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FSSAI urged to crack down on mislabelled formulations
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Saturday, 18 July, 2026, 08 : 00 AM [IST]
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Peethaambaran Kunnathoor, Chennai
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India’s specialized food processing sector is facing a severe compliance wake-up call as regulatory watchdogs are urged to step in and police the increasingly blurred boundary between therapeutic drugs and functional dietary products.
The Jammu and Kashmir Pharmacy Graduates’ Association (JKPGA) has filed a comprehensive representation with Punya Salila Srivastava, chairperson of the Food Safety and Standards Authority of India (FSSAI). The petition calls out food and nutraceutical manufacturers who are allegedly exploiting specialized food licensing categories to bypass the strict clinical and marketing regulations mandated for pharmaceutical drugs.
At the centre of the controversy is the misapplication of the 'Food for Special Medical Purpose (FSMP)' and 'Food for Medicinal Use (FMU)' classifications under the FSSAI framework.
According to statutory definitions, the FSMP category is strictly intended to manage the specific dietary requirements of patients under close medical supervision. However, the representation highlights that a growing segment of the market is misusing this sub-category to launch products with active ingredients that reflect clear therapeutic and pharmacological intents, rather than legitimate nutritional support.
The petition sounds a major alarm for the food industry by citing widespread violations of the Indian Council of Medical Research (ICMR) Recommended Dietary Allowances (RDA) guidelines. A key example brought to the regulator's attention is the marketing of Cholecalciferol (Vitamin D3) formulations at strengths of 60,000 IU and 800 IU under food labels. The 60,000 IU products exceed the ICMR's established daily allowance of 600 IU by approximately 100 times, crossing firmly out of the domain of dietary supplementation and into high-potency medical therapy.
Similarly, the representation highlights that Thiamine Hydrochloride (Vitamin B1) oral drops are currently retailing within the food market at concentrations of 50 mg/ml. This formulation provides consumers with roughly 25 to 40 times the daily intake levels recommended by the ICMR’s 2020 RDA metrics. Industry experts warn that selling such potent vitamin deficiencies treatments under the green "Veg" dot of food articles misleads consumers and distorts the core definition of food products.
Beyond RDA overages, the food industry faces serious legal scrutiny regarding the illicit use of restricted ingredients, most notably Heme Iron Polypeptide. The JKPGA pointed out that several Heme Iron formulations are actively being marketed as nutraceutical food articles to manage iron deficiency anemia. This directly violates the Food Safety and Standards (Fortification of Foods) Regulations, which explicitly command that "wherever 'Iron (As Fe)' is used as a source of nutrient, heme iron shall not be used in any form in any article of food."
Rafi Malik, general secretary of the pharmacy graduates' association argues that allowing therapeutic, high-dose formulations to wear the badge of food articles significantly compromises consumer protection and creates massive ambiguity for food safety enforcement officers. For law-abiding food and beverage enterprises, this "loophole marketing" poses an existential threat, as it risks inviting sweeping, restrictive regulatory crackdowns that could end up damaging the credibility and fair competition of the legitimate functional food and supplement market.
Moving forward, the JKPGA has formally requested that the FSSAI initiate an immediate, comprehensive review of all products licensed under the FSMP banner to ensure strict alignment with the Food Safety and Standards Act of 2006. The regulatory body has been urged to issue updated guidance to manufacturers, marketers, and local licensing authorities. This ensures that products designed to treat or prevent clinical diseases remain bound to the appropriate drug frameworks, compelling the food industry to realign its product development pipelines with correct nutritional standards.
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