Global demand, Regulatory aspect and Current research and Future prospect of Nutraceutical: A Review

 

Shaikh Habeeba

Department of Pharmacognosy, Matoshri Institute of Pharmacy, Dhanore, Maharashtra – India.

*Corresponding Author E-mail: habibashaikh762@gmail.com

 

ABSTRACT:

Nutraceuticals are the supplements that help to prevent disease and maintain the normal body function. Nutraceuticals are gaining popularity due to their nutritional and medicinal effect. The world wide nutraceutical market is valued USD 117 billion, according to estimates. Herbal nutraceuticals support in maintenance of good health and the increase the health life. Nutraceuticals have shown promising outcomes in the treatment of cancer, neurological diseases, cardiovascular diseases, and other ailments. The goal of this review is to provide a information of the different bioactive substances that can be used as nutraceuticals like (nutrients, phytochemicals, alkaloids, medicinal plants) and their role in health benefits and the regulatory aspects of nutraceuticals also covered in this article.

 

KEYWORDS: Nutraceutical, history, scope, classification, global market demand, regulatory aspects, future prospect.

 

 


INTRODUCTION:

Since ancient times, natural substances have been used to manufacturing the medicines for a variety of purposes. Dr. Stephen coined the term "Nutraceuticals" in 1989 to describe a product that combines nutrition and medicine. Dietary supplement regulation is governed by the Dietary Supplement Health and Education Act of 19941. Vitamin, mineral, herbs, amino acid other nutritional component involved in nutraceutical supplements for the human use. There are already over 470 nutraceutical and functional food product is available with proven health advantages2. The art of regulating the effects of many types of food so that they all balance each other is the key to traditional therapies success3.

 

This review summarizes some key facts about the therapeutic use of nutraceuticals as commercial and traditional medicines.

 

History:

The concept of Nutraceuticals went back as far as 3000 years ago. Hippocrates (460–377 B.C) stated ‘let food be thy medicine and medicine be thy food’. In the early 1900s the United States of America food manufacturers started adding small quantity of iodine to salt to prevent goiter. The term nutraceuticals was coined in 1989 by Stephen DeFelice who was the Chairman and Founder of the Foundation for Innovation in Medicine, Cranford, New Jersey. According to DeFelice, nutraceutical can be said to be “a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease.” However, the term nutraceutical as commonly used in marketing has no regulatory definition. In England, Japan and other countries, nutraceuticals are already becoming part of dietary landscape. Diet was first considered by Germany, France and 15the United Kingdom as a more important factor than exercise or hereditary factors in achieving good health. Canada defined them as ‘product of foods but sold in pills, powders, (potions) and other medicinal forms not normally associated with food’. In India, nutraceuticals are seen as the food components made from herbal or botanical raw materials, which are used for preventing or treating different types of chronic and acute maladies4. Nowadays, nutraceuticals are one of the most rapidly growing segments of the industry with an expected compound annual growth rate (CAGR) of 7.5% (Healthcare Packaging 2019). The global nutraceutical market is estimated to increase from $241 billion market in 2019 to $373 billion in 2025 (Healthcare Packaging 2019). The definite use of nutraceuticals has been to achieve desirable therapeutic outcomes with reduced side effects. Herbal Nutraceuticals are powerful instruments in sustaining health and act contrary to nutritionally induced acute and chronic diseases by promoting optimal health, longevity and quality of life6.

 

Scope:

Nutraceuticals are based on the principle of prevention. It's most commonly used in combination with dietary supplements and functional foods.

 

(a)  Dietary Supplements:

Dietary supplements are described as products that contain mineral, amino acid, vitamin or other herbal, constituent, a dietary component for use by the human to augment the diet by enhancing total daily consumption, or a concentrate, extract, or mixtures of these ingredients 4. Nutritional supplements are not intended to treat the disease, but nutraceuticals emphasize the desired outcomes of these product, such as disease prevention or therapy.

