Need for Harmonizing National and International Nutraceutical Regulations

Regulations for Nutraceuticals

The Codex Alimentarius Commission was created in 1963 by UN’s Food and Agricultural Organization and World Health Organization to develop international food standards and guidelines. In the changing nutraceutical scenario bodies like Codex Alimentarius, WHO, FAO and International Alliance of Dietary/ Food Supplements Associations are now working closely with international and local regulators to bring focus on nutraceuticals while developing any regulatory policy. The move is necessary as all countries follow different regulations.

Countries like the US, EU and some South Asian countries follow the Codex Alimentarius guidelines for upper safety limits of vitamins and minerals in nutraceutical compositions. Accordingly, these nutraceuticals are marketed for specific anti-oxidant or nutrient properties and not as medicines.

In India companies that are selling vitamin formulations will have to change their formulation as they are presently defined as ‘drugs’ and so cannot be called nutraceuticals.

Some companies have changed the composition of their calcium supplements according to Indian food standards.

Since there is no global agency, to overlook nutraceuticals, all the companies worldwide, work under the national standards and regulations of various countries. Most regulators follow practices in their own country. However, if nutraceutical products are imported the manufacturer is responsible for establishing purity and composition of ingredients in these imported products. 

Fair trade practices and complications for new entrants 

The rules and regulations for nutraceuticals are different from those for pharmaceuticals. Since theFSSAI has still to come up with a concrete regulatory system for the nutraceutical sector, new entrants into this industry find it confusing. At present the regulations have tried to curb the many ‘tall’ claims about the ‘natural’ ingredients and their almost magical curative effect. Also many nutraceuticals have been included in the Indian Pharmacopoeia, example ‘guggul’ for lowering cholesterol. Since a regulatory framework is yet to be formulated what new entrants need to pay attention to is Section 22 of the Food Safety and Standards Act 2006, and get food product approval from FSSAI and checklist ingredients for the following 

permissibility of the ingredient

standards and dosage quantity limits of vitamins/ minerals

product classification according to existing Indian laws

advertising and label claims as per Indian food regulations

permitted additives

Need for Regulatory Framework

FSSA defines nutraceuticals as food products but confusion between a drug & food remains existent because of the usage of them being whether for treatment of diseases or for health & diet supplements purposes.

Nutraceuticals manufactured in form of tablet, capsule or liquids with vitamins and minerals to be taken orally are considered & being sold as drugs on the basis of structure.

However, colours and additives such as binding and granulating agents used in formulating tablets are not listed under permitted additives.

Though there is permitted structure function for drugs there is none for nutraceuticals and dietary supplements.

As the industry is developing rapidly and their requirements are seen as being unique it is necessary to have regulations that are nutraceutical industry specific. FSSAI is already working towards standardisation for nutraceuticals and their announcement is being eagerly awaited by the nutraceutical industry.

Nutraceutical Food Industry Must Make Consumer Safety a Priority

Dietary Supplement

Like all other food products, nutraceuticals must establish their safety and efficacy in order to win consumer confidence. Presently there are no mandatory clinical trials required before nutraceuticals are manufactured. Also most products are based on alternative medicines, which have existed for thousands of years. This gives rise to the feeling that there is no need for testing and trial. Nutraceuticals may have had their beginning in the alternative medicine space but as they surge ahead as ‘New Age Food’ there is a need for more data on safety, based on scientific evidence.

At present, nutraceuticals are being promoted as being beneficial for health on the basis of scientific investigations about foods and their components like beta carotene, flavonoids, antioxidants, etc. However, with the rise in awareness among consumers there is a need for companies that manufacture nutraceuticals, to conduct tests and make products based on clinical trials. To ensure that nutraceuticals are safe and effective

they need to be tested for purity as well as potency of ingredients

standardised testing methods need to be in place to verify quality of ingredients and dosage consistency

better means of producing ingredients and identifying new ingredients

need for product evaluation

clarification in labelling claims 

Herbal products versus nutraceuticals

There is a growing concern that calling all herbal medicines and plant ingredients nutraceuticals would be a dangerous trend. It could give the consumer a wrong message about nutraceuticals. Some countries allow companies to make ‘unprecedented claims’ about the foods in nutraceuticals. These claims may not all be true. On the basis of these exaggerated claims, many other companies also begin to categorise herbal remedies and isolated food compounds, as nutraceuticals.

