Summary: India’s food regulations have evolved from focusing mainly on hygiene to closely monitoring advertising and health claims. In recent years, enforcement has shifted toward demanding stronger scientific evidence and India‑specific validation to back up product claims. While this may slow down approvals, it rewards businesses that invest in credible research, giving them a competitive edge over those relying only on marketing.
Introduction
Up until 2006, India’s food regulatory framework focused almost exclusively on adulteration and hygiene, with limited oversight on advertising and claims. In 2006, India adopted the Food and Safety Standards Act, 2006 (FSS Act), which brought under its purview additional compliances related to labelling, advertising and claims. The Food Safety and Standards Authority of India (“FSSAI”) was established pursuant to the FSS Act to serve as a regulatory authority responsible for ensuring the effective implementation of the FSS Act. The FSS Act recognises misleading advertisements as standalone offences, and stipulates penalties for violations of prescribed standards.
Regulatory Framework for Claims
Food products in India are increasingly being positioned as providing health benefits in addition to basic nutrition. This has created a regulatory flashpoint where claims may fall into the domain of health and diseases. This resulted in the FSSAI notifying the Food Safety and Standards (Advertising and Claims) Regulation 2018 (“FSS Regulations”), vide F. No. 1-94/FSSAI/SP (Claims and Advertisements)/2017, dated November 19, 2018. These regulations were formulated to regulate claims. In terms of these regulations, claims are required to be truthful, unambiguous, meaningful, non-misleading and supported by scientific literature.[1]
The FSS Regulations inter alia mandate that claims should encourage excess consumption or suggest that ordinary balanced diets are inadequate[2]. Additionally, where health benefits are attributed directly to specific nutrients or substances, peer-reviewed human intervention studies conducted under rigorous clinical practices[3] are required in support of the same. The FSS Regulations ring-fence food product manufacturers into making only those claims that are compliant with the standards laid down thereunder. The FSS Regulations also restrict disease treatment claims, medical endorsements[4], and the use of FSSAI’s own logo as a promotional tool[5]. Usage of words such as “natural”, “fresh”, “pure”, and “authentic” also require adequate disclaimers[6].
The FSS Regulations have established a structured approval process[7], wherein Food Business Operators (“FBOs”) are required to submit an application with the prescribed fee. This application must include the proposed claim, specific ingredients, validated analytical methods, scientific substantiation, and well-designed human intervention studies conducted by established research institutions in case of health claims.
Gaps Between Compliance and Letter of the Law
Despite the FSS Regulations establishing a claims approval procedure, claims were regulated primarily through post market oversight. The substantiation part of it usually came to fore only during inspections or regulatory inquiry.
However, in the last couple of years, there has been a significant increase in state food safety authorities conducting surprise inspections across warehouses, dark stores, distribution centres, especially e-commerce stores. In Telangana[8], food safety officials reportedly inspected multiple e-commerce warehouses, issuing notices, lifting samples and seizing thousands of units of misbranded food articles. Similar enforcement has been reported in Maharashtra[9], in line with rising complaints against online food vendors, the state government launched a special sitewide inspection drive targeting e-commerce vendors.
Change in Enforcement Regime
Lately, FSSAI has actively pursued stricter enforcement of claims. In a landmark decision by the FSSAI[10], only products that followed the WHO recommended composition were allowed to use the term ‘ORS’; previous permissions, even with disclaimers, were revoked. This was in supersession of orders dated July 2022 and February 2024[11], wherein the term “ORS” was permitted on food labels provided it accompanied a warning statement that the “the product is not an ORS formula recommended by WHO”. After a review of the issue, the FSSAI concluded that such practices were misleading to the consumers as they were “false, deceptive, ambiguous and contained erroneous names/ label declarations” and were in contravention of the FSS Act (punishable under FSSAI for being misbranded and misleading)[12].
Simultaneously, the FSSAI has also strengthened consumer facing reporting mechanism, allowing consumers to file misleading labels and claims through online channels.
2026 Developments
Against this enforcement backdrop, according to reports from January 01, 2026[13], new food products will face stricter checks and mandatory scientific backing for claims in relation to safety of the said food product. This new requirement specifically applies to stakeholders that are either introducing a new product in the market or re-evaluating an existing one. It will not trigger a re-examination of food that is already in the market. However, in either of the scenarios, the applicant will be required to provide credible evidence to substantiate safety claims on its product.