 

(b)  Functional Food:

As defined by the United States of America Institute of Medicine’s Food and Nutrition Board, functional food is “any food or food ingredient that may offer a health benefit beyond the traditional nutrients it contains”. The functional food concept is “Food products to be taken as part of the usual diet in order to have helpful effects that go beyond basic nutritional function”. Functional foods contain physiologically active components obtained either from plants or animal sources7.

 

Classification:

Nutraceuticals are categorized in two categories first as natural or traditional, while second one is unnatural or non-traditional nutraceuticals.

(A) It can be classed as products derived from plants, animals, minerals, or microbiological sources based on their natural sources is Traditional Nutraceuticals is the term referring to this category.

(B) Biotechnology-derived nutraceuticals is referred as non Nutraceuticals.

 

A) Traditional Nutraceuticals:

They are natural products with no changes to the food. They contain numerous natural components that convey benefits beyond basic nutrition, like omega-3 fatty acids in salmon, saponins in soy or lycopene in tomatoes. The traditional nutraceuticals can be divided on the basis of

(a) Chemical Constituents.

·      Nutrients.

·      Herbals.

·      Phytochemicals.

(b) Nutraceutical Enzymes.

·      Chemical Constituents.

(c) Probiotic Microorganisms.

 

·      Nutrients:

Nutrients comprise the amino acids, fatty acids, minerals, and vitamins implementing nutritional functions. Vitamins are found in almost all foods and can assist to cure the diseases like stroke, cataracts, osteoporosis, and heart disease. Minerals in plants, animals, and dairy products that help in the prevention anaemia, osteoporosis and the formation of healthy teeth, bones, and muscles. Omega-3 polyunsaturated fatty acids play a vital role in inflammation, brain function, and cholesterol deposition. Table.19 highlights some common nutrients and their associated health benefits.

 

Table1. List of nutrients and their health advantages

Nutrients

Health Advantages

Vitamin A

Antioxidant that is necessary to cure the several skin conditions.

Vitamin K

It's necessary for blood clotting.

Vitamin E

Antioxidants help to build blood cells, muscles, lung tissue, and nerve tissue, as well as strengthen the immune system.

Vitamin C

Antioxidant for bone health, teeth, gum, and skin, as well as wound healing and preventing and reducing cold symptoms.

Vitamin B1

Help in the conversion of food into energy, which is necessary for brain processes.

Vitamin B2

Help in the production of energy or other biochemical process in the body or support the healthy eyes, skin, and nerve function.

Vitamin B3

Promotes the conversion of food into energy support the optimal brain function.

 

Vitamin B6

Provide genetic material for cells, red blood cell production, maintaining the central nervous system, amino acid synthesis, and lipid, protein, and gluconeogenesis.

Folic acid

 

Produces cell genetic materials in pregnancy to protect birth abnormalities, RBC creation, and heart disease protection.

Calcium

Teeth and bones, and also preserving bone strength, are essential for nerve, muscular, and glandular function.

Copper

Necessary for haemoglobin and collagen formation, cardiovascular health, energy production, and iron absorption from the gastrointestinal tract.

Iron

Production of energy, or the delivery the oxygen to tissues.

Phosphorous

Bones and teeth are important for the generation of genetic material, as well as energy generation and storage.

Chromium

Insulin aids in the conversion of carbohydrates and lipids into energy.

Cobalt

Cobalt is an important element of vitamin B12, however it is metabolised in the body to generate the B12 coenzymes.

Iodine

Thyroid function cannot be accomplished without it.

 

·      Herbals:

Herbal nutraceuticals help to improve health and avert chronic diseases. Most of these are analgesic, antinflammatory, astringent, antipyretic and antiarthritic. Flavonoids such as apiol and psoralen, which are astringent, demulcent, and anti-pyretic, are included in some herbals. Menthol, an active component in peppermint (Mentha piperita), help in the treatment of fever and cold10. Tannin, found in certain herbals, is believed to aid in the management of anxiety, colds, stress, cough, hypertension, and asthma, while proanthocyanadin, found in some herbals, is claimed to help in the cancer therapy, ulcers, and urinary tract infections8. Some coomon herbs and their relevance as shown in table.212

 

Table 2. Herbal plant and their effective pharmacological effect

Herbals (Botanical source)

pharmacological effect

Aloe vera gel

(Aloe vera L.N)