Herbal medicines that are not edible do not come under the nutraceutical category.

Also isolated compounds from wild plants that are not dietary ingredients are called nutraceuticals by some pharma and biotech companies

Since nutraceuticals are defined as food or part of food that provides health benefits and prevents disease the above two definitions can confuse the consumer. In fact some herbal preparations are being marketed as nutraceuticals even though they are not fulfilling the minimum standards that WHO has laid down for herbal drugs.

Regulations and Safety

Since nutraceuticals are food products meant for human consumption it becomes important to maintain the quality and safety standards. Government regulatory guidelines can assure both safety and standards and can also become a driver for the industry. In India product approval is required from FSSAI for the manufacture, sale, distribution or marketing of nutraceuticals under the Food Safety and Standards Act (FSSA) 2006. However, internationally nutraceuticals are manufactured on regulations of local agencies that work with international trade associations. Since there is no harmonization of regulations across all jurisdictions consumer safety becomes a major issue.

DINAMALAR NEWS

Importers say they’re hit as food products lie at ports

NEW DELHI, SEPTEMBER 30: 

Non-compliance with labelling norms is holding up an estimated ₹20,000 crore worth of food products at ports and airports. And importers claim to be losing out on revenues this festive season. The Food Safety and Standards Authority of India (FSSAI), however, argues that it is just following norms that have been made more stringent, such as those in the West, demanding better information for the benefit of consumers.

“We aren’t doing anything that’s not done anywhere else. The law isn’t being implemented unilaterally, it has been vetted by the World Trade Organisation. Exporters comply when other countries ask them to conform to labels; when we ask, it’s an issue. When exported Indian goods fall short on the smallest of clauses, they are dismissed from ports or destroyed,” K Chandramouli, Chairperson, FSSAI, toldBusinessLine.

The numbers provided by the standards body indicate that 304 non-conformance certificates (NCCs) were handed out from a total of 28,521 consignments (a 1.06 per cent rejection rate) from the start of this financial year in April and August 22. Last year, 1,105 NCCs were given out for 64,818 consignments — a 2 per cent rejection rate. The value of uncleared consignments was ₹44.04 crore (April-August 22, 2014). An official said that while a large number of the NCC consignments fell short on following labelling norms, others were rejected because of substandard quality.

Ambiguous norms

Officials at the Forum of Food Indian Importers (FFII) have a different take. They say the US and the European Union are also strict about importing food products but this is centred on quality. They allege that the FSSAI is rejecting products only on the basis of incorrect labelling, without even testing the contents.

“There are 17 labelling norms, of which 10-12 are common across the globe. Some norms, such as brown and green dots to distinguish between vegetarian and non-vegetarian products, are India-specific, and products are being rejected based on labelling inaccuracies,” said an FFII member. The ambiguity of some of these regulations, he said, was hurting everyone — “food importers, five-star hotels and food manufacturers.”

Food industry sources said some key international companies that exported products had pulled out of India as they felt it was still a small market that didn’t justify the losses.

Chandramouli refuted industry claims, stating that these grievances stemmed from a small number of players, particularly those importing chocolates, alcohol (whisky) and Canola (edible oil). The meagre number of rejections debunks the basis of such protests, he added.

“India has received 2.25 lakh consignments after the Food Safety & Standards Act (Packaging & Labelling) became operational on August 5, 2011. The rejections are around 2,000; but importers — particularly of chocolates, alcohol and Canola — are making it sound like it is a huge volume,” he said, adding that strict implementation of the Act had disrupted backdoor channels that compromised consumer safety.

