With increased focus on health and nutrition and the convergence of pharma and food industry, there is growing need to tighten food safety mechanisms and regulations

In this pandemic, awareness about nutrition and health has become much stronger and penetrated deep into the minds of the Indian consumer. However, lately, there have been incidents of below-par functional food products and health supplements reaching the consumer. Videos and social media posts of which have been floating widely. Food safety, therefore, is the top concern and a priority for India’s blossoming nutrition and nutraceutical as well as the food and beverage industries. While the Food Safety and Standards Authority of India has been doing its bit in regulating the industry and ensuring quality checks,  there is still a good amount of confusion/misinformation amongst consumers about nutritional supplements, nutrition products and nutraceuticals whether or not these can be consumed without doctor prescriptions. Hence, the industry has a bigger responsibility to ensure quality and safe products to consumers. 

Here is what some industry experts say.

“Nutraceuticals are pharmaceutical alternatives, also known as ‘functional foods’ that provide benefits beyond basic nutrition that we get from the food we consume. Such products may also play a role in reducing the risk of diseases and other health conditions. With changing lifestyle and related diseases, functional ingredients such as vitamins, minerals, amino acids, fatty acids and probiotics, etc., have also become a part of this category. The global nutraceutical market is likely to reach $285.0 billion by 2021, growing at a CAGR of 7.5 per cent. With the increasing risk of diseases such as high blood pressure, obesity, diabetes, and cholesterol, nutraceutical demand is expected to grow globally, as well as in India. Therefore checking them for safety and efficacy are as important as they are for any other pharma product.” says Kamal Narayan, CEO, Integrated Health and Wellbeing (IHW) Council.

Opines Dr Wasim Ghori, Group Medical Director, Physician & Diabetologist at Heart & Diabetes Clinics  & Brand Ambassador, Education UK & British Council, “‘Natural’ does not necessarily mean ‘Safe’. The issue of food safety is important given the little information available on the toxicity and shelf-stability of some of the new naturally sourced ingredients. The FSSAI has, therefore, directed the food safety commissioners of all the States to ensure companies selling products such as health supplements and nutraceuticals comply with RDA norms. A mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not food unless vitamins and minerals are added to an article of food based on a food format. These foods are not permitted to contain hormones, steroids or psychotropic ingredients.”

On similar lines, Rahul Gupta, Business Head, Nutritional Science, Tata Chemicals, shares, “We all are aware of the number of food scandals, including adulterated beef products with horse meat, contaminated milk, bacteria in fresh foods, and melamine, antibiotic and dioxin tainted products, have caught global attention and highlighted the critical necessity to protect the consumer against food contamination issues that do pose a health risk. That is why food safety and security are paramount. Detecting unsafe food, fighting food fraud- the deliberate mislabelling of food products – and food irradiation is among the key issues that the industry is working for alongside scientists, policymakers and experts. Higher rate of technology adaption and solutions like real-time traceability and access to the quality systems will be useful to ensure food safety.”

Moreover, Gupta goes on to say, “There are also false claims about the products and many counterfeit products are available in the market. Consumers too are now alert and demand claims on labels to be clearly mentioned. By self-regulating – one can follow all of the rules and adhere to quality standards to ensure that quality products are delivered and the consumer actually benefits from it.”

Meanwhile, Abhishek Jain- CEO, Vantage by ACG Worldwide, shares insights on the global quality standards. “Global organisations such as the Codex Alimentarius Commission have the principal role in establishing certain food control standards coordinating with governments and intergovernmental organisations. Role of national governments is critical to establish uniform standards to ensure protection, safety and transparency in the food industry”, he states.

A few of the International standards:

  1. US Food and Drug Administration (FDA) is responsible for regulating dietary supplements in the US is been regulated by the USFDA. Dietary Supplement Health and Education Act from 1994 (DSHEA).
  2. European Food and Safety Authority (EFSA). The main EU legislation related to food supplements is Directive 2002/46/EC.
  3. In Canadian regulations, nutraceuticals come under the category known as “Natural Health Products,” as per “The Natural Health Product Regulations” introduced in 2004 by Health Canada. The law is governed by the Food and Drugs Authority of Canada.
  4. Regulations in Japan: The concept of Foods for Specified Health Use (FOSHU) was established in 1991. Foods identified as FOSHU must be approved by the Ministry of Health and Welfare.
  5. Brazil: Nutraceutical industries regulated by ANVISA

“Globally, there is a larger emphasis on Quality Assurance (QA) to address food safety and security issues. QA starts right at the development stage and is now becoming a critical part of the overall manufacturing process to maintain the safety and quality of products. QA programmes nowadays have an emphasis on the use of hazard analysis and critical control point (HACCP) techniques, being adopted voluntarily on a broad scale”, Jain mentions.

