Health Supplements and NutraceuticalsRegulatory Framework for Nutraceutical Industry

June 10, 20220


The bioactive compounds and components of herbs and minerals, as well as dietary supplements with therapeutic potential, are known as nutraceuticals. They are sold as dose formulations in addition to the fundamental nutritional content contained in meals and have become an important part of an average consumer’s diet.

Vitamins, minerals, fatty acid, pre and probiotics, herbal supplements, and other supplements are increasingly widely used for preventive and therapeutic purposes across the world, making it critical to maintain high safety and quality standards. The rapidly growing worldwide nutraceutical business has stressed the necessity for a regulatory framework to be developed for the same.

Although regulations around the globe like that in the United States of America, the United Kingdom and Europe have become more standardized and favorable to the growth of nutraceutical products, the Indian industry and regulatory environment are still advancing and has the scope of growth to be successful with other international agencies.

This is booming business in India, and numerous attempts have been made to put India as one of the leading players in the nutraceutical market in the upcoming years.


The Indian nutraceutical ecosystem is expanding at a rapid rate, with combination of benefits and challenges of scientific breakthroughs with the rising public desire for clean foods that improve general heath. Nutraceuticals are being utilized more often to maintain and improve immunity, bone density, heart and brain health, and overall physical well-being of an individual.

Consumer knowledge and use of nutraceuticals to promote immunity, strength, and holistic health has grown in the last year.

Consumers are shifting to nutraceuticals like Omega 3 and other vitamin supplements to help them avoid acute ailments, which are on the rise all over the world. Increased medical expenditures have prompted customers to turn to nutraceuticals such as multivitamins and superfoods for preventative healthcare. Health-conscious individuals are also turning to enriched foods and beverages as a substitute to prescribed medications.

The nutraceutical industry is not devoid of difficulties. Despite tremendous growth, it still needs greater Government assistance in the form of tighter laws, norms, and tax breaks. A distinct regulatory framework is required for simplified operations and governance.


The Food Safety and Standards Act, 2006 (hereinafter referred to as the “FSSA”) was enacted in order to consolidate the laws with regards to food and to establish the Food Safety and Standards Authority of India (hereinafter referred to as “FSSAI”). The FSSAI was established to regulate the manufacturing, storage, sale, and import of articles of food and to ensure the safe availability of food for human consumption.

According to the FSSA, there is no differentiation amongst functional foods, nutraceuticals, and dietary supplements, as each is specified as food for a special dietary application. Without any declarations concerning nutraceuticals with clinical study findings, FSSA views items with favourable health claims to be equivalent to ‘food’.

In 2015, a draft Report, namely, New Regulation for Nutraceutical – Functional – Novel Foods etc. (hereinafter referred to as “the Report”) was proposed by the Government of India and was also tabled before the World Trade Organization (hereinafter referred to as “WTO”) for comments and suggestions.

The Report enumerated the regulations for nutraceuticals and foods for unique diets and clinical reasons. Components, branding, labelling, additives, containments, and health and nutritional claims were used to identify these groups in the proposed regulation. The standards for the productions and selling of these kinds of foods, as well as recommendations about the doses or intake levels were also concluded by the draft regulation.

On the introduction of the FSSAI and regulation of functional foods and nutraceuticals, the foundation for a robust framework for nutraceuticals was formed. To guarantee nutraceuticals goods are both safe and high-quality, rigorous requirements for the evidence that must back their health claims have also been established, such as, information pertaining to the claimed novel foods, packaging and labelling guidelines, laboratory and sampling analysis reports, etc.


The United Nations Food and Agricultural Organization and the World Health Organization set the stepping stone for evaluating the importance of safety and use of food. In the United States of America, the Food and Drug Administration (hereinafter referred to as the “FDA”), which is responsible for food safety and supplements, recognizes the word ‘nutraceutical’ and applies a separate set of rules to it than it does to regular food and pharmaceuticals.

According to the Dietary Supplement Health and Education Act, 1994, it is the duty of the manufacturer to guarantee the safety of nutraceuticals before it is sold in the market.

Furthermore, for the European Union, in the event of request from Member States, the European Parliament, or stakeholders, the European Food Safety Authority (hereinafter referred to as the “EFSA”) must approve each health claim in detail before it is assessed at a national or European level prior to being introduced in the market. In Canada, nutraceuticals are regulated as food type more rather than a drug.

Japan, by the issue of Food for Specified Health Use (hereinafter referred to as “FOSHU”), became the first country to regulate nutraceuticals. If the product reaches the level of FOSHU standards, food with positive health activities may be approved even though these operations are not backed by science.

In countries such as Australia and China, nutraceuticals are legalized as type of food and national food regulations apply. In certain counties like Columbia, Brazil, and Argentina, they have adopted a basic registration method. While in Mexico and Chile, a notification method route has been taken. However, a stricter approach and a full animal or human scientific study is needed before the registration in countries like China and Taiwan.

Hence, a comprehensive safety evaluation and medical research is required before any nutraceutical or component is released in the market.


It has been proven that nutraceutical products have indeed helped in preventing and treating diseases which in turn lead to its increased demand and high success rate in India. Therefore, in order to decrease unfortunate events of toxicity, contamination, mistreatment, overdose, etc., the respective authorities need to adopt stricter mechanisms like absolute quality checks and safety measures.

Since food products are being exported all over the world, upholding the safety and quality requirements, according to the various regulatory procedures established by the individual Government becomes vital.  Hence, a proper concrete framework should be established and implemented for better regulation of the nutraceutical industry on the national front.

– Team AMLEGALS assisted by Ms. Ayasha Khatri (Intern)

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