Anti-inflammatory, emollient

Chamomile

(Matricaria recutita L)

Spasmolytic, wound healing

Garlic

(Allium sativm)

Antibacterial, antifungal, anti-inflammatory

Ginseng

(Panex ginseng)

Adaptogen

Ginger

Zingiber officinalis

(Zingiberaceae)

Hypoglycemis, chronic bronchitis

Turmeric

Curcuma longa

(Zingibberacae)

Anticancer, anti-inflammatory, antiseptic

Onion

Allium cepa Linn

(Liliaceae)

Hypoglycemia, antiatherosclerosis, antibiotic

Ginkgo

Ginkgo biloba

(Gikgoacea)

Antioxidant,

Cassia angustifolia

(leguminosae)

Purgative

Mulethi

Glycyyhiza glabra

(leguminosae)

Antiviral, anti-inflammatory, anti-allergic

 

b) Phytochemicals:

Plant nutrients having specific biological actions that benefit in human health are known as phytochemicals. Phytonutrients is another name for them. They serve as biochemical reaction substrates, cofactors or inhibitor of biochemical reactions, absorbents that bind to and eliminate unwanted substances in the intestine, and enhance the absorption and stability of vital nutrients among other11.

 

·      Nutraceutical Enzymes:

These enzymes originate from a different sources, including plants, animals, and microbes. Enzymes are vital components of life; without them, our bodies would not function properly. Enzyme supplements in the diet can help with medical ailments such as blood sugar imbalances, digestive issues, and obesity.

 

c) Probiotic Microorganisms:

Probiotics is a term that means "for life." They are considered are probiotic bacteria that confer a therapeutic effect when taken in tolerable quantities13. These microorganisms are sensitive bacteria that help in digestion and nutrition absorption. They primarily function to push out pathogens such as yeasts, other bacteria, and viruses that may cause disease and create a mutually beneficial symbiotic relationship with the human digestive tract14. They have antibacterial effects by changing the microflora, preventing pathogen adherence to the gut wall competing for nutrients required for pathogen survival, producing an antitoxin and reversing some of the effects of infection on the intestinal epithelium, such as secretory changes and neutrophil migration. Probiotics for instance, can help people with lactose intolerance by increasing the production of a specific enzyme (ß-galactosidase), which can hydrolyze the offending lactose into its constituent sugars15. Table3 shows the some bacteria and their action 16.

 

Table 3 list of bacteria and their effect

Name of bacteria

Action

L. rhamnosus

·       Reduces the respiratory damages caused by viruses

·       Atopic dermatitis in children: prevention and severity reduced

·       Lowering the chance of getting allergic disease

·       Potential anti-diabetic properties

·       Necrotizing enterocolitis prevention in infants

·       In the treatment of Acute gastroenteritis in children

·       Lowering the risk of rhinovirus infections in premature babies

 

L. acidophilus

·       It's used to treat diarrhea

·       It's used to treat bacterial vaginitis.

·       Boost immune function by suppressing infections and creating lactocidin and acidophilin.

L. plantarum

 

·       Irritable bowel syndrome symptoms like abdominal pain, bloating, flatulence, and constipation are reduced.

·       Nitric oxide levels are increased by eliminating nitrate.

·       Reduces risk of bleeding

·       Immune responses are improved.

·       Antifungal action, prevention of endotoxin generation

 

B) Non-Traditional Nutraceuticals:

These are biotechnologically generate the artificial foods. Food samples bioactive components are modified to create products that promote human health. Fortified nutraceuticals and recombinant nutraceuticals are two types of nutraceuticals.

 

·      Fortified Nutraceuticals:

Cereals fortified with vitamins and nutrients, milk fortified with cholecalciferol, flour fortified with vitamin B12, prebiotic and probiotic fortified milk with Bifidobacteriumlactis HN019 used to cure diarrhoea, respiratory problems, and severe diseases in children, and orange/ juice/drink fortified with calcium are just a few examples17.

