FSSAI soon to strengthen Regulatory System for Health Supplements

Jul 30, 2018 | by Avantis RegTech Legal Research Team

In December, 2016, the Food Safety and Standards Authority of India (FSSAI) had notified 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. These regulations cover eight categories of foods and carry detailed requirements about their composition, claims, labels etc. These foods are health supplements, nutraceuticals, foods for special dietary use, food for special medical purpose, speciality food containing plants or botanicals, foods containing probiotics, foods containing prebiotics and the novel foods.

The regulations allow the manufacturing and selling of the above category of foods in the form of tablets, capsules and syrups and must fulfil quality requirements and standards as specified in the Indian Pharmacopoeia. As per these regulations, the formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required.

A mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not food unless vitamins and minerals are added to an article of food based on a food format. These foods are not permitted to contain hormones, steroids or psychotropic ingredients. These foods may use approved colours and additives as permitted in Schedule VF of these regulations, natural, nature identical or synthetic flavours as permitted in the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.

The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance (RDA) as specified by the Indian Council of Medical Research (ICMR) and accepted by the FSSAI. These regulations have into force from January 01, 2018.

Since, this is new and emerging area, FSSAI has begun its efforts to bring in global best practices towards harmonisation of regulations on the issue, particularly on vitamins and minerals content in health supplements and nutraceuticals in India. For this purpose, FSSAI had nudged CII to establish ‘Resource Centre for Health Supplements and Nutraceuticals (ReCHaN) in partnership with International Alliance of Dietary/Food Supplement Associations (IADSA).

In order to strengthen the regulatory system for health supplements in the country, the Resource Centre had earlier developed two guidance documents on compliance and good manufacturing practices. Now, it has developed the training manual and presentation deck on food safety management system for use under the FSSAI’s Food Safety Training and Certification (FoSTaC) initiative. These would be used both for food businesses and the regulatory staff.

FSSAI and ReCHaN have been conducting a series of training sessions for regulatory staff on issues of regulatory compliance including labelling, FSMS, enforcement and licensing in health supplement space. Since the regulatory issues in the health supplement space are somewhat different from other food sector, hence the regulatory staff are finding these training sessions very useful. Finally, it is informed that claim regulations on the health supplements would soon be notified. These regulations would help industry to grow further while at the same safeguarding consumer interest.

URL: http://www.fssai.gov.in/dam/jcr:0c57ebff-b4d2-456f-ad17-0ffd0f8a1dd0/Press_Release_Health_Supplements_28_07_2018.pdf


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