Functional Food/Nutraceuticals Regulation In India

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Abstract

Functional Foods/Nutraceuticals in the recent years have witnessed a tremendous increase in the interest among the consumers due to their potential of providing health benefits. India is second largest producer of the food (next only to china), with plethora of nutritive and therapeutic compounds whose value is yet to be realized in modern market places. Although, there were multiple laws and regulations covering the foods in India, but there was no single law that could have significantly regulate the functional foods.  In 2006, the Indian government passed Food Safety and Standard Act to integrate and streamline the many regulations covering nutraceuticals, foods and dietary supplements. The act calls for the creation of the Food Safety and Standards Authority (FSSA). Once established, the FSSA will be charged with drafting rules and regulations for companies in the food sector to be licensed by local authorities, and a system of checks and balances, including product-recall procedures enforcements and penalties.

Keywords: Functional Foods, Nutraceuticals, Health Supplements, Food Safety and Standard Act 2006.

Introduction

Functional Food is the generic term related for food that has been linked to health benefits. The Institute of Medicine ’s Food and Nutrition Board (U.S.) has defined functional food as “any food and food ingredients that may provide health benefit beyond the traditional nutrition that it contains”. Functional food can be either from plant sources or animal sources. The term nutraceutical was coined in the USA and is used to describe foods or food components which have the potential to cure specific disease conditions.1- 4

Historically, in India multiple laws and regulation prescribed varied standards regarding food, food additives, contaminants, food colors, preservatives and labeling. India has recently passed food safety and standard act 2006 –a modern integrated food law to serve as a single reference point in relation to regulation of food products including nutraceutical, dietary supplements and functional food. The food safety and standard act has needed to still make considerably substantive with infrastructure and appropriate stewardship for it to match with international standards of U.S. and Europe.5 A significant augmentation is necessary for act to have magnitude of impact on India functional food and nutraceutical industry like the dietary supplements health education act (DSHEA) 1994 has had on dietary supplement industry in U.S.

The passing of this Indian act is a significant first step; a lot more has to happen to eliminate the confusing overlap with old laws and regulations. Yet, in India functional foods/nutraceuticals are not categorized separately as in U.S, Europe, and Japan. And also, the concept of functional food is somewhat different connotations in different countries. In Japan, for example functional foods are defined based on their use of natural ingredients. In the United States however; functional food concept can include ingredients that are product of biotechnology.6 And in India these functional foods can include herbal extracts, spices, fruits, and nutritionally improved foods or food products with added functional ingredients.The present article deals with the history and present regulatory status of functional foods/nutraceuticals in India.

History Of Food Regulation In India

India is the world’s second largest producers of fruits and vegetables but only a small amount of perishable agriculture products are processed approximately 2% in comparison of 80% in US.5 Barriers to growth on food sector include poor infrastructure and logistic and tight food regulation. The multiplicity of food regulation policy makers and enforcement agencies prevailing in different sectors of food industry contributed to considerable confusion among the consumers, producers, and retailers and business and such a detrimental to growth of functional food and nutraceutical industry.  7-8  By the mid 1990s the food processing sectors laws framed in a veritable grid of regulation including a multitude of states law as well as following national laws:-

  • Export (Quality Control and Inspection) Act 1963
  • Solvent Extracted Oil Control (SEO) Order 1967
  • The Insecticide Act1968
  • Meat Food Products Order MFPO1973
  • Prevention of Food Adulteration Act (PFA) 1954 rules (ministry of health and family welfare & family welfare) with last amendments in 1986
  • Bureau of Indian Standards Act 1986
  • Environmental Protection Act 1986
  • Pollution Control Act 1986
  • Milk and Milk Products Order 1992
  • The Infant Milk substitutes feeding bottles & infants food (regulation of production, supply) Act 1992 & Rules 1993
  • Food Product Order FPO 1995  
  • Agriculture Produce Act
  • Essential Commodities Act 1995(Ministry of Food& Consumers Affairs)
  • Industrial license
  • Vegetable Oil Product Control (VOP) order 1998

In 1998 Prime Minister’s council on trade and industry appointed a subjective group on food and agriculture industries which recommends a unified legislation under a single food regulatory authority. Public experts, member of standing committee of parliament encouraged the convergence of current food laws with single regulatory authorities accountable for public health and food safety in India. Further, integrating all Acts and Orders relating to food and eliminating multilevel & multidepartmental controls over food. Special emphasis was given on nutraceutical and functional food- a poorly defined segment with growing potential and implications on heath of consumers.

