Regulatory hurdles in nutraceuticals market as trend shifts to preventive

The nutraceuticals market is one of the most booming markets today as the trend for treatment is gradually shifting from curative to preventive. Also, an increasing number of young people are becoming aware of the problems individuals face from the changing lifestyle. This is one of the major reasons why they wish to turn towards nutraceuticals. Nutraceuticals include a number of segments such as functional foods, dietary supplements and functional beverages.

The global nutraceuticals market was estimated at US$142.1 billion in 2011 and likely to grow at a rate of 6.3% to reach $204.8 billion by 2018, according to a report by Transparency Market Research. The report states that Asia-Pacific is most likely to have the second-largest share of the market by 2017, behind only North America. This huge demand in the nutraceutical market has also caught the attention of pharmaceutical companies world over which are keen on grabbing a piece of this big pie. A number of pharma companies are partnering with different nutra companies or launching their own nutraceutical products. It is important to point out, at this juncture, that one of the major hurdles faced by companies in launching nutraceuticals is that of ‘regulatory’ affairs. Would nutraceuticals be governed by drug regulations or would they be governed by other specific regulations?  This article throws light on this critical issue.

Regulations in the past (pre-2005 era)
In the pre-2005 era, nutraceuticals were considered as foods under the ‘food & drug’ regulations, and governed by a plethora of legislations, predominant among which was the Prevention of Food Adulteration Act and Rules (PFA). Currently, regulations for food and beverages are in a transition phase from Prevention of Food Adulteration Act and Rules (PFA) to Food Safety and Standards Bill (FSSB).

Before the FSSA came into existence in 2006, nutraceuticals were regulated under PFA but the laws in 2005 were still very different.

Before 2005, food and food processing were governed by multiple laws and ministries such as

The Prevention of Food Adulteration Act, 1954; The Fruit Products Order, 1955; The Meat Food Products Order, 1973; The Vegetable Oil Products (Control) Order, 1947; The Edible Oils Packaging (Regulation) Order, 1998; The Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control) Order, 1967; The Milk and Milk Products Order, 1990; and Essential Commodities Act, 1955 pertaining to food.

The standards for food under all of these laws with regard to manufacturing, processing, packaging, and so on were different. At the time, food was classified into two kinds, either proprietary or fortified.

This governance by multiple Acts and Laws led to a great deal of confusion and a clear cut need was felt to bring all the present laws under one law; which was stressed upon by the Standing Committee of Parliament on Agriculture in its 12th Report that it submitted in April 2005. The Government of India appointed a Group of Ministers (GoM) for proposing an integrated food law. Thus, the Food Safety and Standards Bill, 2005, was introduced into Parliament and referred based on the recommendations made by the standing committee.

Current regulations
On August 23, 2006, Parliament passed the FSSB and it was signed by the president. It was believed to have a major impact on the Indian food processing industry. The Food Safety and Standards Act (FSSA) works at assimilating the food and safety laws in the country such that they develop the food processing industry in a scientific and systematic manner; bringing about a major shift from a regulatory to a self-compliance regime. The Act’s two major objectives are

•  To introduce a single statute relating to food
• To ensure scientific development of the food processing industry

The Act is designed with the intent to create a single reference point for all matters relating to food safety and standards by changing from the multi-level, multi-departmental control to a single line of command. In the FSSA, food was categorised under the following heads: novel foods, genetically- modified food, propriety food, standardised food, foods for special dietary use and functional foods/ nutraceuticals/ health supplements.

Subsequently, in 2011, the Food Safety and Standard Regulations, 2011, were enforced from August 5. These regulations were for control on the manufacture, distribution and sale of nutraceuticals, functional foods and dietary supplements in India.  The increased regulations have been designed to urge manufacturers to come up with long-term market strategies and get rid of any deceitful players or products from the market.

Challenges following the new law
Approval of a product: This is a major cause of concern for a company that wishes to enter the nutraceutical market. Before the FSSAI came into existence, the company had to procure a licence from the PFA to manufacture a product. But now, for obtaining a licence from FSSAI, product approval certificate is mandatory.

