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The Food Safety and Standards Authority of India (FSSAI) on Tuesday directed manufacturers to totally withdraw from the market Mulmin vitamin drops prescribed for one-year-old children. In a notice issued on June 19 to the company, the FSSAI asked the manufacturers to stop manufacture, sale, distribution and import of Mulmin drops and asked the company to recall the existing products from the market with immediate effect.
According to the FSSAI, the scientific panel for functional foods, nutraceuticals, dietetic products, had earlier asked the company to submit safety information and rationale for pine bar addition to the product, including the level of minerals in the product. Significantly, the panel which considered the application along with the information supplied by the company recently observed that the applicant had reduced the composition of ingredients. Moreover, experts also noticed that the applicant had reduced certain nutrients like zinc in the process.
The scientific panel also observed that the product is meant for children of one year age and that unsupervised use of the product raises safety concerns for younger children. It also noted that the product is a combination of synthetic vitamins and minerals. Accordingly, the scientific panel recommended rejection of the product with immediate effect.
The panel noted that the Mulmin Drops was meant for children of one year and observed that unsupervised use of the product may cause health problems among infants, FSSAI director (product approval) Sandhya Kabra told IANS. The no-objection certificate (NoC) was issued by the FSSAI for the product in 2012 for a period of one year. The scientific panel later asked the firm to declare ingredients as per serving size and to revise the label declaration so as to be compliant with food labelling regulations.
However, keeping in view the changes made by the company in the product, the FSSAI withdrew the NoC and directed the company to stop manufacturing, sale, import and distribution of the product with immediate effect. The FSSAI has also asked for recall of all the existing products from the market, citing that it does not recommend approval of the product.
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