It is a well-known fact that infants suffering from Inborn Errors of Metabolism (IEM) require specialized diets. This medical condition affects thousands of infants in the country and they face not only cognitive and physical difficulties, but their very survival depends on this specialised treatment. Specialized diets for IEM fall under the category of Food for Special Medical Purposes (FSMP).
In recent years there has been an increased diagnosis of IEM disorders in India because of the advances in medical technology and improved facilities for testing. It is also important to understand that for children suffering from metabolic disorders, the specialised foods are life-saving, as without these diets/ foods the children will stand a little chance to survive. In order to save the lives of numerous babies FSSAI has harmonised FSMP with provisions of IMS Act.
FSSAI has great regard for the IMS Act and its intention but placing FSMPS in the IMS Food category poses challenges that are genuine
- All infant milk substitutes and infant food labels have to carry a statement “mother’s milk is best for your baby” in capital letters. However, in some cases of IEM the infant cannot digest even mother’s milk. To affix such a label in the specialised diet would be medically contraindicated.
- Products under the IMS Act can be taken under advice of health workers but this cannot be done for IEM diets, which need to be taken only under medical supervision etc. Hence it would not be feasible to apply the IMS Act into Infant FSMPs.
However, in order to ensure that there is no potential misuse by any food manufacturer or distributor on IEM foods FSSAI has placed the following statement in the public domain “while IEM diets are a separate category of Foods for Special Medical Purposes as clarified earlier, the specific provisions of the IMS Act relating to marketing, promotion and sponsorship etc. would henceforth apply to IEM diets also to prevent any potential misuse of this platform to promote normal infant foods or infant milk substitutes as defined under the IMS Act”. The same can be accessed at http://diet4life.fssai.gov.in/faqs.html
Further, to avoid any perceived conflict of interest with IYNCI, the Steering Committee for IEM, which comprises of members from Ministry of Health and Family Welfare, Niti Aayog, representatives from the Medical Fraternity such as AIIMS, MAMC, ISIEM etc. and parent support group, has decided that as a measure of abundant precaution and in the interest of this meaningful initiative, the IYNCI/industry representatives would not constitute a part of the Steering Committee for IEM and a modified order to this effect has already been issued by FSSAI.
According to this order dated 22 February 2018 has a revised Steering Committee for IEM where the FSSAI is also part of the Steering Committee for IEM to manage IEM projects. For more details readers may refer to the Order http://diet4life.fssai.gov.in/data/SC_order_revised_22_02_2018.pdf
FSSAI firmly believes that this is a noble cause and as a measure of abundant precaution and to prevent derailment of a meaningful initiative on such grounds, the authority is taking several steps to improve the life expectancy of infants suffering from this medical condition, and expects that both legislations (IMS and FSMP) would be harmonized to the extent feasible and all concerns regarding potential conflict of interest would be addressed.
While these actions are taken as an interim measure, further as a long term measure, the emended proviso in the Regulations of Foods for Infant Nutrition which covers Food for Special Medical Purposes (FSMPs) intended for infants would be reviewed suitably.