be current and valid for a term of 1-5yrs unless so declared.
III. REGULATORY COMPONENTS FOR NUTRACEUTICALS ([], []-[])
The article of food sold in capsule format, whether hard, soft, or vegetarian, shall comply with the general monograph and quality requirements specified for them in the Indian Pharmacopoeia: provided, however, that the food business operator may use the approved colors and additives permitted in Schedule VF; additionally, provided, however, that the food business operator may use the natural flavors, nature-identical flavors, or synthetic flavors by following per under the provisions of Food Safety and Standards. Under the Food Safety and Standards (Labeling and Packaging) Regulations, 2011, the food business operator may disclose the addition of flavor on the labels of such products. The syrups, capsules, and tablets must meet the general quality criteria given in the Indian Pharmacopoeia, British Pharmacopoeia, or United States Pharmacopoeia.
Following the recommendations made by the Indian Council of Medical Research, the articles of food with standard nutrients or nutritionally complete formulation must contain a composition that delivers the desired level of energy, protein, vitamins, and minerals, along with other essential nutrients needed for the relevant age group, gender, and physiological stage. The Food Authority shall periodically determine and notify in the official gazette of the purity criteria for the ingredients used in the categories of food products covered. The operator of the food establishment must inform the Food Authority of any changes to the purity standards for ingredients when they are adopted. The tolerance level for deviation from the declared value of the nutrients or nutritional components on the label for articles of food during an analysis of samples of finished products shall not be greater than 10%.All substances and products covered by this clause must be manufactured by following per under a recognized good manufacturing practices. Validated scientific data must be used to support the design of food products based on the fundamentals of good nutrition or medicine where necessary.
No psychoactive substances, steroids, or hormones may be included in any food products. The objective, target consumer group, physiological or illness circumstances, recommended usage period, and special labeling criteria as described against each type of article of food must all be specified on the label of food products. The label, accompanying leaflet, or other labeling and advertisement of each type of food item must contain sufficient information about the product's nature, purpose, and specific usage instructions and safety precautions. The format of the information must also be suitable for the intended consumer. An article of food that has not been altered in any way but is suitable for use in a specific dietary regimen due to its natural composition shall not be designated as a health supplement, special diet, specific dietetic, or by any other equivalent term. However, such food may bear a statement on the label that this food is by its nature X, as long as the statement does not deceive the consumer. The Food Authority may stop selling foods that have been introduced to the market if they cannot be easily distinguished from foods intended for regular consumption, are unfit for their purported nutritious purposes, or could damage human health.
General principles for a challenge: the food business operator shall:
i. Prepare and make available the comprehensive product information, safety and claims support data and shall periodically get it reviewed and scrutinized by a scientist or expert with relevant qualifications and experience
ii. Attach the scientific view of the reviewer on claims and their veracity along with the qualification and experience of the reviewer as an essential part of the document
iii. Clarify, in case of a technical query from the Food Authority or on a public complaint lodged with the Food Authority and assist the Food Authority to examine or authorize an appropriate expert group to review the case and
iv. Alter or modify or stop a claim when directed by the Food Authority which shall be based on the opinion of an expert group.
The schedules of nutraceuticals:
Any ingredient listed in schedule I, schedule II, schedule IV, schedule VI, schedule VII, or schedule VIII must be present in the nutraceuticals. No other ingredients except those listed in schedule VI may be utilized as a nutraceutical with standardization to marker chemicals and at daily consumption levels listed there. A Food Business Operator may only use an ingredient’s extract as a nutraceutical by following per under schedule IV.A Food Business Operator may only utilize the additives listed in schedule VA, schedule VE, or schedule VF for preparing nutraceuticals. A Food Business Operator may increase the number of nutrients at a level over the recommended daily consumption while still adhering to the restrictions of vitamins and minerals listed in schedule III. Nutraceuticals may only contain nutraceuticals or extracts of compounds listed in schedule IV. Ingredients listed in schedules IV and VI that are of a botanical or plant origin.
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