The Food Safety and Standards Authority of India (FSSAI) has been urged to strengthen oversight of products marketed under specialised food categories following allegations that some manufacturers are mislabelling therapeutic formulations as food products to bypass pharmaceutical regulations.
The Jammu and Kashmir Pharmacy Graduates’ Association (JKPGA) has submitted a representation to FSSAI chairperson Punya Salila Srivastava, seeking a comprehensive review of products licensed under the ‘Food for Special Medical Purpose’ (FSMP) and ‘Food for Medicinal Use’ (FMU) categories. The association has alleged that certain manufacturers are using these classifications to market products with therapeutic intent while avoiding the stricter regulatory requirements applicable to medicines.
According to the representation, the FSMP category is intended exclusively for the dietary management of patients with specific medical conditions under medical supervision. However, the association claims that some products marketed under this category contain active ingredients and dosage levels that are more consistent with medicinal therapies than nutritional support.
Among the concerns raised is the sale of high-strength Cholecalciferol (Vitamin D3) formulations of 60,000 IU and 800 IU under food labels. The association noted that the 60,000 IU formulation significantly exceeds the Indian Council of Medical Research’s (ICMR) recommended daily allowance of 600 IU, arguing that such products fall outside the scope of dietary supplementation.
The representation also highlighted Thiamine Hydrochloride (Vitamin B1) oral drops marketed as food products at concentrations of 50 mg/ml, stating that the dosage is substantially higher than the intake levels recommended under the ICMR’s 2020 Recommended Dietary Allowance (RDA) guidelines.
In addition, the association alleged that certain products containing Heme Iron Polypeptide are being marketed as nutraceuticals for the management of iron deficiency anaemia, despite provisions under the Food Safety and Standards (Fortification of Foods) Regulations prohibiting the use of heme iron as a nutrient source in food products.
Rafi Malik, general secretary of the JKPGA, said the marketing of high-dose therapeutic formulations as food products could mislead consumers, complicate regulatory enforcement and undermine confidence in the functional food and nutraceutical sector. He added that greater regulatory clarity would also help ensure fair competition for manufacturers complying with existing food safety standards.
The association has requested FSSAI to undertake a comprehensive review of products approved under the FSMP category, issue updated guidance to manufacturers and licensing authorities, and ensure that products intended to treat or prevent diseases are regulated under the appropriate pharmaceutical framework in accordance with the Food Safety and Standards Act, 2006.