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Regulatory aspects of nutraceuticals

Thursday, 10 February, 2022, 12 : 00 PM [IST]

Priyanka Kale & Professor D. R. More

Nutraceuticals are products, which other than nutrition are also used as medicine. A nutraceutical product may be defined as a substance, which has physiological benefit or provides protection against chronic disease. The term "nutraceutical" was coined from "nutrition" and "pharmaceutical" in 1989 by Stephen DeFelice, MD, founder and chairman of the Foundation for Innovation in Medicine (FIM), Cranford, NJ. DeFelice proceeded to define nutraceutical as, "a food (or part of a food), that provides medical or health benefits, including the prevention and/or treatment of a disease".

When functional food aids in the prevention and/or treatment of disease(s) and/or disorder(s) other than anaemia, it is called a nutraceutical. It should be noted that the term nutraceutical, as commonly used in marketing, has no regulatory definition.

Dietary components play beneficial roles beyond basic nutrition, leading to the development of the functional food concept and nutraceuticals. A functional food for one consumer can act as a nutraceutical for another consumer. Examples of nutraceuticals include fortified dairy products (e.g., milk) and citrus fruits (e.g., orange juice). Several naturally derived food substances have been studied in cancer therapies. Vitamin E, selenium, vitamin D, green tea, soy, and lycopene are examples of nutraceuticals widely studied in human health.

While many of these 'natural' compounds have been found to have high therapeutic potential; future studies should include well-designed clinical trials assessing combinations of these compounds to realize possible synergies they bring into human health.

Polyunsaturated fatty acids (PUFAs) (which include the omega-3 and omega-6 fatty acids) and phytochemicals also play an important role as healthy dietary bioactive compounds. A balanced PUFA composition of food influences diverse aspects of immunity and metabolism. Moreover, interactions between PUFAs and components of the gut microbiota may also influence their biological roles. Phytochemicals (bioactive non-nutrient plant compounds), have raised interest in human nutrition because of their potential effects as antioxidants, antiestrogenics, anti-inflammatory, immunomodulatory, and anticarcinogenics.

Gut microbiota can, for example, transform and influence the bioavailability and effects of polyphenols. Phytochemicals and their metabolic products may also inhibit pathogenic bacteria while stimulate the growth of beneficial bacteria, exerting prebiotic-like effects. Interactions between functional food components, such as prebiotics, probiotics, phytochemicals, and intestinal microbiota, have consequences on human health.

Nutraceuticals provide benefits in the prevention and treatment of various diseases. With increasing incidences of lifestyle-related health problems, they have emerged as an essential component of the diet for the common consumer. Vitamins, minerals, fatty acids, prebiotics and probiotics, and herbal supplements are now widely consumed globally for prophylactic and therapeutic purposes, and this has made the maintenance of safety and quality standards extremely important. The rapidly expanding global nutraceutical industry has further emphasized the need for development of such regulatory guidelines.

Although regulations in the United States, the United Kingdom, and Europe are streamlined and have become conducive to the development of nutraceutical products, the Indian industry and regulatory scenario are relatively nascent and have great potential to develop and compete with other international agencies. This is a rapidly growing industry in India and several initiatives have been taken in this direction to make India one of the key future players in the area of nutraceuticals.

Nutraceuticals may range from isolated nutrients, herbal products, dietary supplements, novel foods, and processed food ingredients. In the global marketplace, nutraceuticals have become a multibillion dollar industry. Traditional Chinese herbal medicine, with its long historical use for health promotion and treatment of diseases, is a major resource in the development of nutraceuticals. However, as the demand increased, scandals such as poor quality of raw herbs, misidentification, and adulteration severely jeopardised the industry.

Consumers preferred herbal products manufactured in countries such as Japan and Korea over those manufactured in China. Presently, China exports 65% of raw materials to support health food product manufacturing in other countries, but it is only responsible for 2% of the finished products sold internationally. To regain local and international markets, China had to institute laws to regulate the production and certification of herbal products. In this chapter, the classification of nutraceuticals, the evolution of government regulations and recent developments in nutraceuticals and health food in China are discussed.

Manufacture, storage, distribution, sale and import of nutraceuticals in India are regulated under the Food Safety and Standards Act of 2006. This Act consolidated the laws relating to food and established the Food Safety and Standards Authority of India, to set science-based standards for food items.

