FSSAI Issues Notice on Import of Speciality Foods for IEM Disorders

On 2 November 2016, the FSSAI had issued directions regarding the import of speciality foods for Inborn Errors of Metabolism (IEM) disorders under the FSS Act 2006, Rules and Regulations. The FSSAI had permitted the import of some speciality food products for IEM disorders. FSSAI had permitted the import of these foods because IEM and Hypoallergenic conditions require specialty foods which are not available in India. Hospitals require these foods for the management of infants and children suffering from these medical conditions. FSSAI had permitted the import of these speciality foods and had also clarified the approved products for license and also the labels they would require for these imported foods.

Though speciality foods for IEM disorders are globally available, however, since there are no standards for these foods in India, they are difficult to import. The Scientific Panel on Functional Foods, Nutraceuticals, Dietetic Products and other similar products has begun work on setting standards for these products. However, it is likely to take some time to finalise them. Since the foods are required for serious medical conditions in infants and children, the Scientific Panel has been allowing the import of these speciality foods from time to time after careful consideration. Once permitted the labels must clearly display the medical condition for which such foods are being imported. The importer/manufacturer has to ensure that these speciality foods are consumed only under medical supervision.

On 12 June 2016 and 28 December 2017 the FSSAI had published lists of specialty foods for IEM disorders permitted for import. Now FSSAI has released a new notice on 31 August 2018 which states that four of the earlier permitted speciality foods for hypoallergenic conditions have been withdrawn from the permitted list. These four products have been withdrawn based on the recommendations of the Scientific Panel. The names of the speciality foods no longer permitted for import are

1. Similac Total Comfort Optigro (Birth to 12 months)
2. Similac Total Comfort Intellipro 2 (for after 6 months
3. NAN Optipro HA 1
4. NAN Optipro HA 2

The first two foods listed above had been permitted for imports in the notice of December 2017 while the third and fourth foods had been permitted in the June 2017 FSSAI notice.