As protein products come under increasing scrutiny from regulators, consumers and independent testing initiatives, businesses must ensure that nutritional claims are accurate, substantiated and capable of withstanding legal as well as reputational challenges.
From protein-enriched milkshakes and nutrition bars to protein flour and ice cream, India’s consumer market has seen a significant rise in products that claim to be fortified with extra protein. In fact, protein in particular has emerged as a key differentiator in India’s growing nutrition market, and Food Business Operators (FBOs) are increasingly marketing their products on the strength of these nutritional claims. As these claims come under greater regulatory and public scrutiny, businesses must ensure that such claims are both legally compliant and scientifically substantiated.
In India, protein powders, shakes, drinks and bars are regulated as food (and not as drugs), with the Food Safety and Standards Authority of India (FSSAI) acting as the primary regulator. While the Food Safety and Standards Act, 2006 (FSS Act) provides the overarching legal framework, protein products are regulated through a combination of regulations rather than a single dedicated regulation.
Regulatory Landscape Governing Protein Products in India
Protein products may fall within different regulatory categories depending on their nature and intended use. They may be classified as proprietary foods carrying nutritional claims, health supplements or foods for special dietary or medical purposes. These fall under 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, in effect from 01 January 2018. These regulations permit only listed ingredients, cap added nutrients at the Recommended Dietary Allowance (RDA), bar hormones and steroids, and forbid any claim to cure, prevent or mitigate a disease. The distinction is significant. By prohibiting disease-related claims, the regulatory framework preserves the classification of these products as food rather than drugs, thereby keeping them outside the remit of the drug regulator. Businesses manufacturing or marketing such products are also required to obtain a central FSSAI licence. A product’s protein claims fall under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, which prescribe tiered thresholds: labelling a product as a ‘source of protein’ requires it to contain at least 10% of the RDA of protein per 100 g, and to be labelled ‘high in protein’ or ‘rich in protein’, the product must contain at least 20% of the RDA. Businesses should also note that the applicable RDA values were revised pursuant to FSSAI’s directions dated 02 August 2021, issued on the basis of updated Indian Council of Medical Research (ICMR) recommendations. Any nutritional claims should therefore be assessed against the revised thresholds.
Products intended for athletes must additionally bear the warnings ‘for sportspersons only’ and ‘not for medicinal use’. Non-compliance may have significant consequences, with a false or misleading claim attracting a penalty of up to INR 10 Lakh under Section 53 of the FSS Act.
The Advertising Angle
Compliance risks are not limited to food law. Advertising and promotional claims are also subject to regulatory scrutiny under the Consumer Protection Act, 2019. Under this Act, the Central Consumer Protection Authority (CCPA) enforces the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022. The CCPA may impose penalties of up to INR 50 Lakh and prohibit endorsers from making endorsements for up to three years. From 18 June 2024, following a Supreme Court direction, advertisers must file a self-declaration certificate before an advertisement runs, and FSSAI may now act against misleading claims itself. Thus, the scope of compliance now extends beyond product labels to marketing material and influencer conduct, and a single claim may invite scrutiny from multiple regulators.
Regulatory scrutiny has also been reinforced by growing public attention to the accuracy of nutritional claims. The Citizens Protein Project study, published in April 2024, found that close to 70% of the 36 protein supplements it tested were mislabelled for protein content, some at half the claimed level and several reportedly testing positive for lead. While the findings did not result in a dedicated regulatory framework for protein products, they intensified public scrutiny of nutritional claims and product quality. These developments serve as a reminder that regulatory compliance alone may not shield businesses from reputational risk. Nutritional claims today are increasingly tested not only by regulators but also by independent organisations, consumers and the wider public.
The Road Ahead for Businesses
Further changes to the current regulatory framework may be on the horizon. In November 2024, an inter-ministerial committee proposed shifting disease-risk-reduction nutraceuticals to the drug regulator. However, this would require an amendment to the FSS Act before it could be implemented. Until then, the existing regulatory position continues to apply.
In a recent case involving San Nutrition, the Delhi High Court declined to restrain social media influencers who alleged, based on independent lab tests, that the company’s whey protein product contained less protein than claimed. Although the order is interlocutory and the suit remains pending, making the Court’s observations prima facie in nature, the decision underscores an important point: businesses may find it difficult to restrain criticism supported by credible evidence.
The lesson, however, is already clear: where criticism is supported by credible evidence, the strongest protection lies not in litigation alone, but in ensuring that claims are accurate and substantiated, that labels can withstand independent verification, and that businesses are prepared to respond effectively to public allegations.
