– Dr. R. B. Smarta
Labelling is usually perceived as an important aspect in informing the consumers about the
contents of food/nutraceuticals in the finished products. Claims allow the consumers to
read what the companies claim on their products. They should not be misleading. Labelling
for nutraceuticals and upto some extent foods, vary from country to country. Some
countries like Canada and Australia use labelling that treats nutraceuticals and allied
products more like drugs than food, whereas countries like USA consider nutraceuticals as
food or supplements.
Need for claims
In case of products that are not prescribed i.e. OTC, there is no mediator who can guide,
who is knowledgeable like a physician. In such cases consumers can make an informed or ill
informed decision on their own. To stop consumers from making ill informed decisions
regulations need to be in place for the information provided on the label of a product,
including the claims made on the product. Claims provide the consumers a relation between
the nutrient in the product and the implied health/functional benefits.
Global Scenario: Labelling & Claims
Across countries there are regulatory differences with respect to regulations of
nutraceuticals and foods. Some countries have a body that regulates the use of health
claims (for example, Health Canada in Canada, the Food and Drug Administration in the
USA, The Ministry of Health, Labour, and Welfare in Japan, the Korean Food and Drug
Administration (KFDA), the State Food and Drug Administration (SFDA) in China, and the
Food Control Department in Singapore). Other countries have decided to cooperatively
develop regulations together on health and nutrition claims, European Union, Australia and
New Zealand are among them. None of the countries permit self-regulation.
Apart from the regulatory bodies, as mentioned above the nutrition labelling regulations
vary from country to country, in some countries like Canada, USA, Brazil, Taiwan, Singapore,
Russia, India nutrition labelling is mandatory, while in other countries such as UK, Sweden,
EU the labelling is voluntary unless a claim is made.
As such there is no universal definition for ‘health claim’. Canada is one of the leading and
advanced markets of nutraceuticals and functional foods. In Canada, the generally accepted
definition of health claim on food (nutraceuticals) is ‘any representation in labelling and
advertising that states, suggests, or implies that a relation exists between the consumption
of foods or food constituents and health’ (Health Canada 2010).
Types of claims
Globally the health claims can either be generic and product-specific claims.
Generic claims specify a relationship between a food constituent and health effect and
can be used on any food so long as the food meets the conditions for using the claim.
Product-specific claims, can be used only on products that undergo registration for a
claim that specifies a relationship between the food or food constituent and a health
benefit. In addition the, health claims are divided into two further categories Disease
risk reduction claim and Structure function claim.
Disease risk reduction claims
Disease risk reduction claims specify the relationship between the consumption of a
nutrient and its effects on risk of disease. Eg. Several countries like Canada, USA,
Australia, New Zealand, The Philippines and Japan permit claims linking the presence of
calcium and/or Vitamin D and the reduced risk of osteoporosis.
Structure/function claims connect the presence of a nutrient to normal functioning,
growth or development of the human body. Eg. Claim linking the presence of calcium
and/or vitamin D and proper bone structure.
Nutrition content claims
Nutrition content/nutrition claims can be made on foods and nutraceuticals, they
describe the presence or absence of a nutrient. The permitted claims usually have
positive implications on human health. In a way, nutrient content claims are implied
health claims. Eg. Claim – ‘high in potassium and low in sodium’, both of which
contribute to reduced risk of high blood pressure and cardiovascular disease.
Nutrient Function Claims
Nutrient function claim is a subset of function claims which describes the wellestablished
roles of energy or nutrients that are essential for the maintenance of good
health or for normal growth and development. These claims can be:
General Nutrient Function claim – Eg. Energy (or Name of Nutrient) is a factor in the
maintenance of good health.
Specific Nutrient Function claim – Protein: helps build and repair body tissues/helps
build antibodies. Fat: supplies energy, aids in the absorption of fat-soluble vitamins.
In 2013 India came up with draft regulations which apply to nutrition and health claims
made on commercial communications including internet, whether in labelling, presentation
or advertising (both print & electronic format) for food and nutraceuticals.
The general principles of these draft regulations are: They should be Truthful unambiguous
not misleading, Scientifically substantiated, Not encourage or condone excess consumption,
Not arouse or exploit fear in consumers.