The problem of identifying bioactive agents

Dr Mehta of Biogetica pointing out to a major barrier to greater accountability of nutraceuticals and functional foods on the part of the industry. The scientific community from the nutraceutical segment reveal that there is difficulty in identifying bioactive agents and elucidating their contribution to protecting human health.

Dr Mehta expounds on the same, “There is no lack of science proving that nature works. There is however lack of funding in trying to prove it to the authorities as most natural molecules cannot be patented. Also, the misnomer that a synthesised molecule such as ascorbic acid performs the same way as food-derived vitamin C needs to be eradicated. Nature is in most cases very complete in design. People today believe that a 95 per cent extract of curcumin will work better than Turmeric. It doesn’t mainly because it doesn’t get absorbed. What actually works best are full-spectrum extracts that keep all aspects of the plant in their original ratio in the final pill which is 10 to 100x stronger than the herb itself. Furthermore, there is a great need to keep standardisation of each batch.”

Adding to this he goes on, “Our nutraceutical industry needs to be ethical in sourcing and following WHO GMP guidelines. Each ingredient can be synthesised, animal-derived or plant-derived. Even today one sees animal-derived amino acids in pills claiming to be vegetarian. The nutraceutical industry seems convinced that price is all that counts. We at Biogetica have shown that there is always room at the top and efficacy is what counts. Hence we never skimp on ingredient costs and vegetarian capsules. Furthermore the largest issue in India today is the use of questionable food colourings and synthetic preservatives which is supposedly natural pills. Thousands of companies are using Sodium Benzoate and Methyl Parabens in products which are known carcinogens and hormone disruptors, in a supposedly natural product. We at Biogetica do not make these rather popular juice mixes as we would never take on the karma of giving someone Sodium Benzoate mixed with Vitamin C, a known carcinogenic combination. It’s not that the formulators do not know this. It is just that they are cutting corners for the sake of profits.”  

Speaking about the need for food business to adhere to safety norms Dr Ghori goes on, “Food business operators need to ensure that the quantity of such nutrients in their products is in adherence with the RDA values specified by the FSSAI. Since this is a new and emerging area, FSSAI has begun its efforts to bring in global best practices towards harmonisation of regulations on the issue, particularly on vitamins and minerals contained in health supplements and nutraceuticals in India.”

Just as Dr Ghori points out the efforts taken by the FSSAI to bring in the necessary regulations, I would like to refer to a recent notification issued by the FSSAI that summons companies to engage in the RDA value scrutiny.

FSSAI’s effort in RNA scrutiny of products

According to its latest order, the Food safety authority has directed State food safety commissioners, while granting new licences, to ensure companies making nutraceuticals, health supplements and functional foods comply with the notified RDA norms. It has also asked them to review whether companies with existing licences are adhering to these norms. The order comes after the food safety authority received complaints that certain products with nutrient quantities exceeding the RDA values are being sold in the market.

“It has come to the notice of the FSSAI that licence for the food products as per FSS (food or health supplements, nutraceuticals, foods for special dietary use, foods for medical purpose, functional and novel foods) Regulations, 2016, are being issued by the licensing authorities without duly scrutinising the RDA value of vitamins, minerals and amino acids in the products to be manufactured by the food business operator (FBO) that is applying for the licence,” the FSSAI stated in its order.

The authority also pointed out that all central, as well as State licensing authorities, are hereby advised to strictly implement the limitation for ‘not more than one RDA’ for nutrients” as specified in the FSS Act, 2006, while granting licences to FBOs, except for foods meant for special dietary uses or for special medical uses.

In addition, it has advised central and state licensing authorities to undertake a review of RDAs mentioned by FBOs in the existing licences, issued by their office for health supplements, nutraceuticals etc., and issue notices to such manufacturers to direct them to undertake necessary modifications in compliance with the FSSA Act, 2006.

While the FSSAI has been doing its bit to ensure food safety, nutraceutical and nutritional ingredients and product companies will also need to reinvent their formulation processes to manufacture and market evidence-based products in India. Moreover, with a convergence of pharma and food industry in developing pharma foods that apparently provide similar if not the same therapeutic benefit from a portion of food as from a prescription drug, the need for food safety gets even more significant in the coming times. 

Medical photo created by freepik – www.freepik.com

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