|
|
|
You can get e-magazine links on WhatsApp. Click here
|
|
|
|
|
|
FSSAI clarifies on methylcobalamin usage in supplements
|
|
Saturday, 28 December, 2024, 08 : 00 AM [IST]
|
|
Shardul Nautiyal, Mumbai
|
The Food Safety and Standards Authority of India (FSSAI) has provided clarity on the regulatory framework surrounding the use of methylcobalamin, a form of Vitamin B12, in health supplements, medical purposes and nutraceutical products. Dr. Sanjay Agrawal, scientific advisor at Alkomex, shared the details in a recent statement.
Dr. Agrawal emphasised, “As per the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, the permitted forms of Vitamin B12 currently include cyanocobalamin and hydroxocobalamin. However, methylcobalamin may also be permitted under certain conditions, provided that food business operators notify the Food Authority and submit any additional safety data requested.”
The regulations also stipulate that the level of Vitamin B12 in products must not exceed one Recommended Dietary Allowance (RDA) except in specific categories such as Food for Special Medical Purposes (FSMP) and Food for Special Dietary Use (FSDU). In such cases, prior approval from the Food Authority is required for levels exceeding the RDA.
Vitamin B12, a crucial water-soluble vitamin, is integral to DNA synthesis, red blood cell production, and neurological function. It is predominantly found in animal-based foods like meat, fish, and dairy products, with plant-based foods providing little to none. Deficiency in this vitamin can lead to serious health consequences, often requiring supplementation.
“Methylcobalamin, an active form of vitamin B12, is the most bioavailable and therapeutically effective form. Unlike cyanocobalamin, which requires biotransformation, methylcobalamin is readily absorbed and utilised by the body, making it a preferred choice for supplementation,” says Dr Agrawal.
Dr. Agrawal added, “This development highlights the Government's focus on balancing innovation in the nutraceutical sector with consumer safety. It is crucial for food business operators to remain compliant and ensure transparency in the use of derivatives and salts of vitamins in their formulations.”
The statement comes in response to an official letter issued by the Secretariat of FSSAI’s Expert Committee on Nutraceuticals, addressing industry concerns about the inclusion of methylcobalamin under the regulations.
This clarification will likely guide manufacturers and stakeholders in aligning their products with regulatory standards while addressing the growing demand for diverse forms of Vitamin B12 in health supplements.
|
|
|
|
|
|
|
|
|
|