In 2002, a National non profit Association had been constituted with main objectives that every food manufacturing company should provide scientific based support to their products in order to protect the consumers and to promote & defend a regulatory environment conducive to industry in general as well as consumers’ protection.

In 2003, a Ministry of Health expert group report indicated to need under food laws, to create new categories for regulating functional food and dietary supplements. It is recommended that there should be mandatory safety testing for these products. In India voluntary standards are developed by Bureau of Indian Standards and National standards body, which comprise representatives from various food sectors stakeholder groups. These standards basically deal with product certification, quality, system certification and testing and consumers affairs. Efforts are made to match Indian standards with international ones.9

In 2005, a number of committee, including the standing committees of parliament on agriculture submitted its 12th report in which the need for a single regulatory body and integrated law has emphasized.

And finally Indian food safety standard bill 2005 signed into law, promising a major impact on Indian food processing industry. The Indian Food Safety and Standard Act came into enforcement in 2006 with the two main objectives:

  • To introduce a single statute relating to food, and
  • To provide for scientific development of the food processing industry.

Food Safety And Standard Act 2006

The Food Safety and Standard Act 2006 aims to establish a single reference point for all matters relating to Food Safety and Standards, by moving from multi-level, multi-departmental control to a single line of command. It incorporates the salient provisions of the Prevention of Food Adulteration Act 1954 and is based on international legislations, Instrumentalities and Codex Alimentarius Commission. 7 The salient features of this Act are as follows:

  • The Food Safety and Standards Act, 2006 consolidates the eight laws governing the food sector and establishes the Food Safety and Standards Authority (FSSA) to regulate the sector and other allied committees. FSSA will be aided by several scientific panels and a Central Advisory Committee to lay down standards for food safety. These standards will include specifications for ingredients, contaminants, pesticide residue, Biological hazards, labels and others.
  • Everyone in the food sector is required to get a license or a registration that would be issued by local authorities.
  • The law will be enforced through State Commissioners of Food Safety and local level officials.
  • The Act provides for a graded penalty structure where the punishment depends on the severity of the violation.
  • The responsibility of framing and regulating standards for nutraceuticals is to rest with the Food Safety and Standards Authority of India (FSAI) as outlined in the Food Safety Act, 2006. The authority will be in charge of categories like functional foods, nutraceuticals, dietetic products and other similar products.7- 9
  • Food Safety and Standard Act 2006 consists of 12 chapters, IV chapter article 22 of the Act addresses nutrceutical, functional food, dietary supplements and need to regulate these products such that anyone can manufacture, sell or distributes or import these products. These products include novel foods, genetically modified article of food, irradiated food, organic food, and food for special dietary uses, functional food, nutraceuticals and health supplements. Whereas article 23 & 24 addresses the packaging and labeling of food and restriction of advertisement regarding foods.7 According to this Act Foods for special dietary uses, functional food or nutraceutical or dietary supplements are:-

(a) foods which are specially   processed or formulated in order to satisfy particular dietary requirements which exist because of particular physiological  or physical condition and which are processed as such  wherein the composition of these foodstuffs  must differ significantly from the ordinary food of comparable nature, if such ordinary food exists one or more of the following ingredients namely:

(i) Plants or botanicals in the form of powder, concentrates or extracts in water, ethyl alcohol, single or in combinations

(ii) Minerals, vitamins or proteins (amounts not exceeding recommended daily allowance for Indians) or enzymes

(iii)  Substances from animal origin

(iv) A dietary substance being used by human beings to supplements the diet by increasing the total dietary intake.

(b)(i) a product that is labeled as “food for special dietary uses” functional food or nutrceuticals dietary supplements which is not represented  for use as conventional food  and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;

(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 and rules made there under

(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;

(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 and rules made thereunder and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;

(2)"genetically engineered or modified food" means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modern biotechnology;

(3)"organic food" means food products that have been produced in accordance with specified organic production standards;

(4)"proprietary and novel food" means an article of food for which standards have not been specified but is not unsafe:

 Provided that such food does not contain any of the foods and ingredients prohibited under this Act and the regulations made thereunder.

