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
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
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.
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