Products with S-Adenosyl-L-Methionine (SAMe) are not considered as Food Products

The Food Safety and Standards Authority of India (FSSAI) has issued a notification instructing all food safety enforcement authorities to take action in respect of products with S-Adenosyl-L-Methionine (SAMe) under FSSAI licence. This notification was issued on 12th October, 2023.

FSSAI has observed that ingredients/ products with S-Adenosyl-L-Methionine (SAMe) having FSSAI licence are available in the market and on e-commerce platforms.

The FSSAI has made it abundantly clear the ingredient/ product with S-Adenosyl-L-Methionine (SAMe) is not considered as food. Applications for approval of this compound as a ‘Health Supplement/ Food for Special Medical Purpose (FSMP)/ Food for Special Dietary Use (FSDU)’ have been rejected/ revoked by the FSSAI. Such rejection was effected under the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017.

Therefore, all products containing S-Adenosyl-L-Methionine (SAMe) as an ingredient alone or in combination with other ingredients should not be available in the market under an FSSAI licence.

E-commerce platforms must de-list such products having FSSAI licence from their platforms.

Food Business Operators (FBOs) shall also ensure that such products are not sold under an FSSAI licence either in markets/ e-commerce platforms. They shall also modify their active licences in this respect.

Failure to comply with these directions may result in action under the Food Safety and Standard Act, 2006 and its Rules, which may include suspension or cancellation of licences.

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