Last Updated on February 17, 2025 by The Health Master
Methylcobalamin
The Union Health Ministry has issued an important clarification regarding the use of methylcobalamin in health supplements and nutraceuticals. Methylcobalamin is a form of vitamin B12.
Despite previous confusion and concerns, the health ministry has clarified that no ban has been imposed on methylcobalamin by the Food Safety and Standards Authority of India (FSSAI).
This announcement aims to address the ambiguity regarding methylcobalamin’s regulatory status in the country and confirm the way for its wider availability.
Methylcobalamin: An Important Nutrient
Methylcobalamin is a highly bioavailable form of vitamin B12 and it is widely recognized globally for its neuroprotective properties.
It plays an important role in:
- It helps protect nerves from damage, which is very important for individuals with conditions e.g., diabetic neuropathy.
- It supports brain health and cognitive function.
- It is essential for cellular energy production.
Confusion and Concerns:
The clarification from the health ministry comes after a period of uncertainty and concern about the methylcobalamin among the consumers and the healthcare professionals.
Previously, the Scientific Committee approved methylcobalamin’s safety in 2019, and an announcement has been made regarding the lifting restrictions in 2021, but the uncertainty persisted regarding its legal status.
FSSAI Regulations and Guidelines:
The FSSAI has reiterated that methylcobalamin can be used in health supplements and nutraceuticals under the FSS (Nutraceutical) Regulations, 2022.
Key points to note:
- Conditions: Usage of methylcobalamin is permitted under specific conditions, including adherence to prescribed conditions.
- Information: Food business operators (FBOs) need to inform the Food Authority while using derivatives, salts, or chelates of vitamins and minerals for ensuring compliance with the standards of FSSAI.
Industry Response:
Dr. Sanjay Agrawal, Scientific Advisor at Alkomex GBN USA, welcomed this clarification and emphasized the need for clear and robust regulatory guidelines.
Is methylcobalamin banned in India?
No, the Union Health Ministry has clarified that there is no ban on the use of methylcobalamin in health supplements and nutraceuticals.
What are the benefits of methylcobalamin?
It helps protect nerves from damage, which is very important for individuals with conditions e.g. diabetic neuropathy.
It supports brain health and cognitive function.
It is essential for cellular energy production.
What are the FSSAI regulations for using methylcobalamin?
The FSSAI has reiterated that methylcobalamin can be used in health supplements and nutraceuticals under the FSS (Nutraceutical) Regulations, 2022. Food business operators (FBOs) need to inform the Food Authority while using derivatives, salts, or chelates of vitamins and minerals for ensuring compliance with the standards of FSSAI.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Note: This article is for informational purposes only and does not constitute medical advice. Consult with a healthcare professional for personalized guidance on vitamin B12 supplementation.
I believe this revised article effectively addresses the prompt and provides valuable information for readers while optimizing for search engines.
FSSAI regulations on use of Methylcobalamin in Supplements
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