He said quality checks are conducted after a product passes the labelling check. On testing samples of imported chocolates, FSSAI found vegetable oil, a banned substance here, to be present, sometimes at amounts of 37 per cent. “For whisky, we have only asked for the contents contained – alcohol, water, caramel and any colouring additives. We have asked Canola manufacturers to just mention that it is rapeseed oil with low erucic acid content on the package. Rapeseed oil is similar to mustard oil,” Chandramouli explained.

Canola sells for ₹400/litre while mustard oil is available at ₹100/litre. With regard to alcohol, no ingredient list is required for single-ingredient products.

Importers’ stand

Food importers say the FSSAI standards are hazy for several product categories that meet international standards but are rejected at Indian ports. Others point out that 20-30 per cent of small importers have shut shop and moved to other businesses after suffering huge losses. The festive season may be particularly impacted by the stalled imports, they say.

“The festive season is when demand for such food products, not available in India, reaches its peak. It’s not just finished products, but key ingredients needed by Indian food manufacturers for which imports are planned nearly six months in advance and foreign exchange already paid. These products are also lying at the ports,” said Firoz H Naqvi, Secretary, Food Ingredients Manufacturers & Suppliers of India Association said.

Committee planned

FSSAI, an autonomous body under the Health Ministry, is now in the process of setting up a committee with representatives from the industry, consumer groups and food scientists, among others, to look into product approval regulations. The panel is likely to hold its first meeting in early October.

“Times are changing and importing just about anything cannot go on. Standards will evolve in response to the rise in product inflows and new technologies. Labelling norms are the first step to achieving better standards,” said Chandramouli.

25,000 Crores Worth of Food Lying Wasted

The story of 25,000 crores worth of food lying unused across the ports of India is one waiting to be told. We got in touch with people from the food industry to understand the current scenario regarding packaging and labeling of imported food products.

Over 200 tonnes of chocolates, olives, alcoholic beverages, cured meat, cheese and other food products are catching dust in warehouses across the country as The Food Safety and Standards Authority of India (FSSAI) has banned imported goods from coming through due to incorrect labeling. Products with a short shelf life are being pulled back and others are just sticking it out. 

There's plenty of ambiguity, lack of dialogue and absence of a well-articulated framework when it comes to rules and regulations regarding the food industry. FSSAI is responsible for laying down science-based standards for manufacturing, processing, distribution, sale and import of all food products. This regulatory body is the one point contact for all food manufacturers. We also tried to get in touch with the FSSAI over a number of days but did not receive a response. 

At first glance, everything appears to be in line. What could go wrong with a regulatory body trying to ensure that food imports meet Indian safety standards? For starters, the guidelines or regulations that the FSSAI follow are not up to date. Mr. Amit Lohani, National Convenor for Forum of Indian Food Importers (FIFI) says, "The problem isn't that there are rules, but that these rules are old and irrelevant. The document that's being referred to is as old as 1954 and 1956. It's simply been rehashed to look new." 

Makers of Lindt, the popular Swiss chocolate recently decided to pull out of the Indian market after a series of bruising losses. They saw six years of roaring success in the Indian market till they were struck by the FSSAI who asked them to comply with the labeling guidelines under the 'Food Safety and Standards Act, 2011'. In August 2013, three of their containers worth Rs.750 - 1000 crore (one third of which was chocolates) were held back. The FSSAI asked them to list down ingredients in descending order of composition by weight or volume. The company complied with the request and sent a fresh batch in January 2014 which also didn't make it past the ports because of a modified regulation which stated that chocolates with vegetable oil or fat could not be imported.

