The Food Safety and Standards Authority of India (FSSAI) has clarified the use of methylcobalamin, a form of Vitamin B12, in health supplements, medical treatments, and nutraceutical products. Despite this, the Union Health Ministry’s decision to lift the ban on methylcobalamin is still pending, leaving its regulatory status uncertain.
Pending Formalization of the Ban Lift
The decision to lift the ban on methylcobalamin, a vital derivative of Vitamin B12, has yet to be formalized. Although scientific evidence supports its safety and growing demand for its use in treating conditions such as diabetic neuropathy, the necessary gazette notification to officially lift the ban is still awaited. This delay has created uncertainty among health professionals and industry stakeholders.
Safety Approval and Pending Notification
The Government of India’s Scientific Committee approved the safety of methylcobalamin in 2019. However, despite this approval, the official gazette notification to lift the ban has not been issued, leading to regulatory ambiguity.
Current Regulatory Framework
According to Dr. Sanjay Agrawal, Scientific Advisor of ALKOMEX GBN USA, and a leading pharmaceutical consultant, the Food Safety and Standards Regulations of 2022 allow only two forms of Vitamin B12—cyanocobalamin and hydroxocobalamin—under normal circumstances. Methylcobalamin may also be permitted, but only if food business operators notify the Food Authority and submit additional safety data if requested.
Vitamin B12 Levels and Regulatory Limits
The regulations specify that the Vitamin B12 content in products should not exceed the Recommended Dietary Allowance (RDA) unless they fall under specific categories like Food for Special Medical Purposes or Food for Special Dietary Use. In such cases, approval from the Food Authority is required if the levels exceed the RDA.
Vitamin B12 Deficiency in India
A significant portion of the Indian population is deficient in methylcobalamin, primarily due to dietary habits, with the large vegetarian population being a key factor. Milk and milk products are considered the best sources of methylcobalamin, according to Dr. Agrawal.
Importance of Vitamin B12
Vitamin B12 plays a crucial role in DNA synthesis, red blood cell production, and neurological function. Deficiency in this vitamin can result in severe health issues, often requiring supplementation.
FSSAI Clarification for Manufacturers
The FSSAI’s clarification provides guidance for manufacturers and stakeholders to align their products with regulatory standards. This move addresses the increasing demand for diverse forms of Vitamin B12 in health supplements.
Multiple-Choice Questions (MCQs):
1. What is the current regulatory status of methylcobalamin in India?
A) It is fully approved for use in health supplements.
B) The ban on methylcobalamin has been lifted.
C) The ban on methylcobalamin is yet to be formally lifted.
D) Methylcobalamin is banned for all uses.
Answer: C) The ban on methylcobalamin is yet to be formally lifted.
2. According to the Food Safety and Standards Regulations, 2022, which forms of Vitamin B12 are permitted in products?
A) Methylcobalamin only.
B) Cyanocobalamin and hydroxocobalamin only.
C) Only Vitamin B12 from animal sources.
D) Methylcobalamin and hydroxocobalamin only.
Answer: B) Cyanocobalamin and hydroxocobalamin only.
3. What is the primary reason for Vitamin B12 deficiency in India?
A) Lack of access to Vitamin B12 supplements.
B) High consumption of non-vegetarian foods.
C) A high vegetarian population.
D) Overconsumption of Vitamin B12.
Answer: C) A high vegetarian population.
4. What is the best source of methylcobalamin, as mentioned by Dr. Agrawal?
A) Green leafy vegetables.
B) Fish and seafood.
C) Milk and milk products.
D) Fruits and nuts.
Answer: C) Milk and milk products.
5. What does the FSSAI clarification help manufacturers with?
A) To increase the Vitamin B12 content in products.
B) To align their products with regulatory standards.
C) To remove the ban on methylcobalamin.
D) To stop using Vitamin B12 in supplements.
Answer: B) To align their products with regulatory standards.