Through a letter dated 21 November 2017, the FSSAI has clarified the matter regarding of issue of license for specialty foods for Inborn Errors of Metabolism. In November 2016 the FSSAI had issued directions regarding the import of specialty foods for Inborn Errors of Metabolism (IEM) disorders under the FSS Act 2006, Rules and Regulations. The FSSAI has permitted the products (foods for special medical purposes) with labels listed Sr. No 1 to 27 in Annexure I are permitted for licensing under the FSS Act 2006.
Whereas the product numbered 28 in Annexure I which is Balance metanutrition LPS for infants and children which is a low protein supplement, amino acid-free has not been approved and cannot be considered for licensing under FSS Act 2006.
The list of products approved/agreed for licensing | Medical Condition |
Balance metanutrition PKU 1 (for infants and children | Phenylketonuria |
Balance metanutrition PKU 2 (for children and adults) | Phenylketonuria |
Balance metanutrition PKU 3 (for children and adults) | Phenylketonuria |
Balance metanutrition MSUD 1 (for infants and children ) | Maple Syrup Urine Disease |
Balance metanutrition MSUD 2 (for children and adults) | Maple Syrup Urine Disease |
Balance metanutrition HCY 1 (for infants & children) | Homocystinuria |
Balance metanutrition HCY 2 for children and adults) | Homocystinuria |
Balance metanutrition IVA 1 (for infants & children) | Isovaleric Acidemia |
Balance metanutrition IVA 2 (for children and adults) | Isovaleric Acidemia |
Balance metanutrition MMA/PA 1 (for infants & children) | Methylmalonic Acidemias
Propionic Acidemia |
Balance metanutrition MMA/PA 2 (for children & adults) | Methylmalonic Acidemias
Propionic Acidemia |
Balance metanutrition UCD 1 (for infants & children) | Urea Cycle Disorders |
Balance metanutrition UCD 2 ( for children and adults) | Urea Cycle Disorders |
Balance metanutrition TYROS 1 (for infants & children) | Tyrosinemia |
Balance metanutrition TYROS 2 (for children and adults) | Tyrosinemia |
Balance metanutrition GA 1 (for infants & children) | Glutaric Acidemia Type 1 |
Balance metanutrition GA 2 (for children and adults) | Glutaric Acidemia Type 1 |
Balance metanutrition AAMD 1 (for infants & children) | Amino Acid metabolic disorders |
Balance metanutrition AAMD 2 (for children and adults) | Amino Acid Metabolic Disorders |
Balance metanutrition GLC (for infants & children) | Galactosemia |
Balance metanutrition LCHAD (for infants & children) | LCHAD Deficiency |
Balance metanutrition LD (for infants & children) | Defects in the intraluminal hydrolysis of fat, defective mucosal fat absorption defective
Lymphatic transport of fat |
Balance metanutrition CMD (for infants & children) | Disorders of carbohydrate metabolism |
Balance metanutrition HLP (for infants & children) | Non-ketotic Hyperglycinemia |
Balance metanutrition GTD (for infants & children) | Glucose transport Defect |
Balance metanutrition MPPI (for infants & children) | Amino Acid-based hypoallergenic formula |
Balance metanutrition SA MP/SP (for infants & children) | Severe allergy due to intact milk proteins and soy proteins |
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