Through an order dated 20 June 2019 the FSSAI has asked all Food Safety Commissioners of all States/ UTs to undertake market surveillance of all products covered under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2016. (Nutraceutical Regulations). Since these regulations have already been notified in December 2016 therefore, all Food Business operators manufacturing products covered under these regulations need to comply with the provisions specified under regulation 4 on claims (given below as under) of the NutraceuticalRegulations.
However, it has come to the notice of the FSSAI that some products covered under the Nutraceutical Regulations are being marketed with certain false or exaggerated health claims. In view of this, all Food SafetyCommissioners of States/ UTs have been directed by the FSSAI to undertake a market surveillance drive in those areas that fall within their jurisdiction and also verify the claims made on such products. The FSSAI has asked the Food Safety Commissioners to also carry out a study of the various types of claims being made with regard to products that come under the scope of the above-mentioned Regulations. The compiled reports of the market surveillance must reach the FSSAI by 15 July, 2019. The FSSAI has also provided a format for compiling the market surveillance report which is as under
|S.N||Product Name||Manufactured/ Marketed by||FSSAI License No||Claims made on label along with Photographs of label (clear legible with complete details have to be enclosed)|
Regulation 4 of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2016
- Every food business operator may make nutritional or health claims in respect of an article offood.
- A nutritional claim shall consist of the ‘Ingredients (nutrient ornutritional) content’ of an article of food which shall be subject to the nutritional supplement requirementsspecified in Schedule I, Schedule II, Schedule III, Schedule IV, and Schedule VI of the Nutraceutical Regulations
- For the purposes of these regulations, health claim means any representation in respect of an article of food thatstates, suggests or implies that a relationship exists between the constituent of that nutrient or nutritional, health,and specific disease conditions.
- The health claim in respect of an article of food consists of the following two essential components
(i) nutrient or nutritional ingredients
(ii) health related benefits.
- The health claim in respect of an article of food may include the following types, but not limited to
(i) ingredients (nutrient or nutritional) function claims
(ii) enhanced function claims
(iii) disease risk reduction claims
(iv) health maintenance claims
(v) immunity claims – increased resistance (excluding vaccines)
(vi) anti-ageing claims.
- The other claims in an article of food that are not drug claims may be allowed subject to prior approval of the FoodAuthority.
- The health claims in respect of an article of food shall be commensurate with the adequate level of documentation andvalid proof made available for review by the Food Authority when called for.
- To claim ingredients, nutrient or nutritional, in respect of an article of food for enhanced function and disease riskreduction, regard shall be had to-
(i) claims that led to ingredients (nutrient or nutritional)
(ii) available scientific literature including official traditional texts and post market data or consumerstudies or cohort or retroactive studies based on eating pattern and health benefits, epidemiologicalinternational and national data, and other well documented data;
(iii) consensual, congruent and concurrent validity studies;
(iv) health promotive and disease risk reduction based on proof from literature and human data of efficacyand safety of the nutrient;
(v) not only controlled clinical trials for efficacy and safety data; but alsonutraepidemiological data;
(vi) qualified structure function claims for specific organ or function which are comprehensible toconsumer;
(vii) prohibition of implied claims for curing disease or claims of drug like efficacy such as ‘Prevents bonefragility in post-menopausal women’
(viii) prohibition of implied cure for disease claims by the name of the product such as cancer cure orthrough pictures, vignettes or symbols, namely, electrocardiogram tracing, lipid profile
(ix) for structure-function claims, a case-to-case basis consumer information for specific age or gender orvulnerable population.
- For the product led claims in respect of an article of food based on human studies with evidence-based data,regard shall be had to-
(a) valid data and suitable statistical design proving the benefit for disease risk reduction, that is,human intervention studies;
(b) ingredient, that is, nutrient or nutritional;
(c) the product compatibility for the proposed claim benefit and suitable qualifierssuch as hearthealthy claim on polyunsaturated fatty acids;
(d) the use of word “shown” as depicted in the example below when a single human intervention studyshows significant benefit:
“Product <Name of the Product> is ‘shown’ to be helping in <keeping your heart healthy>or <heart healthy>:
the use of word “Proven” as depicted in the example below when more than one humanintervention studies or epidemiological evidence on Indian population have been provided withconcurrent validity:
“Product <Name of the Product> is ‘proven’ <to make you lose weight>:
- For health claims where scientific support does not exist, or if a novel ingredient is to be introduced, thereshall be a prior approval of the Authority which shall be based on adequate scientific evidence.
If the health claims are product led, the food business operator shall notify to the Food Authority beforeputting the same in the market, by submitting relevantdocuments along with a copy of the label.