EXPLAINED: Nutraceuticals & Related Regulations in India

Nutraceuticals are products made from naturally occurring ingredients that are extracted, isolated, and purified from food or non-food sources, which upon consumption in specific amounts, render a certain physiological benefit and maintain good health.

In India, nutraceuticals are regulated by the Food Safety and Standards Authority of India (‘FSSAI’) under the Food Safety and Standards Act, 2006 (‘FSS Act’), and regulations thereunder, including FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 as amended by the first amendment regulations, 2021 (‘Nutraceutical Regulations or said Regulations’), FSS (Organic Foods) Regulations, 2017, FSS (Food Product Standards and Food Additive) Regulations, 2011, FSS (Packaging and Labelling) Regulations, 2011, FSS (Advertising and Claims) Regulations, 2018, FSS (Licensing and Registration of Food Businesses) Regulation, 2011, and FSS (Contaminants, Toxins and Residues) Regulations, 2011, in addition to the FSS (Import) Regulations, 2017 in case of import of the nutraceuticals.

The Nutraceutical Regulations apply to food items/products/formulations, existing or new, prepared for humans above the age of 2 years, with an aim to promote the maintenance of health. The nutraceuticals may contain ingredients formulated, either alone or in combination, or their extracts (processed / unprocessed), in regular or conventional food formats such as liquid or syrup, suspension or powder, granule, tablet or capsule or any other format approved by the FSSAI. Formulations meant for infant nutrition are governed separately under FSS (Foods for Infant Nutrition) Regulations, 2020. Other dosage formats such as sprays can also be included in the list of permitted food formats.

All Food Business Operators (‘FBOs’) engaged in manufacturing, packaging, selling, offering for sale, marketing or otherwise distribution or import of nutraceuticals in India, whether as domestic FBOs or importers, are required to comply with Nutraceutical Regulations in course of such business.

Interestingly, any product offered in a naturally occurring food form do not categorise as nutraceutical and has been excluded from the Nutraceutical Regulations. For example, all vegetables, cereals, legumes, spices, fruits, or any other plants or botanicals, even if the same is minimally processed in juice / cooked form, are not permitted to be sold as nutraceuticals. Similarly, conventional foods or foods for mass consumption that have the ingredients in their natural composition are also not considered nutraceuticals.

Nutraceutical products are required to contain at least one ingredients/additives specified in Schedule VI (list of ingredients as nutraceuticals) and may contain ingredients specified under Schedule I, II, IV, VII and VIII, with the quantity of nutrients added not exceeding the recommended limits / daily allowances prescribed by ICMR. However, FBOs are also permitted to use the ingredients that are standardized or permitted for use in the preparation of any other standardized food. Organic foods can also be used as ingredients in the manufacturing of nutraceutical products. FBOs must note that ingredients from animal sources need to be used subject to prescriptions under the Nutraceutical Regulations as well as FSS (Food Product Standards and Food Additive) Regulations, 2011. Presently, any ingredient of genetically modified origin is not permitted for safety reasons. Therefore, the use of ingredients of genetically modified and nanotechnology can also be included in the manufacturing and production of nutraceuticals.

The Regulations also provide that the label on such article is required to specify the purpose, target consumer group, physiological / disease conditions that the nutraceutical product addresses, recommended duration of use, instructions, and precautions for the use, in addition to specific labelling requirements.

FBOs are also required to produce data on the scientific rationale for formulation of combination in the nutraceuticals, which may be based on a scientific literature in peer-reviewed journals / publications.

FBOs in business of nutraceuticals may make health benefits related claims such as claims for enhanced function, health maintenance, immunity claims, or ingredients (nutrient or nutritional) claims including claims regarding food for enhanced function and disease risk reduction, having regard to the prescriptions under the Nutraceutical Regulations. However, any sort of claims akin to drugs and claiming to prevent, treat or cure human diseases, or referring to such properties cannot be made by the FBOs for any nutraceutical as they fall under the ambit of Drugs Controller General of India and not FSSAI. Other claims that are not drug claims, or where scientific evidence does not exist, or where a novel ingredient is used/introduced, need prior approval of FSSAI basis sufficient scientific evidence supporting the claims. FSSAI holds power to alter, modify or stop any claims where it deems fit to do so.

The licensing requirements continue to be covered by the FSS (Licensing and Registration of Food Businesses) Regulations, 2011.

Given the competitiveness of the nutraceutical market, the intellectual property considerations are also witnessing a rapid growth with patents as a major protection for the research, development and usage of the nutraceutical products, trademark being source of trust with the consumers, as a defence for unauthorised adoption, determining similarity of marks and distinguishing one company from the other. The copyright also comes in picture owing to the launches of products, marketing and comparative advertising, infringing logos / labels etc. Even though the Courts have held that the test for infringement and passing off for nutraceuticals products is same as the test applicable to the pharmaceutical products, yet the IP rights of nutraceuticals remain of prime focus for the industry players.

Conclusion

The nutraceutical industry has an abundant scope for manufacturing and consumption in India, as there lies a wide customer base, as well as an untapped opportunity for both manufacturers and exporters in India. However, the industry is still in its nascent stage, taking baby steps. There are perhaps certain teething issues which would be eventually resolved with the growth of the industry as well as of the regulatory framework.

(This Article is solely for information purposes, does not constitute legal or professional advisory and should not be relied upon or used as a substitute for legal advice from attorney.)

About the Authors: 

Jayshree Navin Chandra, Senior Partner at ZEUS Law, has been a practicing lawyer since 2001 with extensive corporate and transactional advisory experience. She advises and represents clients ranging from Fortune 500 companies to start-ups as well as Central and State Government departments and public bodies in a wide range of domestic and cross border transactions, across industries in practice areas including Corporate and Company Law, M&A and Joint Venture, Private Equity, FDI & FII, Real Estate and Infrastructure, Data privacy and protection, Intellectual Property & Commercial Law Advisory.

Ms. Anisha Jhawar is an Associate at ZEUS Law and works in the Corporate and Commercial practice vertical.

ZEUS Law Associates is an ISO certified full service corporate commercial law firm with a team of dedicated and experienced lawyers well versed in handling domestic and cross border transactions across sectors, jurisdictions and regulatory landscapes. The firm’s practice areas include Corporate and Company Law, M&A and Joint Venture, Private Equity, FDI & FII, Real Estate and Infrastructure, Intellectual Property & Commercial Law, Litigation, Alternate Dispute Resolution, Indirect Tax and NRI Services.