Food safety regulators have sharply increased scrutiny and enforcement of food safety standards. Regulatory action has been heightened with focus on food business operators (FBOs) across segments, including quick commerce operators, hotels, restaurants and packaged commodity players.
This raises two questions worth addressing: (1) what the statutorily mandated enforcement procedures are, and (2) how FBOs can structure defense preparedness, and mitigate resulting risks.
Overview of enforcement modalities
The Food Safety and Standards Authority of India (FSSAI) is the central nodal authority constituted under the Food Safety and Standards Act, 2006 (FSS Act). The FSSAI has wide-ranging responsibilities including framing regulations that govern various aspects of the food business, such as licensing, labelling, and product claims. Typically, specially constituted departments at the state-level handle inspection and enforcement of food safety standards.
Under the FSS Act, offences are established when a food product is either misbranded, substandard or unsafe. While unsafe food is punishable with imprisonment (and the criminal prosecution machinery), other offences are punishable by fine alone. However, suspension or cancellation of an FBO’s license can follow for offences classified as civil in nature – including the sale of misbranded items. The FSS Act prescribes a civil adjudication mechanism for offences punishable with penalty, while unsafe food prosecutions are handled through the criminal courts.
Enforcement by the FSSAI and state level authorities can be classified into two buckets. For instance, hotels, restaurants, eateries, and warehouses, can be subject to premise level inspections where inspection findings are mapped against a statutorily prescribed checklist. Compliance is typically expressed in percentage terms and assessed against aspects such as hygiene, sanitation, amongst other metrics. In 2026, the FSSAI amended the regulations governing licensing and registration of food businesses, introducing a dynamic, risk-based assessment methodology that will underpin the frequency of regulatory audits. Past compliance history and risk category of the food handled are among the factors informing this risk-based assessment. Further, provisions governing record-keeping of raw materials and hygiene have been tightened including following the principles of First in First Out / First Expired, First Out (FIFO / FEFO) for storage.
Enforcement authorities also typically collect samples of food articles for testing and to verify whether the ingredients meet prescribed thresholds of purity and composition. For packaged food commodities, such sampling may also involve assessing compliance with packaging and labelling requirements. Brand claims on packaging and claims through advertisements are also subject to scrutiny – for instance, the recent notices challenging product purity and efficacy claims.
Historically, FSSAI has issued advisories seeking FBOs to desist from certain labelling, marketing and advertising practices. For instance, the FSSAI has recently sought to enforce its advisory against the use of “100 percent” to advertise product efficacy or ingredients, on the grounds that such terminology has not been approved. While such advisories have been challenged before courts on their legality and binding nature, it is prudent for FBOs to factor these while implementing labelling or marketing strategies.
Mitigating prosecution risks
Given the above, some measures to mitigate prosecution risks and put in place a strategy for prosecution under the FSS Act are set out below.
- Compliance with licensing conditions: Every FBO’s license would typically be accompanied by conditionalities around grant of such license. Typically, these conditions prescribe statutorily mandated hygiene requirements, display of license details prominently in the premises, employment of a qualified person to supervise production, maintaining records of product, raw material utilization amongst other conditions. Critically, FBOs in the packaged foods segment should ensure that their distributors possess the necessary FSSAI licenses. FBOs handling food logistics must ensure that their FSSAI license covers all the food categories handled by them. Categories such as dairy, eggs, and infant formula require the adoption of additional protocols to ensure hygiene and product quality.
- Food sampling protocol by authorities: The FSS Act and Rules prescribe a set of procedures that must accompany every food sample collected during an inspection. Form VA is furnished by the concerned food authority collecting any sample for testing. For companies operating in the packaged foods space, establishing an internal SOP for each collected sample is good practice. This playbook or SOP could include requiring retailers and distributors to communicate sample collection to the manufacturer or marketer, with details such as batch number of the collected sample – which can help the manufacturer / marketer to proactively retain an internal sample for future testing and challenges. Typically, companies maintain reports for batches processed from their facilities, and proactive communication protocols around the downstream supply chain can help retrieve these reports and ensure preparedness ahead of enforcement or investigation.
- Inspection, Improvement Notices and License Suspension / Cancellation: For operators of eateries, hotels, restaurants or warehouses, inspections focus largely on maintenance of hygiene standards, quality of ingredients used, and storage conditions. Schedule IV of the Food Safety & Standards (Licensing & Registration of Food Businesses) Regulations, 2011 (Licensing and Registration Regulations) prescribes hygiene and sanitary practices expected to be followed by an FBO. A common misconception is that the food authorities are required to issue an improvement notice before taking any punitive action such as suspension of license. However, law does not mandate this – food authorities can directly proceed to suspend the license of an FBO if they believe that it is in the interest of public health, or if the nature of offence is such that it warrants immediate suspension without waiting for rectification. The statutory authority for issuing an improvement notice is vested with the Designated Officer (“DO”) and an FBO must be provided with 14 days’ notice to rectify the directions contained in such notice. If the timeline prescribed is lower or the authority prescribing such measures is not the DO, there are grounds for challenge before constitutional courts.
- Maintaining supporting documentation: Recently, the FSSAI has been intensifying scrutiny of product claims that are purportedly misleading. The FSSAI notified separate regulations governing advertisements and claims in 2018. As a matter of good order and prudence, FBOs should document and keep readily available all supporting documentation (including scientific literature) backing claims made on their product labels or advertisements. These regulations provide FBOs an opportunity to justify such claims on receipt of a notice from the food authorities. The authorities have the onus to pass a speaking order on whether the justification is acceptable or not. Since the regulations prescribe an FBO’s opportunity to be heard, they must avail of such remedies where a challenge to claims emerges. The option to approach writ courts always remains available where an authority’s enforcement action is without jurisdiction, without rationale or is violative of statutory provisions – including the right to be heard prior to the passing of punitive orders.
Given the recent flurry of enforcement action and the public discussion around this, FBOs may consider laying out internal SOPs governing their response to an inspection or sampling under the relevant food regulations. Delineating key stakeholder responsibilities, maintaining compliance records (such as audit reports) are among the measures FBOs can adopt as part of their defense strategies.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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