 

·      Recombinant Nutraceuticals:

Probiotics and bioactive substance extraction using enzyme/fermentation methods and also used genetic modification method are the examples of recombinant nutraceuticals. Bread, wine, fermented starch, yoghurt, cheese, vinegar, and other energy-giving foods are also manufactured by using modern biotechnology. Cows with lactoferrin deficiency for example, lactoferrin deficiencies cured by recombinant human lactoferrin (rhLf)18.

 

Global demand of nutracetical:

The nutraceutical sector is divided into three main segments: functional foods, nutritional supplements, and natural products19. The globally nutraceutical market is estimated to be worth USD 118 billion (INR 5148 billion)20. Nutraceutical sales are estimated to reach $74.7 billion in 2007, with a 9.9% annual growth rate. This suggests that the global economy will rebound in 2003, and price competition would reduce21. According to a recent estimate, India's entire nutraceutical market is increasing at a rate of 21% per year. It is presently valued at INR 44 billion (€621 million) but in four years it might be worth more than INR 95 billion22. In India, the term of "Nutraceuticals" is still in its infancy. However, it has grown at a far higher rate than global rates, with a CAGR of 18% over the past three years, primarily to the functional food and beverage categories 23. The fastest expanding areas of the market were dietary supplements (18.6 percent each year) and natural products (11.6 percent per year).

 

Regulatory Aspects of Nutraceuticals:

In India, the regulatory system for nutraceuticals requires attention from the appropriate authorities. Regulatory authorities around the world are aware of changing consumer needs and are proactive in protecting consumers by modifying current legislation to accommodate the changes, but in India, old laws namely the food Adulteration prevention Act, 1954, which regulates packaged foods, remain in place for manufacturers. They must also adhere to a host of other complicated laws, such as:

·      1976 Standards of Weights and Measures Act, as well as the 1976 Standards of Weights and Measures Regulations

·      1977 (Packaged Commodities) Rules (SWMA)

·       The Infant Milk Substitutes, Feeding bottles and infant foods (regulation of production, Supply and Distribution) Act, 1992 with Rules, 1993 (IMS)

·      Packaging for Edible Oils (Regulations) Order,1998

·      Fruits and Fruit Products Order 19 55 (FPO)

·      1973 Meat Product Order

·      Edible Oils Packaging (Regulations) Order,1998

·      Milk and Milk Products Order 1992

·      Vegetable Oils Products (Regulation) Order 1998 (VOP)

·      Atomic Energy Act, 1962 and Atomic Energy (Control or irradiation of Food) Rules 1996

·      Consumer Protection Act 1986 and the Consumer Protection (Amendment) Act, 2002 and Rules 1987

·      Environment Protection Act, 1986 and Rules 1986

·      Agricultural Produce (Grading and Marking) Act, 1937 (as amended up to 1986) and 49

·      General Grading and Marking Rules 1986 and 1988 (AG Mark)

·      Bureau of Indian Standards (BIS) Act 1986

 

Furthermore, the classification of functional foods and nutraceuticals is unclear. Regulators are perplexed as a consequence of this. Drug authorities are sometimes inclined to classify these goods as pharmaceuticals. Genuine manufacturers have been harmed as a result of this. The Food Safety and Standards Act, which will replace the previous PFA, is a major turning point. India will be on a new regulatory route as a result of the new law, which will allow it to compete worldwide of nutraceutical24.

 

This legislation was the outcome of a nearly two-decade reform effort. It achieves a balance in FDA regulations between approving therapeutic items for patient benefit and protecting public health by ensuring that they are safe and effective25. The Japanese Ministry of Health and Welfare introduced a policy called "Foods for Specified Health Uses" (FOSHU) in 1993, which allows some functional foods to make health claims. Foods with health claims (FHC), a 'foods with nutrition function claims (FNFC) system, and a newly formed FOSHU were all adopted in 2001. In 2005, the government updated the FOSHU, FNFC, and other systems which are already in place. Among these developments are FOSHU's new Subsystems, including as

·      Standardized FOSHU

·      Qualified FOSHU

·      Disease risk reduction claims for FOSHU26

 

Current research on nutraceutical:

