– Dr. R. B. Smarta
Nutraceuticals and Functional foods are the products whose safety for human consumption
is very essential, since these products are directly consumed by the consumers and if they
are miss-handled or of poor quality or standards they can have adverse effects on
The main aim of regulating these products is to ensure safety of the consumer’s health.
Apart from this, the regulations help in bringing about fair trade, harmonization, uniformity
in practices, price control etc.
Regulatory scenario in India
In India the regulatory body which legalizes nutraceutical products is the Food Safety and
Standards Authority of India, commonly referred to as FSSAI which has been established
under the Food Safety and Standards Act, 2006. FSSAI has been created for laying down
science based standards for articles of food and to regulate their manufacture, storage,
distribution, sale and import to ensure availability of safe and wholesome food for human
consumption. The Ministry of Health & Family Welfare, Government of India is the
Administrative Ministry for the implementation of FSSAI.
Prior to the establishment of FSS Act 2006, there were a number of different Acts for
different types of foods or other related products. Thus FSS Act was established to be 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. The Food Safety and
Standards Regulations 2011 notified in the Gazette of India came into force on August 5,
2011, to regulate manufacture, distribution and sale of nutraceuticals, functional foods and
dietary supplements in India.
Benefits of the FSS Act
It unifies the earlier eight different laws, this has been a step towards harmonization,
alignment of international regulations, science-based standards, clarity and uniformity on
novel food areas, help to curb corruptions.
FSSAI went for online registration process for product approval. FSSAI Product Approval
System (FPAS) was launched to make product approval & registration easier.
Establishing food parks
The Ministry of Food Processing Industries, Govt. of India has already taken up initiatives
such as approving a number of food parks and coming up with schemes for the
development of food processing to address the constraints in food processing sector. This
initiative was taken in order to attract investments.
On one hand there have been some good initiatives from the FSSAI’s side but on the other
hand we also witnessed uprest regarding regulations was wherein the sudden
implementation of reforms and regulations had given food importers a real tough time.
Over 200 tonnes of foodstuff imported to India was stuck at the Indian seaports and airports
due to Food Safety & Standards Authority of India’s (FSSAI) zero-tolerance policy towards
non-compliance of its regulations. The imports mainly contain chocolates, nutritional
supplements, snack items etc.
In case of exports there has been some haziness regarding the certification process for their
products has dealt a serious blow to Indian exporters of dietary supplements and
nutraceuticals, who are now unable to ship newer products abroad or renew licenses for
older ones. Apart from this the uncertainty over the licensing authority, is hampering the
International Regulatory Scenario
Some of the global food and nutrition policy related bodies are: WHO (World Health
Organisation), CODEX (Codex Alimentarius), WTO (World Trade Organisation), FAO (Food
and Agriculture Organisation).
Every country has its own regulation and nomenclature for nutraceuticals and allied. When
considering the entry into global nutraceuticals market, understanding these varying
regulations becomes quintessential. Some countries have notification based approach for
market entry (Mexico, Chile) while some have registration based approach (India, Brazil,
Colombia and Argentina).
Some countries consider nutraceuticals in food category while others consider in drugs
1. In the USA, the Food and Drug Administration (FDA) regulates nutraceuticals under a
different set of regulations when compared with those covering “conventional” foods
and drug products. According to the Dietary Supplement Health and Education Act from
1994 (DSHEA), it is the manufacturer’s responsibility to ensure that a nutraceutical is
safe before it is marketed.
2. FDA is authorized to take action against any unsafe product after it reaches the market.
Manufacturers have to make sure that the information on the product label is truthful
and not misleading, but they are not obliged to register their products with the FDA nor
get FDA approval before producing or selling nutraceuticals.
3. In Europe the food legislation is largely under the umbrella of European Food and Safety
Authority (EFSA). This legislation focuses on “food supplements”, which are defined as
concentrated sources of nutrients (e.g. proteins, minerals and vitamins) and other
substances with a beneficial nutritional effect.
4. New products from Europe are presumed to have passed stringent European
development and quality requirements. As a result, European nutraceutical companies,
which are generally considered leaders in innovation, enjoy a perception of producing
the highest quality products.
5. In Canada and Australia, nutraceuticals are regulated more closely as a drug than as a
6. In India these is a regulatory body FSSAI for regulation of nutraceuticals and allied
Product Approval requirements across the world
The illustration below depicts the product approval requirements of various countries.
Characteristics of Good/ideal regulations
The regulations should be such that they support and provide real value to the consumers
as well as they should facilitate the growth of the industry and should be business friendly.
Enlisted below are some of the characteristics of good regulations.
Developed with all relevant groups in society
Supported by good science
Developed on a risk based approach
Backed by industry
Promote public health
Stimulate innovation and research
Stimulate economic growth
The nutraceuticals industry in India has knowledge as well as the science and tradition of
natural medicines. But this science and knowledge should reach the consumers i.e. it should
Representation by Interlink Knowledge Cell.
be made available to the population. For this purpose regulations are important. OR This
should be the approach of regulatory bodies while setting up regulations. India still needs
to have regulations that are industry friendly and such regulations that facilitate or
mediate the growth of SME’s (Small and Medium sized enterprises).
Now with the foreign companies looking at India as a potential hub for Nutraceuticals, our
regulations should be conducive to the foreign investors. We need to have stability and
certainty with respect to regulations and guidelines (including defined and time efficient
regulatory and product approval system).
Also the FSSAI need to have certain regulations and guidelines in place for the digital or
online retail of nutraceuticals, dietary supplements and allied products.
– Published in NuFFooDS Spectrum Magazine
Nuffoods Spectrum, Budget – Way forward, Dr. R.B. Smarta.
Regulatory and Product Approval Challenges: Are they Key Impediments in setting up
Nutraceuticals Manufacturing in India? Ric Hobby, Chairman, IADSA, 6th FICCI-HADSA
International Annual Conference.
News-Medical net, Nutraceutical Regulation, Dr. Tomislav Mestrovic.Nutraceuticals Regulatory Purview
– Dr. R. B. Smarta