Nutraceuticals which refer to food-derived products such as vitamins, minerals, herbal extracts, probiotics, amino acids and fortified formulations that are marketed for nutritional, preventive or physiological benefits beyond basic nourishment have increasingly become flagship products of a growing wellness economy. They however currently fall into a fuzzy regulatory realm that lies in the intermediary space, between being food and being drugs. These products are not just sold to be consumed as food but marketed also as products that prevent diseases and keep people fit and healthy. Nutraceuticals remain one of the most loosely defined and least regulated products in India despite their sensitive consumption-based nature.
The nutraceutical conundrum has its roots in functional and ambiguity regulatory. Nutraceuticals are products that fall into the gray zone between food and medication. They are not regular food because they promise health benefits; they are not drugs since most of them do not undergo evidence based trials necessary for drugs. Their ambivalent legal definitional status has facilitated the emergence of a huge market characterized by low oversight on efficacy, variable quality control, and exaggerated health claims.
Internationally, the word “nutraceutical” does not carry one consistent definition in science. The term refers to a range of dietary supplements, fortified foods, botanical extracts, and functional foods used for preventing diseases and promoting general well-being, even when the scientific basis differs. Studies have consistently established that the regulation of these products internationally poses challenges due to their ambiguous placement between nutrition and pharmaceutical science.
Nutraceuticals are governed in India largely by the Food Safety and Standards Act, 2006 via the Food Safety and Standards Authority of India (FSSAI). The relevant rules categorize nutraceuticals as foods with some form of health benefit. In terms of regulation therefore, features such as food safety and labelling, contamination, hygiene, permitted substances and packaging become preponderant. rather medical efficacy and effectiveness as in the case of drugs.
The difference is significant. Prior to getting approves as a medicine in the Drugs and Cosmetics Act, 1940, a drug must fulfill many stringent conditions such as manufacturing control, licensing, adverse effects monitoring and at least theoretical standards of safety and use. However, many nutraceuticals that are sold in India also come in capsule, tablet, syrup and sachet forms just like medicines and sold in pharmacies along with prescription drugs. People therefore conflate them with medicines and presume them to be scientifically tested. In most cases, they are not.
The above practice has led to what scholars term “classification arbitrage”. Nutraceuticals such as those claiming to help with cholesterol control, sleep improvement, sugar levels management or joint pain are not required to undergo rigorous scrutiny and testing when sold as supplements rather than as medicines avoiding costs and regulatory delays while retaining the market perception of therapeutic efficacy.
The recent ORS controversy foregrounds this dilemma aptly . In October 2025, FSSAI issued an advisory requiring firms to remove the term ‘ORS’ from products that were not in compliance with ORS standards. FSSAI opined that the use of such terms in beverages would create a false impression among customers that the beverages are equivalent to ORS. Enforcements measures were taken against such beverages. This injunction holds a lot of significance because the ORS is not an ordinary drink. Its preparation requires adherence to scientific methods using specific salt and sugar proportions. Besides, it is used as a first response to treat millions of people across the globe who suffer from dehydration, especially children suffering from dehydration due to diarrhea. An incorrect ORS formulation claiming similar therapeutic benefits can and has shown to have serious adverse effects. The controversy nevertheless has highlighted the ease with which such therapeutic terms could be commercialized in cases where line between foods and medicines is blurred.
However, while the ORS controversy has gained a lot of traction, similar cases have been witnessed even before in the nutraceutical market. For instances in the aftermath of the Coronavirus pandemic, there was a proliferation of immunity boosters in the market with all kinds of vague claims suggesting their potential against the virus. Likewise, protein shakes are sold under the promise of achieving metabolic excellence without their amino acid profiles being explained to consumers. Similarly herbal remedies promise management of various conditions, including diabetes, hormonal, cognitive or liver disorders, pediatric multivitamin gummies are marketed as candies nudging overuse. Even sleep inducers promote consumption of melatonin mixes even in the absence of any sufficient research.
The issue has in fact been well-studied in international literature. Medical research has documented existence of serious side effects from using “natural” substances: liver failure, nephrotoxicity, contamination and adverse drug interactions to name a few. The situation is aggravated by insufficient monitoring and prevalence of self-medication.