Traditional herbal extracts are the subject of a lot of contemporary research. Investigators are looking at claims that these extracts can help with health and chronic disease prevention. This is a part of an effort to legalise homoeopathic treatments and Eastern medicine, at least in part. It also aims to deliver much-needed safety and efficacy information to patients and physicians. The demand for bioactive compounds in nutraceuticals and functional meals is skyrocketing, owing to a slew of health concerns:

·      Cardiovascular problems

·      Cancers of the breast, skin, colon, and brain

·      Female health issues

·      Neurological disorders

·      Metabolism maintenance

·      Digestive problems

·      Immuno modulation

 

The lack of major research published with clear clinical data is a key difficulty with the use of nutraceuticals in the treatment of diseases. Nutraceutical development, production, packaging, marketing, and sales have gone a long way and are constantly evolving. Nutraceuticals are the favored choice of today's customer when it comes to daily use. The most recent scientific studies and clinical trials continue to support and push this industry forward 27.

 

Future prospects of nutraceuticals:

The world is becoming more complex and fascinating. To address the growing need for healthy nourishment, foods are becoming more palatable, appealing, and fortified. With the creation and recent advances in Living Modified Organisms (LMOs) and Genetically Modified Foods (GMFs), food for all agendas will be accomplished in the future, or malnutrition will be a thing of the past, but new obstacles may arise. The possibilities of nutraceuticals are endless, with pills bursting into the body as nutrients to feed the body with a complete Recommended Dietary Allowance (RDA), including fibre to ensure intestinal or bowel emptying. The potential of nutraceuticals can help food and nutrition societies achieve their goal of a world free of destitution in the future. The rising attentiveness of consumers to how nutraceuticals might contribute to excellent health is at the heart of the value-added market performance. With the expanding consumer demand for nutraceuticals, consumers will not only utilise supplement products to enhance overall dietary consumption in coming days, but they will also view supplementation as an effective strategy to improve health28,8.

 

Table 4 list of some marketed nutraceuticals

Product

Group

Content

Company

Calciferol D-3®

Calcium supplement

Calcium and vitamin

Cadillla health limited India

Coral calcium

Calcium supplement

Calcium and trace mineral

Natures answers Happauge, NY, USA

Wellife®

Amino acid supplement

Granulated –L-glutamine

Daesang America Inc, Hackensach, NJ USA

Proteinex©

Protein supplement

Predigested protein, vitamine

Pfizerltd., Mumbai India

Daytime restores and day time repose

Restful sleep

Ginseng, ginkgo biloba

Xigo

Cognisure

Amino acid supplement

Proline rich polypeptide complex

Metagenic Inc

 

REFERENCE:

1.     Stauffer JE. Nutraceuticals. Cereals Food World. 1999; 44(2): 115-116.

2.     Brower V. Nutraceuticals: poised for a healthy slice of the healthcare market. Nat Biotechnol. 1999; 16: 728-731.

3.     Kessler RC, Davis RB, Foster DF, et al. Long Term Trends in the Use of Complementary and Alternative Medical Therapies in the United States. Ann Intern Med. 2001; 135(4): 344-351.

4.     Bieselskl HK (2001) Chapter 3: Nutraceuticals: the link between nutriton and medicine. In: Nutraceuticals in Health and Disease Prevention, 2nd edn. Marcel Deckker, NewYork, pp 1–26

5.     Zeisel SH (1999) Regulation of “Nutraceuticals”. Science 285:185–186

6.     Thakur N, Gupta BP, Nagariya AK, Jain NP, Banweer J, Jain S (2010) Nutraceutical: New Era’s safe pharmaceuticals. J Pharm Res 3:1243–1247

7.     Ernst E (2001) Functional foods, nutraceuticals, designer foods: innocent fad or counterproductive marketing ploy. Eur J Clin Pharmacol 57:353–355

8.     Chauhan B, Kumar G, Kalam N, Ansari SH (2013) Current concepts and prospects of herbal nutra-ceutical: a review. J Adv Pharm Technol Res 4(1):4–8

9.     Allen LV. Nutritional Products, In: Covington TR, Berardi RR, Young LL, et al. Editors. Handbook of Nonprescription Drugs. Washington DC: American Pharmaceutical Association; 1997.

