The health supplements and nutraceuticals industry are growing at a fast pace and are likely to be a USD 10 Billion industry by 2025. With the rapid growth in the industry, the FSSAI is also gearing itself to bring the regulatory system at par by collaboration and learning from international best practices. 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 were notified in December 2016. These regulations cover eight categories of foods and have details about their composition, claims, labels etc. The regulations cover
- Health supplements
- Foods for special dietary use
- Food for special medical purpose
- Specialty food containing plants or botanicals
- Foods containing probiotics
- Foods containing prebiotics
- Novel foods
These foods can be manufactured and sold in the form of tablets, capsules, and syrups and must fulfill quality requirements and standards as specified in the Indian Pharmacopoeia. Their formulation of these foods need to be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required.
These foods cannot be a mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not considered food unless the vitamins and minerals are added to an article of food based on a food format. They must not contain hormones, steroids or psychotropic ingredients. Only approved colors and additives as permitted in Schedule VF of these regulations, natural, nature identical or synthetic flavors as permitted in the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 are permitted to be used. The number of nutrients added to these 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 come into force from 1 January 2018.
Since the entire sector is in a nascent stage the FSSAI is making efforts to bring in global best practices towards harmonization of the regulations. It is also working to ensure that the vitamins and minerals content in health supplements and nutraceuticals in India are as per recommended daily allowance (RDA). FSSAI has also nudged CII to establish the ‘Resource Centre for Health Supplements and Nutraceuticals (ReCHaN) in partnership with the International Alliance of Dietary/Food Supplement Associations (IADSA). ReCHaN has initiated several scientific dialogues with stakeholders on international best practices with global experts. The recent dialogue was on the issue of “Regulatory approaches to the establishment of maximum levels for Vitamins & Minerals in Health Supplements & Nutraceuticals”.Scientists and experts including those from ICMR and National Institute of Nutrition (NIN) participated in the forum. International experts included Basil Mathioudakis, the key architect of global regulations in the space of health supplements and nutraceuticals, particularly in the EU and Dr. B.H. Lim, a leading expert in this area from the ASEAN region.
Speaking on the occasion, Pawan Agarwal, CEO, FSSAI pointed out that the health supplement sector is important for the country not only from the growth perspective but also because of the impact it has on public health. However, it also faces some challenges which are not seen in the traditional food processing sector. He added that Indian opportunity in this space is particularly large due to plant and botanicals that have traditionally been used in Ayurveda and which are included in the regulations. He also announced that the claim regulations on health supplements would soon be notified. The claim regulations would help the industry to grow further while at the same safeguard consumer interest.
Besides conducting scientific dialogues the Resource Centre had developed two guidance documents on compliance and good manufacturing practices. Now, it has developed the training manual and presentation deck on the 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 training sessions for regulatory staff on issues of regulatory compliance including labeling, FSMS, enforcement and licensing in health supplement space. Since the regulatory issues in the health supplement space are somewhat different from other food sectors, hence the regulatory staff are finding these training sessions very useful.