As per the notification dated 12th October 2023, the FSSAI has directed all food safety enforcement authorities to ensure that products containing S-Adenosyl-L-Methionine (SAMe) as an ingredient alone or in combination with other ingredients are not available with FSSAI license in the market. The FSSAI has clearly stated that the ingredient/product with S-Adenosyl-L-Methionine (SAMe) is not considered as food.
According to File No. RCD-15001/18/2021-Regulatory-FSSAI-Part(1) dated 12th October 2023, the FSSAI advised the food safety enforcement authorities to take action regarding products containing S-Adenosyl-L-Methionine (SAMe) under FSSAI License. FSSAI has identified ingredients/products with S-Adenosyl-L-Methionine (SAMe) with FSSAI license available in the market or under an e-commerce platform. Ingredients/products with S-Adenosyl-L-Methionine are not considered as 'Food'. The applications have been rejected or revoked by the Food Authority for its approval as a 'Health Supplement/FSMP/FSDU' under the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017. Hence, E-commerce platforms must de-list such products having FSSAI license from their platforms. Food business operators shall also ensure that such products are not sold under an FSSAI license and they should modify their active licenses in this respect. Failure to comply with these directions may result in action under the Food Safety and Standards Act 2006 and its Rules.