10.   Ehrlich SD (2009) Peppermint (Mentha piperita): private practice specializing in complementary and alternative medicine. Phoenix, AZ.Review, VeriMed Healthcare Network.

11.   Zhao J (2007) Nutraceuticals, nutritional therapy, phytonutrients, and phytotherapy for improve-ment of human health: a perspective on plant biotechnology application. Bentham Science Publishers.

12.   Tyler VE, Foster F. Herbs and phytochemicals, In: Covington TR, Berardi RR, Young LL et al. editors. Handbook of NonprescriptionDrugs. Washington DC: American Pharmaceutical Association; 1996

13.   Michail S, Sylvester F, Fuchs G, Issenma R (2006) Clinical efcacy of probiotics: Review of the evidence with focus on children, clinical practice guideline. J Pediatr Gastroenterol Nutr 43(4)

14.   Holzapfel WH, Haberer P, Geisen R, Bjorkroth J, Schillinger U (2001) Taxonomy and important features of probiotic microorganisms in food and nutrition. Am J Clin Nutr 73:365S–373S

15.   Oak SJ, Jha R (2019) The effects of probiotics in lactose intolerance: A systematic review. Crit Rev Food Sci Nutr 59(11):1675–1683

16.   O. B. Maia, R. Duarte, A. M. Silva, D. C. Cara, J. R. Nicoli, Evaluation of the components of a commercial probiotic in gnotobiotic mice experimentally challenged with Salmonella enterica subsp. enterica ser. Typhimurium, Vet. Microbiol, 2001; 79(2): 183–189.

17.   Sazawal S, Dhingra U, Hiremath G, Sarkar A, Dhingra P, Dutta A, Verma P, Menon VP, Black RE (2010) Prebiotic and probiotic fortied milk in prevention of morbidities among children: community-based, randomized, double-blind, controlled trial. PLoS One 5:e12164

18.   Hyvonen P, Suojala L, Orro T, Haaranen J, Simola O, Rontved C, Pyorala SP (2006) Transgenic cows that produce recombinant human lactoferrin in milk are not protected from experimental Escherichia coli Intramammary Infection. Infect Immun 74:6206–6212

19.   Das L, Bhaumik E, Raychaudhuri U, Chakraborty R. Role of nutraceuticals in human health. J Food Sci Technol 2011.

20.    Rishi RK, Nutraceutical: Borderline between food and drug. Pharma Review 2006. Available from: http://www.kppub.com/articles/herbal-safety-pharmareview-004/nutraceuticalsborderline-between-food-anddrugs.html. [Last accessed on [Last accessed on 2012 Mar 24].].

21.   Nutrition business journal estimates (NBJ data).

22.   Joanne B, Linda AA, Phillipson DJ. Herbal medicines. 3rd ed. RPS Publishing; p. 48, 263.

23.   FICCI study on Implementation of Food Safety and Standard Act 2006: An Industry Perspective. Available from: http://www.Indiaenvironmentportal.org.in/Files/food_safety_study.pdf. [Last accessed on 2009 Mar 1]

24.   Shashank B. Capacity building in the Indian food industry: Opportunities and Challenges, Proc. Ind. symp, CFTRI Mysore (India), June23-25, 2006.

25.   Scarlett T. How modernized is FDA now? FDLI Update. 3:1, 1998.

26.   Ohama H, Ikeda H and Moriyama H. Health foods and Foods with health claims in Japan. Toxicology. 2006;221:95-111

27.   http://www.technology-catalysts.com/pdf/nut4bro.pdf (accessed on 12 Dec 2011)

28.   Onyeka Nwosu, 2020. Nutraceuticals: History, Classification and Market Demand: In book: Functional Foods and Nutraceuticals (pp.13-22.

 

 

 

Received on 31.05.2022        Modified on 20.06.2022

Accepted on 05.07.2022   ©AandV Publications All Right Reserved

Res.  J. Pharma. Dosage Forms and Tech.2022; 14(3):249-254.

DOI: 10.52711/0975-4377.2022.00041