Despite this, unlike drugs, there is no robust requirement for nutraceuticals to furnish evidence about the effectiveness of the product prior to its marketing. The research cited is more about individual ingredients rather than the product itself. Nutraceuticals manufacturers often quote generic scientific research done on turmeric, magnesium, and probiotics but go on to sell a multi-component product claiming effectiveness without proving its safety and performance at certain dosage levels.
The issue of quality control poses another problem. FSSAI has taken cognizance of the non-compliance by nutraceuticals firms and has begun tightening norms following the discovery of nutraceuticals containing higher than prescribed amounts of nutrients even using prohibited substances, or making false claims. However, enforcement remains uneven among states and online marketplaces have enhanced the level of supervision required.
The weakest link however is advertising. Indian consumers are bombarded with advertisements such as “boosts immune system”, “promotes sugar metabolism”, “detoxifies liver”, “hormonal wellness”, “brain stimulant”, and “clinically proven fat loss”. Such statements are carefully drafted, clear enough to convince consumers but vague enough not to evade liability. Despite laws on Consumer Protection and misleading advertisement such as Drugs and Magic Remedies (Objectionable Advertisements) Act, digital commerce easily outpaces traditional reinforcement. Influencers across social media too promote the sale of these supplements without showcasing credible evidence, conflicts of interest, or any adverse risks. Supplement manufacturers do not have to demonstrate product efficacy before marketing and action from regulatory agencies is usually taken in only post facto and in response to any highlighted adverse effects as in the case of ORS.
What then should India do?
In such a scenario what India requires today is a careful balancing act. What is needed today is not an outright ban on nutraceuticals, but a systematic regulatory framework wherein the risk is calibrated with oversight. The starting point, however, needs to be a statutory demarcation of the line between ordinary nutritional products and quasi-medical ones. Nutritional products which make disease management claims, contain pharmacologically active ingredients, or act as substitutes for approved therapeutic treatment, need to be treated differently from those ordinary dietary supplements. While some of these products may require stricter scrutiny than what they get under the current system, others need to undergo a hybrid regulatory process involving aspects of both food and drug legislation.
Simultaneously, India should also consider implementing a graded evidence approach for nutraceuticals based on the type of claims. A simple multivitamin required for nutritional deficiency need not regulated at par a product which aims at controlling the level of glucose in blood or improving cognitive functions, hormone regulation or cardiovascular wellness.
The reform must also be accompanied with a transparent claim governance approach. Any assertions such “supports immunity” or “promotes gut health” should be linked to a publicly available evidence registry prepared by the regulators. Any stakeholder interested in the truth behind a claim can verify the scientific rationale behind the approval of the supplement in question. It will drive the industry away from fuzzy marketing language towards credible science.
Equally crucial is the need to establish a national nutrivigilance framework analogous to pharmacovigilance in medicine. Currently, the risks associated with using certain dietary supplements largely go undocumented even though such products may react with other drugs, contain undisclosed substances, or cause organ toxicity.
The digital market deserves immediate attention as well. Influencers, celebrities, and algorithmic advertising have become effective means of disseminating dubious health claims. It is unacceptable that platforms act as mere conduits while making money from fraudulent promotional campaigns. It is their duty to directly verify adherence to the law, withdraw any illegal ads, and require sponsors of health-related advertisements to clearly identify their role. Given that consumers today often receive their health information from social media, regulating the digital market becomes crucial in protecting consumers.
However, the measures discussed above will only succeed when the fragmentation of roles between FSSAI and CDSCO, the Indian agencies responsible for ensuring food safety standards and therapeutic efficacy respectively, has been addressed. Nutraceuticals currently slip through the regulatory gaps as they sit right at the intersection between food and drugs. This calls for a coordinated approach and a collaboration effort to classify borderline products in order to prevent them from exploiting the jurisdictional overlap between both authorities. In this regard, India can also learn from the scientific approach adopted by the EU which validates health claims scientifically prior to releasing the products in markets through the Nutrition and Health Claims Regulation read with assessments conducted by the European Food Safety Authority (EFSA). This ensures that unsupported claims are regularly rejected. India presently resembles the permissive American model more than the precautionary European one, but without equivalent enforcement capacity.
Using the language packaging and trust associated with medicine and yet not meeting the corresponding medical requirements defeats the purpose of consumer autonomy. The real problem however is not only the undermining of the consumer right to make informed choices but damage to the public health. If regulated well, nutraceuticals can play a legitimate role in preventive healthcare. Hence if evidence-based healthcare is what India wants, there should be no conflation of nutrition with medicine.
