The difference between a food and a drug is that a drug has a defined mechanism of action, binding to a specific receptor in the body with a characterised effect and a food is ingested for nutrition. Functional foods are foods that provide health benefits in addition to basic nutrition, and as such have biological activity with mechanisms of action which are identical to drugs. Therefore, functional foods provide both nutrition as well as benefits normally associated with the ingestion of drug compounds.
The total market size in India for nutraceuticals and functional foods is set to grow dramatically in the coming years provided we establish clear guidelines for manufacturing and control. Apart from the current low per capita spend on these products in India, other factors that could support the growth of nutraceuticals in India are increasing obesity in the population and rising instances of diabetes and cardiovascular diseases. The government is also chipping in by funding vitamin fortification initiatives due to increasing food security concerns in India and need for additional nutrition. Dietary factors play an important role in premature chronic disease appearance, disease progression, morbidity and mortality.
Use of food as medicine for treatment and prevention of various disorders is not a recent development. Fortification of table salt with iodine and wheat flour with iron/ folic acid has been used with specific aims of prevention of iodine deficiency goiter and anemia for long. Similarly, food fortified with Vitamin A has been found to be a feasible and cost-effective approach to reduce Vitamin A deficiency.
As commercial interest in the marketing of these foods and components grows, regulatory agencies face new challenges. Our current understanding of the benefits and risks related to health claims on such products is more qualitative than quantitative. The detection and quantification of target compounds play a critical role in nutraceutical quality assurance and control; such analytical testing not only measures the levels of nutritional and non-nutritive additives but also acts as a safety measure to detect any impurities or contaminants that could have been introduced during the manufacturing process.
The global nutraceutical industry is growing each year with the introduction of new products. With this growth, come many more analytical challenges. For all nutraceuticals, the compositional quality and safety must be monitored to track contamination, adulteration, product consistency, and to ensure regulatory compliance. Food safety is today a challenging field in which modern analytical chemistry must provide accurate, precise, and robust methods to determine any harmful compounds or organisms that might be present in food at very low concentrations. The evolution of MS and the application of ‘Foodomics’ technologies have a very significant impact on this field, and improve even further the limits demanded by food safety legislation. A clear example of this trend is the continuous development of multi-residue methods for the sensitive determination of contaminants in food, mainly pesticides and antimicrobials.
The detection of food allergens is a hot topic in the food safety field. Food allergens are naturally present in some foods, and might induce adverse reactions in susceptible individuals. A relatively high number of proteins have been identified as food allergens in different food products, such as dairy products, eggs, soybeans, peanuts, cereals or fish, for instance. Consequently, proteomics has become a very useful tool for the identification of allergens in food products. In this regard, MS is widely used for the sensitive detection and identification of allergen food proteins.
Adulteration and contamination continue to present critical issues for the industry - generally these products have the tendency to be contaminated with active pharmaceutical ingredients (APIs), approved prescription drug ingredients, controlled substances and untested and unstudied ingredients. Having public standards and reference material widely available to manufacturers of dietary supplements is crucial to increase and maintain quality controls in the dietary supplements industry.
Many industries manufacture and market the nutraceuticals, where the side effects (especially consumed in large quantities) of these nutraceuticals not reported or often not proven. In order to assess a product as per the Indian regulations, it is very important to examine each active ingredient and additive in the context of permissibility, standards and dosage of vitamins/minerals allowed as per the therapeutic, prophylactic or recommended daily allowance for Indians so that manufacturers are clear whether their products will be classified as food or food supplement or drug. Creating consumer awareness about these products is critical to ensure that they enjoy the benefits and not suffer the side effects.
Testing complex finished products requires high-tech instrumentation, test methods and expertise that many companies do not have in-house. “Some finished products have upwards of 20 to 50 different ingredients and label claims. This becomes even more complex as testing and verification involves trace amounts —micrograms and milligrams in dosage quantities. The challenge can sometimes lie in selecting the appropriate test methods and instruments. Training is essential for maintaining high standards of quality assurance and compliance with GMPs.
High performance liquid chromatography (HPLC) is often most suitable for the analysis of various phytochemicals. Other instruments that may be required for different analysis are Mass Spectrometry, Inductively coupled plasma (ICP) Instruments, ICP mass spectrometry (ICPMS); gas chromatography (GC) instruments are required.
The Food Safety and Standard Authority have also issued regulations about licensing and registration of food business, packing and labelling, food products standard and additive etc. These acts, rules and regulations have been implemented from August, 2011. Thus, now there is one single legislation and specified authorities to regulate manufacture, sale and distribution of nutraceuticals, functional food and dietary supplement in India. As nutraceutical regulations are evolving in India, it is a possibility that some of the content is conflicting/confusing. Yet, for the Indian industry to take shape, these have to be streamlined particularly in the areas of product evaluation, product analysis, and developing India specific health and label claims.
The biodiversity and traditional knowledge could make India a world leader in nutraceutical market. India is an ideal location for manufacturing nutraceuticals products because of availability of natural products, good quality fruits and vegetables. India has advantages like qualified human resources, world-class R&D facilities and varied raw material aspects that give our country a leading edge. Most of the leading pharmaceuticals companies have ventured into nutrition and nutraceuticals space and have a growing portfolio of such products which targets various therapeutic segments. This trend is increasingly on the rise and will continue to grow to a large extent in turn adding to the growth of the nutraceuticals industry.