A new contentious domain: product approval advisories

The Food Safety and Standards Act, 2006 (FSSA), not only repealed some existing enactments and consolidated the laws relating to food but also established the Food Safety and Standards Authority of India (FSSAI) for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure the availability of safe and wholesome food for human consumption.

Cause for concern

The FSSAI’s issuance of various advisories has aroused industry concern. A few industry players have even taken this issue to courts across the country, seeking the quashing of such advisories as being without any statutory force and ultra vires.

Food is seen as the fastest growing sector in India and food business is estimated at US$121 billion, so the regulatory concerns cannot be ignored.

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Current battle

One heavily contested battle between the food industry and the FSSAI is taking place in Bombay High Court and relates to the food product approval advisory dated 11 May 2013. Vital Nutraceuticals (the petitioner) and the Indian Drug Manufacturers’ Association, whose members include all the top drugs and health product makers in India, challenged the advisory on the ground of being without any force and ultra vires.

The advisory, which supersedes all earlier advisories concerning food product approval, contemplates obtaining product approval prior to obtaining the licence required under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

On behalf of the petitioner, it was argued that subjecting companies such as the petitioner, whose products have been in existence for 10-15 years, to prior product approval is clearly bad in law. Further, it was contended that the FSSAI did not have the authority or power under the provisions of the FSSA, read with the rules and regulations framed under the FSSA, to issue the impugned advisory.

Scope of powers

It was specifically contended that regulations such as the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and the Food Safety and Standards (Licensing and Registration of Food Business) Regulations, 2011, categorically empowered the FSSAI to issue necessary regulations only. In the absence of specific power or authority conferred on the FSSAI, any rules, regulations or advisories issued by the FSSAI would be arbitrary, illegal and contrary to the provisions of the act and its corresponding rules and regulations.

On behalf of the FSSAI, it was argued that the advisories issued from time to time (including the impugned advisory) were well within the framework and powers vested in the FSSAI under the FSSA, and serve as guidance as to how and in what manner the particular issue is to be dealt with, depending on the different products for which a particular advisory has been issued. Further, the provisions of the FSSA which specifically empower and authorize the FSSAI were highlighted to substantiate that the FSSAI had acted properly in issuing the impugned advisory/guidelines.

Split decision

Bombay High Court delivered a split decision on the issue of whether the FSSAI had the power and authority to issue the advisory in question. Justice VM Kanade entirely agreed with the petitioner’s arguments and held that the advisory was issued without the force of law and that an existing licence holder under the previous enactment was not required to seek a fresh product approval under the FSSAI’s advisory.

In contrast, Justice Girish Kulkarni upheld the validity of the impugned advisory. Justice Kulkarni strongly relied on an earlier Supreme Court judgment on food safety and reiterated that the right to safe and uncontaminated food is a fundamental right enshrined under the constitution. Justice Kulkarni also held that there was nothing illegal in the FSSAI bringing about a regime with a concept of product approval for existing licence holders or in relation to any food business operated in India.

Everything on hold

The case is currently before the third bench of Bombay High Court where the order is awaited. With the advisory having been stayed, the order will have substantial ramifications on the food industry as no person can currently come out with any fresh products.

Further, importers of food are also facing problems in getting their consignments cleared by the custom authorities. The custom authorities can only release food products which have received the approval of the FSSAI. At present, the FSSAI is neither taking samples of imported food for testing nor granting approvals, prompting importers to approach the court for the release of consignments. This situation needs to be resolved immediately to avoid further disruption in the food industry.

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Sidhartha Srivastava and Gurmeet Kainth are partners at DH Law Associates.