The regulators should cautiously explore the issue from a variety of perspectives. For
For regulatory purposes, how should nutraceuticals/functional foods be defined with
Should nutraceuticals be a separate category or come under either foods or drugs?
What kinds of health claims, should be allowed on the food labels?
What kind of evidence would be valid / necessary / sufficient to prove a health benefit?
Should there be any standardization / guidelines for the evidence required?
How can nutraceuticals / functional foods be regulated without compromising the right
of consumers to take greater responsibility of their own health?
The type of claims mentioned in the draft regulations are:
The draft regulations also provide a list of scientific substantiation that needs to be
submitted to the regulatory committee while getting product approval.
Hypothesis, Prove or Disapprove, Done with Scientific Rigor, Peer reviewed, validated,
Independent, Based on claim the type of study- animal (in vitro/ in vivo)/ human
intervention/ double blind study, Target population, Exact formulation, Stability, Claimed
effect Vs pattern of consumption, Influence of food matrix, Statistical population, adequate
Certain additional labelling guidelines mentioned in the draft regulations are:
The label should contain Quantity of nutrient/substance used, Target population, Maximum
safe intake, Contraindications, as applicable under FSDU/FSMP regulation, No curative
claims and that all the disclaimers are to be in bold in same field of vision.
Claims in Perspective
Approved claims in world – Canada
Currently, in Canada there are nine approved generic disease risk reduction health claims
permitted on food which can also be used on natural health products (NHPs). Canada
requires a premarket approval for all health claims and has a relatively lengthy and stringent
process of new claim approval.
The nine claims are:
1. Low sodium and High potassium linked to reduced risk of high blood pressure
2. Adequate vitamin D and calcium intake linked to reduced risk of osteoporosis
3. A diet low in saturated and trans fatty acids linked to reduced risk of heart disease
4. Consumption of fruit and vegetables linked to reduced risk of some kinds of cancer
5. Maxima fermentable carbohydrates in gum linked to reduced risk of dental caries or
6. Phytosterols linked to lowering cholesterol
7. Oat fibre linked to reduced risk of heart disease
8. Barley products and blood cholesterol lowering
9. Unsaturated fat and blood cholesterol lowering
There are 26 approved structure/function claims and no claims approved yet under
therapeutic claims. In addition to these claims, nutrition content claims can also be made.
There is also mandatory food labelling and in most cases labelling must be in both French
How did Canada achieve it?
They initially developed a Policy guided by following principles:
Products with proven physiological benefits should be available to Canadians.
The regulatory environment should fairly and responsibly permit the promotion to
consumers of food and drug products that have been substantiated with valid scientific
evidence to improve health.
Health claims need to be supported by information that is not misleading, clearly stated,
substantiated, truthful and not likely to lead to any harm.
A Draft Policy Options Analysis Paper was prepared which included the discussions from
stakeholder workshops and other written comments. This draft was considered as a
conceptual framework for regulating health claims on nutraceuticals/functional foods. The
working group reviewed a variety of possible models based on claims. The models ranged
from an unregulated environment to strict government control of the health claims on food
and food products. The working group also established criteria for evaluating the options.
The working group, in light of the criteria suggested a preferred option, which was
highlighted in the Draft Policy Options Analysis Paper. The working group’s suggestion was
supported by the External Advisory Panel and the draft paper was circulated for public
comments in 1997. The preferred policy option received broad support among interested
parties and this document is the final Policy Paper for claims.
In India, we need to develop a policy framework to address regulatory issues related to
health claims on nutraceuticals / functional foods and related products. Although we have
draft guidelines in place, it is high time that we finalize the guidelines and regulation for
claims made on products.
FSSAI needs to study and provide the industry with a list of claims that can be used on the
products. These claims should be formulated keeping in mind that the end beneficiaries of
these are the consumers.
The claims should be such that they are clearly understood and not misleading, they should
all be science based, the industry should get a clarity as to which claim can be used for what
type of product or due to presence of which ingredient/s.
Apart from this all countries should give emphasis on harmonization of the claims across
world, as this would facilitate growth of business and trade.
Canadian Food Inspection Agency: Food labelling, Health claims
Health Canada, Policy Paper – Nutraceuticals/Functional Foods and Health Claims On
– Dr. R. B. Smarta