The regulator has issued a statement calling for e-commerce platforms to delist all health supplements, Food for Special Medical Purposes (FSMP), and Foods for Special Dietary Uses (FSDU) containing SAMe.
Food business operators are also told to ensure that such products are not sold under the FSSAI license, either in markets or e-commerce platforms.
The FSSAI said it has been notified that ingredient and products containing SAMe with the FSSAI license are available for sale.
However, in India, the ingredient is banned in the above products, though it is permitted for use in OTC drugs and prescription medicines.
Elsewhere in the US, the ingredient, which has been reported to decrease pain and joint stiffness in osteoarthritic patients, is sold as a health supplement.
The FSSAI said it has rejected the applications of health supplements, FSMP, and FSDU containing the ingredient.
In addition, products which already had the approval have had their approval revoked.
“It is informed that the ingredient / product with S-Adenosyl-L-Methionine (SAMe) has not been considered as ‘Food’ and the applications for approval of the same as ‘Health Supplement / FSMP / FSDU’ under Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017, have been rejected / revoked by the Food Authority,” it said in the notice.
It also ordered government officials to ensure that within their jurisdiction, health supplements, FSMP, and FSDU containing SAMe will not be made available in the markets with the FSSAI license.
“It is hereby directed to advise all the concerned enforcement authorities under your jurisdiction to ensure that such products containing S-Adenosyl-L-Methionine (SAMe) as an ingredient alone, or in combination with other ingredients, are not available in the market with the FSSAI license.”
The FSSAI had warned that failure to comply would result in penalties stated in the FSS Act, 2006 and Rules.
Calls to reject FSSAI’s decision
A former FSSAI director, Pradip Chakraborty, told NutraIngredients-Asia that SAMe was “absolutely safe” and said that companies could seek to overturn FSSAI’s decision through the legislative court.
Calling FSSAI’s ban on SAMe in health supplements a “wrong decision”, he said that the US FDA has already considered the ingredient to be safe for use as a dietary supplement that was good for osteoarthritis.
However, the scientific panel in FSSAI has considered SAMe should not be a health supplement but a pharmaceutical drug.
“In India, even vitamins can be considered as pharmaceuticals.
“Personally, I believe that the decision on SAMe is a wrong one, because pharmaceutical drug can also be used as supplements in limited quantities.”