Benefits Of Implementation Of Act

  • Unification of eight laws i.e. steps to Harmonization.
  • Alignment of international regulations.
  • Science based Standards.
  • Clarity and uniformity on novel food areas.
  • Help curb corruptions.

Problems Of Implementation Of Act

·Regulation broadly defines the intervention of Government in industry.

·Regulation primarily controls the product quality in case of food.

Every system of regulation has its own pros and cons. But the benefits from the implementation of Food Safety and Standards Act overwhelmed the problems that rise due to implementation of this Act. Unlike the US, where the DSHEA is in place to regulate these products, in India the Government is in the process of drafting a law to regulate manufacturing, importing and marketing of health foods, dietary supplements and other nutraceuticals.(8,9)

Emerging Opportunities

The United States Pharmacopoeia Convention (USP) decided to have a separate advisory panel on nutraceuticals and will be joining hands with Indian scientific community for developing safety standards for the entire range of dietary supplements and nutraceuticals that are currently not under the strict regulatory classification of either drugs or foods.10 Domestic and multinational companies are vying for position in the US$500m Indian nutraceuticals  market, which is growing at 40% annually.11 Central Food Technological Research Institute (CFTRI), Mysore, is to be the major agency to associate with USP in this regard. The US and Europe are going to be emerging markets for nutraceutical exports from India because an existing large market base is already in place and consumers are looking for better and healthier options to prevent lifestyle-related diseases.11, 12 The market potential for the US and European markets alone for nutraceutical exports from India by 2013 will be to the tune of $75 billion. Companies like Amway India and Herbalife are utilizing direct multi-level marketing, to reach new consumers with about their products delivered by someone known and trusted. However, most of the large companies have not ventured into nutraceuticals or dietary supplements due to regulatory confusion, lack of adequate awareness and understanding, and poor vision of the market.11

Claim Regulation

There is currently no official harmonized definition or harmonization of the technical requirements and guidelines for functional food products in Asia. Academics and food companies generally understand functional foods to contain or to be fortified with nutrients or other bioactive compounds that help to maintain and promote health. Functional foods in Asia tend to be regulated under the conventional food category. Claims permitted in Asian country are:-

• Nutrient content claims – which state the level of certain nutrients on the product label.
• Nutrient comparative claims – which describe the nutrient content or energy value relative to other similar foods.

Disease risk reduction claim established by international standard setting body the codex alimentarius (references used by Asian food authority for the national food legislation) are generally not permitted in Asia. However these claims are used in northern Asian countries that have established regulation for functional food. However, health claims regulatory environment is evolving and significant changes in next five years are expected.13, 14, 15

Recommendation And Conclusion

  • Although, Food Safety and Standard Act 2006 define functional food/nutraceuticals legally, still there are further effective regulations; guideline and suitable protocols are required to gain momentum for effective implementation across the nation. Still there is need to clarify and formulate the regulatory framework. If substantiation enforced effectively the Food Safety and Standard Act has potential to open up tremendous opportunity for functional food or nutraceutical industry.
  • To grab a larger pie from this world opportunity, Indian producers of nutraceutical products should unite to form a platform, to market India as a brand. There is a need for an increased collaboration on the manufacturing and research and development front among Indian manufacturers. There has to be coordination among all agencies, including policymakers, regulators and manufacturers. The manufacturing, validation, R&D and intellectual property protection needs to be standardized.
  • There should be expansion of Indian standards like Indian Pharmacopoeia so that manufacturer of functional food/nutraceuticals complies with their safety and quality standards.
  • Indian Government has still to amend its laws regarding nutrition labeling as Nutrition Labeling Education Act 1990 of U.S so that consumers become aware of safe and healthy facts regarding functional foods/nutraceuticals. Joints efforts by the Govt. & private agencies in term of suitable legislation and help from food scientist, there is tremendous potential for processed functional food in India in future.
  • There should be new retailing programmes, increased validation and clinical research, heightened awareness due to media and government focus, and greater corporate responsibility due to health awareness programmes as well as new marketing and communication methods, innovation R&D and product development skills.

