The FSSAI has received a jolt, yesterday, from the Supreme Court for issuing an advisory for which it apparently had no power to do so in the first place. A Supreme Court bench has stated that the FSSAI does not have the power to issue advisories for products which already have licenses and which are being sold in the open market, if it is not in consonance with the Food Safety and Standards Act, 2006 (FSS Act, 2006). The Bombay High Court in an earlier verdict had indicated that till amendments to this Act were made and till Parliamentary approval had come into place, the particular advisory issued by FSSAI would become null-and-void since it didn’t have the power to issue the advisory in the first place. The Supreme Court has backed Bombay High Court’s previous verdict.
FSSAI Advisory Challenged
According to the advisory, FSSAI required those marketing or manufacturing nutraceuticals, as well as novel foods, functional foods, food supplements etc. to take prior approval. The Indian Drug Manufacturers Association (IDMA) (formed in 1961 and having 800 members from industry) and Vital Nutraceuticals Pvt. Ltd. (manufacturers of neutraceuticals, functional foods, and dietary food supplements; located in Ambernath, Maharashtra) had challenged the advisory since the FSSAI didn’t possess the power or authority to issue the advisory as it amounted to amending regulations framed under section 92 of the FSS Act 2006, and hence should be considered illegal and without statutory force as it did not fall either under section 92 of the Act nor was it in consonance with section 16(2) and 18(2)(d) of the Act.
Importantly, the advisory had put 37 nutraceutical products under the scanner, including Nutralite, Nutralite Iron Folic tablets, Nutralite Bio C etc.
Original Verdict by Bombay High Court
The Bombay High Court had quashed the FSSAI advisory on product approval issued in May 2013. The Bombay High Court opined that the advisory, which required that prior approval be taken for dietary foods and health supplements already licensed and existing in the market, was “unlawful”.
Is Product Approval required?
As per the FSS Act Rules & Regulations (under Clause 22), food business operators (FBOs) who manufacture proprietary foods, functional foods, health supplements, nutraceuticals, genetically modified foods, non-conventional food products or products for which the standards have not been prescribed and which are new and have been introduced for the first time in India, are required to apply for product approval with FSSAI. This clause, however, does not mention anywhere that already licensed food products or those already existing in the market, would have to go through the process of product approval. Therefore the existing manufacturers believe that product approval is not required for these neutraceuticals and other health food products, which are already licensed and available in the open market.
FSSAI advisory issued on May 11, 2013
Section 22 of FSS Act states – No person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, Neutraceuticals, health supplements, proprietary foods and such other articles of food without taking product approval from the central government.
As per FSS Act, Rules & Regulations, if the food product is manufactured by using the ingredients and additives for which there are no guidelines issued under FSS Act/Rules & Regulations, then such food products must be verified and approved by FSSAI, only then shall be allowed to be put in the market for consumption.
FSSAI’s advisory of May 11, 2013 had defined categories that required food product approval. As per the advisory food products that are listed in category 1(a) would be given approval immediately as they are in compliance with Codex Alimentarius Commission, the United States Food and Drug Administration (USFDA), the European Union (EU), Food Standards Australia New Zealand (FSANZ) and so those seeking approval for these ‘1a’ products must apply with documentation to FSSAI.
Category 1(b) foods are not compliant with the Codex Alimentarius or with USFDA but these products have documentary evidence of being safe and so they have been standardised for the Indian consumer. In case any new manufacturer wishes to manufacture any product already being manufactured under category 1(a) and 1(b) then he has to file an application with FSSAI to obtain clearance to manufacture the same.
However, foods listed in 1(c) are those that FSSAI has not cleared as being safe and the product approval shall be granted or denied on the basis of risk assessment.
FSSAI’s Draft Regulations for Nutraceuticals, Health Supplements & Others
FSSAI has recently introduced the draft regulations – Food Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional Foods, and Novel Food) Regulations, 2015. These draft regulations will be finalized and published in the Official Gazette of India after receiving comments & suggestions from the Public domain and the regulations will come into force w.e.f. the subsequent 1st January or 1st July of the year subject to a minimum 180 days from the date of final notification in the Official Gazette. Consequently, the various FBOs will need to comply with these regulations.