The norms are as follows:

The nutraceuticals shall provide a physiological benefit and help maintain good health.
A food business operator may extract, isolate and purify nutraceuticals from food or non-food sources, that is preparing amino acids and their derivatives by bacterial fermentation under controlled conditions.
A food business operator may prepare and sell the nutraceuticals in the food format of granules, powder, tablet, capsule, liquid, jelly or gel, semi-solids and other formats and may be packed in sachet, ampoule, bottle, and in any other format as measured unit quantities except those formats that are meant for parenteral administration.
The quantity of nutrients added where applicable, shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standard laid down by international food standards body, namely Codex Alimentarius Commission shall apply.
A nutraceutical which is not provided in these regulations but its safety has been established in India or in any other country, shall be manufactured or sold in India only on prior approval of the Food Authority.
The Food Authority may from time to time specify the nutraceuticals as approved by it after undertaking proper scientific evaluation.
No ingredient other than those specified in Schedule VI shall be used as nutraceutical with standardisation to marker compounds specified and at daily usage levels specified therein.
The ingredient for which the standardisation of the marker compound has not been specified shall comply with manufacturer specifications or quality requirements and purity criteria as specified in regulation.
For the ingredient for which the daily minimum and maximum usage levels have not been specified, the food business operator shall adopt the usage level based on relevant scientific data and retain the documentary evidence of such data.
No food business operator shall use the extract of ingredient as nutraceutical other than that specified in Schedule IV. Provided that the ingredient of plant or botanical origin specified in Schedule IV and Schedule VI may be used either in the given form, or their extract, subject to the extractive ratios in relation to the daily usage value.
The labelling, presentation and advertisement shall not claim that the nutraceutical has the property of preventing, treating or curing a human disease, or refer to such properties.
No food business operator shall use additives for nutraceutical formulation except those specified.
The statement by the food business operator relating to the structure or function or the general well-being of the body may be allowed by the Food Authority, if the statement is supported by the generally accepted scientific data.
Every package of food containing nutraceutical shall carry the following information on the label, namely:

(a) the word “NUTRACEUTICAL”;
(b) the common name of the nutraceutical;
(c) a declaration as to the amount of each nutraceutical ingredient in the product that either has a nutritional or physiological effect;
(d) where it is appropriate, the quantity of nutrient shall be expressed
in terms of percentage of the relevant recommended daily allowances as
specified by the Indian Council of Medical Research even when
the nutrient is present along with a nutraceutical as an adjunct and
shall bear an advisory warning ‘not to exceed the stated recommended daily usage’;
(e) an advisory warning for ‘recommended usage’ ;
(f) an advisory warning ‘NOT FOR MEDICINAL USE’ prominently written;
(g) an advisory warning in cases where a danger may exist with excess consumption;
(h) an advisory warning or any other precautions to be taken while consuming, known side effects, if any, contraindications, and product-drug interactions, as applicable;

(i) a statement that the product is required to be stored out of reach of children;

List of ingredients as nutraceuticals

Sr. No.	Nutraceutical ingredients	Permitted Range
1	Caffiene	3 mg/kg b/w per day, subject to a maximum limit of 300mg per day and not more than 200mg in a single dose (only for adults and not recommended for pregnant and lactating women).
2	Citrus Bioflavonoids	150 - 600 mg / day
3	CoQ10 from non GM source Co enzyme	100-1,000 mg / day
4	Glucosamine hydrochloride	1,500-3,000 mg/day
5	Glucosamine sulphate	2,500-5,000 mg/day
6	Gymnema sylvestre extract powder	500-1,500mg / day
7	Lactase (ßgalactosidase)	3,000 – 9,000 IU (or FCC units) / day,
8	Piper nigrum / Piper longum extract	15 mg/day of piperine (Duration of use: maximum 30 days)
9	Quercetin obtained from extracts of citrus fruits and other vegetables	100 mg / day
10	Spirulina (algae) from Spirulina platensis (Arthrospira platensis)	500 - 3,000 mg / day
11	Calcium hydroxyl methyl butyrate (CaHMB)	3 - 6 g / day (Not recommended for use by pregnant women and lactating mothers)
12	Chlorella vulgaris – dried powder	1 – 4 g/day
13	Colostrum	Bovine colostrum spray dried powder at usage level of 15g per day (containing 3g of IgG) or 3g per day (containing 0.3g IgG) without any efficacy claims.
15	Cryptoxanthin / Mesoxanthin	3 mg / day
16	Melatonin	2 – 10 mg / day
17	L-carnosine	130 - 600 mg / day
18	Camellia sinensis-Black /green tea extract, standardized powder	0.5 g - 2 g/day
19	Zeaxanthin	4 mg/day
20	Camellia sinensis-Tea catechins (epigallo catechin gallate, epicatechin, catechin gallates)	0.7 g/day
21	Lycopene	5-7mg/day
22	Isoflavone	40 to 120 mg/day
23	Allicin	12 mg alliin or up to 5 mg allicin per day.
24	Curcumin	60-100 mg /day

(Kale is research scholar, College of Food Technology, VNMKV, Parbhani; More is associate professor and head, Department of Food Business Management, College of Food Technology, VNMKV, Parbhani. They can be reached at priyankakale665@gmail.com)