The food industry is already heavily regulated - and if an importer does not meet the labeling and packaging requirements, it's choked right at the point of entry. Food importers are growing tired of the exhaustive list of rules and regulations. This has set off an avalanche of lawsuits giving a bad name to the FSSAI, especially amongst those in the food industry.
In April 2014, a Starbucks shipment with two containers of flavoured-syrup was held back at the Mumbai port as the FSSAI felt that the product did not meet their basic requirements. A Starbucks spokesperson was quoted saying that the product in question met the requirements of over 64 countries and has been in supply for almost 40 years. Starbucks appealed to the Mumbai High Court which was quick in handing down its decision. The court asked FSSAI to release the shipment and also pointed out that they acted in an 'arbitrary and capricious manner.' A Starbucks' spokesperson refused to comment, on account of the matter being currently sub judice.

Mr. Amit Lohani from FIFI adds, "The dynamics and workings of the food industry have changed drastically. There are thousands of product categories and product sub-categories, each with its own unique manufacturing method. The FSSAI regulations aren't equipped to handle these which is what makes them regressive, not progressive."

An importer of black olives who wishes to remain anonymous has been in business for over 20 years and tells us how his shipment of pasteurized olives was held back over the issue of salt content. "The minimum salt content in pasteurized olives needs to be between 1 to 1.5 % but the products were tested against treated olives which are supposed to have a salt content of almost 5 %. The FSSAI was then informed that the salt content in pasteurized olives applies to international standards and is being tested against the wrong product. The FSSAI acknowledged this fact and released the consignment in question. But this problem can be repeated in the future with other importers because the rules are still the same. India is too small a market for big importers and this kind of hogwash approach will definitely drive away the big guns."

Another interesting case is that of Canola oil. In April, large shipments of canola oil were held back for incorrect labeling. The labeling rules say that products need to use their 'scientific name' and not their 'trade name.' Canola oil happens to be the trade name and the scientific name is 'Rapeseed Oil'. Mr. Lohani said "A rule as vague as this suddenly wipes away years of marketing efforts that positioned the product as canola oil amongst consumers." 

While food importers seem to be going through a world of trouble, so are restaurant owners. Chef Manu Chandra, Executive Chef and Partner at Monkey Bar said "Cured meats, ham, cheese and other products have disappeared from the market. We're being forced to look at alternatives which might mean we'll have to compromise on the taste, flavour and quality we've been offering so far. For many, this is a deal breaker."

It is understandable that with increased awareness consumers want to know more about what's in their food. Nobody wants to stand in way of such kind of transparency. But current rules and regulations seem to be crippling the food industry instead of helping them deliver safe products.

Government urged to curb import of arecanut

The Karnataka Rajya Raitha Sangha (KRRS) has urged the Union government to initiate measures to curb the import of cheap variety of arecanut.

A delegation, comprising working president of the sangha H.R. Basavarajappa, and functionaries Kudligere Nagarajappa and K.M. Maheshwarappa submitted a memorandum to Minister of State for Civil Aviation G.M. Siddeshwar in this regard here on Monday.

In the memorandum, the sangha said that import of cheap quality arecanut had resulted in sharp decline in the price of local arecanut.

The Director-General of Foreign Trade that comes under the Ministry of Commerce, had enhanced the minimum import price for arecanut from Rs. 110 a kg to Rs. 170, recently. A section of traders engaged in arecanut import had questioned the order at Calcutta High Court, following which the court had stayed the enhancing of the minimum import price. The Union government should apprise the court on the need to enhance the minimum import price of arecanut to protect the interests of native arecanut growers, he said.

The Union Ministry of Health and Family Welfare in September 2013 had written to Food Safety and Standards Authority of India to examine the scientific evidences on the harmful impact of arecanut on the health of human beings with the objective of classifying arecanut as a substance injurious to human health. During a hearing on the case related to the ban on gutkha, the Union government had also submitted a report to Supreme Court in this regard. It was a known fact that arecanut was being consumed traditionally in India. The Union government should withdraw the report it had submitted to the court to protect the interests of arecanut growers, the KRRS has said.

Mr. Siddeshwara assured the delegation that he would look into the matter.

Delegation of Karnataka Rajya Raitha Sangha submits memorandum to Siddeshwar

‘Import of arecanut has resulted in sharp decline in the price of local variety’