Improvising Claims - 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 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 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 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. OR 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.
Indian Scenario 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 example: For regulatory purposes, how should nutraceuticals/functional foods be defined with precision? 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. Scientific Substantiation 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 duration safety. 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 cavities 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 and English. 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. Way Forward 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. - - Published in NuFFooDS Spectrum Magazine References Canadian Food Inspection Agency: Food labelling, Health claims Health Canada, Policy Paper - Nutraceuticals/Functional Foods and Health Claims On Foods