To gain this much-needed product approval, the company would have to give an application in the stated format along with a non-refundable initial payment of Rs 25,000. This is certainly something to worry about for the manufacturer/ supplier as it creates technical snags while increasing the cost incurred at the same time.

Different food licence for packed food items:  To ensure that misrepresentation of health claims does not happen, the FSSAI had sent notices to manufacturers of Bournvita, NutriChoice and Pediasure. The notices ask them to give scientific basis of their claims. The Act has thus made it mandatory to procure a different licence for such products.

Labelling and advertising norms: The claims made on the product labels and advertisements need to be scientifically proven and not simply to attract the consumers. The FSSAI approval has prohibited the companies from making any health claims that are false or deceptive in any way on proprietary/ functional/ novel foods.

Conclusion
Although the nutraceutical market is on the rise, the regulations and rules put hurdles in its path. So, it is essential that the government takes appropriate steps which facilitate the growth of the nutraceutical market. The registration process for any product is certainly a complex one. To ensure complete transparency, it should include these five elements: registration, claims, labelling, packaging and quality. This is crucial if more and more people have to opt for these nutra products along with their daily diet to fulfil all their dietary needs. India is moving slowly but swiftly on the path to create a proper and systematic regulatory method which makes it convenient not only for the consumers but also the stakeholders.

Nestle discovers horse meat in food items

Biggest Food Co Latest To Find Traces Of Horse DNA In Beef Products In Italy, France & Spain

London: The horse meat scandal in Europe is only getting worse with the world’s biggest food company now saying that tests have found traces of horse DNA in their packed products made from beef in Italy, France and Spain.
    Nestle on Tuesday said, “Our tests have found traces of horse DNA in two products made from beef. The levels found are above the 1% threshold the UK’s Food Safety Agency uses to indicate likely adulteration or gross negligence.” It added, “When reports first emerged in the UK about the fraudulent mislabeling of beef, we enhanced testing of our products and the raw materials we use across Europe. We are now suspending deliveries of all our finished products produced using beef supplied by a German firm.”
    Nestle added that there was no food safety issue “but the mislabeling of products means they fail to meet the very high standards consumers expect from us. We are also enhancing our existing comprehensive quality assurance programme by adding new tests on beef for horse DNA prior to production in Europe. We want to apologize to consumers and reassure them that the actions being taken to deal with this issue will result in higher standards and enhanced traceablity.”
    An update on test results from throughout the food industry will be published by the Food Standards Agency of UK next Friday with a further update to be published on March 1. After that, food businesses will update the FSA on their tests results every three months.
    UK’s environment secretary Owen Paterson meanwhile met representatives of food businesses including retailers, manufacturers, wholesalers and trade associations asking them to conduct tests on all their products.
    At the meeting, food businesses right through the supply chain agreed to do their level best to report back as many testing results as possible to the FSA by Friday.
    Latest revelations on the horse meat scandal shows that FSA had written a letter to the department for environment, food and rural affairs (Defra) in April 2011 warning that horse meat was being passed off as beef.
    The letter also warned Defra that packaged food was also being contaminated with horse meat, but the warnings were ignored. Paterson has now asked FSA to investigate the claims that the govenment was indeed warned .
    John Young, a former manager at the Meat Hygiene Service write a letter to former minister Sir Jim Paice on behalf of Britain’s largest horse meat exporter, High Peak Meat Exports warning that its effort to stop meat containing the anti-inflammatory drug phenylbutazone, known as bute, getting into the food chain was a “debacle”. “I have discussed it with the chief executive of the FSA and she is going to go back through the records and see exactly what was said at the time,” he said.
    The FSA meanwhile has submitted a full file and evidence on this scandal to Europol. The data submitted is now being analysed by both Europol and law enforcement agencies in 35 countries across Europe and elsewhere. Latest data shows horse meat has been consumed by millions of children and hospital patients across Europe.
Another victim: Top Brazil beef producer
    The world’s top beef producer, JBS of Brazil, was on Tuesday the latest firm to be embroiled in Europe’s horse meat scandal. JBS which used HJ Schypke as a subcontractor, said its Belgian branch would stop buying European meat. It added, “Schypke, a German manufacturer of processed meat products, is not in any way part of the JBS Group.”