Data, post submission, will be evaluated by the FSSAI’s Science and Standards Division, wherein expert panels will decide the status of the said product, i.e. whether a product can be approved, continued in the market, be restricted, or be subject to stricter limits.
Basis the report, it can be observed that FSSAI has standardised the way scientific and technical submissions are to be made for regulatory evaluation, particularly where products, ingredients or standards require scientific scrutiny. These scientific submissions now focus on structured data sets, including toxicological information, dietary exposure assessments, global regulatory status and India-specific consumption patterns.
Submissionsmay include detailed data, reflecting Indian consumption patterns. Past submissions often lacked consistent data, hindering robust risk assessment. Officials emphasise that Indian consumption patterns matter because overseas data may not reflect local realities.
Where a claimed health benefit is attributed directly to a product, it must be supported by statistically significant, well-designed human intervention studies under Good Clinical Practices and published or peer-reviewed[14], claims must be scientifically substantiated[15] by validated methods of characterising or quantifying the ingredient or substance that is the basis for the claim.
In effect, the requirement of scientific substantiation is taking the centre stage, irrespective of the category of the claim.
Impact of the Shift
From a legal standpoint, the standards governing food claims have not materially changed. However, one of the possible impacts of the shift, as discussed above, might be the extension of approval timelines, if the application for claim approval lacks adequate substantiation. Further, there may be a requirement for reorganisation at the operational level, with equal, if not more focus on research and development departments when compared to marketing divisions.
FBOs relying on general assurances without specific evidence, including those using overseas data without India-specific validation, may face enhanced scrutiny from the FSSAI. Going forward, FBOs that prioritise marketing strategies over evidence-based practices may encounter increased challenges in obtaining approval. On the other hand, FBOs that have already invested in scientific research and maintain comprehensive data for their products are expected to benefit in terms of their competitive standing.
Conclusion
Notably, the shift towards enhanced scientific scrutiny has not been accompanied by a new standalone notification and no formal amendment to the FSS Regulations has yet been gazetted. The implication here is that India’s food related claim approval regime is not undergoing a paradigm shift. The only change is enhanced focus on scientific review to ensure that Indians eat healthy and are aware of what they are being served. With the advent of social media and growing consumer exposure to available data, it has become increasingly important that every claim made is supported by scientific substantiation, backed by material that can showcase the qualities of the products that the FBO is trying to communicate to the consumer.
[1] Section 4 of the FSS Regulations
[2] Section 4(3) of the FSS Regulations
[3] Section 7(5) of the FSS Regulations
[4] Section 10(2) of the FSS Regulations
[5] Section 4(9) of the FSS Regulations
[6] Section 4(7) of the FSS Regulations
[7] Section 12 of the FSS Regulations
[8] https://www.thehindu.com/news/national/telangana/telangana-food-safety-officials-flag-compliance-issues-by-e-commerce-players/article70331881.ece
[9] https://timesofindia.indiatimes.com/city/nagpur/online-food-vendors-under-scanner-in-maharashtra/articleshow/122212605.cms
[10] https://fssai.gov.in/upload/advisories/2025/10/68ef8cea74223clarification_151025.pdf
[11]https://fssai.gov.in/upload/advisories/2025/10/68ee3ba06bb7eWithdrawal%20of%20Orders%20regarding%20Usage%20of%20the%20term%20ORS%20along%20with%20brand%20names%20dt%2014.10.2025.pdf
[12] https://www.hindustantimes.com/india-news/how-hyderabad-doctor-dr-sivaranjani-santosh-8-year-fight-forced-fssai-to-drop-ors-tag-from-energy-drinks-101760759258452.html#google_vignette
[13] https://economictimes.indiatimes.com/news/new-updates/from-2026-new-food-products-will-face-stricter-checks-fssai-requires-companies-to-back-every-claim-with-scientific-evidence/articleshow/126267565.cms?from=mdr
[14] Regulation 7(5) of the FSS regulations
[15] Regulation 12(1) of the FSS regulations