FSSAI’s Warning against Sale of Human Milk and Products in India

July 9, 2024
The Food Regulator

By Rupin Chopra and Apalka Bareja

Human milk provides the perfect balance of nutrients essential for an infant’s growth and development. In a new discovery by the FSSAI, it has been found that numerous Food Business Operators are engaging in sale of human milk across the country for high monetary benefits.

On May 24, the food regulator issued an advisory[1] stating that “activities related to the commercialization of human milk and its products should be immediately stopped.” The food safety authority stated that it has received multiple requests from registered FBOs regarding the same, but it is illegal and is supposed to be used to feed newborns and infants in health facilities only. FSSAI has not approved the processing and/or sale of such milk under the FSS Act, 2006, and the rules/regulations enacted thereunder.

Strict Enforcement Measures:

FSSAI insists that the State and Central Licensing Authorities should ensure that no license/registration is granted to such FBOs (Food Business Operators) involved in the processing or selling of Human milk. The regulator cautioned that any breach is never permitted, and action would be taken in accordance with the Food Safety and Standards Act of 2006[2]. According to the guidelines for Lactation Management Centres in public health facilities, human milk cannot be commercialized.[3] As per the criteria, such milk can be donated willingly, however the donor cannot get monetary compensation.

Suggestive Measures for Prevention of Sale of Human Milk:

To prevent the sale of human milk for monetary benefits, several measures can be implemented:

Regulatory Framework: Establishing and enforcing strict regulations and guidelines for such milk donation and banking can help to combat the concern. This includes clear legal provisions that prohibit the sale of human milk for profit.

Monitoring of Centers: Ensuring that milk banks and lactation management centers are regularly monitored by health authorities, can help maintain ethical practices. Regular audits and inspections can prevent illegal sales and ensure compliance with standards.

Education and Awareness: Raising awareness among healthcare providers, lactating mothers, and the general public about the ethical aspects of milk donation and the risks associated with purchasing human milk can deter the sale of milk for monetary gain.

Reporting Mechanisms: Establishing anonymous reporting mechanisms for individuals to report suspected illegal sales of such milk can help authorities take timely action against unethical practices.

Conclusion:

FSSAI Advisory on prohibition of human milk is a welcome step. FSSAI can introduce mandatory tests for dairy products as examining and ensuring tests of such products can help to identify FBOs who are indulging in such practices. Government can also consider to implement laws prohibiting the sale of human milk. This shall help FSSAI to fulfill its aim to regulate the market and ensure that human milk is not commercialized, safeguarding public health and ethical standards related to human milk banking and distribution.

Aishwarya Rajput, Assessment Intern at S.S. Rana & Co. has assisted in the research of this article.

[1] Available at https://fssai.gov.in/upload/advisories/2024/05/66508a0caa73dAdvisory%20on%20selling%20of%20Human%20Milk.pdf

[2]Available at https://www.fssai.gov.in/upload/uploadfiles/files/FOOD-ACT.pdf

[3]Available at Page 26, https://nhm.gov.in/images/pdf/programmes/IYCF/National_Guidelines_Lactation_Management_Centres.pdf

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