In conclusion the passing of Food Safety and Standard Act 2006 was significant first step but a lot more has to happen to eliminate the overlap of old laws and regulations.

References

1.International Food Information Council Functional Foods Now. Washington, DC:International Food and Information Council; 1999. (Accessed on October, 1, 2008)

2.Kalra EK. Nutraceutical: Definition & Introduction AAPS Pharmsci 2003; 5(2)  Article 25 DOI.10.1208/PS/0500225. (Accessed on January, 1, 2009)

3. Gil Hardy PhD Nutraceutical and Functional Food: Introduction and Meaning, Nutrition, 2000, volume 16, 688-689.

4. Brower V. Nutraceuticals: poised for healthy slice of healthcare market? Nat Biotechnol. 1998, 16, 728-731.

5. Regulation of functional food in Indian Subcontinent, food and beverages  news., http://www.efenbeonline.com/view_story. asp? type=story&id=880). (Accessed on November, 1, 2008)

6.New Food Words: Functional Foods and Nutraceuticals, Phytochemicals    http://www.extension.iastate.edu/publications/PMI846.pdf, (Accessed on  December 1, 2008 )

7. http://www.commonlii.org/in/legis/num_act/fsasa2006234/ Accessed January, 9, 2009   

8. India together: Legislative Brief, at http://www.indiatogether.org/2006/feb/laws- foodsafe/htmal/hilite). (Accessed on February, 1, 2009 )

9. FICCI study on Implementation of Food Safety and Standard Act 2006: An Industry Perspective at http://www.indiaenvironmentportal.org.in/Files/food_safety_study.pdf) (Accessed on March, 1, 2009).

10. Ashriti KaK, Supplementary growth Express Pharma, February 16-29,2008.

11. Kevin Jacobs; INDIA: Nutraceutical Market sees 40% growth, Just- Food, 17 June 2008.

12.Akshay G Mehta, Untapped Wealth of Nutraceutical Exports, The Hindu Business Line, August 15, 2008.

13.http://www.asiafoodjournal.com/article-5565-definingfiunctionalfood claims- Asia.html.)(Accessed on October, 2, 2009)

14.http://www.Nutraceuticalsworld.Com/Articles/2008/11/India.(Accessed on February 9, 2009).

15.http://sitesources.worldbank.org/INTARD/ResourcesHealthEnhancing_Food  ARD _DP_30_final_pdf) (Accessed on December 2008)

About Authors:

Deepak Kaushik

Deepak Kaushik
Department of Pharmaceutical Sciences, M.D.University, Rohtak-124001

Nisha kaushik

Nisha kaushik
Department of Pharmaceutical Sciences, M.D.University, Rohtak-124001                                                                                 

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Comments

Amol Malpani's picture

Dear Deepak,
You are suggested some lacunae and challenges related to Indian regulation.
Which country have better regulation in nutraceuticals? Please suggest.
Nice collection.
Regards,
Amol

deepkaushik's picture

Dear amol,
Thanks for the encouragement..
well talking specifically on functional foods, then japan have got the most structured regulations on functional foods.
as far as India is concerned, we are in process of framing a concrete law on functional foods which could take some time to come into force.
regards
Deepak

Deepak kaushik
Lecturer,
Department of Pharmaceutical Sciences,
M.D.University, Rohtak-124001
Haryana, INDIA

drgunasakaran1's picture

Dear Deepak,

Nice review article. What about the FDA and EMEA stance on regulation of nutraceuticals in US and European Union. Is there any variations prevails in these countries compared with India.

Dr.S.Gunasakaran,MBBS,MD. Head - Clinical Research & Medical Affairs www.clinicalresearchsociety.org/forum
deepkaushik's picture

Dear sir,
Thanks for liking my article..There are lot of variations in our regulations on nutraceuticals as compared to EMEA and FDA. to begin with India do not have a specific regulaions on nutraceuticals..In US there is a specific act called DSHEA which covers this whole category of dietary supplements..although EMEA have no specific regulation on nutraceuticals but have strict control over regulation of nutraceuticals.

Deepak kaushik
Lecturer,
Department of Pharmaceutical Sciences,
M.D.University, Rohtak-124001
Haryana, INDIA